Sagimet Biosciences has dosed the first patient in its AURORA Phase 3 clinical trial for moderate to severe acne vulgaris in the United States, a development that marks the next stage in the commercialization of its lead fatty acid synthase inhibitor, denifanstat. The company expects topline results from this pivotal study in the second half of 2027.
The AURORA trial follows successful earlier data from a Phase 3 study conducted in Greater China by Sagimet's license partner, Ascletis. In that trial, denifanstat met all primary and secondary endpoints and was generally well-tolerated. Ascletis announced in December 2025 that the National Medical Products Administration (NMPA) of China accepted denifanstat's New Drug Application (NDA) for review.
Sagimet's management team, led by President and CEO Dave Happel, emphasizes the differentiated method of action of denifanstat as a FASN inhibitor. The company states that strong clinical data has demonstrated proof of concept for the molecule. Beyond acne, Sagimet is evaluating denifanstat for metabolic dysfunction-associated steatohepatitis (MASH). The company reported a successful Phase 2b trial in MASH where denifanstat met both primary endpoints with significant fibrosis reduction. However, Sagimet stated that further MASH development will only proceed upon securing non-dilutive funding.
The company is also advancing a follow-on FASN inhibitor, TVB-3567, which received Investigational New Drug (IND) clearance from the FDA in March 2025. A first-in-human Phase 1 trial for an acne indication began in June 2025. Sagimet reported that dosing for single and multiple ascending doses and food effect parts is complete, with the drug generally well-tolerated. Phase 2 doses have been identified, and a proof-of-concept Phase 2 trial is anticipated to begin before the end of 2026.
Financially, Sagimet reported $257.6 million in cash, cash equivalents, and marketable securities as of June 30, 2026. This balance includes proceeds from an $115 million underwritten offering of Series A Common Stock completed in September 2026. The company expects this capital to fund current operations through mid-2029, covering the denifanstat Phase 3 readout and NDA submission.
Intellectual property protection is a central component of Sagimet's strategy. The composition of matter patent for denifanstat expires in 2032, with a potential patent term extension to 2037. For TVB-3567, the composition of matter patent expires in 2035, with a potential extension to 2038. Sagimet is exploring pathways to extend protection into the 2040s. Additionally, a patent for the combination of denifanstat and resmetirom was granted in the third quarter of 2026, expiring in 2044.