Ogsiveo FDA Approval History
Last updated by Melisa Puckey, BPharm on Nov 28, 2023.
FDA Approved: Yes (First approved November 27, 2023)
Brand name: Ogsiveo
Generic name: nirogacestat
Dosage form: Tablets
Company: SpringWorks Therapeutics, Inc.
Treatment for: Desmoid Tumor
Ogsiveo (nirogacestat) is a gamma secretase inhibitor indicated for adult patients with progressing desmoid tumors who require systemic treatment.
- Desmoid tumors are rare and aggressive tumors of the soft tissues. Sometimes referred to as aggressive fibromatosis, or desmoid fibromatosis, these soft tissue tumors can be serious, debilitating, and in rare cases can be life-threatening.
- Nirogacestat works by inhibiting gamma secretase, an enzyme that cleaves multiple transmembrane protein complexes, including Notch, which is believed to play a role in activating pathways that contribute to the growth of desmoid tumors.
Development timeline for Ogsiveo
Further information
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