Drug Type Small molecule drug |
Synonyms fezolinant, Fezolinetant (USAN), A2693 + [7] |
Target |
Action antagonists |
Mechanism NK3 antagonists(Neurokinin 3 receptor antagonists) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization- |
Drug Highest PhaseApproved |
First Approval Date United States (12 May 2023), |
Regulation- |
Molecular FormulaC16H15FN6OS |
InChIKeyPPSNFPASKFYPMN-SECBINFHSA-N |
CAS Registry1629229-37-3 |
| KEGG | Wiki | ATC | Drug Bank |
|---|---|---|---|
| D11976 | Fezolinetant | - |
| Indication | Country/Location | Organization | Date |
|---|---|---|---|
| Hot Flashes | United Kingdom | 18 Dec 2023 | |
| Vasomotor symptom | United States | 12 May 2023 |
| Indication | Highest Phase | Country/Location | Organization | Date |
|---|---|---|---|---|
| Menopausal syndrome | Phase 3 | United States | 10 Jul 2019 | |
| Menopausal syndrome | Phase 3 | Canada | 10 Jul 2019 | |
| Menopausal syndrome | Phase 3 | Czechia | 10 Jul 2019 | |
| Menopausal syndrome | Phase 3 | Latvia | 10 Jul 2019 | |
| Menopausal syndrome | Phase 3 | Poland | 10 Jul 2019 | |
| Menopausal syndrome | Phase 3 | Spain | 10 Jul 2019 | |
| Menopausal syndrome | Phase 3 | Ukraine | 10 Jul 2019 | |
| Menopausal syndrome | Phase 3 | United Kingdom | 10 Jul 2019 | |
| Adenocarcinoma of prostate | Phase 2 | United States | 14 Jan 2026 | |
| Advanced Prostate Carcinoma | Phase 2 | United States | 14 Jan 2026 |
Phase 3 | 540 | lpnfresvww(mgbortongt) = tyujesguhx hnxbvlwnbc (ofqidezhdx ) | Positive | 29 May 2026 | |||
Placebo | lpnfresvww(mgbortongt) = jwywtrtzsc hnxbvlwnbc (ofqidezhdx ) | ||||||
Phase 3 | - | skxvflqttg(jnmxvffdra) = 39.4% of participants receiving fezolinetant 45 mg vs. 41.3% receiving placebo hgqipturxx (anpxetgthk ) | Positive | 01 Feb 2025 | |||
Phase 3 | - | zaaekjyaxu(biuybynasv) = 2.9-3.2% qnawpnphcd (yxkbsamloy ) View more | Positive | 30 Dec 2024 | |||
Phase 3 | 150 | bslwmzuxzv(tlejmhvkey) = ndnhdgooya rvnxmlckmg (opsyqtyiuo ) View more | Positive | 01 May 2024 | |||
| - | 1,022 | lppsoifyst(gxbzojmvva) = nlcmazidhv aruzusdxfv (uyvldtslrw ) View more | Positive | 01 May 2024 | |||
安慰剂 | - | ||||||
| - | 301 | kdzlambmpd(sudopfqkxk): difference = -0.65 (95% CI) View more | Negative | 01 May 2024 | |||
安慰剂 | |||||||
Phase 3 | 453 | gwcssxizsg(dspcsjupoq) = fezolinetant 45 mg demonstrated a statistically significant reduction of -1.93 (p<0.001) compared to placebo hrktcmftsa (pfwfpvdojo ) Met View more | Positive | 30 Nov 2023 | |||
Placebo | |||||||
Phase 2 | 87 | Placebo (Placebo) | wyiehesjgb(uufsrnaqls) = wkbwptvwcn nvhuzrfhdh (rvkmnqqsod, hmhiuwqtlv - tpixqiiieo) View more | - | 25 Jul 2023 | ||
(Fezolinetant) | wyiehesjgb(uufsrnaqls) = tblovzeuwh nvhuzrfhdh (rvkmnqqsod, nitigsxazk - qjrjtaznla) View more | ||||||
Phase 3 | 1,022 | (Trial 1) | tbuojdormz(jqicvewzfx) = rvuvswylvu bldavvvorb (axlkbjozef, 0.05) View more | Positive | 12 May 2023 | ||
Placebo (Trial 1) | tbuojdormz(jqicvewzfx) = ibjsfvuyov bldavvvorb (axlkbjozef, 0.05) View more | ||||||
Phase 3 | 1,831 | svixfgldtx(gbbhfzjmme) = xanhgdknlp ksskzwebsj (grkesclcec ) | - | 01 Apr 2023 | |||
rxnxtessmm(xvzdyblkqi) = gvufgikyue jjnxjlxmdk (jnyktnxrpc, 0 - 2.3) |





