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    DRUG CLASS:

    γ-secretase inhibitor

    Related drugs:
    10d
    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)
    17d
    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)
    17d
    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, Recruiting, Springworks Therapeutics Inc.
    New P1 trial
    |
    Ogsiveo (nirogacestat)
    1m
    A Study of a New Drug, Nirogacestat, for Treating Desmoid Tumors That Cannot be Removed by Surgery (clinicaltrials.gov)
    P2, N=35, Active, not recruiting, Children's Oncology Group | Trial completion date: Mar 2026 --> Dec 2032
    Trial completion date
    |
    CTNNB1 (Catenin (cadherin-associated protein), beta 1)
    |
    Ogsiveo (nirogacestat)
    2ms
    Phase II clinical trial of nirogacestat in patients with relapsed ovarian granulosa cell tumours. (PubMed, Clin Transl Med)
    This Phase II clinical trial of a rare tumour achieved its enrolment target in under 1 year and completed primary analysis within 2 years. 87% (46 of 53 patients who received nirogacestat) had fresh or archival biopsies that were analysed by next-generation sequencing for mutational profiling. Of the 3 patients with activating NOTCH1 mutations, all achieved 6-month progression-free survival (PFS6); 8 other patients also achieved PFS6 but did not share a common mutation.
    P2 data • Journal
    |
    NOTCH1 (Notch 1) • NOTCH2 (Notch 2) • NOTCH3 (Notch Receptor 3) • FOXL2 (Forkhead Box L2)
    |
    Ogsiveo (nirogacestat)
    3ms
    NIR-OGT-201: Nirogacestat in Ovarian Granulosa Cell Tumors (clinicaltrials.gov)
    P2, N=53, Completed, SpringWorks Therapeutics, Inc. | Active, not recruiting --> Completed | Trial completion date: Dec 2027 --> Jul 2025 | Trial primary completion date: Jul 2026 --> Jul 2025
    Trial completion • Trial completion date • Trial primary completion date
    |
    Ogsiveo (nirogacestat)
    3ms
    To Determine the Effect of CYP Induction Following Administration of Nirogacestat in Healthy Adult Male Participants (clinicaltrials.gov)
    P1, N=16, Recruiting, SpringWorks Therapeutics, Inc.
    New P1 trial
    |
    Ogsiveo (nirogacestat) • midazolam hydrochloride • omeprazole
    3ms
    A Study of a New Drug, Nirogacestat, for Treating Desmoid Tumors That Cannot be Removed by Surgery (clinicaltrials.gov)
    P2, N=35, Active, not recruiting, Children's Oncology Group | Trial completion date: Dec 2025 --> Mar 2026 | Trial primary completion date: Dec 2025 --> Mar 2026
    Trial completion date • Trial primary completion date
    |
    CTNNB1 (Catenin (cadherin-associated protein), beta 1)
    |
    Ogsiveo (nirogacestat)
    4ms
    Implication of an exosome-based gene signature for estimating clinical outcomes of triple-negative breast cancer and assisting in individualized therapy. (PubMed, Sci Rep)
    High-risk tumors owned shorter overall survival time, but were suitable for treatment with docetaxel and several small-molecule agents (MK-0752, BRD-K33199242, IC-87114, fumonisin B1, ilomastat, GW-788388, afobazole, and batimastat). Experimentally, inhibition of FAM129B effectively attenuated proliferative and aggressive phenotypes of TNBC cells. Collectively, our findings proposed the exosome-based gene signature for accurate estimation of clinical outcomes and assisting in individually tailoring therapies in TNBC as well as discovered FAM129B as a potential therapeutic target.
    Clinical data • Journal • Gene Signature • IO biomarker
    |
    CD276 (CD276 Molecule) • TNFRSF4 (TNF Receptor Superfamily Member 4) • SERPINE1 (Serpin Family E Member 1) • THY1 (Thy-1 membrane glycoprotein) • NRP1 (Neuropilin 1) • TNFSF4 (TNF Superfamily Member 4) • KRT6A (Keratin 6A) • PGK1 (Phosphoglycerate Kinase 1)
    |
    docetaxel • MK-0752
    4ms
    The role of YTHDF1 in the diagnosis and prognosis of lung adenocarcinoma and its inhibitor LY-411575 in the targeted intervention of lung adenocarcinoma growth. (PubMed, Transl Cancer Res)
    Our study indicates that elevated expression of YTHDF1 is a predictor of poor prognosis in patients with LUAD and may serve as a potential diagnostic biomarker and therapeutic target for this disease. In addition, we identified LY-411575 as a YTHDF1 inhibitor that effectively inhibits the proliferation of LUAD cells in vivo and in vitro, highlighting its potential as a LUAD targeted therapy.
    Journal
    |
    YTHDF1 (YTH N6-Methyladenosine RNA Binding Protein 1)
    |
    LY-411575
    5ms
    A Study of a New Drug, Nirogacestat, for Treating Desmoid Tumors That Cannot be Removed by Surgery (clinicaltrials.gov)
    P2, N=35, Active, not recruiting, Children's Oncology Group | Trial completion date: Sep 2025 --> Dec 2025 | Trial primary completion date: Sep 2025 --> Dec 2025
    Trial completion date • Trial primary completion date
    |
    CTNNB1 (Catenin (cadherin-associated protein), beta 1)
    |
    Ogsiveo (nirogacestat)
    5ms
    A Varegacestat Hepatic Impairment Study (clinicaltrials.gov)
    P1, N=44, Active, not recruiting, Immunome, Inc. | Recruiting --> Active, not recruiting
    Enrollment closed
    |
    varegacestat (AL102)