Nirogacestat is a gamma secretase inhibitor indicated for adult patients with progressing desmoid tumors who require systemic treatment. It is available as tablets for oral use. MedsAcross supplies Nirogacestat for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
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.
Source: US FDA prescribing information
Nirogacestat is a gamma secretase inhibitor that blocks proteolytic activation of the Notch receptor. When dysregulated, Notch can activate pathways that contribute to tumor growth.
Source: US FDA prescribing information
The recommended dosage is 150 mg orally twice daily until disease progression or unacceptable toxicity. See Full Prescribing Information for dosage modifications due to adverse reactions.
Source: US FDA prescribing information
None. None.
Source: US FDA prescribing information
Diarrhea: Severe diarrhea can occur. Monitor and dose modify for Grade 3-4 diarrhea. Ovarian Toxicity: Female reproductive function and fertility may be impaired. Advise females of reproductive potential of the potential risk prior to treatment and monitor routinely. Hepatotoxicity: Elevated AST and ALT can occur. Monitor AST and ALT regularly and modify dose as recommended. Non-Melanoma Skin Cancers: Perform dermatologic examination prior to initiation of OGSIVEO and routinely during treatment. Electrolyte Abnormalities: Monitor phosphate and potassium regularly and modify dose as recommended. Hypersensitivity Reactions: Monitor for signs and symptoms of hypersensitivity, interrupt or permanently discontinue OGSIVEO based on severity. Embryo-Fetal Toxicity: Can cause fetal harm.
Source: US FDA prescribing information
The following serious adverse reactions are described elsewhere in the labeling: Diarrhea Ovarian Toxicity Hepatotoxicity Non-Melanoma Skin Cancers Electrolyte Abnormalities Hypersensitivity Reactions The most common ( > 15 %) adverse reactions are diarrhea, ovarian toxicity, rash, nausea, fatigue, stomatitis, headache, abdominal pain, cough, alopecia, upper respiratory tract infection and dyspnea. The most common laboratory abnormalities (≥15%) are decreased phosphate, increased urine glucose, increased urine protein, increased AST, increased ALT, and decreased potassium.
Source: US FDA prescribing information
Strong or moderate CYP3A inhibitors: Avoid concomitant use. Strong or moderate CYP3A inducers: Avoid concomitant use. Gastric acid reducing agents: Avoid concomitant use with proton pump inhibitors and H2-receptor antagonists. If concomitant use cannot be avoided, OGSIVEO administration can be staggered with antacids.
Source: US FDA prescribing information
Store at 20°C to 25°C (68°F to 77°F). Excursions permitted between 15°C to 30°C (59°F to 86°F). See USP Controlled Room Temperature.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
2 presentations of Nirogacestat, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Ogsiveo 100 mg tabletOral | SpringWorks Therapeutics | US FDA | Available on request |
| Ogsiveo 150 mg tabletOral | SpringWorks Therapeutics | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Yes, on request. MedsAcross lists 2 presentations of Nirogacestat and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Nirogacestat, including Ogsiveo.
Yes. The US FDA first approved Nirogacestat on 27 November 2023, according to Drugs@FDA.
Yes. Nirogacestat has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
No listed presentation of Nirogacestat is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Nirogacestat is classified under ATC code L01XX81 (Nirogacestat).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.