Fact-checked by Grok 2 weeks ago

Fibroblast growth factor

Fibroblast growth factors (FGFs) are a family of 22 structurally related polypeptide growth factors that function as key signaling molecules in mammals, regulating essential cellular processes such as , , , survival, and . These proteins are evolutionarily conserved and play pivotal roles in embryonic development, homeostasis, and repair by binding to specific receptors on target cells. The FGF family is divided into seven subfamilies based on and function: FGF1 (FGF1 and FGF2), FGF4 (FGF4, FGF5, FGF6), FGF7 (FGF3, FGF7, FGF10, FGF22), FGF8 (FGF8, FGF17, FGF18), FGF9 (FGF9, FGF16, FGF20), FGF15/19 (FGF19, FGF21, FGF23), and FGF11 (FGF11–FGF14, which are intracellular and non-secretory). Most FGFs (the or paracrine subtypes) require proteoglycans as co-factors to bind and activate their receptors, while the endocrine FGFs (FGF19, FGF21, FGF23) depend on klotho proteins for specificity and activity. Signaling occurs primarily through four receptors (FGFR1–FGFR4), each with alternative splice variants (e.g., IIIb and IIIc isoforms) that confer specificity, leading to activation of downstream pathways including MAPK/ERK, PI3K/AKT, and PLCγ. In health, FGFs are indispensable for organogenesis—such as limb, lung, and skeletal development—and adult physiological processes like angiogenesis, wound healing, metabolic regulation (e.g., glucose and phosphate homeostasis via FGF21 and FGF23), and tissue regeneration. Dysregulation of FGF signaling contributes to numerous pathologies, including congenital disorders like achondroplasia and craniosynostosis (due to FGFR mutations), metabolic diseases such as obesity and chronic kidney disease, and cancers where amplified FGFRs or overexpressed FGFs promote tumorigenesis in organs like the bladder, breast, and prostate. Ongoing research explores FGF-targeted therapies, including receptor inhibitors for oncology and recombinant FGFs for regenerative medicine.

Molecular Structure and Families

Protein Structure

Fibroblast growth factors (FGFs) are a family of secreted polypeptides typically comprising 150–300 , with mature proteins exhibiting molecular weights in the range of 17–34 kDa. These proteins lack signal peptides in some cases, such as FGF1 and FGF2, leading to non-classical secretion mechanisms, while others possess cleavable N-terminal extensions. The defining structural feature of FGFs is a conserved central core domain of approximately 120–130 that adopts a β-trefoil fold, characterized by 12 antiparallel β-strands (β1–β12) arranged into three β-sheet subdomains with approximate threefold . This compact fold is stabilized by hydrophobic interactions and includes heparin-binding sites primarily located in the β1–β2 loop and the β10–β12 region, which facilitate interactions with components. Divergent N- and C-terminal extensions flank this core, varying in length and sequence across family members to influence , proteolytic , and . Most FGFs contain a conserved residue at position 83 (numbered relative to the core domain), which remains free in canonical members like FGF1 and FGF2, contributing to thermodynamic stability without forming intramolecular . In contrast, certain subfamilies, such as FGF8 and FGF19, feature an additional at position 66 that forms a bond with Cys83, enhancing by approximately 14 kJ/mol. For example, human FGF1 ( P05230) has at positions 16, 83, and 117, none of which participate in disulfide bridges, preserving a monomeric essential for function. Post-translational modifications further modulate FGF stability and activity. sites, such as Ser116 in human FGF1, can alter protein and signaling potency when mutated, as demonstrated by the S116R that enhances extracellular signal-regulated . , a non-enzymatic modification occurring under hyperglycemic conditions, targets and residues in FGF2, reducing angiogenic activity and in endothelial cells by impairing binding. High-resolution crystal structures have elucidated these features; for instance, the structure of human FGF2 was determined at 1.9 resolution, revealing the β-trefoil core and solvent-exposed loops critical for interactions. These intrinsic structural motifs, particularly the β-trefoil and heparin-binding regions, underpin the capacity of FGFs to engage fibroblast growth factor receptors.

Classification into Families

In humans, the fibroblast growth factor (FGF) family consists of 22 ligands, encoded by Fgf genes and designated FGF1 through FGF14 and FGF16 through FGF23, with FGF15 being the ortholog of human FGF19 in mice. These ligands are classified into three main functional groups based on their modes of action and expression patterns: paracrine-acting FGFs, which primarily include FGF1–10, FGF16, FGF17, FGF18, FGF20, and FGF22 and function locally by binding cell-surface receptors; /autocrine-acting FGFs (FGF11–14), which lack signal peptides and exert effects intracellularly without secretion; and endocrine-acting FGFs (FGF19, FGF21, and FGF23), which circulate systemically and require co-receptors such as β-klotho for binding to fibroblast growth factor receptors (FGFRs). Phylogenetically, the FGF family is divided into seven subfamilies based on , evolutionary relationships, and conserved chromosomal synteny, reflecting their divergence from a common . These subfamilies are: FGF1/2 (canonical paracrine); FGF4/5/6 (canonical paracrine, sharing over 40% sequence identity); FGF3/7/10/22 (paracrine, involved in epithelial-mesenchymal interactions); FGF8/17/18; FGF9/16/20 (paracrine, expressed in mesenchymal tissues); FGF11/12/13/14 (); and FGF19/21/23 (endocrine, with lower sequence similarity to others but distinct hormone-like functions). This classification highlights evolutionary expansions, such as duplications within subfamilies, and underscores functional diversification, with paracrine members typically sharing a conserved β-trefoil core domain for receptor binding. The Fgf genes are distributed across multiple , often in that preserve synteny across vertebrates, indicating coordinated regulation. For example, FGF1 is located on chromosome 5q31.3, FGF2 on 4q26, FGF3 and FGF4 on 11q13.3, and FGF23 on 12p13.32, with some subfamilies showing proximity such as the FGF3/4/19 on 11q13. Many FGF genes produce multiple isoforms through or other mechanisms, enhancing functional versatility; for instance, FGF2 generates four isoforms (18, 21, 22, and 24 kDa) via alternative translation initiation from a single mRNA, influencing subcellular localization and activity.

Receptors and Binding Mechanisms

Fibroblast Growth Factor Receptors (FGFRs)

Fibroblast growth factor receptors () are a of receptor kinases that transduce signals from fibroblast growth factors (FGFs) to regulate cellular processes such as and . The four principal members, FGFR1 through FGFR4, share a conserved structural consisting of an extracellular ligand-binding domain, a single transmembrane helix, and an intracellular split kinase domain. The extracellular domain comprises three immunoglobulin-like (Ig-like) loops, designated , D2, and D3, with D2 featuring a cysteine-rich region that contributes to receptor folding and stability through formation. Mutations in the cysteine-rich domain of D2, such as those altering sites, can enhance receptor stability and promote aberrant signaling, as observed in certain developmental disorders and cancers. Alternative splicing primarily affects the third Ig-like domain (D3) in FGFR1, FGFR2, and FGFR3, generating two major isoforms: IIIb and IIIc. The IIIb isoform, encoded by 8 in FGFR1, FGFR2, and FGFR3, predominates in epithelial tissues and exhibits specificity for mesenchymal-derived FGFs, such as FGF7 (also known as growth factor) binding to FGFR2-IIIb. In contrast, the IIIc isoform, encoded by 9 in FGFR1, FGFR2, and FGFR3, is prevalent in mesenchymal cells and binds paracrine FGFs like FGF2. FGFR4 lacks this splicing variability and expresses only the IIIc-like form. The transmembrane domains of FGFRs harbor motifs that facilitate ligand-induced dimerization and oligomerization, enabling cooperative signaling. FGFRs display distinct tissue-specific expression patterns that correlate with their physiological roles. FGFR1 is ubiquitously expressed across multiple tissues, including , , and , supporting broad developmental functions. FGFR2 is enriched in epithelial structures during embryogenesis, while FGFR3 is prominently expressed in and , influencing bone growth. FGFR4 shows restricted distribution, such as in liver and . The genes encoding these receptors are located on specific chromosomal sites: FGFR1 at 8p11.23, FGFR2 at 10q26.13, FGFR3 at 4p16.3, and FGFR4 at 5q35.2. A fifth member, FGFR5 (also termed FGFRL1), diverges from the tyrosine kinase family by lacking an intracellular kinase domain and instead possessing a short histidine-rich tail; it functions as a modulator of FGFR1 signaling through interactions via its extracellular Ig-like domains. proteoglycans serve as essential co-receptors that enhance FGFR-FGF interactions.
ReceptorGene LocationMajor IsoformsKey Tissue Expression
FGFR18p11.23IIIb, IIIcUbiquitous (e.g., , )
FGFR210q26.13IIIb, IIIcEpithelial tissues
FGFR34p16.3IIIb, IIIc,
FGFR45q35.2IIIc onlyLiver,
FGFR54p16.3None (single)Variable, regulatory

Ligand-Receptor Interactions

Fibroblast growth factors (FGFs) interact with fibroblast growth factor receptors (FGFRs) primarily through high-affinity binding between the core domain of the FGF and the D2 immunoglobulin-like () loop of the FGFR extracellular domain, with dissociation constants (Kd) typically in the range of 10-100 nM for the binary complex. This forms the initial basis for signal initiation, where the D2 domain serves as the primary contact site, facilitating subsequent complex assembly. The formation of a stable signaling complex requires heparan sulfate proteoglycans (HSPGs), such as syndecans and glypicans, which act as co-receptors to bridge and stabilize a ternary complex through electrostatic interactions with clusters of basic residues (e.g., and ) on the FGF surface. These HSPGs enhance binding affinity, reducing the Kd to the low nanomolar range (e.g., from ~62 nM to ~2.7 nM for FGF2-FGFR1), and promote the organization of a 2:2:2 stoichiometric dimer essential for activation. In contrast, endocrine FGFs exhibit reduced HSPG affinity, relying instead on alternative co-receptors. Ligand-receptor specificity is governed by structural features in both FGFs and FGFR isoforms, with FGF1 capable of binding all FGFRs (1-4) due to its versatile interface, while FGF7 shows high specificity for FGFR2-IIIb, restricting its activity to epithelial tissues. For endocrine FGFs, such as FGF23, binding to FGFR1 (particularly the IIIc isoform) is facilitated by α-klotho as a co-receptor, enabling regulation, whereas β-klotho co-operates with FGFR1c for FGF19 and FGF21 in metabolic control. Upon binding, FGFs induce conformational changes in the FGFR extracellular domains, particularly involving and of the D2 and D3 loops, which drive receptor dimerization and align the transmembrane helices for signal propagation. These interactions are optimized under physiological conditions, with binding affinity peaking at 7.4 and moderate (~150 mM NaCl), where electrostatic contributions from HSPGs are most effective.

Signaling Pathways

Activation and Intracellular Signaling

Upon ligand binding, fibroblast growth factor receptors (FGFRs) undergo dimerization, typically forming a 2:2:2 complex with FGF and heparan sulfate proteoglycans, which positions the intracellular tyrosine kinase domains for trans-autophosphorylation. This process activates the kinase, with sequential phosphorylation of specific tyrosine residues in the activation loop, such as Y653 and Y654 in FGFR1, leading to a 50- to 100-fold increase in activity at Y653 and a further enhancement to 500- to 1,000-fold upon Y654 phosphorylation. Half-maximal receptor activation occurs at ligand concentrations of approximately 5–10 nM, depending on the FGF isoform and cellular context, reflecting the high-affinity binding (K_d ≈ 10–60 nM for FGF2-FGFR1 interactions). Autophosphorylation creates docking sites for adaptor proteins, notably FRS2α, which constitutively associates with the juxtamembrane region of FGFR via its phosphotyrosine-binding domain and becomes phosphorylated at residues like Y463 upon activation. FRS2α then recruits the GRB2-SOS complex, initiating the Ras-MAPK pathway through guanine nucleotide exchange on Ras, followed by sequential activation of Raf, MEK, and ERK kinases to promote . Parallel recruitment of GRB2-GAB1 activates the PI3K-Akt pathway, generating PIP3 to recruit and phosphorylate Akt, which inhibits pro-apoptotic factors like FOXO1 and TSC2 for cell survival. Additionally, phosphorylation of Y766 in FGFR1 directly binds and activates PLCγ, leading to hydrolysis of PIP2 into IP3 and DAG, which mobilize intracellular calcium and activate PKC. Negative regulation attenuates signaling to prevent excessive activation; for instance, Sprouty proteins (e.g., Spry1/2) are transcriptionally induced and inhibit the Ras-MAPK cascade by binding GRB2 or Raf, forming a feedback loop. FGFR-specific phosphatases, such as SHP2, dephosphorylate receptor tyrosines, while MAPK phosphatases (e.g., MKPs) target ERK to terminate the cascade. Cross-talk with other receptor tyrosine kinases enhances pathway integration; notably, FGFR signaling intersects with VEGF receptor (VEGFR) pathways in angiogenesis, where FGF2 upregulates VEGFR2 expression and cooperates to amplify endothelial cell responses via shared PI3K-Akt activation.

Downstream Effects

Upon activation of fibroblast growth factor receptors (FGFRs), the downstream signaling primarily engages the MAPK/ERK pathway, leading to the and activation of transcription factors such as Etv4 (Pea3) and Etv5 (Erm). These factors drive the expression of specific transcriptional targets that regulate cellular responses. For instance, FGF signaling upregulates Dusp6 (dual specificity phosphatase 6, also known as MKP3) and Spry1 (sprouty 1), which function as regulators to attenuate ERK activity and prevent excessive signaling. This feedback loop ensures temporal control of the response, as demonstrated in studies showing Dusp6 dephosphorylates ERK to limit pathway duration. FGF signaling promotes cell proliferation by inducing the expression of , a key regulator that facilitates the G1/S phase transition in the . This occurs through ERK-mediated activation of transcription factors that enhance CCND1 transcription, driving cyclin-dependent kinase 4/6 (CDK4/6) activity and (Rb) phosphorylation to release transcription factors. Additionally, FGF exerts anti-apoptotic effects by modulating members, upregulating pro-survival proteins like and while suppressing pro-apoptotic ones such as Bax. This modulation, often via ERK and PI3K/Akt pathways, protects cells from stress-induced , as evidenced in neuronal and models. In endocrine FGFs, such as FGF21, signaling induces metabolic shifts toward enhanced , partly through stabilization and activation of hypoxia-inducible factor 1α (HIF-1α), which transcriptionally upregulates glycolytic enzymes like and . This adaptation supports energy demands in metabolic tissues. Feedback inhibition further refines signaling, with ERK phosphorylating FGFR1 at Ser777 in the C-terminal tail, thereby inhibiting receptor phosphorylation and downstream signaling as a mechanism. Such mechanisms maintain signaling . FGF signaling also influences epigenetic landscapes by promoting histone acetylation, particularly through recruitment of histone acetyltransferases such as p300, which mediates acetylation of H3K27 at target enhancers to facilitate gene activation. This is critical for selective expression of developmental and proliferative genes.

Biological Functions

Roles in and Growth

Fibroblast growth factors (FGFs) play pivotal roles in embryogenesis and , orchestrating key processes such as , migration, and through , as classified in their subfamily structures. These factors are essential for establishing body axes, inducing layers, and patterning tissues during early development. For instance, FGF signaling integrates with pathways like MAPK to regulate spatiotemporal , ensuring coordinated embryonic growth. During and induction, FGF4 and FGF8 are critical for formation and mesodermal specification. FGF4/8 activate MAPK signaling to promote cell ingression and maintain paraxial mesoderm markers such as MyoD and Myf5, while inhibiting primitive blood formation. In Fgf4^{-/-} embryos, mesoderm maintenance is disrupted, leading to early lethality post-implantation. Similarly, Fgfr1 null mutants exhibit defective during , highlighting the dosage sensitivity of FGF signaling in these early stages. In neural tube patterning, FGFs establish the anterior-posterior axis via concentration gradients that regulate expression in neuroectodermal progenitors. FGF3 and FGF8, expressed in caudal regions, posteriorize the and support axis extension by maintaining neuromesodermal progenitors. For example, FGF8 acts as a diffusible from posterior , shifting rostrocaudal domains of genes like Hoxb6. Knockout studies show that double Fgf4; Fgf8 conditional mutants in mice result in truncated axes and reduced progenitor markers such as and Tbx6. FGF3 null mutants further demonstrate premature specification and axis truncation due to altered signaling in the neuroepithelium. FGFs also drive limb bud development through AER-FGF signaling, where FGF8 and FGF10 from the apical ectodermal ridge (AER) and underlying promote proximal-distal outgrowth. FGF8 induces Shh expression in the zone of polarizing activity (ZPA) for anterior-posterior patterning, while FGF10 initiates ectodermal Fgf8 expression in a feedback loop that sustains AER integrity. In Fgf8^{-/-} mice, severe limb defects occur, including loss of distal skeletal elements and truncated appendages, underscoring the precise dosage requirements for limb . AER-specific Fgf8 inactivation at embryonic day 10.5 leads to loss and skeletal abnormalities. Angiogenesis during embryogenesis relies on FGF2 to stimulate endothelial and vessel formation. FGF2, expressed in embryonic , promotes vascular endothelial growth by activating FGFR1 and upregulating genes for migration and tube assembly, essential for establishing the embryonic . In , FGF9 exemplifies stage-specific roles, particularly in lung branching . FGF9 from distal lung signals to epithelial progenitors via FGFRs, driving iterative branching and alveolar specification through epithelial-mesenchymal interactions. Disruptions in FGF9 signaling impair lung bud outgrowth, as seen in models with reduced branching complexity.

Physiological Roles in Adults

In adult organisms, fibroblast growth factors (FGFs) play essential roles in maintaining homeostasis, repair, and adaptive responses through paracrine and endocrine signaling. These functions are distinct from their developmental roles, focusing instead on steady-state regulation and response in mature tissues. Key members such as FGF2 and FGF7 contribute to by stimulating migration and synthesis, while endocrine FGFs like FGF19, FGF21, and FGF23 regulate metabolic and balance. FGF2 and FGF7 are critical for and preventing excessive in adult and other . FGF2 promotes , migration, and remodeling by activating /MAPK and PI3K-AKT pathways, which upregulate matrix metalloproteinases (MMP2 and MMP9) to facilitate repair without promoting formation. Similarly, FGF7 enhances migration and epithelialization through FGFR2 IIIb activation and AKT-NF-κB signaling, supporting re-epithelialization during cutaneous repair. These actions help maintain integrity and limit fibrotic responses in response to minor injuries. Angiogenesis and vascular remodeling in adults rely on FGF1 and FGF2 to sustain endothelial function and vessel stability. FGF1 and FGF2 induce (VEGF) expression in endothelial cells, promoting capillary formation and maturation via synergistic interactions with PDGF-BB, which increases coverage and reduces . This process supports tissue perfusion during physiological adaptations, such as exercise-induced vascular changes, by enhancing arteriogenesis through MCP-1 induction in mesenchymal cells. FGF23 maintains by regulating levels through the . Secreted from osteocytes, FGF23 binds FGFR1/3/4 in complex with klotho on renal proximal tubules, downregulating sodium- cotransporters (e.g., NPT2a) to promote phosphaturia and prevent , thereby supporting mineral balance for maintenance. This endocrine axis coordinates bone-derived signals with renal function to sustain skeletal integrity in adults. Metabolic regulation involves FGF21 and FGF19 in the liver-adipose and enterohepatic axes, respectively. FGF21, primarily produced in the liver during , enhances and lipid oxidation in adipocytes via PPARγ activation and β-Klotho/FGFR1c signaling, improving insulin sensitivity and maintaining . FGF21 also inhibits hepatic , promoting β-oxidation to balance . Complementing this, FGF19, secreted from ileal enterocytes in response to s via FXR activation, suppresses hepatic CYP7A1 expression through FGFR4/β-Klotho, inhibiting synthesis and preventing cholestatic overload. FGFs contribute to hematopoiesis in the adult niche, particularly during from stress or injury. FGF2 stimulates osteoblastic niche cells via FGFR1, FGFR2, and FGFR3, upregulating CXCL12 (SDF-1), SCF, and Jagged-1 to support self-renewal and mobilization after bone marrow damage. This signaling expands endosteal osteoblasts to aid hematopoietic .

Clinical Significance

Dysregulation in Diseases

Dysregulation of fibroblast growth factors (FGFs) and their receptors (FGFRs) contributes to multiple pathologies through mechanisms such as activating mutations, overexpression, and aberrant signaling activation. In , FGFR3 mutations are prevalent in , affecting approximately 70% of non-muscle-invasive cases and 15% of muscle-invasive cases, where they drive ligand-independent receptor dimerization and oncogenic signaling. Similarly, FGF2 overexpression in gliomas promotes by enhancing endothelial and via heparan sulfate-mediated interactions with FGFRs. The FGF19-FGFR4 axis has emerged as a key driver in (HCC), particularly in the 2020s, where amplified signaling fosters tumor proliferation, metastasis, and resistance to therapies like through downstream activation of pathways such as and ERK. Skeletal dysplasias arise from gain-of-function alterations in FGFR3, most notably the p.G380R mutation responsible for over 97% of cases, which constitutively activates the receptor and inhibits differentiation, leading to impaired and disproportionate . In metabolic disorders, excessive FGF23 production by mesenchymal tumors causes tumor-induced osteomalacia, resulting in severe due to enhanced renal wasting and suppressed 1,25-dihydroxyvitamin D synthesis, often presenting with profound and fractures. Recent studies also implicate FGF21 resistance in , where elevated circulating levels fail to elicit beneficial metabolic responses, exacerbating and dysfunction through impaired FGFR1c-beta-klotho signaling. Cardiovascular diseases involve FGF dysregulation in plaque ; loss of endothelial FGFR1 signaling triggers endothelial-to-mesenchymal transition, promoting vascular cell accumulation and fibrous cap formation in atherosclerotic lesions. In (CKD), progressive elevation of FGF23 precedes phosphate retention and correlates with faster decline, , and higher mortality risk, serving as an independent predictor of end-stage renal disease.

Therapeutic Applications

Fibroblast growth factors (FGFs) have been harnessed in recombinant forms to promote , particularly in chronic ulcers. Trafermin, a recombinant human basic FGF (FGF2), was approved in in 2001 for the treatment of pressure ulcers and skin ulcers associated with or collagen diseases, demonstrating accelerated formation and epithelialization in clinical studies. Becaplermin, a recombinant (PDGF-BB) gel approved by the FDA in 1997 for diabetic neuropathic foot ulcers, exhibits synergistic effects with FGFs in preclinical models of impaired healing, where combined PDGF and FGF administration reverses deficits in and synthesis in protein-malnourished diabetic mice. These therapies leverage FGFs' roles in stimulating fibroblast proliferation and vascularization to enhance repair in non-healing wounds. In , inhibitors targeting FGF receptors (FGFRs) have emerged as precision therapies for cancers driven by FGFR alterations. Erdafitinib, a selective FGFR , received FDA accelerated approval in 2019 for adults with locally advanced or metastatic urothelial harboring susceptible FGFR3 or FGFR2 alterations who progressed after platinum-containing , showing an objective response rate of 40% in the pivotal phase II trial. Futibatinib, another irreversible FGFR inhibitor, was granted FDA accelerated approval in 2022 for previously treated, unresectable, locally advanced, or metastatic intrahepatic with FGFR2 fusions or other rearrangements, based on a 42% objective response rate and median duration of 9.7 months in the FOENIX-CCA2 phase II study. These approvals highlight FGFR inhibitors' efficacy in FGFR-altered tumors, though responses are limited to genetically selected patients. Targeting dysregulated FGF signaling has also yielded therapies for metabolic bone disorders. Burosumab, a fully monoclonal antibody against FGF23, was approved by the FDA in 2018 for the treatment of (XLH) in adults and children aged 1 year and older, neutralizing excess FGF23 to normalize levels and improve severity, as evidenced by increased serum phosphorus and healing of rachitic lesions in phase II/III trials. This approach addresses FGF23-mediated renal wasting, offering a targeted alternative to traditional supplementation. Gene therapy strategies delivering FGFs aim to induce therapeutic in ischemic conditions. NV1FGF, a non-viral encoding acidic FGF (FGF1), has been evaluated in phase II trials for critical limb ischemia, showing improved amputation-free survival rates compared to in patients unsuitable for , with intramuscular injections promoting collateral vessel formation without significant safety concerns. Although a subsequent phase III trial (TAMARIS) in 2011 did not meet its primary endpoint for reducing amputation or death, earlier phase II data supported its potential in . Despite these advances, therapeutic applications of FGF modulators face significant challenges, including off-target effects and acquired resistance. FGFR inhibitors often cause hyperphosphatemia, ocular toxicity, and due to inhibition of wild-type FGFRs in non-tumor tissues, limiting tolerability in long-term use. Resistance frequently arises from secondary FGFR kinase domain mutations, such as the gatekeeper T670M variant, which sterically hinders inhibitor binding and reactivates downstream signaling, as observed in post-treatment biopsies from responsive patients. These mechanisms underscore the need for combination strategies or next-generation inhibitors to overcome relapse. As of 2025, the FGF21 analog pipeline shows promise for metabolic disorders like nonalcoholic steatohepatitis (NASH). Pegozafermin (formerly pegbelfermin), a PEGylated FGF21 variant from 89bio, is in phase III trials (e.g., MAESTRO-NASH) for NASH with fibrosis, demonstrating reductions in hepatic fat content by up to 26% and fibrosis improvement without worsening of NASH in phase II studies, with ongoing data supporting progression to advanced stages. In September 2025, Roche acquired 89bio, which will support the continued development of pegozafermin. This reflects broader efforts to exploit FGF21's insulin-sensitizing and anti-fibrotic properties for liver disease therapy.

History and Research Developments

Discovery and Early Studies

The discovery of fibroblast growth factors (FGFs) began in the early with efforts to identify mitogenic agents in mammalian tissues. In 1973, Hugo A. Armelin reported that extracts from bovine pituitary glands stimulated the growth of 3T3 mouse , marking the initial observation of a potent later identified as part of the FGF family. This activity was further characterized in 1974 by David Gospodarowicz, who purified a fraction from bovine pituitary that promoted proliferation of and other cell types, establishing the mitogenic properties of what would become known as acidic FGF (FGF1). The isolation of basic FGF (FGF2) followed in 1984, when Peter Bohlen, Andrew Baird, and David Gospodarowicz purified a heparin-binding from bovine and pituitary extracts, noting its strong affinity for heparin-Sepharose , which facilitated its enrichment. This protein demonstrated enhanced mitogenic and angiogenic effects compared to FGF1, particularly in endothelial cells. During the mid-1980s, efforts advanced the field: cDNA for human FGF1 was isolated from a library in 1986, revealing its sequence and chromosomal localization, while bovine FGF2 cDNA was cloned the same year, mapping to 4q26 in humans. These sequences confirmed the structural similarities between FGF1 and FGF2, both lacking signal peptides yet exhibiting extracellular functions. Early functional studies in the 1980s highlighted FGF2's role in ; for instance, assays using gels demonstrated that FGF2 induced capillary sprouting and tube formation in endothelial s, providing evidence for its involvement in vascular development. The identification of the first FGF receptor (FGFR), termed flg (now FGFR1), occurred in when its cDNA was cloned from a endothelial library, revealing it as a transmembrane receptor that binds FGFs with high affinity. By the early , the FGF family expanded with the characterization of FGF3 (previously int-2), an activated by insertions, which shared with FGF1 and FGF2, linking it to developmental and tumorigenic processes. These milestones laid the foundation for understanding FGF signaling as a key regulator of and .

Recent Advances

The completion of the in 2001 enabled the comprehensive of the fibroblast growth factor (FGF) family, identifying 22 distinct members in humans and highlighting polymorphisms in (FGFR) genes that influence signaling specificity and disease susceptibility. This genomic insight expanded understanding of FGF diversity beyond earlier biochemical isolations, revealing evolutionary conservation and paralogous gene clusters across chromosomes. Advances in during the 2000s elucidated the molecular basis of FGF-FGFR interactions, with the determination of the of a FGF-FGFR-heparin complex in 2000 demonstrating heparin's dual role in facilitating receptor binding and dimerization. Subsequent studies, including analyses of FGFR2 mutations in 2007, further clarified how extracellular and intracellular domain alterations disrupt signaling, providing a framework for interpreting disease-associated variants. The discovery of endocrine FGFs marked a in the , exemplified by the of FGF23 in 2000 as the causative gene in autosomal dominant hypophosphatemic rickets, which established its role as a regulating . By 2004, targeted experiments confirmed FGF23's central function in suppressing renal phosphate reabsorption and 1,25-dihydroxyvitamin D synthesis, integrating bone-kidney axes in mineral metabolism. In the 2010s, CRISPR/ facilitated precise FGF knockout models, with FGF21-null mice revealing its protective effects against diet-induced , hepatic , and through enhanced energy expenditure and . These studies underscored FGF21's therapeutic potential in metabolic disorders, showing that its absence exacerbates high-fat diet-induced pathologies while highlighting compensatory mechanisms in adipose and liver tissues. Single-cell sequencing in the has uncovered spatial and functional heterogeneity in FGF expression within tumor microenvironments, particularly among cancer-associated fibroblasts in and cancers as of 2023. These analyses identified distinct FGF subtypes driving pro-tumorigenic and extracellular matrix remodeling, with implications for subtype-specific targeting in heterogeneous solid tumors. Recent innovations in 2024-2025 have leveraged for in , enabling the identification of potent, selective FGFR1 inhibitors with nanomolar affinity and reduced off-target effects from millions of compounds. Concurrently, phase III trials of FGFR inhibitors, such as the ongoing FIRST-308 trial of tinengotinib in FGFR-altered (as of 2025), aim to demonstrate improved over standard in refractory cases.

References

  1. [1]
    FGF/FGFR signaling in health and disease - Nature
    Sep 2, 2020 · In this review, we provide a comprehensive overview of the current understanding of FGF signaling and its roles in organ development, injury ...
  2. [2]
    The Fibroblast Growth Factor signaling pathway - Ornitz - 2015
    Mar 13, 2015 · The signaling component of the mammalian Fibroblast Growth Factor (FGF) family is comprised of eighteen secreted proteins that interact with four signaling ...<|control11|><|separator|>
  3. [3]
    The FGF family: biology, pathophysiology and therapy - PMC - NIH
    In this article, we briefly review current knowledge regarding FGF–FGFR signalling and then focus on the biology, pathology and recent developments ...
  4. [4]
    4YOL: Human fibroblast growth factor-1 C16S/A66C/C117A/P134A
    Mar 16, 2016 · Engineering a Cysteine-Free Form of Human Fibroblast Growth Factor-1 for "Second Generation" Therapeutic Application. ; Fibroblast growth factor ...
  5. [5]
    An S116R Phosphorylation Site Mutation in Human Fibroblast ...
    Stabilizing mutations of FGF-1 can yield a gain of function as regards extracellular signal-regulated kinase phosphorylation signaling and maintenance of human ...Missing: glycation | Show results with:glycation
  6. [6]
    Effect of glycation on basic fibroblast growth factor ... - PubMed
    Effect of glycation on basic fibroblast growth factor induced angiogenesis and activation of associated signal transduction pathways in vascular endothelial ...
  7. [7]
    High-Resolution Solution Structure of Basic Fibroblast Growth Factor ...
    A best fit superposition of the NMR structure of FGF-2 with the 1.9 Å resolution X-ray structure by Zhu et al.
  8. [8]
    Pathology and Therapeutic Significance of Fibroblast Growth Factors
    Based on their mode of action, there are three families of FGFs: paracrine FGFs (FGF 1–10, 16, 17, 18, 20, and 22), intracrine FGFs (FGF 11–14), and endocrine ...
  9. [9]
    Fibroblast growth factors: from molecular evolution to roles in ... - NIH
    Fibroblast growth factors (FGFs) are a family of structurally related polypeptides that are essential for embryonic development and that function postnatally.
  10. [10]
    Fibroblast Growth Factors: Biology, Function, and Application for ...
    This review will introduce the biology and cellular functions of FGFs and deal with the biomaterials based delivery systems and their current applications for ...
  11. [11]
    Classification of the fibroblast growth factor (FGF) family based on...
    Classification of the fibroblast growth factor (FGF) family based on phylogenetic analysis. Seven subfamilies i.e. FGF-1, FGF-4, FGF-7, FGF-9, FGF-8, FGF- 11, ...
  12. [12]
    The human FGF gene family: chromosome location and ... - PubMed
    The human FGF gene family: chromosome location and phylogenetic analysis.
  13. [13]
    Functional roles of fibroblast growth factor receptors (FGFRs ... - NIH
    The fibroblast growth factor receptors (FGFRs) regulate important biological processes including cell proliferation and differentiation during development ...
  14. [14]
    Targeting FGFR for cancer therapy
    Jun 3, 2024 · Fibroblast growth factor receptor 5 (FGFR5) is a co-receptor for FGFR1 that is up-regulated in beta-cells by cytokine-induced inflammation.
  15. [15]
    Receptor Specificity of the Fibroblast Growth Factor Family
    The involvement of these hydrogen bonds in conferring specificity between the FGF7 subfamily and FGFR2b ... FGF1 is the universal FGF and can activate all FGFRs.
  16. [16]
    Mechanism of FGF receptor dimerization and activation - Nature
    Jan 4, 2016 · The fibroblast growth factor receptor (FGFR) family includes four receptors that bind 18 ligands called fibroblast growth factors, using heparin ...Missing: review | Show results with:review
  17. [17]
    Engineering a Cysteine-Free Form of Human Fibroblast Growth ...
    Disulfide bonds are neither required, present, nor compatible with full activity of human recombinant acidic fibroblast growth factor. Growth Factors. 1990 ...
  18. [18]
    Kinetic model for FGF, FGFR, and proteoglycan signal ... - PubMed
    Binding constants for binary FGF2/FGFR1 (KD = 62 nM), FGF2/heparin (KD = 39 nM), and FGFR1/heparin (KD = 3.2 microM) interactions correlate to the magnitude of ...
  19. [19]
    FGF-FGFR Signaling Mediated through Glycosaminoglycans ... - NIH
    The half-maximal concentrations for CSB and CSE were 5.6 nM 10.1 nM, respectively. Heparin showed a half-maximal value of 2.5 nM. These results afford ...
  20. [20]
    FGF-dependent regulation of VEGF receptor 2 expression in mice - JCI
    Jun 1, 2011 · A combination of FGF and VEGF signaling inhibition may have a far more profound effect on the vasculature, as the rebound in vascular growth is ...
  21. [21]
    The Fibroblast Growth Factor signaling pathway - PMC
    The signaling component of the mammalian Fibroblast Growth Factor (FGF) family is comprised of eighteen secreted proteins that interact with four signaling ...Missing: optimal | Show results with:optimal
  22. [22]
    Spry1 and Spry2 Are Necessary for Lens Vesicle Separation ... - NIH
    Aug 29, 2011 · The ETS domain transcription factors, Erm and Pea3, and the MAP kinase phosphatase DUSP6 (MKP3) have been shown to be targets of FGF signaling.
  23. [23]
    Negative Regulation of FGFR (Fibroblast Growth Factor Receptor ...
    Several studies show that Dusp6 transcription is activated by FGF signaling and suggest a negative feedback role for MKP3 in FGF signaling [92,93,94]. FGFR ...
  24. [24]
    Paradoxical cancer cell proliferation after FGFR inhibition ... - NIH
    Mar 29, 2024 · In ER + breast cancer, FGFs and FGFR1 amplification promote proliferation by activating MAPK signaling and increase cyclin D1 levels [21, 22].
  25. [25]
    Fibroblast Growth Factor 9 (FGF9) Regulation of Cyclin D1 and ...
    To determine the mechanism by which fibroblast growth factor 9 (FGF9) alters granulosa (GC) and theca (TC) cell proliferation, cell cycle proteins that ...
  26. [26]
    Fibroblast Growth factor-2 Induces Translational Regulation of Bcl ...
    Thus, MEK/extracellularly regulated kinase signaling is critical in the coordinate modulation of both pro- and anti-apoptotic Bcl-2 family members by FGF-2.
  27. [27]
    FGF-2 inhibits TNF-α mediated apoptosis through ... - PubMed
    Taken together, our data demonstrate that a subset of Bcl2 family proteins are the targets of FGF-2 signaling that promotes the survival of ATDC5 cells.
  28. [28]
    Biological and pharmacological functions of the FGF19- and FGF21 ...
    May 16, 2023 · ... HIF1a signaling, which consequently activates glycolytic genes and promotes GSIS (116). ... endocrine FGF signaling. Nature (2018) 553:501–5. doi: ...
  29. [29]
    ERK-mediated phosphorylation of fibroblast growth factor receptor 1 ...
    Feb 12, 2013 · Our data reveal a negative feedback mechanism that controls FGF signaling and thereby protects the cell from excessive activation of FGFR.Missing: inhibition | Show results with:inhibition
  30. [30]
    GCN5 Regulates FGF Signaling and Activates Selective MYC Target ...
    Here, we report that GCN5, a histone acetyltransferase essential for embryonic development, is required for proper expression of multiple genes encoding ...
  31. [31]
    Enhancer activation by FGF signalling during otic induction - PMC
    FGF signalling enhances H3K27 acetylation at enhancers associated to otic-epibranchial specific genes. ... Histone acetylation is associated with increased ...
  32. [32]
    FGF signalling: diverse roles during early vertebrate embryogenesis
    Nov 15, 2010 · During embryogenesis, FGF signalling plays an important role in the induction/maintenance of mesoderm and neuroectoderm, the control of ...Introduction · FGF signalling: an overview · The role of FGF signalling...
  33. [33]
  34. [34]
  35. [35]
    The Multiple Roles of FGF Signaling in the Developing Spinal Cord
    An FGF3-BMP signaling axis regulates caudal neural tube closure, neural crest specification and anterior-posterior axis extension. PLoS Genet. 12:e1006018 ...
  36. [36]
  37. [37]
    An FGF3-BMP Signaling Axis Regulates Caudal Neural Tube ... - NIH
    May 4, 2016 · We show that FGF3 in the caudal vertebrate embryo regulates BMP signaling in the neuroepithelium, which in turn regulates neural tube closure, neural crest ...
  38. [38]
    The roles of FGFs in the early development of vertebrate limbs
    Several lines of evidence suggest that FGF genes, particularlyFgf8 and Fgf10, play a role in mediating the initial outgrowth of the limb and in establishing the ...Fgf Ligand And Receptor... · Fgf Function In The... · Fgf Function In Limb Bud...
  39. [39]
  40. [40]
  41. [41]
    The Role of Fibroblast Growth Factor (FGF) Signaling in Tissue ... - NIH
    In this review, we summarize the roles of FGFs in diverse cellular processes and shed light on the importance of FGF signaling in mechanisms of tissue repair ...
  42. [42]
    Fibroblast growth factor regulation of neovascularization - PMC
    Fibroblast growth factors (FGFs) are potent angiogenic inducers; however, their precise roles in angiogenesis have not been well understood.
  43. [43]
    Role of FGF23 in Vitamin D and Phosphate Metabolism - NIH
    FGF23 is a bone-derived hormone that regulates systemic phosphate homeostasis, vitamin D metabolism and α-klotho expression through a novel bone-kidney axis.
  44. [44]
    FGF21 as Modulator of Metabolism in Health and Disease - Frontiers
    FGF21, a member of the FGF family, plays an important role in the regulation of peripheral glucose tolerance and lipid metabolism while improving metabolic ...FGF21 and Metabolism · FGF21 Expression and... · FGF21 in Humans, a...
  45. [45]
    Fibroblast Growth Factor 15/19 Expression, Regulation, and Function
    FGF19 is unique in that it is a dietary-responsive endocrine hormone linked with bile acid homeostasis, glucose and lipid metabolism, energy expenditure, and ...
  46. [46]
    Fibroblast growth factor 2 supports osteoblastic niche cells during ...
    Jun 29, 2017 · Taken together, FGF2 signaling can regulate osteoblastic niche cells to support HSC homeostasis in response to bone marrow damage. Background.5fu-Damaged Bone Marrow... · Fgfrs Subtype Expression In... · Expression Of Fgfrs And The...
  47. [47]
    Transcriptional profiling reveals roles of intercellular Fgf9 signaling ...
    We demonstrate a coordinated neuron-astrocyte Fgf9 signaling network that functions to regulate astrocyte maturation, perineuronal net structure, and synaptic ...
  48. [48]
    The roles of FGFR3 and c-MYC in urothelial bladder cancer - PubMed
    Jul 20, 2024 · Activating mutations of FGFR3 are observed in around 70% of NMIBC cases and ~ 15% of MIBCs. Activated FGFR3 leads to ligand-independent receptor ...
  49. [49]
    Heparan sulfate proteoglycans as regulators of fibroblast growth ...
    Fibroblast growth factor-2 (FGF2) is a potent angiogenic factor in gliomas. Heparan sulfate promotes ligand binding to receptor tyrosine kinase and ...
  50. [50]
    FGF19- FGFR4 Signaling in Hepatocellular Carcinoma - PubMed
    Jun 4, 2019 · Aberrant expression of fibroblast growth factor 19-fibroblast growth factor receptor 4 (FGF19-FGFR4) is reported to be an oncogenic-driver pathway for HCC ...
  51. [51]
    EGFR Inhibition Overcomes Resistance to FGFR4 ... - PubMed
    Dec 1, 2023 · Aberrant activation of the FGF19-FGFR4 signaling pathway plays an essential role in the tumorigenesis of hepatocellular carcinoma (HCC).
  52. [52]
    Knock-in human FGFR3 achondroplasia mutation as a mouse ...
    Feb 23, 2017 · Achondroplasia (ACH), the most common genetic dwarfism in human, is caused by a gain-of function mutation in fibroblast growth factor ...
  53. [53]
    Treatment Advances in Tumor-Induced Osteomalacia - PubMed - NIH
    Jan 4, 2025 · FGF23 excess causes chronic hypophosphatemia through renal phosphate losses and decreased production of 1,25-dihydroxy-vitamin-D.
  54. [54]
    Fibroblast growth factor 21 in metabolic syndrome - PubMed
    Jul 27, 2023 · Here, we review the current regulatory mechanisms of FGF21, summarize its role in obesity, diabetes, hyperlipidemia, and hypertension.Missing: studies | Show results with:studies
  55. [55]
    Fibroblast growth factor 21 resistance is associated with body shape ...
    Jun 22, 2023 · FGF21 resistance occurs in patients of HP in T2DM, and positively correlates with body shape parameters (especially waistline and BMI).Missing: review | Show results with:review
  56. [56]
    Endothelial-to-mesenchymal transition drives atherosclerosis ...
    Oct 26, 2015 · These data demonstrate a link between loss of protective endothelial FGFR signaling, development of EndMT, and progression of atherosclerosis.
  57. [57]
    FGF23 in chronic kidney disease - PubMed
    Recent studies suggest that increased FGF23 is associated with mortality, left ventricular hypertrophy, endothelial dysfunction and progression of CKD.
  58. [58]
    Fibroblast growth factor 23 (FGF23) predicts progression of chronic ...
    Jul 26, 2007 · FGF23 is a novel independent predictor of progression of renal disease in patients with nondiabetic CKD.
  59. [59]
    FGF Family: From Drug Development to Clinical Application - PMC
    In 1988, KAKEN of Japan purchased the recombinant bacteria strain ... After 13 years of research, trafermin was approved in 2001 in Japan for the ...
  60. [60]
    The Use of Becaplermin (rhPDGF-BB) Gel for Chronic Nonhealing ...
    Albertson S, Hummel RP, Breedon M, et al. PDGF and FGF reverse the healing impairment in protein-malnourished diabetic mice. Surgery, 114 (1993), pp. 368-373.
  61. [61]
    Therapeutic role of growth factors in treating diabetic wound - PMC
    PDGF and FGF stimulate wound healing in the genetically diabetic mouse. ... (becaplermin) in patients with chronic neuropathic diabetic ulcers. A phase ...
  62. [62]
    FDA grants accelerated approval to erdafitinib for metastatic ...
    Apr 12, 2019 · On April 12, 2019, the Food and Drug Administration granted accelerated approval to erdafitinib (BALVERSA, Janssen Pharmaceutical Companies) ...
  63. [63]
    FDA grants accelerated approval to futibatinib for cholangiocarcinoma
    Sep 30, 2022 · On September 30, 2022, the Food and Drug Administration granted accelerated approval to futibatinib (Lytgobi, Taiho Oncology, Inc.)
  64. [64]
    Futibatinib for FGFR2-Rearranged Intrahepatic Cholangiocarcinoma
    Jan 18, 2023 · Futibatinib showed antitumor activity and generally low-grade toxic effects in heavily pretreated patients with advanced, FGFR-altered tumors.
  65. [65]
    Burosumab Therapy in Children with X-Linked Hypophosphatemia
    May 23, 2018 · We investigated burosumab, a monoclonal antibody that targets FGF-23, in patients with X-linked hypophosphatemia.
  66. [66]
    A Randomized, Double‐Blind, Placebo‐Controlled, Phase 3 Trial ...
    This double‐blind, placebo‐controlled, phase 3 trial demonstrates that burosumab, by binding excess circulating FGF23, increased renal phosphate reabsorption ...
  67. [67]
    Therapeutic angiogenesis with intramuscular NV1FGF ... - PubMed
    Therapeutic angiogenesis with intramuscular NV1FGF improves amputation-free survival in patients with critical limb ischemia · Authors · Affiliation.
  68. [68]
    Understanding and Overcoming Resistance to Selective FGFR ... - NIH
    The clinical benefit generated by selective FGFR inhibitors in patients with FGFR2-driven cancer is hampered by the inevitable occurrence of resistance. We ...
  69. [69]
    Pituitary extracts and steroid hormones in the control of 3T3 cell growth
    Results are reported showing that pituitary extracts stimulate growth of 3T3 cells, an established line of mouse fibroblast. Cells were cultured in medium ...Missing: mitogenic | Show results with:mitogenic
  70. [70]
    Characterization of int-2: a member of the fibroblast growth factor ...
    int-2 was discovered as a proto-oncogene transcriptionally activated by MMTV proviral insertion during mammary tumorigenesis in the mouse.
  71. [71]
    Fibroblast growth factors | Genome Biology | Full Text - BioMed Central
    Mar 9, 2001 · This review article addresses the developmental implications of the interactions between FGFs, FGFRs and heparan sulfate proteoglycans. The ...
  72. [72]
    Evolution of the Fgf and Fgfr gene families - ScienceDirect.com
    Chromosomal locations of human FGF genes. As described previously, the human FGF gene family is divided into seven subfamilies (Figure 1). Members of each ...
  73. [73]
    Crystal structure of a ternary FGF-FGFR-heparin complex ... - PubMed
    This model provides a structural basis for FGFR activation by small molecule heparin analogs and may facilitate the design of heparin mimetics.Missing: HS 2007
  74. [74]
    Structural basis for reduced FGFR2 activity in LADD syndrome
    We aimed to elucidate the mechanism by which a missense mutation in the tyrosine kinase domain of FGFR2, described in the sporadic case of LADD syndrome, leads ...
  75. [75]
    Fgf21 knockout mice generated using CRISPR/Cas9 reveal genetic ...
    Fgf21 was shown to affect hair follicle development and growth cycle, which may be associated with Pi3k/Akt and Mapk/Erk signaling pathways.
  76. [76]
    FGF21 deletion mildly exacerbates hepatic dysfunction in GAN diet ...
    May 28, 2025 · FGF21 knockout mice on a high-fat diet exhibit a worsening of metabolic liver injury, hepatic steatosis, and MASH-HCC transition. Here ...
  77. [77]
    Cancer-associated fibroblast classification in single-cell and spatial ...
    Jul 18, 2023 · To define CAF phenotypes, we analyse a single-cell RNA sequencing (scRNA-seq) dataset of over 16,000 stromal cells from tumours of 14 breast ...
  78. [78]
    Single-cell and bulk RNA sequencing reveal cancer-associated ...
    Aug 11, 2023 · Single-cell and bulk RNA sequencing reveal cancer-associated fibroblast heterogeneity and a prognostic signature in prostate cancer.Missing: FGF | Show results with:FGF
  79. [79]
    AI-assisted discovery of potent FGFR1 inhibitors via virtual ...
    To address this challenge, the present study employed an AI-driven virtual screening approach, integrating molecular docking (MD) and molecular dynamics ...
  80. [80]
    First-308: Phase III study of tinengotinib versus physician's choice in ...
    Jan 22, 2024 · Tinengotinib, a novel multi-kinase inhibitor with high potency against a variety of FGFR2 kinase domain mutations, has shown promising clinical ...