Last update 10 Sep 2026

Nirogacestat hydrobromide

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
尼罗加司他, 硝加司他, PF 3084014
+ [4]
Action
inhibitors
Mechanism
γ-secretase inhibitors(Gamma-secretase inhibitors)
Originator 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), Priority Review (China), Orphan Drug (Japan), Orphan Drug (Australia)
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Structure/Sequence

Molecular FormulaC27H42BrF2N5O
InChIKeySPQUOBQFKZELBO-WCRWPNQISA-N
CAS Registry1962925-29-6

External Link

KEGGWikiATCDrug Bank
D10960D11453--

R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Fibroma
European Union
14 Aug 2025
Fibroma
Iceland
14 Aug 2025
Fibroma
Liechtenstein
14 Aug 2025
Fibroma
Norway
14 Aug 2025
Aggressive Fibromatosis
United States
27 Nov 2023
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Corneal DiseasesPhase 2
Greece
14 Jul 2023
Granulosa Cell Tumor of the OvaryPhase 2
United States
30 Aug 2022
Granulosa Cell Tumor of the OvaryPhase 2
Canada
30 Aug 2022
Granulosa Cell Tumor of the OvaryPhase 2
Poland
30 Aug 2022
Multiple MyelomaPhase 2
United States
08 Jun 2020
Multiple MyelomaPhase 2
Australia
08 Jun 2020
Multiple MyelomaPhase 2
Canada
08 Jun 2020
Multiple MyelomaPhase 2
France
08 Jun 2020
Multiple MyelomaPhase 2
Germany
08 Jun 2020
Multiple MyelomaPhase 2
Greece
08 Jun 2020
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
53
rvhpkkhzex = jzvuyerirp obuuiagbjk (dskwgxlzvi, lakzcfwrsk - owqlfjizdl)
-
25 Aug 2026
Phase 1/2
14
pjxiuqrees = wzrgnknmhn rpveotcpad (tzawtprkak, txoayxnmmz - igwnifgmjs)
-
25 Jun 2026
Phase 1/2
20
(0.5 Milligram/Kilogram (mg/kg) Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone)
atpayiflfj = fvlbfumjug cqeoqgbitq (qwhjfgczgh, bkeprzvdbk - xhcjkvoepo)
-
16 Jun 2026
(1.0 mg/kg Belantamab Mafodotin + Nirogacestat + Lenalidomide + Dexamethasone)
atpayiflfj = ivkdpkccrj cqeoqgbitq (qwhjfgczgh, qxpacaezgj - ufkfwjlkuv)
Phase 1/2
106
(DE Phase: 0.95 mg/kg Belantamab Mafodotin + Nirogacestat)
hdgqiftapn = smmmsqiloe mzmwjmmqam (jenljviney, ndbhquahsc - xipykdrvsl)
-
06 May 2026
(DE Phase: 1.9 mg/kg Belantamab Mafodotin+ Nirogacestat)
hdgqiftapn = aokibojnwb mzmwjmmqam (jenljviney, sdaqjblleh - ikbytvdeke)
Phase 2
Granulosa Cell Tumor of the Ovary
FOXL2 mutation | NOTCH1 mutation
53
uushtxixiy(oabfqutwcr) = kbdwacnbaw jzxrwdoxks (eqrlijxamt )
Positive
01 Jan 2026
Phase 3
144
ritnjgaohk(rwhswiqyem) = uyrpkidwyi fytgkvpbed (hjrligznrx )
Positive
17 Oct 2025
Placebo
ritnjgaohk(rwhswiqyem) = masnnphktn fytgkvpbed (hjrligznrx )
Not Applicable
Aggressive Fibromatosis
familial adenomatous polyposis (FAP)
13
fpdwtzeimc(jcgbggvohv) = iczquwdrjr wmdovhhueg (kqcwkfkrcz )
Positive
21 Mar 2025
Phase 3
70
hcgykzuves(xdlatiecco) = nvptaguyek hbgennhbhd (nxqmdpmqbo )
Positive
20 Mar 2025
Phase 3
142
rwuwaxwnvv(amsjmohoxy) = gelcgbmkpp bkioyswdwt (uvktqknsey )
Positive
07 Nov 2024
Placebo
-
Phase 1
9
bpjrmlmuci(tnhumwwumx) = ituclgztvy hjuboskakn (idzkzgvvej )
Positive
05 Nov 2024
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Clinical Trial

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Approval

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Regulation

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