AUS
NZ
UK
CA
USA
IND
Highlights
- Sagimet Biosciences has entered into a global, exclusive license agreement with TAPI covering resmetirom API intellectual property.
- The agreement supports technical evaluation, manufacturing, and potential development of a fixed-dose combination of denifanstat and resmetirom.
- Sagimet’s Phase 1 pharmacokinetic trial of the combination is ongoing, with topline data expected by the end of 2025.
Sagimet Biosciences Inc. (Nasdaq:SGMT), a clinical-stage biopharmaceutical company focused on therapies for metabolic and fibrotic diseases, has announced that it has entered into a license agreement with Assia Chemical Industries Ltd., operating as TAPI Technology & API Services, a subsidiary of Teva Pharmaceutical Industries Ltd. The agreement provides Sagimet with rights to certain resmetirom-related intellectual property to support evaluation, manufacturing, and potential combination product development.
Terms of the licensing agreement
Under the agreement, TAPI has granted Sagimet a global, exclusive license to specific intellectual property rights covering innovative forms of TAPI’s resmetirom active pharmaceutical ingredient. These rights allow Sagimet to conduct technical evaluations and manufacturing activities and, if the company elects, to pursue further development of a fixed-dose combination product that includes denifanstat and resmetirom.
Pending patent applications filed by both Sagimet and TAPI cover the fixed-dose combination and the innovative forms of resmetirom, respectively.
Phase 1 combination study underway
In September 2025, Sagimet announced that the first participants had been dosed in a Phase 1 pharmacokinetic study evaluating a combination of denifanstat and resmetirom. Denifanstat is an oral, once-daily fatty acid synthase inhibitor, while resmetirom is a thyroid hormone receptor beta agonist.
The Phase 1 study is designed to assess single- and multiple-dose pharmacokinetics, evaluate the potential for drug–drug interactions, and examine safety and tolerability of the combination. Topline results from the trial are expected by the end of 2025. Subject to the study outcomes and regulatory consultations, Sagimet plans to advance the combination into a Phase 2 trial in the second half of 2026 for patients with F4-stage metabolic dysfunction-associated steatohepatitis.
Preclinical and clinical foundation
Sagimet’s combination program is supported by preclinical findings presented at the European Association for the Study of Liver Congress in 2024. These data showed synergistic effects from combining a fatty acid synthase inhibitor with resmetirom across key liver disease markers.
Denifanstat has previously demonstrated improvements in liver fibrosis in the Phase 2b FASCINATE-2 clinical trial. These results were observed in a subset of patients with metabolic dysfunction-associated steatohepatitis who were digitally diagnosed with cirrhosis, providing a clinical foundation for further development in advanced disease stages.
Broader development pipeline
Sagimet is advancing a portfolio of oral fatty acid synthase inhibitors targeting conditions linked to metabolic and fibrotic dysfunction. Denifanstat met all primary endpoints in the Phase 2b FASCINATE-2 trial in metabolic dysfunction-associated steatohepatitis and achieved primary and secondary endpoints in a Phase 3 trial for moderate-to-severe acne conducted by the company’s license partner in China.
In addition to denifanstat, Sagimet is developing TVB-3567, a second oral fatty acid synthase inhibitor currently being evaluated in a Phase 1 first-in-human clinical trial for acne.
