Quick answers
- What is Nirogacestat used for?
- The FDA-approved label (Ogsiveo, SpringWorks Therapeutics, Inc., September 1, 2026) says: “OGSIVEO 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.” This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
- Does Nirogacestat have a boxed warning?
- No. None of the 1 FDA labels we found for this medicine has a boxed warning.
- Is there a shortage of Nirogacestat?
- No current shortage is listed by the FDA for the products of this medicine (FDA data from October 30, 2026).
- Has Nirogacestat been recalled?
- No recall linked to the products of this medicine appears in the FDA enforcement reports we use.
- Who makes Nirogacestat?
- 1 company lists prescription products of Nirogacestat in the FDA NDC Directory, including SpringWorks Therapeutics, Inc..
What Nirogacestat is used for
Quoted from the “Indications and Usage” section of the FDA-approved label.
OGSIVEO 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 label: Ogsiveo, SpringWorks Therapeutics, Inc., effective September 1, 2026. Read the full label on DailyMed →
This page is not medical advice. Talk to your doctor or pharmacist before you start, stop or change any medicine.
Boxed warning
A boxed warning (“black box”) is the FDA’s strongest warning on a drug label, for serious or life-threatening risks.
The label quoted above has no boxed warning.
Forms and how it is given
| Dosage forms | Tablet, film coated |
|---|---|
| Route | Oral |
| Prescription products | 2 in the FDA NDC Directory |
| Brand names | Ogsiveo |
Companies that list this medicine
Labelers in the FDA NDC Directory: the company named on the package (maker or distributor), with the number of prescription products.
- SpringWorks Therapeutics, Inc.2 products
FDA approval history
- NDA: New Drug Application: how a new (usually brand-name) medicine is approved.
| Application | Sponsor | Approved | Later changes approved |
|---|---|---|---|
| NDA217677 OGSIVEO | Springworks | November 27, 2023 | 4, latest August 20, 2026 2026: Labeling · 2026: Labeling · 2026: Labeling |
Shortage status
The FDA drug shortage list does not show these products.
Recalls
No recall linked to these products (by their NDC code) appears in the FDA enforcement reports.
Official identifiers
Sources
- FDA-approved label on DailyMed (National Library of Medicine) — Ogsiveo, SpringWorks Therapeutics, Inc., effective September 1, 2026; via openFDA, FDA data exported October 30, 2026, retrieved October 31, 2026
- NDC Directory (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drugs@FDA (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
- Drug recall enforcement reports (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 27, 2026, retrieved October 31, 2026
- Drug shortages (openFDA) — U.S. Food and Drug Administration (FDA), FDA data exported October 30, 2026, retrieved October 31, 2026
openFDA data is provided by the FDA as is; it may be incomplete. Always rely on the label that comes with your medicine. FDA Enforcement Report search →