Nirogacestat bulk supplier for pharma manufacturers

Nirogacestat 50 mg Suppliers & Bulk Manufacturers

Available Forms: Tablets

Available Strengths: 50 mg

Reference Brands: Ogsiveo (US/EU)

Nirogacestat 50 mg tablets, an oral gamma-secretase inhibitor for adults with progressing desmoid tumours. For oncology hospital pharmacies and specialist importers using authorised or named-patient access.

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Product Description:

Nirogacestat is an oral gamma-secretase inhibitor. Gamma-secretase releases the active fragment of the Notch receptor, a signalling pathway that drives desmoid tumour cell growth, so blocking it slows or shrinks these tumours. Desmoid tumours, or aggressive fibromatosis, are rare soft-tissue growths that do not spread to distant organs but invade nearby tissue, causing pain and loss of movement. This page covers 50 mg film-coated tablets, which give patients a systemic option taken at home.

It is approved for adults with progressing desmoid tumours who need systemic treatment, and was the first medicine licensed specifically for this condition. The labelled dose is 150 mg twice daily, three 50 mg tablets each time, swallowed whole. Diarrhoea, rash, nausea and fatigue are common. It can cause ovarian toxicity and harms the foetus, so effective contraception is required. Liver tests, phosphate and potassium are monitored, and the skin is checked for new skin cancers. Avoid strong CYP3A inhibitors or inducers, grapefruit and proton pump inhibitors.

Sourcing notes. Nirogacestat is a recent, patent-protected innovator medicine. In most markets it reaches patients through the originator's authorised channels or through named-patient and special-access schemes, so check its registration in your country first. Documents to collect are a CoA for each lot, GMP evidence and a CoPP. The tablets are stored at room temperature in bottles, with no cold chain. Handle and dispense them under your local policy for oral anticancer medicines. In your enquiry, give the quantity or patient numbers, the access route and the remaining shelf life you need.

How Nirogacestat is supplied today, and licensing ahead of patent expiry

Nirogacestat is a patented innovator medicine. Where its patents are in force, which today includes most major markets, it can only be supplied by the originator or its licensees, through the routes below. Patents do expire, though, and generic development and licensing deals for post-patent markets start years in advance. If you are developing Nirogacestat, hold a dossier for it or want to license it, talk to us.

Where nirogacestat is approved

Checked 3 Oct 2026

Market	Status	Brand · regulator · date
United States	Approved	Ogsiveo · FDA · Nov 2023
European Union	Approved	Ogsiveo · European Commission · Aug 2025
Generic / biosimilar	None	None approved as of the check date

Not approved in your country? A hospital or doctor can often still import it for a named patient, through a special-access, import-permit or compassionate-use route. We confirm which route applies in your country and the documents needed before quoting. Ask about named-patient supply →

Named-patient import Where a patient needs the product in a market where it is not registered, named-patient import is the lawful route. It requires the treating physician's documentation and authorisation from the destination regulator. We handle this pathway. Named-patient access

Authorised distribution For registered markets, supply runs through the manufacturer's authorised distribution channel. We can identify the authorised route for your market and tell you whether the product is registered there at all. Innovator sourcing

A genericised alternative Where the clinical requirement is the drug class rather than this specific molecule, there is often an off-patent alternative that is faster to register and materially cheaper. Tell us the indication and target market and we will say plainly whether one exists. Discuss alternatives

Licensing and generic development Patents expire country by country, and in many countries development and dossier filing can start before expiry under research and regulatory-review exemptions. We connect manufacturers developing this molecule, dossier holders, licensees and tech-transfer partners for markets where it is, or will become, off-patent. Partner on this molecule

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Frequently Asked Questions

Nirogacestat (Ogsiveo) treats adults with desmoid tumours (aggressive fibromatosis) that are growing and need treatment with medicine. The US FDA approved it in November 2023, the first medicine approved for desmoid tumours. The European Commission approved it in August 2025.

It is a small-molecule gamma-secretase inhibitor. It blocks Notch signalling, which desmoid tumour cells use to grow.

Ogsiveo.

As tablets by mouth, twice a day.

Ogsiveo (Nirogacestat) is developed and sold by SpringWorks Therapeutics (Merck KGaA). PharmaTradz handles enquiries for authorised supply of the originator product, named-patient import where it is not registered, and licensing or development work ahead of patent expiry.