Prescription medicine
Nirogacestat Brand names: Ogsiveo
Nirogacestat (Ogsiveo) is a prescription medicine with an FDA approval on record since 2023. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the nirogacestat FDA label on DailyMed (effective September 1, 2026, SpringWorks Therapeutics, Inc.); the NDA 217677 record on Drugs@FDA; every nirogacestat label on DailyMed.
Highlights of the record
FDA label of September 1, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageOGSIVEO is indicated for adult patients with progressing desmoid tumors who require systemic treatment.
Forms and strengths
- 100 mg
- 150 mg
Film-coated tablet.
On the market
- Earliest approval on file
- November 27, 2023 Ogsiveo, Springworks; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- May 19, 2043 Ogsiveo tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 838 through July 30, 2026
What is nirogacestat used for?
From the label: indications and usageOGSIVEO is indicated for adult patients with progressing desmoid tumors who require systemic treatment. OGSIVEO is a gamma secretase inhibitor indicated for adult patients with progressing desmoid tumors who require systemic treatment.
FDA pharmacologic class: Gamma Secretase Inhibitor.
Source: FDA drug label (OGSIVEO), SpringWorks Therapeutics, Inc., effective September 1, 2026 (SPL set f172e6ff-3190-41b0-b95a-58a7ef9e9e1e), via openFDA; the full label on DailyMed
What does the patient leaflet for nirogacestat say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What should I avoid while taking OGSIVEO?Avoid eating or drinking grapefruit products, Seville oranges, and starfruit during treatment with OGSIVEO.
Source: FDA drug label (OGSIVEO), SpringWorks Therapeutics, Inc., effective September 1, 2026 (SPL set f172e6ff-3190-41b0-b95a-58a7ef9e9e1e), via openFDA; the full label on DailyMed
Is there a generic for nirogacestat (Ogsiveo)?
No generic nirogacestat is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 29 patents for Ogsiveo tablets: the compound patent runs to August 9, 2039, and the last listed entry to May 19, 2043. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2023 earliest approval on file
- 2043 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for nirogacestat?
The FDA Adverse Event Reporting System holds 838 reports that list nirogacestat among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 8 are coded as a death and 113 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Nirogacestat side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other