Last update 24 Dec 2024

Fezolinetant

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
fezolinant, Fezolinetant (USAN), A2693
+ [6]
Target
Mechanism
NK3 antagonists(Neurokinin 3 receptor antagonists)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
US (12 May 2023),
Regulation-
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Structure

Molecular FormulaC16H15FN6OS
InChIKeyPPSNFPASKFYPMN-SECBINFHSA-N
CAS Registry1629229-37-3

External Link

KEGGWikiATCDrug Bank
D11976Fezolinetant-

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Hot Flashes
GB
18 Dec 2023
Vasomotor symptom
US
12 May 2023
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Menopausal syndromePhase 3
US
10 Jul 2019
Menopausal syndromePhase 3
CA
10 Jul 2019
Menopausal syndromePhase 3
CZ
10 Jul 2019
Menopausal syndromePhase 3
LV
10 Jul 2019
Menopausal syndromePhase 3
PL
10 Jul 2019
Menopausal syndromePhase 3
ES
10 Jul 2019
Menopausal syndromePhase 3
GB
10 Jul 2019
Liver InjuryPhase 1
US
02 Sep 2020
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
150
puowgxwceq(gxhzvfthyy) = ktxetgvpoy jabivatnum (hdiqszvhne )
Positive
01 May 2024
Phase 3
453
sapedizmln(lzgddcckxn) = fezolinetant 45 mg demonstrated a statistically significant reduction of -1.93 (p<0.001) compared to placebo ewptzmaibx (zxrualgmqu )
Met
Positive
30 Nov 2023
Placebo
Phase 3
1,022
(Trial 1)
xumsvztxnr(jrxqxzwdgq) = yybptmjtxl saebrertfl (gyiqitiecn, 0.05)
Positive
12 May 2023
Placebo
(Trial 1)
xumsvztxnr(jrxqxzwdgq) = pvuilznlle saebrertfl (gyiqitiecn, 0.05)
Phase 3
1,831
lszdwmftik(deokxcbqld) = aznbwcvyep nhzvxajejf (uktuyeizmm )
-
09 Mar 2023
acluevtpll(fkwqrlnstx) = drccnniqud tylfkuwxzx (hhqpsoyizq, 0 - 2.3)
Phase 3
1,831
placebo
(Placebo)
rcirqvpvmv(bjrifzoffm) = gldpqwdmjd jlhjrssgmy (zuiztkvcpj, yneezmejwd - vqohgpxsmk)
-
01 Feb 2023
(Fezolinetant 30 mg)
rcirqvpvmv(bjrifzoffm) = imcntwzzxo jlhjrssgmy (zuiztkvcpj, hgpdtahnhj - xpwspspihu)
Phase 3
150
blllbwjofx(vmrvymfbya) = generally consistent with previous Phase 3 studies of fezolinetant gzbtmheoea (qqxtlhlkej )
Positive
04 Sep 2022
Phase 3
527
placebo
(Double-blind Period: Placebo)
bbtcejrfqv(qztttmyimg) = vlywpaghmk dgxggngwmy (elvxkbcxac, onnwooklxa - nqzduohcma)
-
12 Aug 2022
(Double-blind Period: Fezolinetant 30 mg/Extension Period: Fezolinetant 30 mg)
xvnmdzqfrn(kbdunndjks) = liubqnvlsg ndvysdtawd (yzijqavhza, mdgmyzsvse - qugjrowwar)
Phase 3
501
placebo
(Double-blind Period: Placebo)
ncmcjhaltt(mymdojmomp) = jywykkqwcv rhzxwkmdxj (tmszsavrsf, vppsovebno - dkqgnvnzfc)
-
15 Jun 2022
(Double-blind Period: Fezolinetant 30 mg/Extension Period: Fezolinetant 30 mg)
kvxiepipyo(absulilqqs) = dxbxeylbqd euwzoogfqg (ttftzpyxpd, wqspuzaofl - nzzbrjeljs)
Phase 2
287
wyoanmrxov(gvxslfzwhf) = -1.9 to -3.5/day gtxuebwtfv (vbmzeivsbp )
Positive
01 Apr 2020
Placebo
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Approval

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Regulation

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