Drugs / Nirogacestat

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved EU (EMA) Ogsiveo 2025-08-14 europa.eu
Approved US (FDA) OGSIVEO 2023-11-27 fda.gov

Trials 25 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 17 trials
Phase 1 NCT05556798 Oct 2022 → Oct 2026 expected plasma cell myeloma Memorial Sloan Kettering Cancer Center Active not recruiting No outcome recorded
Phase 1 NCT05137054 Aug 2022 → Mar 2028 expected plasma cell myeloma Regeneron Pharmaceuticals Recruiting No outcome recorded
Phase 1 NCT04171843 Apr 2020 → Oct 2022 refractory plasma cell neoplasm Precision BioSciences, Inc. Terminated No outcome recorded
Phase 1 NCT04093596 Sep 2019 → Jan 2025 refractory plasma cell neoplasm Allogene Therapeutics Completed No outcome recorded
Phase 1 NCT02462707 Jul 2015 → Jun 2016 cancer Pfizer Withdrawn No outcome recorded
Phase 1 NCT01876251 Nov 2013 → Dec 2015 breast carcinoma Pfizer Terminated No outcome recorded
Phase 1 NCT00878189 Jun 2009 → Jan 2013 neoplasm Pfizer Completed No outcome recorded
Phase 1/22 trials
Phase 1/2 NCT07084896 Jun 2020 → Apr 2025 overdue plasma cell myeloma GlaxoSmithKline Active not recruiting No outcome recorded
Phase 1/2 NCT04126200 Oct 2019 → Apr 2025 overdue plasma cell myeloma GlaxoSmithKline Active not recruiting No outcome recorded
Phase 212 trials
Phase 2 NCT07539454 Sep 2026 → Feb 2030 expected Kaposi's sarcoma AIDS Malignancy Consortium Not yet recruiting No outcome recorded
Phase 2 NCT07170644 Aug 2025 → May 2027 expected desmoid tumor SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany Active not recruiting No outcome recorded
Phase 2 NCT05879146 Nov 2024 → Jan 2027 expected neoplasm M.D. Anderson Cancer Center Recruiting No outcome recorded
Phase 2 NCT05949099 Aug 2023 → Feb 2028 expected desmoid tumor Nam Bui Recruiting No outcome recorded
Phase 2 NCT05348356 Aug 2022 → Jul 2025 ovarian cancer, ovarian granulosa cell tumor SpringWorks Therapeutics, Inc. Completed No outcome recorded
Phase 2 NCT05090566 Oct 2021 → Feb 2025 plasma cell myeloma Pfizer Terminated No outcome recorded
Phase 2 NCT04195399 Oct 2020 → Mar 2026 overdue desmoid tumor Children's Oncology Group Active not recruiting No outcome recorded
Phase 2 NCT02137564 Jul 2015 HIV infectious disease, Kaposi's sarcoma AIDS Malignancy Consortium Withdrawn No outcome recorded
Phase 2 NCT02338531 Jun 2015 → Sep 2018 breast cancer Jules Bordet Institute Withdrawn No outcome recorded
Phase 2 NCT02299635 Feb 2015 → Jan 2016 triple-negative breast carcinoma Pfizer Terminated No outcome recorded
Phase 31 trial
Phase 3 NCT03785964 Apr 2019 → Apr 2022 desmoid tumor SpringWorks Therapeutics, Inc. Completed No outcome recorded
Phase 41 trial
Phase 4 NCT07176689 Sep 2025 → Jan 2031 expected desmoid tumor SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany Recruiting No outcome recorded
Phase not stated2 trials
NCT05041036 desmoid tumor SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany Available No outcome recorded
NCT02955446 desmoid tumor University of Colorado, Denver No longer available No outcome recorded
Also used as a comparator or background therapy in 6 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 13 trials
Phase 1 NCT07259330 Comparator Oct 2025 → Mar 2026 SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany Completed No outcome recorded
Phase 1 NCT07171619 Comparator Aug → Nov 2025 SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany Completed No outcome recorded
Phase 1 NCT04722146 Background Mar 2021 → Oct 2025 overdue plasma cell myeloma Janssen Research & Development, LLC Active not recruiting No outcome recorded
Phase 1/23 trials
Phase 1/2 NCT05573802 Background Jul 2023 → Oct 2026 expected corneal disorder, monoclonal paraproteinemia disease, plasma cell myeloma Hellenic Society of Hematology Recruiting No outcome recorded
Phase 1/2 NCT07150104 Background Aug 2022 → Apr 2025 overdue plasma cell myeloma GlaxoSmithKline Active not recruiting No outcome recorded
Phase 1/2 NCT07150091 Background Jul 2022 → Apr 2025 overdue plasma cell myeloma GlaxoSmithKline Active not recruiting No outcome recorded

Press releases naming this drug 1 release

DateIssuerRelease
2020-10-05 Pfizer SpringWorks Therapeutics Announces Clinical Collaboration with PfizerInc. to Evaluate Nirogacestat in Combination with PF‐06863135 in Patients with Relapsed or Refractory Multiple Myeloma pfizer.com

Evidence & citations 10 cited values

Every value below carries the sentence it was read from. 33 sources stand behind the page.

FieldValueCited text
Known as Nirogacestat ClinicalTrials.gov intervention name — accepted as the source's own label NCT05041036
21

NCT05348356

NCT03785964

NCT07170644

NCT07084896

NCT07539454

NCT05879146

NCT05137054

NCT07171619

NCT07150091

NCT07176689

NCT04093596

NCT05949099

NCT05573802

NCT04722146

NCT04195399

NCT07150104

NCT07259330

NCT04126200

NCT05556798

NCT05090566

NCT04171843

Known as Nirogacestat dihydrobromide ChEMBL registry synonym — accepted as the source's own label CHEMBL1770916
Known as NIROGACESTAT HYDROBROMIDE ChEMBL registry synonym — accepted as the source's own label CHEMBL1770916
Known as Ogsiveo ChEMBL registry synonym — accepted as the source's own label CHEMBL1770916
Known as PF 3084014 ChEMBL registry synonym — accepted as the source's own label CHEMBL1770916
Known as PF-03084014 “nirogacestat (a gamma-secretase inhibitor; PF-03084014)” PMID 33682447 Mar 2021
10

PF-03084014NCT02137564

NCT02109445

NCT02137564

NCT02299635

NCT02338531

NCT00878189

NCT02462707

NCT01876251

NCT01981551

NCT02955446

Known as PF-03084014-04 ChEMBL registry synonym — accepted as the source's own label CHEMBL1770916
Action Inhibit “gamma-secretase inhibitor” NCT00878189
Modality Small molecule “Treatment with the selective small-molecule \>=-secretase inhibitor PF- 3084014 caused significant tumor shrinkage” NCT01981551
Route Oral “PF 03084014 will be administered orally” NCT01876251