Last update 28 Aug 2026

Fezolinetant

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
fezolinant, Fezolinetant (USAN), A2693
+ [7]
Target
Action
antagonists
Mechanism
NK3 antagonists(Neurokinin 3 receptor antagonists)
Originator Organization
License Organization-
Drug Highest PhaseApproved
First Approval Date
United States (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
United Kingdom
18 Dec 2023
Vasomotor symptom
United States
12 May 2023
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Menopausal syndromePhase 3
United States
10 Jul 2019
Menopausal syndromePhase 3
Canada
10 Jul 2019
Menopausal syndromePhase 3
Czechia
10 Jul 2019
Menopausal syndromePhase 3
Latvia
10 Jul 2019
Menopausal syndromePhase 3
Poland
10 Jul 2019
Menopausal syndromePhase 3
Spain
10 Jul 2019
Menopausal syndromePhase 3
Ukraine
10 Jul 2019
Menopausal syndromePhase 3
United Kingdom
10 Jul 2019
Adenocarcinoma of prostatePhase 2
United States
14 Jan 2026
Advanced Prostate CarcinomaPhase 2
United States
14 Jan 2026
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
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 )
Positive
30 Dec 2024
Phase 3
150
bslwmzuxzv(tlejmhvkey) = ndnhdgooya rvnxmlckmg (opsyqtyiuo )
Positive
01 May 2024
-
1,022
lppsoifyst(gxbzojmvva) = nlcmazidhv aruzusdxfv (uyvldtslrw )
Positive
01 May 2024
安慰剂
-
-
301
kdzlambmpd(sudopfqkxk): difference = -0.65 (95% CI)
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
Positive
30 Nov 2023
Placebo
Phase 2
87
Placebo
(Placebo)
wyiehesjgb(uufsrnaqls) = wkbwptvwcn nvhuzrfhdh (rvkmnqqsod, hmhiuwqtlv - tpixqiiieo)
-
25 Jul 2023
(Fezolinetant)
wyiehesjgb(uufsrnaqls) = tblovzeuwh nvhuzrfhdh (rvkmnqqsod, nitigsxazk - qjrjtaznla)
Phase 3
1,022
(Trial 1)
tbuojdormz(jqicvewzfx) = rvuvswylvu bldavvvorb (axlkbjozef, 0.05)
Positive
12 May 2023
Placebo
(Trial 1)
tbuojdormz(jqicvewzfx) = ibjsfvuyov bldavvvorb (axlkbjozef, 0.05)
Phase 3
1,831
svixfgldtx(gbbhfzjmme) = xanhgdknlp ksskzwebsj (grkesclcec )
-
01 Apr 2023
rxnxtessmm(xvzdyblkqi) = gvufgikyue jjnxjlxmdk (jnyktnxrpc, 0 - 2.3)
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Core Patent

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Clinical Trial

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Approval

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Regulation

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