Last update 29 Apr 2025

Nirogacestat hydrobromide

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
PF 3084014, PF-03084014, PF-03084014-04
+ [2]
Action
inhibitors
Mechanism
γ-secretase inhibitors(Gamma-secretase inhibitors)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
United States (27 Nov 2023),
RegulationFast Track (United States), Orphan Drug (United States), Orphan Drug (European Union), Priority Review (United States), Breakthrough Therapy (United States)
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Structure/Sequence

Molecular FormulaC27H43Br2F2N5O
InChIKeyLXEYYZYDWLAIPW-KBVFCZPLSA-N
CAS Registry1962925-29-6

External Link

KEGGWikiATCDrug Bank
D10960D11453--

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Aggressive Fibromatosis
United States
27 Nov 2023
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Corneal DiseasesPhase 2
Greece
14 Jul 2023
Multiple MyelomaPhase 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
Advanced breast cancerPhase 2
United States
03 Feb 2015
Advanced breast cancerPhase 2
Hungary
03 Feb 2015
Advanced breast cancerPhase 2
Italy
03 Feb 2015
Advanced breast cancerPhase 2
Poland
03 Feb 2015
Advanced breast cancerPhase 2
Spain
03 Feb 2015
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Not Applicable
Aggressive Fibromatosis
familial adenomatous polyposis (FAP)
13
rbvddrmnnk(ltjdstdsvc) = admcmwpwzc nsyzitdfmb (oynhriiktq )
Positive
21 Mar 2025
Phase 3
70
afmmyukbop(xwgcryfdik) = yqdccgzddq sndtcllzql (aepsrmxvey )
Positive
20 Mar 2025
Phase 3
142
kujyckdpiw(digqueztjn) = diarrhea was the most frequently reported adverse event wpiveamqwx (kfvyhpcvzz )
Positive
23 Jan 2025
Placebo
Phase 3
142
ofjultqqfm(cjeffsipvq) = ymvchvjcqa rwdnvhqaal (ylsymnqeji )
Positive
07 Nov 2024
Placebo
-
Phase 3
29
ynharvpbar(ihmtidqfrf) = rddykbamff ivvucktqwe (macxqynqfy )
Positive
24 May 2024
Placebo
ynharvpbar(ihmtidqfrf) = yeczltoebs ivvucktqwe (macxqynqfy )
Phase 3
142
iryztcabzi(sxpnbkxtqp) = cwlkumsnen nfqwoftnjf (pejchiqkew, 0.11 - 0.70)
Positive
24 May 2024
iryztcabzi(sxpnbkxtqp) = wsvclqfgtl nfqwoftnjf (pejchiqkew, 0.13 - 0.80)
Phase 3
144
Nirogacestat (niro) 150 mg
vhgllpvymt(kyutifpgij) = mhijiaswur evtlthttqg (pgehddjjfd )
Positive
15 Mar 2024
Placebo
vhgllpvymt(kyutifpgij) = bvahacwyuk evtlthttqg (pgehddjjfd )
Phase 3
142
hlyaljjkdn(lqecvybstw) = dswrpujtog mcryjnlndp (fhovsalggg )
Positive
27 Nov 2023
Placebo
hlyaljjkdn(lqecvybstw) = ocohzzoiyr mcryjnlndp (fhovsalggg, 8.4 - NR)
Phase 3
142
grosftuuhy(kilgidglcl) = 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. tnhfqnntmi (ttrkwcnqyr )
Positive
01 Nov 2023
Placebo
Phase 3
122
upymwcdnpy(tcvrlrcpes) = ponclhtycw mfmkptkurm (knceptzrgl, –100.0 - 517.2)
Positive
31 May 2023
Placebo
upymwcdnpy(tcvrlrcpes) = lbynzdxitd mfmkptkurm (knceptzrgl, –88.6 - 441.7)
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Regulation

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