Nirogacestat bulk supplier for pharma manufacturers

Nirogacestat 50 mg Suppliers & Bulk Manufacturers

Available Forms: Tablets

Available Strengths: 50 mg

Reference Brands: Ogsiveo (US/EU, SpringWorks / Merck KGaA)

Nirogacestat is a Oncology Cancer Care product available as Tablets in strengths 50 mg. It corresponds to the reference brands Ogsiveo (US/EU, SpringWorks / Merck KGaA). Verified GMP manufacturers and suppliers on PharmaTradz offer it in bulk for import worldwide, with regulatory documentation and dossier support available on request.

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Product Description:

Nirogacestat is an oral anti-cancer medication approved for the treatment of desmoid tumors, a rare and locally aggressive type of soft tissue tumor. It is a selective gamma-secretase inhibitor that works by blocking the Notch signaling pathway, which plays a critical role in tumor cell growth and survival. By inhibiting this pathway, nirogacestat helps slow tumor progression and reduce disease-related symptoms.

Marketed under the brand name Ogsiveo, nirogacestat was approved for medical use in the United States in November 2023. It is the first medication approved by the US Food and Drug Administration (FDA) specifically for the treatment of desmoid tumors, representing a significant advancement in targeted cancer therapy. The drug is administered orally, making it a convenient option for long-term treatment compared to invasive therapies.

Nirogacestat has shown meaningful clinical benefits in patients with progressive or symptomatic desmoid tumors, including tumor size reduction and improved quality of life. Its approval provides a targeted, non-surgical treatment option for patients who previously had limited therapeutic choices, supporting personalized and effective oncology care.

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.