Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
TVB-3567 · 1 trial · 1 indication
Area under the concentration-time curve from time zero until the last observed concentration
Area under the concentration-time curve from time zero to infinity
Maximum concentration measurement in plasma
| Arm | Type | Description |
|---|---|---|
| Part A (SAD in Healthy Participants) | EXPERIMENTAL | - |
| Part B (Food Effect) | EXPERIMENTAL | - |
| Part C (MAD in Healthy Participants) | EXPERIMENTAL | - |
| Part D (MAD in Acne Participants) | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| TVB-3567 | DRUG | Orally administered capsule |
| Placebo | DRUG | Orally administered capsule |
Inclusion Criteria: Healthy Participants (Parts A, B and C) 1. Healthy, adult, male or female 18-55 years of age 2. Body mass index (BMI) ≥18.0 and ≤32.0 kg/m2 3. Medically healthy with no clinically significant medical history 4. Understands the study procedures in the informed consent form (ICF)...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Sanofi SA Sponsored ADR | SNY | 4 | PHASE2 | Acne mRNA vaccine |
| Sagimet Biosciences Inc. Class A | SGMT | 2 | PHASE3 | Denifanstat, TVB-3567 |
| Hoth Therapeutics, Inc. | HOTH | 1 | PHASE2 | HT-001 |
TVB-3567 is an investigational small molecule drug being developed by Sagimet Biosciences for acne. It is in Phase 1 clinical development and is designed to target FASN (fatty acid synthase). It is not yet approved for any use and remains under study in healthy participants with or without acne.
TVB-3567 targets FASN, or fatty acid synthase, a protein enzyme. By acting on FASN, the small molecule is being studied for its effects in acne. FASN is the molecular target identified for this investigational compound in its Phase 1 development program.
TVB-3567 is being developed by Sagimet Biosciences Inc., which trades under the ticker SGMT. The company is advancing the small molecule through Phase 1 clinical testing for acne, with a study currently recruiting participants in the United States and Australia.
TVB-3567 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA. The Phase 1 program is evaluating the drug in healthy participants with or without acne, and the single listed trial is currently recruiting.
TVB-3567 is being studied in the Phase 1 trial NCT06989840, titled a study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of TVB-3567 in healthy participants with or without acne. The randomized, double-blind, controlled trial is recruiting 152 participants aged 18 and older in the United States and Australia.