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Ipamorelin

Ipamorelin is a synthetic pentapeptide with the chemical sequence Aib-His-D-2-Nal-D-Phe-Lys-NH₂, molecular formula C₃₈H₄₉N₉O₅, and molecular weight of 711.9 Da, designed as a selective agonist of the ghrelin/growth hormone secretagogue receptor (GHSR), specifically the GHSR1a subtype, to mimic the action of ghrelin and stimulate the pulsatile release of endogenous growth hormone (GH) from the anterior pituitary gland.^[1]^[2] Developed by Novo Nordisk in the late 1990s, it represents the first growth hormone-releasing peptide (GHRP) with high selectivity for GH secretion, exhibiting minimal effects on other hormones such as adrenocorticotropic hormone (ACTH), cortisol, prolactin, or follicle-stimulating hormone, unlike earlier non-selective GHRPs like GHRP-6.^[2]^[3] Pharmacologically, ipamorelin binds to GHSR in the hypothalamus and pituitary, activating intracellular signaling pathways including phospholipase C and increases in intracellular calcium, which promote GH release without significantly altering appetite or gastric motility in the same pronounced manner as ghrelin itself.^[2]^[4] Its selectivity profile mirrors that of growth hormone-releasing hormone (GHRH), making it a potent GH secretagogue with a short plasma half-life of approximately 2 hours following subcutaneous administration.^[5]^[2] Preclinical studies in rats have demonstrated its ability to induce longitudinal bone growth and enhance GH-dependent processes,^[6] while early human phase II trials explored its potential for treating postoperative ileus by accelerating gastrointestinal recovery through GH-mediated mechanisms.^[7] Despite promising research applications in areas such as growth hormone deficiency, muscle wasting, and age-related GH decline, ipamorelin remains investigational and has not received approval from the U.S. Food and Drug Administration (FDA) for any therapeutic use in humans as of 2025.^[8]^[9] The FDA has identified significant safety risks associated with its use in compounded formulations, including potential adverse events like hypersensitivity and cardiovascular effects, leading to restrictions on its inclusion in bulk drug substances for compounding pharmacies.^[10]^[11] Ongoing research continues to evaluate its efficacy and safety in combination with other peptides like CJC-1295 for enhanced GH stimulation, but clinical translation is limited by regulatory hurdles and the need for further long-term data.^[12]^[3]

Chemistry

Chemical structure

Ipamorelin is a synthetic pentapeptide characterized by the molecular formula C₃₈H₄₉N₉O₅ and the amino acid sequence Aib-His-D-2-Nal-D-Phe-Lys-NH₂, where Aib represents α-aminoisobutyric acid, a non-proteinogenic amino acid, and D-2-Nal denotes the D-isomer of 2-naphthylalanine.^[1]^[2] This sequence incorporates two D-amino acids (D-2-Nal at position 3 and D-Phe at position 4) along with the N-terminal Aib modification, which collectively enhance proteolytic stability against enzymatic degradation while promoting high selectivity for growth hormone release over other pituitary hormones.^[2] The amidated C-terminal lysine (Lys-NH₂) serves as a key anchoring element in the peptide's structure, facilitating receptor interaction.^[2] As a ghrelin mimetic, Ipamorelin exhibits structural parallels to ghrelin particularly in its C-terminal region, where the basic lysine residue and overall peptidic framework support mimicry of ghrelin's receptor-binding conformation despite ghrelin's longer 28-amino-acid chain.^[1]^[2]

Synthesis and properties

Ipamorelin is primarily synthesized via solid-phase peptide synthesis (SPPS), a standard method for assembling short peptides like this pentapeptide. The process begins with the attachment of the C-terminal amino acid (lysine) to a resin support, followed by iterative cycles of deprotection of the N-terminal protecting group (typically Fmoc), coupling of the next protected amino acid (such as D-phenylalanine, D-2-naphthylalanine, histidine, and α-aminoisobutyric acid), and washing steps to remove byproducts. After chain assembly, the peptide is cleaved from the resin using a mixture of trifluoroacetic acid (TFA) and scavengers, with simultaneous side-chain deprotection, and purified by reverse-phase high-performance liquid chromatography (HPLC).^[13] The resulting Ipamorelin free base appears as a white to off-white lyophilized powder. It has a molecular weight of 711.9 g/mol. Ipamorelin shows limited solubility in water (approximately 0.003 mg/mL for the free base, though higher for the acetate salt at up to 10 mg/mL in PBS), and is soluble in DMSO (up to 20 mg/mL) and DMF (up to 20 mg/mL).^[14]^[15] Ipamorelin exhibits enhanced stability against enzymatic degradation compared to natural peptides, attributed to the inclusion of two D-amino acids (D-2-naphthylalanine and D-phenylalanine), which resist protease cleavage, and C-terminal amidation, which protects against carboxypeptidase activity. It remains stable in aqueous solutions when refrigerated but is susceptible to degradation at room temperature or in non-sterile conditions.^[16]^[17]

Pharmacology

Mechanism of action

Ipamorelin acts as a selective agonist at the ghrelin/growth hormone secretagogue receptor subtype 1a (GHSR-1a), a G-protein-coupled receptor primarily expressed on pituitary somatotroph cells, where it mimics the stimulatory effects of endogenous ghrelin on growth hormone (GH) secretion while avoiding significant appetite stimulation associated with ghrelin activation in the hypothalamus. This selectivity arises from its structural modifications as a pentapeptide, enabling targeted peripheral receptor engagement without robust central nervous system effects that drive orexigenic responses. The compound demonstrates high potency at GHSR-1a, with an in vitro EC₅₀ of approximately 1.3 nM for GH release from primary rat pituitary cells, reflecting strong receptor binding and activation efficiency comparable to other growth hormone-releasing peptides (GHRPs) like GHRP-6. Upon binding, Ipamorelin triggers pulsatile GH secretion by promoting the exocytosis of GH-containing vesicles from somatotrophs, enhancing the amplitude of endogenous GH pulses without altering their frequency. Activation of GHSR-1a by Ipamorelin initiates intracellular signaling through G_q/11 protein coupling, which stimulates phospholipase C (PLC) activity, leading to inositol trisphosphate (IP₃) production and subsequent calcium influx from intracellular stores and voltage-gated channels.^[18] This calcium mobilization, often augmented by protein kinase C activation, directly facilitates GH release; additionally, in certain cellular contexts, GHSR-1a engages G_s proteins to elevate cyclic adenosine monophosphate (cAMP) levels, further potentiating the response via protein kinase A pathways.^[18] Unlike non-peptide or less selective GHSs such as hexarelin or MK-677, Ipamorelin exhibits minimal stimulation of the hypothalamic-pituitary-adrenal axis, with no significant elevations in cortisol, prolactin, or adrenocorticotropic hormone (ACTH) even at supratherapeutic doses exceeding 200 times the ED₅₀ for GH release.

Pharmacokinetics

Ipamorelin is typically administered via subcutaneous injection, resulting in rapid absorption with a time to maximum plasma concentration (Tmax) of approximately 0.5 hours and bioavailability exceeding 70%. Following intravenous administration, which provides insight into its systemic behavior, Ipamorelin demonstrates linear pharmacokinetics characterized by a short terminal half-life of about 2 hours, a clearance rate of 0.078 L/h/kg, and a steady-state volume of distribution of 0.22 L/kg.^[19] The peptide undergoes enzymatic degradation primarily by peptidases present in plasma and tissues, exhibiting moderate resistance to metabolism such that 60-80% of the administered dose is recovered intact in bile and urine. Excretion occurs predominantly through the kidneys, with urinary elimination as the main pathway for clearance of both intact peptide and metabolites.^[20] Growth hormone secretion in response to Ipamorelin is dose-dependent, with subcutaneous doses of 100-200 mcg typically eliciting maximal pituitary stimulation without inducing receptor desensitization, as evidenced by sustained efficacy across escalating dose levels in human studies.^[19]

Research and uses

Growth hormone stimulation

Ipamorelin exhibits potent growth hormone (GH)-releasing activity both in vitro and in vivo. In vitro studies using primary rat pituitary cells demonstrate that ipamorelin stimulates GH release with an EC50 of 1.3 ± 0.4 nmol/L and maximal efficacy (Emax) of 85 ± 5%, comparable to the reference compound GHRP-6 (EC50 = 2.2 ± 0.3 nmol/L, Emax = 100%).^[2] In vivo, subcutaneous or intravenous administration in anesthetized rats induces dose-dependent GH release with an ED50 of 80 ± 42 nmol/kg and Emax of 1545 ± 250 ng GH/mL, while in conscious swine, it achieves an ED50 of 2.3 ± 0.03 nmol/kg and Emax of 65 ± 0.2 ng GH/mL.^[2] These effects translate to substantial increases in basal GH levels, up to more than 10-fold in animal models such as swine and dogs following oral or intravenous dosing.^[21] In human research contexts, similar dose-dependent elevations have been observed, though direct comparative fold increases are less extensively documented due to limited clinical trials. Peak GH concentrations typically occur 30-60 minutes post-administration, as modeled in pharmacokinetic-pharmacodynamic studies showing a single release episode with a peak at approximately 0.67 hours.^[19] Unlike continuous GH elevation from exogenous administration, ipamorelin promotes a pulsatile secretion pattern that closely mimics the natural circadian rhythms of endogenous GH release. This selective agonism at the growth hormone secretagogue receptor (GHSR) triggers discrete GH pulses without sustained hypersecretion, preserving physiological feedback mechanisms and avoiding desensitization of somatotroph cells.^[2] Such pulsatility is a key feature distinguishing ipamorelin from non-peptide secretagogues, supporting intermittent GH surges aligned with sleep-wake cycles and metabolic demands.^[22] Ipamorelin demonstrates synergistic effects when combined with growth hormone-releasing hormone (GHRH), leading to amplified GH pulses. As a GHRP analog, ipamorelin's action at GHSR complements GHRH signaling at pituitary somatotrophs, resulting in greater-than-additive GH release—often several-fold higher than either agent alone—while maintaining the pulsatile profile and minimizing ancillary hormone disruptions.^[23]^[2] This combination enhances the amplitude of GH secretion without proportionally increasing side effects, making it a researched approach for optimizing endogenous GH dynamics.

Potential therapeutic applications

Ipamorelin has been investigated in preclinical and early clinical studies for its potential to address growth hormone deficiency (GHD) by stimulating endogenous GH release, which may help restore disrupted hormonal axes. In GH-deficient mouse models, ipamorelin administration increased body weight and relative fat pad weights independently of GH, suggesting a role in modulating body composition even in deficient states.^[24] However, human data remain limited, with no large-scale trials confirming efficacy for GHD treatment. In the context of anti-aging and age-related conditions, ipamorelin, as a growth hormone secretagogue (GHS), shows promise for countering sarcopenia and frailty in elderly populations by enhancing pulsatile GH secretion and potentially improving muscle strength and function. Preclinical studies in rats demonstrate that ipamorelin promotes longitudinal bone growth and counteracts glucocorticoid-induced reductions in bone formation, which could support bone density maintenance in aging subjects.^[6]^[25] Small-scale research also indicates potential benefits for lean mass preservation, though direct elderly human trials are scarce and primarily extrapolate from GH effects.^[26] For recovery from injury, ipamorelin has been explored in models of postoperative ileus (POI), a common surgical complication involving delayed gastrointestinal motility. A randomized, placebo-controlled proof-of-concept trial in patients undergoing bowel resection found that intravenous ipamorelin infusions (0.03 mg/kg twice daily) reduced the time to first tolerated solid meal (median 25.3 hours vs. 32.6 hours for placebo), though the difference was not statistically significant (p=0.15); gastric emptying was also assessed.^[7] Rodent studies further support this, showing ipamorelin enhances gastric contractility and emptying in POI models via ghrelin receptor activation.^[27] Off-label use in bodybuilding and wellness communities leverages ipamorelin's GH-stimulating effects to promote fat loss, muscle preservation, and improved sleep quality, attributed to elevated IGF-1 levels that support anabolic processes and metabolic regulation. These applications stem from its selective GH release without significant cortisol or prolactin elevation, though they lack robust clinical validation beyond general GHS pharmacology. As of 2025, ongoing research explores ipamorelin for sarcopenia and metabolic disorders, with preclinical evidence suggesting benefits in muscle wasting and adiposity control, as well as potential anti-emetic effects and influences on germ cell development. However, no FDA approval exists for any human therapeutic use due to insufficient large-scale safety and efficacy data.^[26]^[28]^[29]^[10]^[9]

Safety and side effects

Common adverse effects

Ipamorelin is generally well tolerated in available studies, with no serious adverse reactions reported. In a randomized, placebo-controlled phase II trial involving patients undergoing bowel resection, ipamorelin was administered intravenously, and treatment-emergent adverse events occurred in 87.5% of participants receiving ipamorelin compared to 94.8% in the placebo group, suggesting that most events were attributable to the postoperative condition rather than the drug itself.^[7] For subcutaneous administration, commonly used in research settings, mild reactions reported include injection site redness and swelling, headaches, flushing, and transient nausea. These effects are generally infrequent, dose-related, often linked to the short half-life of the peptide, and resolve quickly without intervention. No long-term tolerance issues have been reported in available studies. The U.S. Food and Drug Administration (FDA) has identified significant safety risks associated with ipamorelin in compounded formulations, including potential hypersensitivity and cardiovascular effects.^[2]^[10] To minimize risks of over-stimulation, regular monitoring of growth hormone (GH) and insulin-like growth factor 1 (IGF-1) levels is recommended during ipamorelin therapy.^[30]

Contraindications and interactions

Ipamorelin should be avoided in individuals with active malignancy, including hormone-sensitive cancers, due to the potential for growth hormone (GH) stimulation to accelerate tumor growth. It should also be avoided in patients with uncontrolled diabetes, as GH secretagogues like ipamorelin can worsen insulin resistance and glucose metabolism. Additionally, use is not recommended in those with active pituitary disorders, such as tumors, because of risks related to GH axis disruption. Due to insufficient safety data, ipamorelin is contraindicated during pregnancy and breastfeeding.^[31]^[32]^[33]^[5] Ipamorelin may exhibit additive effects when combined with other GH secretagogues, such as sermorelin, leading to enhanced GH release and potentially amplified physiological responses. Caution is advised with concomitant use of insulin, as ipamorelin-induced GH elevation can antagonize insulin action and impair glucose homeostasis. Similarly, interactions with corticosteroids require monitoring, given their suppressive effects on the GH axis and potential to exacerbate metabolic disturbances when combined with GH-promoting agents.^[15]^[34]^[35] At high doses, ipamorelin may carry risks of effects related to excessive GH stimulation, such as water retention and joint pain.^[36]

History and legal status

Development

Ipamorelin, with the developmental code NNC 26-0161, was developed by Novo Nordisk A/S in the 1990s as part of a research program aimed at creating selective growth hormone (GH) secretagogues. It emerged from structural modifications to earlier peptides in the growth hormone-releasing peptide (GHRP) family, particularly GHRP-1, by removing the central Ala-Trp dipeptide and incorporating N-terminal changes such as replacing L-Ala with Aib to enhance potency and specificity while minimizing side effects like elevated cortisol levels. This pentapeptide was first described in scientific literature in 1998 as the inaugural selective GH secretagogue, demonstrating high efficacy in stimulating GH release through the GHRP-like receptor without broadly affecting other hormones.^[2] Preclinical studies focused on establishing ipamorelin's selectivity and potency. In vitro assays using rat pituitary cells showed an EC50 of 1.3 nmol/L and Emax of 85% relative to GHRP-6, indicating strong GH stimulation. In vivo, anesthetized rats exhibited an ED50 of 80 nmol/kg and peak GH levels up to 1545 ng/mL. Further testing in conscious swine confirmed these findings, with an ED50 of 2.3 nmol/kg and Emax of 65 ng/mL GH, comparable to GHRP-6 but without influencing plasma levels of follicle-stimulating hormone (FSH), luteinizing hormone (LH), prolactin (PRL), or thyroid-stimulating hormone (TSH). Notably, ipamorelin did not elevate adrenocorticotropic hormone (ACTH) or cortisol even at doses exceeding 200 times the ED50 for GH release, contrasting with non-selective GHRPs like GHRP-6 and GHRP-2 that provoke such increases. These results in rats and pigs underscored ipamorelin's targeted action on the GH axis, paving the way for advanced evaluation.^[2] Initial human trials in the late 1990s and early 2000s prioritized pharmacokinetic (PK) and pharmacodynamic (PD) profiling. A 1999 dose-escalation study in healthy male volunteers administered intravenous infusions of ipamorelin at rates from 4.21 to 140.45 nmol/kg over 15 minutes, revealing dose-proportional PK with a terminal half-life of 2 hours, clearance of 0.078 L/h/kg, and volume of distribution of 0.22 L/kg. PD modeling indicated a single GH release peak at approximately 0.67 hours post-infusion, with half-maximal stimulation at 214 nmol/L plasma concentration and a maximal production rate of 694 mIU/L/h, though inter-individual variability was higher for PD than PK parameters. This study confirmed ipamorelin's favorable disposition and GH-stimulating profile in humans. A subsequent phase 2 proof-of-concept trial (NCT00672074) evaluated ipamorelin for postoperative ileus in 114 bowel resection patients, administering 0.03 mg/kg intravenously twice daily. The drug was well tolerated, with adverse events similar to placebo (87.5% vs. 94.8%), but showed no significant reduction in median time to first tolerated meal (25.3 hours vs. 32.6 hours; p=0.15), limiting further therapeutic development.^[19]^[7]

Regulatory status

Ipamorelin is not approved by the U.S. Food and Drug Administration (FDA) for any human therapeutic use as of 2025, and it remains classified as a research chemical rather than a pharmaceutical drug.^[10] The FDA has identified potential safety risks associated with compounded preparations containing ipamorelin acetate, including immunogenicity concerns for certain administration routes, leading to its placement under scrutiny for compounding under sections 503A and 503B of the Federal Food, Drug, and Cosmetic Act.^[10] Although previously nominated for inclusion in bulk drug substance lists for compounding, ipamorelin was removed from Category 2 in September 2024 due to withdrawal of nominations by nominators. On October 29, 2024, the Pharmacy Compounding Advisory Committee (PCAC) voted against its inclusion on the 503A Bulks List (0 yes, 12 no, 1 abstention), further limiting its availability through licensed pharmacies to investigational contexts only.^[37]^[38] In other regions, ipamorelin's status reflects similar restrictions. The World Anti-Doping Agency (WADA) prohibits ipamorelin at all times as a growth hormone secretagogue under section S2.2 of its 2025 Prohibited List, banning its use by athletes in and out of competition due to its potential to enhance performance.^[39] In the European Union, regulated by the European Medicines Agency (EMA), ipamorelin lacks marketing authorization as a medicinal product and is treated as an unauthorized substance, prohibiting its sale or distribution for human consumption.^[9] Despite these regulations, ipamorelin is widely available online as a research chemical, nootropic, or dietary supplement, often marketed for laboratory or experimental purposes rather than therapeutic application.^[12] Such products carry significant risks related to purity, contamination, and inconsistent dosing, as they are not subject to the same quality controls as approved pharmaceuticals, prompting warnings from regulatory bodies about sourcing from unverified vendors.^[10]

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