VEOZAH (fezolinetant)
VEOZAH is indicated for the treatment of Vasomotor Symptoms.
How VEOZAH Works
Fezolinetant acts as a selective neurokinin 3 (NK3) receptor antagonist. It blocks neurokinin B (NKB) binding on kisspeptin/neurokinin B/dynorphin (KNDy) neurons within the hypothalamic thermoregulatory center to modulate neuronal activity and restore body temperature homeostasis. It demonstrates high affinity for the NK3 receptor (Ki: 19.9 to 22.1 nmol/L), with greater than 450-fold selectivity over NK1 and NK2 receptors.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2023-05-12
- Patent Cliff
- 2034
- Routes
- ORAL
- Dosage Forms
- TABLET
VEOZAH Approval History
What VEOZAH Treats
1 indicationsVEOZAH is approved for 1 conditions since its original approval in 2023. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Vasomotor Symptoms
VEOZAH Boxed Warning
RISKS OF HEPATOTOXICITY Hepatotoxicity has occurred with the use of VEOZAH in the postmarketing setting ( 5.1 ). • Perform hepatic laboratory tests prior to initiation of treatment to evaluate for hepatic function and injury. Do not start VEOZAH if either aminotransferase is ≥ 2 x the upper limit of normal (ULN) or if the total bilirubin is ≥ 2 x ULN for the evaluating laboratory. • Perform follow-up hepatic laboratory testing monthly for the first 3 months, at 6 months, and 9 months of treatmen...
WARNING: RISKS OF HEPATOTOXICITY Hepatotoxicity has occurred with the use of VEOZAH in the postmarketing setting ( 5.1 ). • Perform hepatic laboratory tests prior to initiation of treatment to evaluate for hepatic function and injury. Do not start VEOZAH if either aminotransferase is ≥ 2 x the upper limit of normal (ULN) or if the total bilirubin is ≥ 2 x ULN for the evaluating laboratory. • Perform follow-up hepatic laboratory testing monthly for the first 3 months, at 6 months, and 9 months of treatment ( 2.1 , 5.1 ). • Advise patients to discontinue VEOZAH immediately and seek medical attention including hepatic laboratory tests if they experience signs or symptoms that may suggest liver injury (new onset fatigue, decreased appetite, nausea, vomiting, pruritus, jaundice, pale feces, dark urine, or abdominal pain) ( 2.1 , 5.1 ). • Discontinue VEOZAH if transaminase elevations are > 5 x ULN, or if transaminase elevations are > 3 x ULN and the total bilirubin level is > 2 x ULN. • If transaminase elevations > 3 x ULN occur, perform more frequent follow-up hepatic laboratory tests until resolution ( 5.1 ). WARNING: RISKS OF HEPATOTOXICITY See full prescribing information for complete boxed warning. Hepatotoxicity has occurred with the use of VEOZAH in the postmarketing setting ( 5.1 ). • Perform hepatic laboratory tests prior to initiation of treatment to evaluate for hepatic function and injury. Do not start VEOZAH if either aminotransferase is ≥ 2 x ULN or if the total bilirubin is ≥ 2 x ULN for the evaluating laboratory. • Perform follow-up hepatic laboratory testing monthly for the first 3 months, at 6 months, and 9 months of treatment ( 2.1 , 5.1 ). • Advise patients to discontinue VEOZAH immediately and seek medical attention including hepatic laboratory tests if they experience signs or symptoms that may suggest liver injury (new onset fatigue, decreased appetite, nausea, vomiting, pruritus, jaundice, pale feces, dark urine, or abdominal pain) ( 2.1 , 5.1 ). •
VEOZAH Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to VEOZAH
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
22 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06917313 | 2000037181 | Ph 2 | recruiting | FLASH-Breast: Evaluating the Efficacy of Fezolinetant in Reducing Vasomotor Symptoms in Women With Breast Cancer on Endocrine Therapy |
| NCT06617455 VEnT | UMCC 2024.059 NCI-2024-06543, HUM00256706 | Ph 2 | terminated | Fezolinetant for the Improvement of Vasomotor Symptoms in Breast Cancer Patients Taking Endocrine Therapy, VENT Trial |
| NCT07568236 | CRE-2025.427-T | Ph 2 | not yet recruiting | A Trial on Fezolinetant for Vasomotor Symptoms in Men Receiving Androgen Deprivation Therapy (ADT) |
| NCT06975111 | 25-0943 U1111-1322-1036 | Ph 2, Ph 3 | recruiting | Focusing on the Menopausal Transition to Improve Mid-Life Women's Health |
| NCT06206421 Starlight 3 | 2693-CL-0311 jRCT2031230584 | Ph 3 | completed | A Study to Assess Long-term Safety of Fezolinetant Given to Japanese Women Going Through Menopause |
| NCT06440967 | 2693-CL-1303 2024-510719-31-00 | Ph 3 | active not recruiting | A Study to Confirm if Fezolinetant Helps Reduce Hot Flashes in Women With Breast Cancer Who Are Having Hormone Therapy |
| NCT06812754 | 2693-CL-0313 CTR20250084 | Ph 2 | completed | A Study to Confirm if Fezolinetant Helps Reduce Hot Flashes in Chinese Women Going Through Menopause |
| NCT06972875 FLASH | UVMCC2408 | Ph 2 | recruiting | Fezolinetant for Treating Hot Flashes in Men With Prostate Cancer |
| NCT06206408 Starlight 2 | 2693-CL-0310 jRCT2031230571 | Ph 3 | completed | A Study to Confirm if Fezolinetant Helps Reduce Hot Flashes in Japanese Women Going Through Menopause |
| NCT04451226 Moonlight 3 | 2693-CL-0307 CTR20200676 | Ph 3 | completed | A Study to Assess the Safety and Tolerability of Fezolinetant in Women Seeking Treatment for Relief of Vasomotor Symptoms (VMS) Associated With Menopause |
| NCT04234204 Moonlight 1 | 2693-CL-0305 CTR20200360 | Ph 3 | completed | A Study to Find Out if Fezolinetant Helps Reduce Moderate to Severe Hot Flashes in Women in Asia Going Through Menopause |
| NCT05419908 results posted | ESN364_HF_204 2015-002578-20 | Ph 2 | completed | Trial to Investigate the Effect of ESN364 in Early Postmenopausal Women Suffering From Hot Flashes |
| NCT03192176 results posted | ESN364_HF_205 | Ph 2 | completed | A Dose-ranging Study of the Efficacy of ESN364 in Postmenopausal Women Suffering Vasomotor Symptoms (Hot Flashes) |
| NCT04003142 Skylight 2 results posted | 2693-CL-0302 2018-003529-27 | Ph 3 | completed | A Study to Find Out if Fezolinetant Helps Reduce Moderate to Severe Hot Flashes in Women Going Through Menopause - 2 |
| NCT04003389 Skylight 4 results posted | 2693-CL-0304 2019-000275-16 | Ph 3 | completed | A Study to Find Out How Safe Long-term Treatment With Fezolinetant is in Women With Hot Flashes Going Through Menopause |
| NCT04003155 Skylight 1 results posted | 2693-CL-0301 2018-003528-35 | Ph 3 | completed | A Study to Find Out if Fezolinetant Helps Reduce Moderate to Severe Hot Flashes in Women Going Through Menopause |
| NCT04793204 | 2693-CL-0030 | Ph 1 | completed | A Study to Evaluate the Pharmacokinetics and Safety of Fezolinetant in Healthy Chinese Female Subjects |
| NCT05034042 Starlight | 2693-CL-0206 jRCT2031210334 | Ph 2 | completed | A Study to Find the Best Dose of Fezolinetant to Treat Hot Flashes in Women Going Through Menopause |
| NCT05033886 Daylight | 2693-CL-0312 2021-001685-38 | Ph 3 | completed | A Study of Fezolinetant to Treat Hot Flashes in Women Going Through Menopause |
| NCT04641260 | 2693-CL-0012 | Ph 1 | completed | A Study to Assess the Effect of Food With Fezolinetant in Healthy Female Participants |
| NCT04482270 | 2693-CL-0007 | Ph 1 | completed | A Study to Investigate the Effect of Mild and Moderate Hepatic Impairment on the Safety and Tolerability of Fezolinetant Compared to Participants With Normal Hepatic Function |
| NCT04476849 | 2693-CL-0008 | Ph 1 | completed | A Study to Investigate the Effect of Renal Impairment on the Safety and Tolerability of Fezolinetant Compared to Participants With Normal Renal Function |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
VEOZAH FDA Label Details
Indications & Usage
FDA Label (PDF)VEOZAH is indicated for the treatment of Vasomotor Symptoms.
WARNING: RISKS OF HEPATOTOXICITY Hepatotoxicity has occurred with the use of VEOZAH in the postmarketing setting ( 5.1 ). • Perform hepatic laboratory tests prior to initiation of treatment to evaluate for hepatic function and injury. Do not start VEOZAH if either aminotransferase is ≥ 2 x the upper...
VEOZAH Patents & Exclusivity
Patents (4 active)
Exclusivity
Pro Intelligence Preview
Deep insights for VEOZAH
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2034
- • 4 active patents
Trial Analysis
- • 21 total trials
- • Stage: Declining
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment