OGSIVEO

GrowthSM

nirogacestat

NDAORALTABLETPriority Review
Approved
Nov 2023
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
15

Mechanism of Action

Gamma Secretase Inhibitors

Pharmacologic Class:

Gamma Secretase Inhibitor

Clinical Trials (5)

NCT07259330Phase 1Recruiting

To Determine the Effect of CYP Induction Following Administration of Nirogacestat in Healthy Adult Male Participants

Started Nov 2025
16 enrolled
Healthy
NCT07176689Phase 4Recruiting

Nirogacestat in Premenopausal Females With Desmoid Tumor/Aggressive Fibromatosis (DT/AF)

Started Sep 2025
50 enrolled
Desmoid TumorAggressive Fibromatosis
NCT07171619Phase 1Recruiting

Evaluate the Effects of Famotidine or Rabeprazole on the PK of Nirogacestat

Started Sep 2025
24 enrolled
Healthy
NCT07170644Phase 2Recruiting

A Study of Nirogacestat in Japanese Adults With Desmoid Tumors/Aggressive Fibromatosis (DT/AF)

Started Aug 2025
18 enrolled
Desmoid TumorAggressive Fibromatosis
NCT05879146Phase 2Recruiting

Evaluation of the Response and Non-response of Nirogacestat in Desmoid Tumors- Clinical Study

Started Nov 2024

Loss of Exclusivity

LOE Date
May 19, 2043
209 months away
Patent Expiry
May 19, 2043
Exclusivity Expiry
Nov 27, 2030

Patent Records (5)

Patent #ExpiryTypeUse Code
7795447
Aug 18, 2030
Substance
10710966
Aug 9, 2039
Substance
U-3754
10941118
Aug 9, 2039
Substance
U-3754
10590087
Aug 9, 2039
Substance
11820748
Aug 9, 2039
Product