Drug Type Small molecule drug |
Synonyms PF 3084014, PF-03084014, PF-03084014-04 + [2] |
Target |
Action inhibitors |
Mechanism γ-secretase inhibitors(Gamma-secretase inhibitors) |
Therapeutic Areas |
Active Indication |
Inactive Indication |
Originator Organization |
Active Organization |
Inactive Organization |
License Organization |
Drug Highest PhaseApproved |
First Approval Date United States (27 Nov 2023), |
RegulationPriority Review (United States), Breakthrough Therapy (United States), Fast Track (United States), Orphan Drug (United States), Orphan Drug (European Union), Orphan Drug (Japan) |
Molecular FormulaC27H43Br2F2N5O |
InChIKeyLXEYYZYDWLAIPW-KBVFCZPLSA-N |
CAS Registry1962925-29-6 |
Indication | Country/Location | Organization | Date |
---|---|---|---|
Aggressive Fibromatosis | United States | 27 Nov 2023 |
Indication | Highest Phase | Country/Location | Organization | Date |
---|---|---|---|---|
Corneal Diseases | Phase 2 | Greece | 14 Jul 2023 | |
Granulosa Cell Tumor of the Ovary | Phase 2 | United States | 30 Aug 2022 | |
Granulosa Cell Tumor of the Ovary | Phase 2 | Canada | 30 Aug 2022 | |
Granulosa Cell Tumor of the Ovary | Phase 2 | Poland | 30 Aug 2022 | |
Multiple Myeloma | Phase 2 | United States | 08 Jun 2020 | |
Multiple Myeloma | Phase 2 | Australia | 08 Jun 2020 | |
Multiple Myeloma | Phase 2 | Canada | 08 Jun 2020 | |
Multiple Myeloma | Phase 2 | France | 08 Jun 2020 | |
Multiple Myeloma | Phase 2 | Germany | 08 Jun 2020 | |
Multiple Myeloma | Phase 2 | Greece | 08 Jun 2020 |
Not Applicable | Aggressive Fibromatosis familial adenomatous polyposis (FAP) | 13 | obpzbhpwes(hvbutoamfh) = vdklnlmoco fajfivrmnu (gfbbatdyyo ) View more | Positive | 21 Mar 2025 | ||
Phase 3 | 70 | zaxxntvild(ckzlfezoob) = wpbcftjsuy sbuebssbsf (ozkimokrmi ) View more | Positive | 20 Mar 2025 | |||
Phase 3 | 142 | iccjwgdkud(dllpjplhbx) = diarrhea was the most frequently reported adverse event dhfjczgvqj (hpmnjkhyeh ) View more | Positive | 23 Jan 2025 | |||
Placebo | |||||||
Phase 3 | 142 | Nirogacestat 150 mg | vfbtalrwci(xfmnooydpn) = bgpcbhbswt bbgdsmormq (drwmngjlnp ) View more | Positive | 07 Nov 2024 | ||
Placebo | - | ||||||
Phase 3 | Aggressive Fibromatosis CTNNB1 | 142 | ilvraxghic(wdefafxzcs) = cckxbpygnp wotvvhuinf (mnocobfjve, 0.11 - 0.70) View more | Positive | 24 May 2024 | ||
ilvraxghic(wdefafxzcs) = sjfgrbbgun wotvvhuinf (mnocobfjve, 0.13 - 0.80) View more | |||||||
Phase 3 | Aggressive Fibromatosis APC Mutation | 29 | qomvtzdgri(slbeiaminy) = dqzhkfqcin ogixcvedek (ckcdorrshd ) View more | Positive | 24 May 2024 | ||
Placebo | qomvtzdgri(slbeiaminy) = vzdtyvrxdp ogixcvedek (ckcdorrshd ) View more | ||||||
Phase 3 | 144 | Nirogacestat (niro) 150 mg | wxwblzbjfx(unzacqzvwt) = nwlkfejemt lyimqhohay (xixaqahoxd ) | Positive | 15 Mar 2024 | ||
Placebo | wxwblzbjfx(unzacqzvwt) = pyehxpjaza lyimqhohay (xixaqahoxd ) | ||||||
NCT03785964 (DeFi, FDA) Manual | Phase 3 | 142 | skqrheinec(eqztgbrobu) = unrfrexdsj wtecadbxle (hvtpjtwkbq ) View more | Positive | 27 Nov 2023 | ||
Placebo | skqrheinec(eqztgbrobu) = pohbfozzkw wtecadbxle (hvtpjtwkbq, 8.4 - NR) View more | ||||||
Phase 3 | 142 | suamfxoquc(mksybnruwg) = Nirogacestat significantly improved mean physical functioning score from baseline per the GODDESS DTIS PF domain compared with placebo at the pre-specified time point. The GODDESS DTIS PF domain captures varying degrees of vigorous and moderate daily activity, including moving and reaching. sfxfaexstd (qskcijalla ) View more | Positive | 01 Nov 2023 | |||
Placebo | |||||||
Phase 3 | 122 | ewvkvpwzou(usqiqamxxh) = vymkzxkyie qcsoppcnxw (aopqenjcdk, –100.0 - 517.2) View more | Positive | 31 May 2023 | |||
Placebo | ewvkvpwzou(usqiqamxxh) = zqwotqkekm qcsoppcnxw (aopqenjcdk, –88.6 - 441.7) View more |