Nirogacestat Suppliers & Bulk Manufacturers
Available Forms: Tablets
Available Strengths: 50 mg
Reference Brands: Generic formulations marketed under different names
Category: Oncology Cancer Care
Nirogacestat is available in Tablets and strengths such as 50 mg. Sourced from GMP-certified and ISO-compliant manufacturers, this API meets global pharmacopeia standards (USP/EP/JP as applicable). Ideal for pharmaceutical formulation and commercial manufacturing, Nirogacestat is supplied in bulk quantities with complete regulatory support including DMF, COA, and MSDS.
| Technical Specifications & Supply Details | |
|---|---|
| Lead Time | 7 to 60 days (depending on batch size & schedule) |
| MOQ | As per manufacturer’s batch size |
| COA | Available with every batch |
| Regulatory Dossier / DMF | Available upon request |
| Export Documentation | FSC, COA, Manufacturing License, Product Permission |
| Standards | IP, BP, USP |
| Certifications | WHO-GMP, EU-GMP, USFDA (as applicable) |
Nirogacestat can be exported to over 30 countries across Asia, Africa, Europe, and Latin America. Flexible packaging, competitive pricing, and a verified supplier network make Pharmatradz a trusted sourcing partner for pharmaceutical companies and contract manufacturers worldwide.
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.
The Trade Mark owner has been correctly identified under the heading Manufacturer / TM Owner as required by the Act.
Frequently Asked Questions
Nirogacestat is an investigational drug used for the treatment of desmoid tumors (aggressive fibromatosis) and other solid tumors. It is designed to inhibit tumor growth in patients with progressive or symptomatic disease.
Nirogacestat is a small-molecule gamma-secretase inhibitor that blocks the Notch signaling pathway, which is implicated in tumor cell proliferation and survival.
Nirogacestat does not yet have a widely approved trade name, as it is still in clinical development.
Nirogacestat is developed by SpringWorks Therapeutics.
The generic name is nirogacestat.
Currently, there is no approved brand name.
Nirogacestat is manufactured in clinical-grade facilities under the oversight of SpringWorks Therapeutics for clinical trials.
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