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Fezolinetant

Fezolinetant is a non-hormonal oral medication approved for the treatment of moderate to severe vasomotor symptoms (VMS), such as hot flashes and night sweats, associated with menopause.^[1] It acts as a selective neurokinin 3 (NK3) receptor antagonist, targeting the hypothalamus to block neurokinin B signaling and thereby regulate body temperature imbalances caused by estrogen decline during menopause.^[2] Developed by Astellas Pharma, it was first approved by the U.S. Food and Drug Administration (FDA) in May 2023 under the brand name Veozah, marking the first NK3 receptor antagonist for this indication, and subsequently by the European Medicines Agency (EMA) in December 2023 as Veoza, in Australia in March 2024 as Veoza, and in Canada in December 2024 as Veozah.^[1]^[3]^[4] Clinical trials, including the phase 3 SKYLIGHT 1 and 2 studies, demonstrated significant reductions in VMS frequency and severity, with the standard 45 mg daily dose achieving up to 61% reduction in hot flash frequency by week 12 compared to 40% with placebo, and effects observable within one week of initiation.^[5] These trials involved over 1,800 postmenopausal women and also showed improvements in sleep disturbances and quality of life measures, such as the Menopause-Specific Quality of Life questionnaire.^[5] Unlike hormone therapies, fezolinetant does not replace estrogen and is suitable for women who cannot or prefer not to use hormonal treatments, though it does not address other menopausal symptoms like vaginal dryness or provide benefits such as bone protection.^[1]^[5] Safety data from trials indicate a favorable profile, with common adverse effects including abdominal pain, diarrhea, insomnia, and back pain, occurring in 2% to 4% of users and mostly mild in severity; however, it carries a boxed warning for hepatotoxicity, including rare but serious liver injury (as of December 2024), necessitating baseline and periodic liver function monitoring for the first nine months.^[1]^[5]^[6]^[7] Contraindications include severe hepatic impairment (cirrhosis), severe renal impairment, and concomitant use with strong CYP1A2 inhibitors like paroxetine, due to its metabolism primarily via CYP1A2, CYP2C9, and CYP2C19 enzymes.^[2]^[7] Long-term data from a 52-week extension study confirmed sustained efficacy with low discontinuation rates due to adverse events (around 5%).^[5]

Pharmacology

Mechanism of action

Fezolinetant is a selective antagonist of the neurokinin 3 (NK3) receptor, which prevents the binding of neurokinin B (NKB) to these receptors on kisspeptin/neurokinin B/dynorphin (KNDy) neurons located in the hypothalamus.^[2] These KNDy neurons play a central role in regulating the gonadotropin-releasing hormone (GnRH) pulse generator and the hypothalamic thermoregulatory center.^[8] By blocking NK3 receptor activation, fezolinetant inhibits NKB-mediated signaling, thereby dampening the excitability of KNDy neurons.^[9] In postmenopausal women, declining estrogen levels lead to reduced inhibition of NKB release, resulting in hyperactivity of KNDy neurons and disruption of the hypothalamic thermoregulatory center, which manifests as vasomotor symptoms such as hot flashes. Fezolinetant modulates this pathway by decreasing KNDy neuronal activity, thereby restoring balance in the thermoregulatory center and reducing the frequency and severity of these symptoms.^[8] This action targets the underlying neurokinin B-driven hyperactivity without directly altering estrogen levels or other hormonal pathways.^[2] As a non-hormonal therapy, fezolinetant distinguishes itself from estrogen-based treatments by specifically antagonizing NK3 receptors to normalize GnRH pulsatility through indirect modulation of the KNDy network, avoiding direct interference with reproductive hormones.^[9] This mechanism helps mitigate the estrogen withdrawal effects on thermoregulation while preserving overall endocrine function. Preclinical studies have demonstrated that fezolinetant administration decreases the frequency of luteinizing hormone (LH) pulses and lowers plasma LH levels without significantly affecting follicle-stimulating hormone (FSH).^[10] Early clinical investigations in women have corroborated this, showing reductions in LH pulsatility that correlate with NK3 receptor inhibition and subsequent alleviation of menopausal symptoms.

Pharmacokinetics

Fezolinetant is administered orally and exhibits dose-proportional pharmacokinetics across the therapeutic range of 20 to 60 mg once daily, with steady-state plasma concentrations achieved after approximately two doses and minimal accumulation thereafter.^[11] The median time to reach peak plasma concentrations (T<sub>max</sub>) is 1.5 hours (range: 1–4 hours) following administration in healthy women.^[11] Food has no clinically significant effect on fezolinetant's exposure, allowing for administration with or without meals.^[11] The apparent volume of distribution at steady state (V<sub>z</sub>/F) is approximately 189 L, indicating moderate tissue distribution.^[11] Fezolinetant is approximately 51% bound to plasma proteins.^[11] It crosses the blood-brain barrier to access central neurokinin 3 (NK3) receptors in the thermoregulatory center of the hypothalamus.^[12] Metabolism of fezolinetant occurs primarily via cytochrome P450 (CYP) 1A2, with minor contributions from CYP2C9 and CYP2C19.^[11] The major circulating metabolite, ES259564, is approximately 20-fold less potent than the parent compound at the NK3 receptor and does not contribute significantly to pharmacological activity.^[11] The effective half-life of fezolinetant is 9.6 hours, supporting once-daily dosing.^[11] The apparent clearance at steady state is 10.8 L/h.^[11] Following oral administration, 76.9% of the dose is excreted in urine (1.1% as unchanged drug) and 14.7% in feces (0.1% as unchanged drug), primarily as metabolites.^[11] In patients with mild or moderate hepatic impairment (Child-Pugh Class A or B), exposure to fezolinetant is increased (AUC up to 96% higher), but no dose adjustment is recommended; it is contraindicated in severe hepatic impairment (Child-Pugh Class C).^[11] For renal impairment, no dose adjustment is needed in mild (eGFR 60–<90 mL/min/1.73 m²) or moderate (eGFR 30–<60 mL/min/1.73 m²) cases, but fezolinetant is contraindicated in severe impairment (eGFR 15–<30 mL/min/1.73 m²) or end-stage renal disease (eGFR <15 mL/min/1.73 m²).^[11]

Medical uses

Indications

Fezolinetant is indicated for the treatment of moderate to severe vasomotor symptoms (VMS), including hot flashes and night sweats, associated with menopause in postmenopausal women.^[1]^[13] This approval by the U.S. Food and Drug Administration (FDA) in May 2023 and the European Medicines Agency (EMA) in December 2023 positions fezolinetant as a non-hormonal option for women who cannot or prefer not to use hormone therapy due to contraindications or personal choice.^[1]^[14] It is not recommended for women with moderate or severe hepatic impairment (Child-Pugh Class B or C).^[7]^[13] The efficacy of fezolinetant in reducing VMS frequency and severity was demonstrated in the pivotal phase 3 SKYLIGHT 1 and SKYLIGHT 2 trials, which enrolled postmenopausal women with at least seven moderate to severe VMS episodes per day or 50 per week.^[15] In these randomized, double-blind, placebo-controlled studies, fezolinetant at 45 mg once daily significantly reduced the frequency of moderate to severe VMS by approximately 60% from baseline after 12 weeks compared to about 45% with placebo, with similar improvements in severity scores.^[16] These benefits were sustained through a 52-week extension period, indicating ongoing effectiveness for up to one year of treatment.^[16]^[17] Fezolinetant is specifically approved for VMS and is not indicated for other menopausal conditions such as vaginal dryness, sexual dysfunction, or osteoporosis prevention and management.^[7]^[13] Treatment is intended for symptomatic relief rather than long-term prevention of menopausal symptoms.^[13]

Administration

Fezolinetant is administered orally at a standard dose of 45 mg once daily, taken with or without food at the same time each day to maintain consistent levels.^[7] The tablet should be swallowed whole with liquid and must not be cut, crushed, or chewed.^[7]^[18] Treatment can be initiated at any time for women experiencing moderate to severe vasomotor symptoms associated with menopause, with no dose titration required; however, baseline liver function tests (including ALT, AST, alkaline phosphatase, and bilirubin) are recommended before starting to assess suitability.^[7]^[18] Periodic monitoring of liver function is advised, with tests conducted monthly for the first three months, then at six and nine months, or more frequently if signs of liver injury appear, due to the potential for transaminase elevations.^[7]^[18] For a missed dose, it should be taken as soon as remembered on the same day if more than 12 hours remain before the next scheduled dose; otherwise, the dose should be skipped, and the regular dosing schedule resumed without doubling up.^[7]^[18] The medication is available as 45 mg film-coated tablets, which should be stored at controlled room temperature (20°C to 25°C or 68°F to 77°F), with excursions permitted between 15°C to 30°C (59°F to 86°F), in a closed container away from heat, moisture, and direct light.^[7]^[18] No specific tapering is required upon discontinuation, though vasomotor symptoms typically return within one week after stopping treatment.^[19]^[20]

Safety profile

Adverse effects

Fezolinetant is generally well tolerated, with most adverse effects being mild to moderate and occurring at rates similar to placebo in phase 3 clinical trials. The most frequent adverse effects, reported in ≥2% of patients receiving fezolinetant 45 mg and greater than placebo, include abdominal pain (4.3%), diarrhea (3.9%), insomnia (3.9%), back pain (3.0%), hot flushes (2.5%), and elevated hepatic transaminases (2.3%). These gastrointestinal effects, such as abdominal pain and diarrhea, occurred in approximately 3-4% of patients in the pooled 52-week safety data, with most cases resolving without treatment discontinuation.^[11] Elevations in liver enzymes (ALT or AST >3× upper limit of normal) were observed in 2.3% of fezolinetant-treated patients compared to 0.9% on placebo, typically asymptomatic and transient. It carries a Boxed Warning for rare but serious drug-induced liver injury (DILI), with postmarketing reports as of May 2025 including approximately 402 hepatic disorder cases, at least one confirmed severe case within 40 days of initiation featuring ALT >10× ULN, elevated bilirubin and alkaline phosphatase, fatigue, nausea, jaundice, and abdominal pain, which resolved after discontinuation. Additional serious DILI cases have prompted regulatory updates, including warnings from MHRA (April 2025) and TGA (October 2025).^[7]^[6]^[21]^[22]^[23] Rare but notable adverse effects include hypersensitivity reactions such as rash and pruritus. Due to the risk of hepatotoxicity, liver function tests (ALT, AST, alkaline phosphatase, and bilirubin) should be monitored at baseline (do not initiate if ALT or AST >2× upper limit of normal), monthly for the first 3 months, at 6 and 9 months, and if symptoms of liver injury (e.g., fatigue, nausea, jaundice, abdominal pain, dark urine, or itching) occur; discontinue if transaminases >5× ULN or >3× ULN with symptoms or bilirubin >2× ULN.^[7] In long-term studies up to 52 weeks, fezolinetant did not increase the risk of endometrial hyperplasia (incidence 0.5%, similar to placebo) or cardiovascular events, with no new safety signals emerging. Management of common adverse effects is typically symptomatic; for gastrointestinal symptoms and insomnia, supportive measures such as dietary adjustments or sleep hygiene are recommended, while fezolinetant should be discontinued if transaminases exceed 3× upper limit of normal accompanied by symptoms or 5× upper limit of normal regardless of symptoms.^[24]^[11]^[6]

Contraindications and precautions

Fezolinetant is contraindicated in patients with known cirrhosis, severe renal impairment (eGFR 15 to <30 mL/min/1.73 m²), end-stage renal disease (eGFR <15 mL/min/1.73 m²), and concomitant use with strong or moderate CYP1A2 inhibitors (e.g., fluvoxamine, mexiletine), due to significant increases in fezolinetant exposure (up to 840% for AUC with strong inhibitors). Concomitant use with estrogen-containing oral contraceptives is also contraindicated due to weak CYP1A2 inhibition increasing exposure.^[11]^[7] Precautions are advised in patients with moderate hepatic impairment (Child-Pugh B), where exposure to fezolinetant is increased, though no dose adjustment is required; liver function tests should be monitored at baseline and periodically (e.g., at 3, 6, and 9 months) due to risk of transaminase elevations. Similarly, no dose adjustment is needed for mild to moderate renal impairment (eGFR ≥30 mL/min/1.73 m²), but caution is recommended with monitoring for efficacy and safety. Fezolinetant should be avoided during pregnancy, as there are no adequate human data, and animal studies demonstrated embryo-lethality and reduced fetal weight at exposures greater than those in humans; the background risk of major birth defects is 2-4% and miscarriage 15-20%. Breastfeeding is not recommended, as fezolinetant or its metabolites are present in rat milk, with unknown excretion in human milk and potential for serious adverse reactions in nursing infants.^[11]^[7] In special populations, fezolinetant has not been studied in men or premenarchal females and is indicated only for postmenopausal women; its use in these groups is not recommended. For geriatric patients over 65 years, data are insufficient to determine differences in response compared to younger postmenopausal women, but no specific precautions beyond general monitoring are noted.^[11] Regarding drug interactions beyond contraindications, CYP1A2 inducers such as smoking (a moderate inducer) may decrease fezolinetant exposure (Cmax by ~28%, AUC by ~52%), potentially reducing efficacy, though clinical data suggest no significant impact on vasomotor symptom reduction; patients should be monitored for treatment response, and smoking cessation is encouraged.^[11]^[13] In cases of overdose, limited data are available; treatment should involve discontinuation of fezolinetant and initiation of general supportive measures, as no specific antidote exists.^[11]

History

Development

Fezolinetant was discovered and developed by Astellas Pharma as a selective neurokinin 3 receptor (NK3R) antagonist targeting the KNDy pathway in the hypothalamus, informed by early 2010s research elucidating the role of KNDy neurons—coexpressing kisspeptin, neurokinin B, and dynorphin—in menopause neurobiology and vasomotor symptom generation.^[20]^[25] Preclinical studies in animal models of menopause, including ovariectomized rats and ewes, demonstrated that NK3R blockade by fezolinetant reduced hot flash analogs such as tail skin temperature fluctuations and core body temperature elevations, while also attenuating luteinizing hormone (LH) surges by modulating KNDy neuron activity.^[26]^[27] The broader class of NK3R antagonists, including fezolinetant, originated from efforts in the 1990s and 2000s to address schizophrenia through modulation of tachykinin signaling, but was repurposed for menopause following mechanistic insights into NKB/NK3R dysregulation in the hypothalamic-pituitary-gonadal axis.^[20]^[28] Phase 2 trials conducted from 2017 to 2018 focused on dose-finding, evaluating fezolinetant at daily doses of 30–120 mg in postmenopausal women with moderate to severe vasomotor symptoms; these studies established efficacy in reducing symptom frequency and severity relative to placebo, with 45 mg identified as optimal due to its balance of effectiveness and tolerability.^[29]^[30] The phase 3 SKYLIGHT program, spanning 2019 to 2022, included two 12-week randomized, double-blind, placebo-controlled trials (SKYLIGHT 1 and 2; n ≈ 1,000 total) that confirmed fezolinetant at 30 mg and 45 mg daily doses superior to placebo in decreasing the frequency and severity of moderate to severe vasomotor symptoms, with rapid onset by week 1 and sustained benefits through week 12; a parallel 52-week extension trial (SKYLIGHT 4) further supported long-term safety.^[31]^[32]^[33] Key development milestones encompassed submission of the New Drug Application to the U.S. FDA in June 2022, which benefited from priority review via a priority review voucher, leading to approval on May 12, 2023, as the first NK3R antagonist for menopausal vasomotor symptoms.^[1]^[34]

Regulatory approvals

Fezolinetant received approval from the U.S. Food and Drug Administration (FDA) on May 12, 2023, for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause, marketed under the brand name Veozah.^[1] This marked the first approval of a neurokinin 3 (NK3) receptor antagonist for this indication, providing a novel nonhormonal mechanism distinct from prior options like selective serotonin reuptake inhibitors approved over a decade earlier.^[11] The European Medicines Agency (EMA) followed with a positive opinion from its Committee for Medicinal Products for Human Use in October 2023, leading to European Commission authorization on December 7, 2023, as Veoza for the same moderate to severe VMS indication in menopausal women. It was also approved in Switzerland by Swissmedic on December 4, 2023, as Veoza, and in the United Kingdom by the Medicines and Healthcare products Regulatory Agency (MHRA) on December 14, 2023, as Veoza, for the same indication.^[3]^[14]^[35] The EU labeling includes specific guidance on potential drug interactions, such as with moderate or strong CYP1A2 inhibitors, recommending dose adjustments or avoidance in affected patients. Subsequent approvals occurred in Australia on February 26, 2024, by the Therapeutic Goods Administration (TGA) as Veoza for moderate to severe VMS, and in Canada on December 2, 2024, by Health Canada as Veozah for the identical indication.^[37]^[38] Approvals are pending or under review in additional regions, including Japan, where phase 3 studies by Astellas Pharma are ongoing as of 2025.^[39] These authorizations were based on data from the pivotal phase 3 SKYLIGHT 1 and SKYLIGHT 2 trials, which demonstrated statistically significant reductions in VMS frequency and severity compared to placebo over 12 weeks, with the 45 mg daily dose selected for approval.^[40] The FDA did not require a Risk Evaluation and Mitigation Strategy (REMS) program, but the product labeling mandates baseline and periodic hepatic enzyme monitoring due to observed elevations in transaminases during trials.^[11] Similar requirements for liver function assessments are included in the EMA, TGA, and Health Canada labels. Post-approval, regulatory agencies have implemented ongoing pharmacovigilance, including a December 20, 2024, FDA update adding a boxed warning for rare but serious liver injury cases reported in global surveillance, with recommendations for immediate discontinuation if symptoms or lab abnormalities occur, and an October 16, 2025, TGA update adding warnings on hepatotoxicity risk with monitoring recommendations.^[6]^[23] No further major label changes have been issued as of November 2025. Following approvals, fezolinetant launched commercially in the United States and European Union in late 2023, with subsequent availability in Australia and Canada in 2024; market access and pricing vary by region and are linked to the branded formulations under Astellas Pharma.^[14]^[41]

Society and culture

Legal status

Fezolinetant is not classified as a controlled substance by the DEA in the United States or equivalent agencies elsewhere, and it is available exclusively by prescription (Rx-only) in all jurisdictions where approved.^[42]^[3]^[43] In the United States, fezolinetant received FDA approval as a new chemical entity in May 2023, granting it market exclusivity with no generic competition permitted until patent expiration around March 2034.^[1]^[44]^[45] In the European Union, it obtained centralized marketing authorization from the EMA in December 2023 and is designated as a prescription medicine under Directive 2001/83/EC.^[3]^[13] In Australia, it was approved by the Therapeutic Goods Administration (TGA) in March 2024.^[37] Similar prescription-only status applies in Canada following Health Canada approval in December 2024, though fezolinetant remains unapproved in countries such as Japan, restricting import and access.^[38]^[46] Reimbursement for fezolinetant treatment of vasomotor symptoms is offered by many U.S. insurers, often with patient assistance programs to offset costs, whereas in the EU, coverage decisions and eligibility vary by national health systems and health technology assessments.^[47]^[48]^[49] No off-label uses for fezolinetant have been established, and its application is limited strictly to the approved indication for moderate to severe vasomotor symptoms associated with menopause.^[50]^[51]

Brand names

Fezolinetant is marketed under the brand name Veozah in the United States and Canada, where it is available as a prescription medication for treating moderate to severe vasomotor symptoms associated with menopause.^[1]^[52] In the European Union, the United Kingdom, and Australia, the drug is sold under the brand name Veoza.^[3]^[53]^[37] All commercial formulations of fezolinetant are marketed exclusively by Astellas Pharma, with no generic versions available as of 2025 due to ongoing patent protection following its initial approvals.^[44] The medication is provided solely as 45 mg film-coated tablets for oral administration, with no combination products or alternative dosage strengths approved for market use.^[54]^[55] Prior to its commercialization, fezolinetant was designated by the investigational code name ESN-364 during clinical development phases.^[40]

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