^
    Contact us  to learn more about
    our Premium Content:  News alerts, weekly reports and conference planners
    DRUG:

    Ogsiveo (nirogacestat)

    i
    Other names: PF-03084014 , PF03084014, PF 03084014
    Company:
    EMD Serono
    Drug class:
    γ-secretase inhibitor
    Related drugs:
    5d
    DREAMM 5: Platform Study of Belantamab Mafodotin as Monotherapy and in Combination With Anti-cancer Treatments in Participants With Relapsed/Refractory Multiple Myeloma (RRMM) (clinicaltrials.gov)
    P1/2, N=208, Active, not recruiting, GlaxoSmithKline | Phase classification: P2 --> P1/2
    Phase classification
    |
    lenalidomide • Jemperli (dostarlimab-gxly) • dexamethasone • pomalidomide • Sarclisa (isatuximab-irfc) • Blenrep (belantamab mafodotin-blmf) • Ogsiveo (nirogacestat) • feladilimab (GSK3359609) • GSK3174998
    10d
    To Determine the Effect of CYP Induction Following Administration of Nirogacestat in Healthy Adult Male Participants (clinicaltrials.gov)
    P1, N=20, Completed, SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany | Active, not recruiting --> Completed
    Trial completion
    |
    Ogsiveo (nirogacestat) • midazolam hydrochloride • omeprazole
    18d
    MagnetisMM-4: Umbrella Study of Elranatamab (PF-06863135) in Combination With Anti-Cancer Treatments in Multiple Myeloma (clinicaltrials.gov)
    P2, N=46, Terminated, Pfizer | Active, not recruiting --> Terminated; A business decision was made by Pfizer to terminate the study and not proceed with the Phase 2 expansion of this study. The reason for study termination is not due to any safety concerns or requests from regulatory authorities.
    Trial termination
    |
    lenalidomide • dexamethasone • Elrexfio (elranatamab-bcmm) • Ogsiveo (nirogacestat)
    21d
    Nirogacestat in Patients With Kaposi Sarcoma (clinicaltrials.gov)
    P2, N=28, Not yet recruiting, AIDS Malignancy Consortium
    New P2 trial
    |
    CD4 (CD4 Molecule)
    |
    Ogsiveo (nirogacestat)
    27d
    A Study of a New Drug, Nirogacestat, for Treating Desmoid Tumors That Cannot be Removed by Surgery (clinicaltrials.gov)
    P2, N=31, Active, not recruiting, Children's Oncology Group | Trial completion date: Dec 2032 --> Apr 2027
    Trial completion date
    |
    CTNNB1 (Catenin (cadherin-associated protein), beta 1)
    |
    Ogsiveo (nirogacestat)
    1m
    Nirogacestat in Premenopausal Females With Desmoid Tumor/Aggressive Fibromatosis (DT/AF) (clinicaltrials.gov)
    P4, N=50, Recruiting, SpringWorks Therapeutics, Inc.
    Trial initiation date
    |
    Ogsiveo (nirogacestat)
    1m
    A Study of Nirogacestat in Japanese Adults With Desmoid Tumors/Aggressive Fibromatosis (DT/AF) (clinicaltrials.gov)
    P2, N=20, Active, not recruiting, SpringWorks Therapeutics, Inc. | Recruiting --> Active, not recruiting | Trial completion date: Dec 2030 --> Oct 2029 | Trial primary completion date: May 2028 --> Mar 2027
    Enrollment closed • Trial completion date • Trial primary completion date
    |
    Ogsiveo (nirogacestat)
    1m
    Evaluate the Effects of Famotidine or Rabeprazole on the PK of Nirogacestat (clinicaltrials.gov)
    P1, N=24, Completed, SpringWorks Therapeutics, Inc. | Recruiting --> Completed
    Trial completion
    |
    Ogsiveo (nirogacestat)
    1m
    To Determine the Effect of CYP Induction Following Administration of Nirogacestat in Healthy Adult Male Participants (clinicaltrials.gov)
    P1, N=20, Active, not recruiting, SpringWorks Therapeutics, Inc. | Recruiting --> Active, not recruiting | Trial completion date: Oct 2026 --> Mar 2026
    Enrollment closed • Trial completion date • Trial initiation date
    |
    Ogsiveo (nirogacestat) • midazolam hydrochloride • omeprazole
    3ms
    NIR-DT-106: Phase 1 Study to Determine the Effect of CYP Induction Following Administration of Nirogacestat in Healthy Men Participants (2025-521402-18-00)
    P1, N=16, Active, not recruiting, Springworks Therapeutics Inc. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    Ogsiveo (nirogacestat)
    3ms
    MagnetisMM-4: Umbrella Study of Elranatamab (PF-06863135) in Combination With Anti-Cancer Treatments in Multiple Myeloma (clinicaltrials.gov)
    P2, N=46, Active, not recruiting, Pfizer | N=34 --> 46
    Enrollment change
    |
    lenalidomide • dexamethasone • Elrexfio (elranatamab-bcmm) • Ogsiveo (nirogacestat)
    3ms
    NIR-DT-401: An Open-label, Phase 4 Study of Nirogacestat in Adult Premenopausal Females with Desmoid Tumor/Aggressive Fibromatosis (DT/AF). (2024-515215-21-00)
    P4, N=47, Recruiting, Springworks Therapeutics Inc.
    New P4 trial
    |
    Ogsiveo (nirogacestat)