NDAORALTABLETPriority Review
Approved
Nov 2023
Lifecycle
Growth
Competitive Pressure
0/100
Clinical Trials
15
Data completeness
6/8 — Strong
Priority Review
OGSIVEO (nirogacestat) by SpringWorks Therapeutics is gamma secretase inhibitors [moa]. First approved in 2023.
Drug data last refreshed 7h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
OGSIVEO (nirogacestat) is an oral gamma secretase inhibitor approved by the FDA on November 27, 2023. It targets gamma secretase to modulate Notch signaling pathways implicated in rare dermatologic and genetic conditions. The drug represents a novel mechanism for treating diseases driven by aberrant Notch pathway activation.
$0.429MPart D
Growth16.9 years to LOEEarly-stage product with minimal market penetration; commercial team is actively building awareness and patient access infrastructure in a nascent indication.
Mechanism of Action
Gamma Secretase Inhibitors
Pharmacologic Class:
Gamma Secretase Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (15)
To Determine the Effect of CYP Induction Following Administration of Nirogacestat in Healthy Adult Male Participants
Started Oct 2025
20 enrolled
Healthy
Nirogacestat in Premenopausal Females With Desmoid Tumor/Aggressive Fibromatosis (DT/AF)
Started Sep 2025
50 enrolled
Desmoid TumorAggressive Fibromatosis
Evaluate the Effects of Famotidine or Rabeprazole on the PK of Nirogacestat
Started Aug 2025
24 enrolled
Healthy
A Study of Nirogacestat in Japanese Adults With Desmoid Tumors/Aggressive Fibromatosis (DT/AF)
Started Aug 2025
20 enrolled
Desmoid TumorAggressive Fibromatosis
Evaluation of the Response and Non-response of Nirogacestat in Desmoid Tumors- Clinical Study
Started Nov 2024
40 enrolled
Tumor
Worked on OGSIVEO at SpringWorks Therapeutics? Share your interview experience or compensation data (+7 days Pro)
Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.