Ogsiveo, nirogacestat
Named-patient access overview. Ogsiveo is coordinated by Reserve Meds for international patients via physician-led cross-border sourcing.
About Ogsiveo
Ogsiveo (nirogacestat) is manufactured by SpringWorks Therapeutics and was approved by the US FDA in November 2023 for adult patients with progressing desmoid tumors who require systemic treatment. Desmoid tumors are a form of aggressive fibromatosis: locally invasive soft-tissue tumors that, while not metastatic, can cause significant morbidity through infiltration of surrounding structures. Ogsiveo is an oral, selective small-molecule gamma-secretase inhibitor; by reducing gamma-secretase activity it suppresses downstream Notch signalling and influences the Wnt / beta-catenin pathway activity implicated in desmoid biology, which is the mechanism supported by the DeFi Phase 3 pivotal trial.
Ogsiveo is taken by mouth twice daily as set out in the prescribing information, with monitoring for diarrhea, electrolyte disturbance, rash, headache, and hepatotoxicity. The label highlights ovarian toxicity, including premature ovarian insufficiency, as a notable risk in females of reproductive potential, and counselling on this risk is required before treatment. For international patients, Ogsiveo may be coordinated through Named Patient Program or personal-import pathways with the destination country's regulator and the patient's treating physician handling the documentation.
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How Reserve Meds coordinates Ogsiveo
- Patient or treating physician submits a named-patient request.
- Clinical team verifies appropriateness of Ogsiveo for the patient and destination country.
- Treating physician issues prescription and clinical justification.
- Country-specific NPP / personal-import documentation is prepared.
- Ogsiveo is sourced from a DSCSA-compliant US specialty wholesaler with full serial traceability.
- Shipment is coordinated to the patient's physician or hospital pharmacy (cold-chain where required).
Access by country
Reserve Meds publishes a detailed country deep-dive for Ogsiveo in every market we coordinate. Each page below covers the destination-country regulatory pathway (named-patient framework), real costs in local currency and USD, indicative timelines, physician-credential requirements, and cold-chain handling for the route into that country. Tap any country to read the full deep-dive.
Start a request for Ogsiveo
Submit a 60-second intake. Our clinical team will reach out as our first cohort opens with case-specific feasibility, timeline, and a formal quote.
Frequently asked questions
How can I get Ogsiveo if it is not approved or available in my country?
Reserve Meds coordinates US-sourced Ogsiveo for patients through a physician-led, named-patient cross-border pathway. Your treating physician provides the prescription and clinical justification; Reserve Meds prepares the named-patient documentation for your country and arranges DSCSA-compliant US sourcing and delivery to your physician or hospital pharmacy.
Can I access Ogsiveo through named-patient or compassionate-use import?
Yes. Named-patient access (also called compassionate use or personal import) is the core route Reserve Meds operates for Ogsiveo. Eligibility and paperwork depend on the regulator in your country, and Reserve Meds maps the specific pathway for each market it coordinates.
Do I need a prescription to access Ogsiveo through Reserve Meds?
Yes. Reserve Meds is not a pharmacy and does not prescribe. A valid prescription and clinical justification from your treating physician are required, and all clinical decisions remain with your physician.
How does Reserve Meds deliver Ogsiveo to a patient?
Reserve Meds sources Ogsiveo from a DSCSA-compliant US specialty supplier with full traceability and coordinates delivery to your treating physician or hospital pharmacy, with appropriate handling for the product.
How long does it take, and what does Ogsiveo cost through Reserve Meds?
After a short intake, the clinical team responds within one business day with case-specific feasibility, an indicative timeline, and a formal written quote. Cost depends on the destination, the prescribed regimen, and the duration of therapy, and is confirmed in writing before anything proceeds.
How do I start a request for Ogsiveo?
Submit a 60-second intake through the Reserve Meds patient portal, or message the concierge team on WhatsApp. A named coordinator follows up within 24 hours.