Nirogacestat hydrobromide is under clinical development by SpringWorks Therapeutics and currently in Phase III for Soft Tissue Sarcoma. According to GlobalData, Phase III drugs for Soft Tissue Sarcoma have a 64% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Nirogacestat hydrobromide’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Nirogacestat hydrobromide overview

Nirogacestat hydrobromide (Ogsiveo) acts as an antineoplastic agent. It is formulated as film coated tablets for oral route of administration. Ogsiveo is indicated for adult patients with progressing desmoid tumors who require systemic treatment. 
Nirogacestat hydrobromide (PF-03084014-04) is under development for the treatment of pediatric and adult desmoid tumors or aggressive fibromatosis, relapsed/refractory multiple myeloma, ovarian granulosa tumors and soft tissue sarcoma. The therapeutic candidate is administered through oral route in the form of tablet. It acts by targeting selective gamma-secretase (GS). It was under development for the treatment of pancreatic ductal adenocarcinoma, triple negative breast cancer (TNBC), Alzheimer's disease, AIDS-associated Kaposi sarcoma, T-cell acute lymphoblastic leukemia and lymphoblastic lymphoma.
It was also under development for as an adjuvant to docetaxel in castration-resistant prostate cancer (CRPC).

SpringWorks Therapeutics overview

SpringWorks Therapeutics is a drug development company that develops therapeutic medicines for various diseases. The company’s pipeline products include Nirogacestat, MEK ½ Inhibitor, Senicapoc and FAAH Inhibitor. Its Nirogacestat is a gamma-secretase inhibitor used for the treatment of Desmoid tumors. SpringWorks Therapeutics’ Senicapoc is a Gardos channel blocker used for the treatment of hereditary xerocytosis. The company’s FAAH Inhibitor is used for the treatment of post-traumatic stress disorder. It partners with biopharmaceutical companies, scientists, patient groups and philanthropists. SpringWorks Therapeutics is headquartered in Stamford, Connecticut, the US.

For a complete picture of Nirogacestat hydrobromide’s drug-specific PTSR and LoA scores, buy the report here.

This content was updated on 20 February 2024

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GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.