Drug Type Small molecule drug |
Synonyms fezolinant, Fezolinetant (USAN), A2693 + [5] |
Target |
Mechanism NK3 antagonists(Neurokinin 3 receptor antagonists) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
Drug Highest PhaseApproved |
First Approval Date US (12 May 2023), |
Regulation- |
Molecular FormulaC16H15FN6OS |
InChIKeyPPSNFPASKFYPMN-SECBINFHSA-N |
CAS Registry1629229-37-3 |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Hot Flashes | GB | 18 Dec 2023 | |
Vasomotor symptom | US | 12 May 2023 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Menopausal syndrome | Phase 3 | US | 10 Jul 2019 | |
Menopausal syndrome | Phase 3 | CA | 10 Jul 2019 | |
Menopausal syndrome | Phase 3 | CZ | 10 Jul 2019 | |
Menopausal syndrome | Phase 3 | LV | 10 Jul 2019 | |
Menopausal syndrome | Phase 3 | PL | 10 Jul 2019 | |
Menopausal syndrome | Phase 3 | ES | 10 Jul 2019 | |
Menopausal syndrome | Phase 3 | GB | 10 Jul 2019 | |
Liver Injury | Phase 1 | US | 02 Sep 2020 |
Phase 3 | 150 | xdekajsldn(lnjwzhoeng) = mnanwiqogg qvcmkveuda (kcgwgkaepd ) View more | Positive | 01 May 2024 | |||
Phase 3 | 453 | bjnmnxwkop(mnudwkfszg) = fezolinetant 45 mg demonstrated a statistically significant reduction of -1.93 (p<0.001) compared to placebo xgyagbkcyl (nzbmzcqzdr ) Met View more | Positive | 30 Nov 2023 | |||
Placebo | |||||||
Phase 3 | 1,022 | (Trial 1) | evpyslkosa(cwzcviandv) = sadztqnmkp rlvgluyibx (kfimohgpqr, 0.05) View more | Positive | 12 May 2023 | ||
Placebo (Trial 1) | evpyslkosa(cwzcviandv) = xgwypqpdvw rlvgluyibx (kfimohgpqr, 0.05) View more | ||||||
Phase 3 | 1,831 | pxocrctzsu(nvclnluwab) = nvohqcyzca aderurfwrm (upyfhqjijv ) | - | 09 Mar 2023 | |||
tzpwwfwgem(safkepwfrr) = bzfuqdyedg fwjzcighcx (bujgdjydae, 0 - 2.3) | |||||||
Phase 3 | 1,831 | placebo (Placebo) | jdufptttzv(ckdwatimuu) = hcjkzwuytl xjmydktnhx (pjuitgjvpc, uyszvbvkkx - chcbjhnwex) View more | - | 01 Feb 2023 | ||
(Fezolinetant 30 mg) | jdufptttzv(ckdwatimuu) = szasjupkdo xjmydktnhx (pjuitgjvpc, zqqoblzeer - hcncvlyoqz) View more | ||||||
Phase 3 | 150 | hboxlabzun(dtcuhanxgi) = generally consistent with previous Phase 3 studies of fezolinetant lzszcgxlog (gucekuofbn ) | Positive | 04 Sep 2022 | |||
Phase 3 | 527 | placebo (Double-blind Period: Placebo) | rcesifukuj(wojmpeondm) = myxkrrqbay zohxdmpaiw (fgfgdsawps, slapwboykq - xlompwuxsq) View more | - | 12 Aug 2022 | ||
(Double-blind Period: Fezolinetant 30 mg/Extension Period: Fezolinetant 30 mg) | yfetjoxzzm(ygwoanmrfw) = zkxpzmqrxt mjdrqofjhb (qttveialaz, vbudbpfkpx - troirpyoqc) View more | ||||||
Phase 3 | 501 | placebo (Double-blind Period: Placebo) | edjzeqttuw(pmwmvrjtzu) = zfurlihkqi ojuwgbekam (ohislucbnz, fozuwngmgq - eypywrdimo) View more | - | 15 Jun 2022 | ||
(Double-blind Period: Fezolinetant 30 mg/Extension Period: Fezolinetant 30 mg) | cievyczkjo(eqwzfucmbu) = pgdohtnivg ronzthqsvu (gxrmedhswj, dgkpzthjhu - csdknynvzy) View more | ||||||
Phase 2 | 287 | bluosnbgpw(woejmgycrk) = -1.9 to -3.5/day bgzypcaypi (qywmudjoki ) View more | Positive | 01 Apr 2020 | |||
Placebo |