Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TERN-501 · 1 trial · 1 indication
| Name | Type | Description |
|---|---|---|
| TERN-501 | DRUG | Investigational drug |
| TERN-101 | DRUG | Investigational drug |
| Placebo | OTHER | Matching placebo |
TERN-501 is an investigational small molecule being developed for nonalcoholic steatohepatitis, or NASH, a metabolic liver disease. It is not approved for any indication and remains in clinical development. Terns Pharmaceuticals is evaluating it in noncirrhotic adults with presumed NASH, both as a monotherapy and in combination with another agent.
TERN-501 targets THR-beta, the thyroid hormone receptor beta. THR-beta is a nuclear receptor that regulates genes involved in lipid metabolism and liver fat handling. By acting on this receptor, TERN-501 is designed to reduce liver fat accumulation, a key feature of NASH. It is a small molecule receptor agonist.
TERN-501 is being developed by Terns Pharmaceuticals, Inc., which trades on the Nasdaq under the ticker TERN. The company is the sponsor of the clinical program evaluating the compound in NASH. Terns Pharmaceuticals is a clinical-stage biopharmaceutical company focused on metabolic and liver diseases.
TERN-501 is in Phase 2 clinical development. It has not been approved by the FDA or any other regulatory agency and is investigational. The Phase 2 program has completed, and the drug remains in clinical development for nonalcoholic steatohepatitis. No approval status has been granted for this asset.
TERN-501 has been studied in the DUET Study, registered as NCT05415722. This Phase 2 trial evaluated the safety, efficacy, pharmacokinetics, and pharmacodynamics of orally administered TERN-501 as monotherapy and in combination with TERN-101 in noncirrhotic adults with presumed nonalcoholic steatohepatitis. The trial enrolled 162 participants and is completed.
The Phase 2 DUET Study of TERN-501 enrolled 162 participants. It was an uncontrolled trial, meaning it did not use randomization or a double-blind design. The study assessed TERN-501 both alone and in combination with TERN-101 in noncirrhotic adults with presumed nonalcoholic steatohepatitis. The trial is now completed.