Drugs / Fezolinetant

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved EU (EMA) Veoza 2023-12-07 europa.eu
Approved US (FDA) VEOZAH 2023-05-12 fda.gov

Trials 24 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 15 trials
Phase 1 NCT04793204 Mar → May 2021 Astellas Pharma Inc Completed No outcome recorded
Phase 1 NCT04641260 Nov 2020 → Feb 2021 Astellas Pharma Global Development, Inc. Completed No outcome recorded
Phase 1 NCT04482270 Sep 2020 → Mar 2021 Astellas Pharma Global Development, Inc. Completed No outcome recorded
Phase 1 NCT04476849 Aug 2020 → Mar 2022 impaired renal function disease Astellas Pharma Global Development, Inc. Completed No outcome recorded
Phase 1 NCT03436849 Feb → May 2018 Astellas Pharma Inc Completed No outcome recorded
Phase 28 trials
Phase 2 NCT07568236 Jul 2026 → Dec 2027 expected prostate cancer Chinese University of Hong Kong Not yet recruiting No outcome recorded
Phase 2 NCT06957691 Jan 2026 → Aug 2028 expected metastatic prostate carcinoma, prostate adenocarcinoma Shehzad Basaria, M.D. Recruiting No outcome recorded
Phase 2 NCT06972875 Dec 2025 → Jan 2027 expected prostate cancer University of Vermont Recruiting No outcome recorded
Phase 2 NCT06812754 Mar 2025 → Feb 2026 Astellas Pharma Global Development, Inc. Completed No outcome recorded
Phase 2 NCT06617455 Oct 2024 → Oct 2025 ductal breast carcinoma in situ, female breast carcinoma University of Michigan Rogel Cancer Center Terminated No outcome recorded
Phase 2 NCT05034042 Nov 2021 → Nov 2022 Astellas Pharma Inc Completed No outcome recorded
Phase 2 NCT03192176 Jul 2017 → Sep 2018 Astellas Pharma Global Development, Inc. Completed No outcome recorded
Phase 2 NCT05419908 Sep 2015 → Sep 2016 Ogeda S.A. Completed No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT06975111 Mar 2026 → Oct 2029 expected cardiovascular disorder University of Colorado, Denver Recruiting No outcome recorded
Phase 310 trials
Phase 3 NCT07606664 Sep 2026 → Nov 2029 expected premature menopause Rebecca Thurston Not yet recruiting No outcome recorded
Phase 3 NCT06440967 Jul 2024 → Jun 2026 overdue Astellas Pharma Global Development, Inc. Active not recruiting No outcome recorded
Phase 3 NCT06206421 Feb 2024 → Mar 2026 Astellas Pharma Inc Completed No outcome recorded
Phase 3 NCT06206408 Feb 2024 → Oct 2025 Astellas Pharma Inc Completed No outcome recorded
Phase 3 NCT05033886 Nov 2021 → Mar 2023 Astellas Pharma Global Development, Inc. Completed No outcome recorded
Phase 3 NCT04451226 Jul 2020 → Jun 2022 Astellas Pharma Inc Completed No outcome recorded
Phase 3 NCT04234204 Mar 2020 → Apr 2022 Astellas Pharma Inc Completed No outcome recorded
Phase 3 NCT04003155 Jul 2019 → Oct 2020 Astellas Pharma Global Development, Inc. Completed No outcome recorded
Phase 3 NCT04003389 Jul 2019 → Jan 2022 Astellas Pharma Global Development, Inc. Completed No outcome recorded
Phase 3 NCT04003142 Jul 2019 → Jul 2020 Astellas Pharma Global Development, Inc. Completed No outcome recorded
Also used as a comparator or background therapy in 1 trial
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 2 NCT06917313 Comparator Dec 2025 → Mar 2028 expected female breast carcinoma Yale University Recruiting No outcome recorded

Evidence & citations 11 cited values

Every value below carries the sentence it was read from. 27 sources stand behind the page.

FieldValueCited text
Known as Fezolinetant ClinicalTrials.gov intervention name — accepted as the source's own label NCT06812754
23

NCT04476849

NCT04482270

NCT07568236

NCT04641260

NCT06975111

NCT06957691

NCT06617455

NCT07606664

NCT06206408

NCT04793204

NCT05033886

NCT06972875

NCT04003155

NCT03192176

NCT05034042

NCT04003142

NCT05419908

NCT06917313

NCT04003389

NCT04234204

NCT06206421

NCT04451226

NCT06440967

Known as A-2693 ChEMBL registry synonym — accepted as the source's own label CHEMBL3608680
Known as AS-3472693-00 ChEMBL registry synonym — accepted as the source's own label CHEMBL3608680
Known as ES-256364 ChEMBL registry synonym — accepted as the source's own label CHEMBL3608680
Known as ESN364 ClinicalTrials.gov intervention name — accepted as the source's own label NCT03436849
Known as Veoza ChEMBL registry synonym — accepted as the source's own label CHEMBL3608680
Known as Veozah ChEMBL registry synonym — accepted as the source's own label CHEMBL3608680
Action Inhibit “fezolinetant, a selective neurokinin 3 receptor antagonist” PMID 32102086 Apr 2020
1

“Neurokinin 3 receptor antagonist” CHEMBL3608680

Modality Small molecule CHEMBL3608680
Route Oral “Participants received fezolinetant 15 mg capsules orally, BID for a period of 12 weeks.” NCT03192176
Target TACR3 “Neurokinin 3 receptor antagonist” CHEMBL3608680