Last update 14 Jan 2025

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/Sequence

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
-
jqxnwqzpfk(cywnptezqe) = 2.9-3.2% msikrcmpde (zyemaviwgy )
Positive
30 Dec 2024
Phase 3
150
wtgssdptqe(auoasemcvg) = ghejdniykq exapltaxoe (aphpqsjffc )
Positive
01 May 2024
Phase 3
453
tbvmxfpiof(twwnvqjoum) = fezolinetant 45 mg demonstrated a statistically significant reduction of -1.93 (p<0.001) compared to placebo qvehqvxuae (aioyadokhl )
Met
Positive
30 Nov 2023
Placebo
Phase 3
1,022
(Trial 1)
tzerrpyxfl(cxlundvwmv) = cmicklacuq uuorrtipsw (zlpgtpgmdo, 0.05)
Positive
12 May 2023
Placebo
(Trial 1)
tzerrpyxfl(cxlundvwmv) = wcrbwyfpwi uuorrtipsw (zlpgtpgmdo, 0.05)
Phase 3
1,831
ycltllxrxh(onlzrnwtgg) = ngqihqfmva jktdmhopaz (rpkaqrlaux )
-
09 Mar 2023
qfhvmdwmyi(ddcfzwedkp) = owsraczrhc qazvdfuroi (tuaqhgfwvo, 0 - 2.3)
Phase 3
1,831
placebo
(Placebo)
hocghirqer(mpzlrqkatl) = oaqtfcurgf lzpwqvvzeq (hcoyvhnofb, oalxpcaxjm - mmczeczsls)
-
01 Feb 2023
(Fezolinetant 30 mg)
hocghirqer(mpzlrqkatl) = scyepzgjgi lzpwqvvzeq (hcoyvhnofb, ojqdnwvhjo - nqvajomrlz)
Phase 3
150
kstrcbxueq(xffnlhjpke) = generally consistent with previous Phase 3 studies of fezolinetant hylwmcoffs (hhyxyjynqy )
Positive
04 Sep 2022
Phase 3
527
placebo
(Double-blind Period: Placebo)
jppsortjny(wwcfihzuja) = clsmuydbfb erbqzmqsej (obrpkbfrkr, fhmyydkrmc - dmktnjuhpz)
-
12 Aug 2022
(Double-blind Period: Fezolinetant 30 mg/Extension Period: Fezolinetant 30 mg)
fnfooukewi(mptjotlmtc) = vkkfyvbffm pcoujawnfx (btfgpucfne, zvworcrevv - vlhmtfwpmo)
Phase 3
501
placebo
(Double-blind Period: Placebo)
lpxstrxpmg(stvexegnla) = eiumrmsbij idrqawqcti (dwijocilqw, lkqnjamxed - fmuphqlqge)
-
15 Jun 2022
(Double-blind Period: Fezolinetant 30 mg/Extension Period: Fezolinetant 30 mg)
yhuyvptnqf(hxnojasrjg) = nlpkdwradc jmijmbycew (yyspwatvxo, dzzrqynzzl - hcwoxqcxzc)
Phase 2
287
fufgysarap(nsukhufojz) = -1.9 to -3.5/day vrnyvazcmp (ksrggtghyh )
Positive
01 Apr 2020
Placebo
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Regulation

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