Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Denifanstat · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | Effect of resmetirom on pharmacokinetics of denifanstat |
| Cohort 2 | EXPERIMENTAL | Effect of denifanstat on pharmacokinetics of resmetirom |
| Name | Type | Description |
|---|---|---|
| Denifanstat | DRUG | Once daily |
| Resmetirom | DRUG | Once daily |
Additional inclusion and exclusion criteria may apply. Inclusion Criteria: * Seated blood pressure is ≥ 90/40 mmHg and ≤ 140/90 mmHg at the screening visit. * Seated pulse rate is ≥ 40 bpm and ≤ 99 bpm at the screening visit. * QTcF interval is ≤ 460 msec (males) and ≤ 470 msec (females) and has E...
Denifanstat is an investigational small molecule being studied in healthy adult participants. Its most recent clinical trial evaluated it in a drug-drug interaction study with resmetirom, meaning the drug is being assessed for how it interacts when given alongside another medication. It is not approved for any disease indication.
Denifanstat is being developed by Sagimet Biosciences Inc., which trades under the ticker SGMT. The company is conducting clinical research on this small molecule drug candidate in the United States.
Denifanstat is in Phase 1 clinical development. The single completed trial was a Phase 1 study, and the drug remains investigational, meaning it has not been approved by the FDA for any use. It has received a breakthrough therapy designation from the FDA.
Denifanstat has one completed clinical trial, registered as NCT07216313. This Phase 1 study was a drug-drug interaction trial of denifanstat and resmetirom in healthy adult participants, enrolling 40 people in the United States. The trial was controlled but not randomized or double-blinded.
Denifanstat is not FDA approved. It is an investigational drug that has completed a Phase 1 clinical trial in healthy volunteers. While it has received a breakthrough therapy designation from the FDA, this designation does not mean the drug is approved; it remains in clinical development.