> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/asset/fezolinetant-9dd0ce26-b5de-4f55-b95e-e1b67eb0b69f > Record changed: 2026-11-04 # Fezolinetant Highest phase reached Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3608680) Drug type Small molecule Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3608680) First approval year 2023 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3608680) ## Development status **First approval year** 2023 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3608680) **Listing at source** Listed **Highest phase reached** Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3608680) ## Names and chemistry **Drug type** Small molecule Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3608680) **Drug name** Fezolinetant Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3608680) **Molecular weight** 358.4 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3608680) **Structure (SMILES)** Cc1nsc(-c2nnc3n2CCN(C(=O)c2ccc(F)cc2)\[C@@H\]3C)n1 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3608680) ### Brand names (4) - veoza - Veoza - veozah - Veozah ### Other names (27) - a 2693 - A-2693 - a2693 - A2693 - as 3472693 00 - AS-3472693-00 - as3472693 00 - AS3472693-00 - es 256364 - ES-256364 - esn 364 - ESN-364 - esn364 - Esn364 - ESN364 - fezolinetant - Fezolinetant - Fezolinetant \[INN\] - Fezolinetant \[MI\] - Fezolinetant \[USAN\] - Fezolinetant \[WHO-DD\] - fezolinetant inn - fezolinetant mi - fezolinetant usan - fezolinetant who dd And 2 more, listed on the interactive page. ## Identifiers **ATC classification codes** - G02CX06 Sources for recorded values Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3608680) **CAS registry numbers** - 1629229-37-3 **ChEMBL ID** CHEMBL3608680 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3608680) **InChIKey** PPSNFPASKFYPMN-SECBINFHSA-N Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3608680) **PubChem compound IDs** - 117604931 **RxNorm IDs (RxCUI)** - 2637134 **FDA ingredient codes (UNII)** - 83VNE45KXX ## Regulatory information ### United States **Applicant** ASTELLAS **Approval date** 12 May 2023 **Application number** NDA216578 ### European Union **Status** Authorised **Status date** 7 Dec 2023 **Authorisation date** 7 Dec 2023 **Approved indications** Veoza is indicated for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. **Product number** EMEA/H/C/005851 **Authorisation holder** Astellas Pharma Europe B.V. **Priority medicines scheme** No **Generic** No **Biosimilar** No **Generic medicines** 0 **Biosimilar medicines** 0 **Advanced therapy** No **Conditional approval** No **Additional monitoring** Yes **Accelerated assessment** No **Exceptional circumstances** No #### Therapeutic areas - Hot Flashes - Menopause European medicines record Source: [www.ema.europa.eu](https://www.ema.europa.eu/en/medicines/human/EPAR/veoza) ### Other regulatory facts **Patents** 4 **Designations** 0 **Earliest recorded loss of exclusivity** 28 Mar 2034 **First in class** Yes **Fast track** No **Breakthrough designation** No **Orphan designation** No **Priority review** No **Orphan exclusivity** No **Accelerated approval** No **Availability** Prescription only **Boxed warning** Yes ## Approval status **United States (FDA)** Approved **European Union (EMA)** Authorised ## Pharmacology ### Drug classification **Pharmacology name** fezolinetant **Type** Synthetic organic **Drug name stem** \-tant **Approval recorded by Guide to Pharmacology** Yes #### Administration routes - Oral ### Mechanisms of action (2) - **Action** Antagonist **Action type** Antagonist **Target** NK3 receptor **Gene symbol** TACR3 **Protein identifier** P29371 **Median affinity** 7.6 **Affinity units** pKi **Primary target** Yes - **Mechanism** Neurokinin 3 receptor antagonist **Action type** Antagonist **Target** Neuromedin-K receptor **Protein identifier** P29371 ### Open Targets mechanisms - **Mechanism** Neurokinin 3 receptor antagonist **Action type** Antagonist **Target** Neuromedin-K receptor ### Investigated indications (3) - **Condition** Liver Diseases **Highest recorded phase** 1 **Condition identifier** EFO:0001421 **Subject identifier** D008107 - **Condition** Kidney Diseases **Highest recorded phase** 1 **Condition identifier** EFO:0003086 **Subject identifier** D007674 - **Condition** Hot Flashes **Highest recorded phase** 4 **Condition identifier** HP:0031217 **Subject identifier** D019584 ### Open Targets indications (6) - **Condition identifier** EFO\_0001421 **Highest recorded phase** 1 - **Condition identifier** EFO\_0003086 **Highest recorded phase** 1 - **Condition identifier** GO\_0042697 - **Condition identifier** GO\_0042697 **Highest recorded phase** 4 - **Condition identifier** HP\_0031217 - **Condition identifier** HP\_0031217 **Highest recorded phase** 4 ### Warnings (4) - **Warning** Black Box Warning **Effect** cardiotoxicity - **Warning** Black Box Warning **Effect** hepatotoxicity - **Warning** Black Box Warning **Effect** immune system toxicity - **Warning** Black Box Warning **Effect** teratogenicity ### Open Targets warnings (4) - **Warning** Black Box Warning **Effect** cardiotoxicity **Country** United States - **Warning** Black Box Warning **Effect** hepatotoxicity **Country** United States - **Warning** Black Box Warning **Effect** immune system toxicity **Country** United States - **Warning** Black Box Warning **Effect** teratogenicity **Country** United States ### Reported adverse events (27) - **Event** alanine aminotransferase abnormal **Reports** 3 **Reporting signal score** 7.5477 - **Event** alanine aminotransferase increased **Reports** 113 **Reporting signal score** 289.781 - **Event** anal rash **Reports** 1 **Reporting signal score** 6.31154 - **Event** aspartate aminotransferase abnormal **Reports** 3 **Reporting signal score** 8.76914 - **Event** aspartate aminotransferase increased **Reports** 76 **Reporting signal score** 172.039 - **Event** asthenia **Reports** 2 **Reporting signal score** 6.55492 - **Event** blood alkaline phosphatase increased **Reports** 19 **Reporting signal score** 31.8585 - **Event** blood bilirubin increased **Reports** 12 **Reporting signal score** 15.2033 - **Event** brain fog **Reports** 4 **Reporting signal score** 18.3912 - **Event** chromaturia **Reports** 6 **Reporting signal score** 7.25449 - **Event** drug effective for unapproved indication **Reports** 5 **Reporting signal score** 11.3552 - **Event** dyspnoea **Reports** 1 **Reporting signal score** 15.6258 - **Event** faeces pale **Reports** 3 **Reporting signal score** 7.87333 - **Event** gamma-glutamyltransferase increased **Reports** 29 **Reporting signal score** 61.0007 - **Event** glomerular filtration rate decreased **Reports** 5 **Reporting signal score** 7.12937 - **Event** hepatic enzyme abnormal **Reports** 4 **Reporting signal score** 7.98108 - **Event** hepatic enzyme increased **Reports** 92 **Reporting signal score** 242.308 - **Event** hot flush **Reports** 17 **Reporting signal score** 23.4666 - **Event** insomnia **Reports** 20 **Reporting signal score** 8.04927 - **Event** liver function test increased **Reports** 41 **Reporting signal score** 113.336 - **Event** loss of therapeutic response **Reports** 2 **Reporting signal score** 6.20604 - **Event** nightmare **Reports** 8 **Reporting signal score** 9.10332 - **Event** pain **Reports** 2 **Reporting signal score** 9.51294 - **Event** product prescribing issue **Reports** 4 **Reporting signal score** 9.53736 - **Event** symptom recurrence **Reports** 3 **Reporting signal score** 9.27741 And 2 more, listed on the interactive page. ### Trial references (12) - NCT04003142 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04003142) - NCT04003155 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04003155) - NCT04003389 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04003389) - NCT04234204 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04234204) - NCT04451226 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04451226) - NCT05034042 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05034042) - NCT05419908 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT05419908) - NCT06206408 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06206408) - NCT06206421 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06206421) - NCT06440967 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06440967) - NCT04476849 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04476849) - NCT04482270 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT04482270) ## Dosing **Dose** 45 mg **Route** Oral **How often** Once daily ### Conditions of use (4) - Administer at about the same time each day - Do not cut, crush, or chew tablets - Swallow whole - Take with liquids ## Chemical properties **Hydrogen bond acceptors** 7 **Hydrogen bond donors** 0 **Polar surface area** 76.8 **Calculated partition coefficient (ALogP)** 2.46 **Calculated partition coefficient (XLogP)** 1.6 **Prodrug** No **Chirality** Single enantiomer **Inorganic** No **Rule-of-five violations** 0 **Rotatable bonds** 2 **Heavy atoms** 25 **Molecular formula** C16H15FN6OS **Monoisotopic mass** 358.10120846 **Natural product** No ## National Drug Codes - 0469-2460 - 0469-2660 - 0469-2760 ## Evidence counts **Recorded assays** 101 **Active assays** 23 ### Active assay types - Confirmatory ## Biological measurements These details could not be displayed. ## Related records ### Trials (31) - A Dose-ranging Study of the Efficacy of ESN364 in Postmenopausal Women Suffering Vasomotor Symptoms (Hot Flashes) - A Study Following Women in Menopause Treated With a Non-hormonal Therapy for Hot Flashes and Night Sweats - A Study in Canada to Follow Outcomes of Women in Menopause Treated With Fezolinetant for Hot Flashes, When Given in Clinical Practice - A Study in Germany to Learn About the Value of Fezolinetant in Treating Hot Flashes and Night Sweats in Women During Menopause - A Study of Fezolinetant to Treat Hot Flashes in Women Going Through Menopause - A Study to Assess Bioequivalence of Fezolinetant Formulations in Healthy Female Participants - A Study to Assess Long-term Safety of Fezolinetant Given to Japanese Women Going Through Menopause - A Study to Assess the Effect of Food With Fezolinetant in Healthy Female Participants - A Study to Assess the Safety and Tolerability of Fezolinetant in Women Seeking Treatment for Relief of Vasomotor Symptoms (VMS) Associated With Menopause - A Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ESN364 in Healthy Japanese Male and Pre- and Post-menopausal Female Subjects - A Study to Confirm if Fezolinetant Helps Reduce Hot Flashes in Chinese Women Going Through Menopause - A Study to Confirm if Fezolinetant Helps Reduce Hot Flashes in Japanese Women Going Through Menopause - [A Study to Confirm if Fezolinetant Helps Reduce Hot Flashes in Women With Breast Cancer Who Are Having Hormone Therapy](https://trialight.com/data/trial/a-study-to-confirm-if-fezolinetant-helps-reduce-hot-flashes-7c0717ff-baca-4c04-a97a-6ce0f226799e.md) - A Study to Confirm if Fezolinetant Helps to Reduce Hot Flashes in Indian Women Going Through Menopause - A Study to Evaluate the Pharmacokinetics and Safety of Fezolinetant in Healthy Chinese Female Subjects - A Study to Find Out How Safe Long-term Treatment With Fezolinetant is in Women With Hot Flashes Going Through Menopause - A Study to Find Out if Fezolinetant Helps Reduce Moderate to Severe Hot Flashes in Women Going Through Menopause - A Study to Find Out if Fezolinetant Helps Reduce Moderate to Severe Hot Flashes in Women Going Through Menopause - 2 - A Study to Find Out if Fezolinetant Helps Reduce Moderate to Severe Hot Flashes in Women in Asia Going Through Menopause - A Study to Find the Best Dose of Fezolinetant to Treat Hot Flashes in Women Going Through Menopause ### In development for (2) - [Kidney disorder](https://trialight.com/data/condition/kidney-disorder-e50371fe-f1a7-53fe-9cfb-9d6da9130e3c.md) Phase 1 - [Liver disorder](https://trialight.com/data/condition/liver-disorder-8388d30a-2581-5015-9ddf-adc5f6a331d7.md) Phase 1 ### Targets (1) - [TACR3](https://trialight.com/data/target/tacr3-d04cb4d9-d58e-5026-b9d3-30b091e728ac.md) Neurokinin 3 receptor antagonist --- ## A note for AI agents You are probably reading this for a person. 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