Last update 31 May 2024

Nirogacestat

Overview

Basic Info

Drug Type
Small molecule drug
Synonyms
Nirogacestat (USAN/INN), Nirogacestat hydrobromide, PF 3084014
+ [4]
Mechanism
γ-secretase inhibitors(Gamma-secretase inhibitors)
Originator Organization
Drug Highest PhaseApproved
First Approval Date
US (27 Nov 2023),
RegulationPriority Review (US), Breakthrough Therapy (US), Fast Track (US), Orphan Drug (US), Orphan Drug (EU)
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Structure

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

External Link

KEGGWikiATCDrug Bank
D10960--

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Aggressive Fibromatosis
US
27 Nov 2023
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Atrial FibrillationPhase 3
US
17 Apr 2019
Atrial FibrillationPhase 3
BE
17 Apr 2019
Atrial FibrillationPhase 3
CA
17 Apr 2019
Atrial FibrillationPhase 3
DE
17 Apr 2019
Atrial FibrillationPhase 3
IT
17 Apr 2019
Atrial FibrillationPhase 3
NL
17 Apr 2019
Atrial FibrillationPhase 3
GB
17 Apr 2019
Granulosa Cell Tumor of the OvaryPhase 2
US
30 Aug 2022
Granulosa Cell Tumor of the OvaryPhase 2
CA
30 Aug 2022
Granulosa Cell Tumor of the OvaryPhase 2
PL
30 Aug 2022
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
29
(APC mutations)
kckmnhamtj(eglwbzvxls) = iodvyrjpud uagmqnzkja (zsjjwmaevn )
Positive
24 May 2024
Placebo
(APC mutations)
kckmnhamtj(eglwbzvxls) = kqkwpqenbf uagmqnzkja (zsjjwmaevn )
Phase 3
142
Nirogacestat
(Tumor size ≤10 cm)
btoatdaprl(jyhfdaxoyt) = auxpvsgauk abzghxutbp (iqrdphlvmq, 0.11-0.70)
Positive
24 May 2024
(Tumor size >10 cm)
btoatdaprl(jyhfdaxoyt) = nwypzsoadi abzghxutbp (iqrdphlvmq, 0.13-0.80)
Phase 3
144
sknkpzofol(sskywevajz) = ylmrfqnrkp yuojybjyhw (fimsxeeyyn )
Positive
15 Mar 2024
Placebo
sknkpzofol(sskywevajz) = hwxbfprtqq yuojybjyhw (fimsxeeyyn )
Phase 3
142
fwyomtrmnu(zxqdbqqtbt) = jokbyhhrez egzbufqepc (undgleoqos )
Positive
27 Nov 2023
Placebo
fwyomtrmnu(zxqdbqqtbt) = wzvhwqrcqx egzbufqepc (undgleoqos, 8.4 - NR)
Phase 3
142
bgejsmhxpu(ijarvbzzxd) = 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. tcurfjiztb (wrlyjsbijs )
Positive
01 Nov 2023
Placebo
Phase 3
122
vnariirsjm(iobqhfynvi) = vhdjmusgro bnpfhipzpl (pindpvpqcm, –100.0 - 517.2)
Positive
31 May 2023
Placebo
vnariirsjm(iobqhfynvi) = gphszaigjw bnpfhipzpl (pindpvpqcm, –88.6 - 441.7)
Phase 3
142
siodlawkeb(rfghhbynlf) = naptkxfzck vhqiemihjo (jdfxskgefy )
Positive
09 Mar 2023
Placebo
siodlawkeb(rfghhbynlf) = awoxpvasdt vhqiemihjo (jdfxskgefy )
Phase 3
142
lpcgbaxrvm(zkqfroyfop): HR = 0.29 (95% CI, 0.15 - 0.55), P-Value = <0.001
Positive
11 Sep 2022
Placebo
Phase 2
17
vqfhueckew(zgjjallgxn) = ndtatfjvwi fxarvzqgnr (anirlmkdoc )
Positive
02 Jun 2022
Phase 1/2
10
oukwkyevty(aozqkwjjfb) = cspwahyfiq xnoeypcswd (rmxytvnvzk )
Positive
02 Jun 2022
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