Denifanstat
- Generic Name
- Denifanstat
- Brand Names
- -
- Drug Type
- Small Molecule
- Chemical Formula
- C27H29N5O
- CAS Number
- 1399177-37-7
- Unique Ingredient Identifier
- 4GF95B2LZA
- Background
Denifanstat is an orally bioavailable fatty acid synthase (FASN) inhibitor. Due to its antineoplastic activities, it is being investigated for various cancers.
- Associated Conditions
- -
- Associated Therapies
- -
Sagimet receives FDA breakthrough therapy designation for denifanstat
FDA grants Breakthrough Therapy designation to Sagimet Biosciences' denifanstat for treating noncirrhotic metabolic dysfunction-associated steatohepatitis with moderate to advanced liver fibrosis, based on positive Phase 2b FASCINATE-2 trial results. Denifanstat showed significant improvements in MASH resolution and fibrosis reduction, with generally well-tolerated safety profile. Phase 3 program planned by end of 2024.
Sagimet Receives FDA Breakthrough Therapy Designation for Denifanstat in MASH
FDA grants Breakthrough Therapy designation to Sagimet Biosciences' denifanstat for treating MASH with moderate to advanced liver fibrosis, based on positive Phase 2b FASCINATE-2 trial data. Denifanstat targets fat accumulation, inflammation, and fibrosis in MASH, showing significant improvements in primary endpoints and safety. Sagimet plans to initiate Phase 3 program by end of 2024.
Drug Development Updates
Stay informed with timely notifications on clinical trials, regulatory changes, and research advancements related to this medication.
© Copyright 2024. All Rights Reserved by MedPath