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Breakthrough therapy
Nirogacestat
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    Nirogacestat

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    Nirogacestat
    Nirogacestat.png
    Clinical data
    Other names PF-03084014
    ATC code
    • None
    Identifiers
    • (S)-2-((S)-5,7-Difluoro-1,2,3,4-tetrahydronaphthalen-3-ylamino)-N-(1-(2-methyl-1-(neopentylamino)propan-2-yl)-1H-imidazol-4-yl)pentanamide
    CAS Number
    PubChem CID
    DrugBank
    ChemSpider
    UNII
    KEGG
    CompTox Dashboard (EPA)
    Chemical and physical data
    Formula C27H41F2N5O
    Molar mass 489.656 g·mol−1
    3D model (JSmol)
    • CCC[C@@](N[C@@]1([H])CCC2=CC(F)=CC(F)=C2C1)([H])/C(O)=N/C3=CN(C(C)(CNCC(C)(C)C)C)C=N3
    • InChI=1S/C27H41F2N5O/c1-7-8-23(32-20-10-9-18-11-19(28)12-22(29)21(18)13-20)25(35)33-24-14-34(17-31-24)27(5,6)16-30-15-26(2,3)4/h11-12,14,17,20,23,30,32H,7-10,13,15-16H2,1-6H3,(H,33,35)/t20-,23-/m0/s1
    • Key:VFCRKLWBYMDAED-REWPJTCUSA-N

    Nirogacestat (PF-03084014) is a selective gamma secretase inhibitor developed by SpringWorks Therapeutics that has potential anti-tumor activity. It was granted FDA breakthrough drug designation in September 2019 for adult patients with progressive, unresectable, recurrent or refractory desmoid tumors or deep fibromatosis.

    Medical uses

    Nirogacestat is currently in Phase 2 clinical trials for unresectable desmoid tumors. In addition, a Phase 3 clinical trial, DeFi, is currently in progress for nirogacestat for adults with desmoid tumors and aggressive fibromatosis. In addition, three trials are presently recruiting patients that include nirogacestat with other anticancer therapies in multiple myeloma, including the UNIVERSAL study for nirogacestat with the allogeneic CAR-T therapy ALLO-715.



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