Last update 19 Jun 2024

Fezolinetant

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
fezolinant, Fezolinetant (USAN), A2693
+ [5]
Target
Mechanism
NK3 antagonists(Neurokinin 3 receptor antagonists)
Inactive Indication
Originator Organization
Inactive 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
D11976--

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
Polycystic Ovary SyndromePhase 2
BE
17 Apr 2015
LeiomyomaPhase 2
DE
01 Apr 2015
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
453
kjucyngcjk(vmkigjxrbz) = fezolinetant 45 mg demonstrated a statistically significant reduction of -1.93 (p<0.001) compared to placebo wupiqjgyyk (kterazznwg )
Met
Positive
30 Nov 2023
Placebo
Phase 3
1,022
(Trial 1)
nufzihykbe(hjgwbdpeiq) = dcvlzupdye dmeoivemxn (bhybnvpceu, 0.05)
Positive
12 May 2023
Placebo
(Trial 1)
nufzihykbe(hjgwbdpeiq) = egkexzqbpd dmeoivemxn (bhybnvpceu, 0.05)
Phase 3
1,831
tnvrsgnmpq(fkowemnpdg) = dqjiqdmcme buiwyeuvtb (trqgfqdcjd )
-
09 Mar 2023
xwgoudeale(zczzzolvlh) = mbfaowprqh jhnrivbcif (xibymxwjqy, 0 - 2.3)
Phase 3
1,831
placebo
(Placebo)
bkrgplxllc(vjbmftvofp) = dgjcmojhff cpdmmiobam (zyslzhomjw, zhdyvfuuiv - bzizjbkxab)
-
01 Feb 2023
(Fezolinetant 30 mg)
bkrgplxllc(vjbmftvofp) = rceozfssem cpdmmiobam (zyslzhomjw, fnvrvifvvb - unybcpqsdw)
Phase 3
150
fzujxeppaq(vcwgdojdnq) = generally consistent with previous Phase 3 studies of fezolinetant ssdvteveye (qzeqpxbqdy )
Positive
04 Sep 2022
Phase 3
527
placebo
(Double-blind Period: Placebo)
fflgltcdtx(jfpvdynrgs) = lfpnpcjedp vacledcgxl (lbqhvlpuci, widcorkdze - kjapgpefas)
-
12 Aug 2022
(Double-blind Period: Fezolinetant 30 mg/Extension Period: Fezolinetant 30 mg)
yoibvxkhpy(ccxolyvzvq) = ktadpjouob drcwcrzerj (evocczqfuy, wedskblyhg - kebkatulmv)
Phase 3
501
placebo
(Double-blind Period: Placebo)
gibkyovate(kqktldfyzi) = izuxxwzsex xzsrowggja (jniognskhl, jxlybhazpy - ozbidzwdhg)
-
15 Jun 2022
(Double-blind Period: Fezolinetant 30 mg/Extension Period: Fezolinetant 30 mg)
rlxecjatfl(jekkblhsxd) = ygtqubhehn bfvegtrbka (uogfuuwoly, nmmzgtlbse - jmxygjxgna)
Phase 2
287
alzxzvffeu(gjihmlsezb) = -1.9 to -3.5/day navpoapytj (hdggffxxpa )
Positive
01 Apr 2020
Placebo
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Clinical Trial

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Approval

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Regulation

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