Denifanstat is under clinical development by Sagimet Biosciences and currently in Phase II for Metabolic Dysfunction-Associated Steatohepatitis (MASH). According to GlobalData, Phase II drugs for Metabolic Dysfunction-Associated Steatohepatitis (MASH) have a 25% phase transition success rate (PTSR) indication benchmark for progressing into Phase III. GlobalData’s report assesses how Denifanstat’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.

Denifanstat overview

Denifanstat (TVB-2640) is under development for the treatment of metabolic syndrome, astrocytoma, non-alcoholic steatohepatitis, non alcoholic fatty liver disease, liver cirrhosis, advanced solid tumors including breast cancer, non-small cell lung carcinoma, colon cancer, metastatic castration resistant prostate cancer and glioblastoma multiforme. It is administered through oral route in the form of tablet. The drug candidate is a small molecule and acts by targeting fatty acid synthase. The drug candidate was also under development for the treatment of chronic hepatitis C, ovarian cancer, peritoneal cancer and acne vulgaris.

It was also under development for the treatment of non-small cell lung cancer.

Sagimet Biosciences overview

Sagimet Biosciences is a clinical-stage pharmaceutical company that develops novel therapeutics in metabolic diseases. The company offers TVB-2640, a fatty acid synthase inhibitor used for the treatment of solid tumors, including non-small cell lung cancer (NSCLC), breast cancer and ovarian cancer. Its pipeline program includes fatty acid synthase inhibitors and a research platform in the treatment of solid tumors. Sagimet Biosciences provides an FASN inhibitor, an essential enzyme that is responsible for the synthesis of palmitic acid and used in tumor metabolism, tumor cell survival and lipid signaling. The company develops antiviral therapeutic candidates for respiratory syncytial virus, cytomegalovirus, and other human pathogens. Sagimet Biosciences is headquartered in San Mateo, California, the US.

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

This content was updated on 10 June 2024

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GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

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.