Sagimet Biosciences
- Country
- 🇺🇸United States
- Ownership
- -
- Employees
- 10
- Market Cap
- $97.8M
- Introduction
Sagimet Biosciences, Inc. is a clinical-stage biopharmaceutical company, which engages in the development of novel therapeutics for the treatment of infectious diseases. Its lead drug candidate, denifanstat, is an oral, once-daily pill and selective fatty acid synthase (FASN) inhibitor in development for the treatment of nonalcoholic steatohepatitis (NASH). The company was founded by Urs F. Greber, Ari Helenius, and Lucas Pelkmans on December 19, 2006 and is headquartered in San Mateo, CA.
Clinical Trials
9
Trial Phases
3 Phases
Drug Approvals
0
Drug Approvals
No drug approvals found
This company may not have drug approvals in our database
Clinical Trials
Distribution across different clinical trial phases (9 trials with phase data)• Click on a phase to view related trials
Phase 1 Study to Evaluate the Safety, Tolerability, PK, and PD of TVB-3567 in Healthy Participants With or Without Acne
- First Posted Date
- 2025-05-25
- Last Posted Date
- 2025-05-25
- Lead Sponsor
- Sagimet Biosciences Inc.
- Target Recruit Count
- 128
- Registration Number
- NCT06989840
- Locations
- 🇺🇸
Celerion, Inc., Tempe, Arizona, United States
A Phase 3 Study Evaluating the Safety and Efficacy of Denifanstat in Patients With MASLD and MASH
- Conditions
- Nonalcoholic SteatohepatitisNonalcoholic Fatty LiverMASLDMASHNASHMetabolic Dysfunction-Associated Steatotic Liver DiseaseMetabolic Dysfunction-Associated Steatohepatitis
- Interventions
- Drug: Placebo
- First Posted Date
- 2024-11-18
- Last Posted Date
- 2025-05-15
- Lead Sponsor
- Sagimet Biosciences Inc.
- Target Recruit Count
- 2000
- Registration Number
- NCT06692283
A Phase 3 Study Evaluating the Safety and Efficacy of Denifanstat in Patients With MASH and F2/F3 Fibrosis
- Conditions
- MASHNASHMetabolic Dysfunction-associated SteatohepatitisNoncirrhotic Metabolic Dysfunction-associated SteatohepatitisNonalcoholic SteatohepatitisNonalcoholic Fatty Liver
- Interventions
- Drug: Placebo
- First Posted Date
- 2024-09-19
- Last Posted Date
- 2025-05-15
- Lead Sponsor
- Sagimet Biosciences Inc.
- Target Recruit Count
- 1260
- Registration Number
- NCT06594523
A Phase I Pharmacokinetic Study of TVB-2640 (Denifanstat) in Subjects With Mild, Moderate, or Severe Hepatic Impairment Compared to Subjects With Normal Hepatic Function
- Conditions
- Hepatic ImpairmentCirrhosisNon-alcoholic Steatohepatitis
- Interventions
- Drug: TVB-2640 - 50 mg
- First Posted Date
- 2023-04-28
- Last Posted Date
- 2023-12-26
- Lead Sponsor
- Sagimet Biosciences Inc.
- Target Recruit Count
- 48
- Registration Number
- NCT05835180
- Locations
- 🇺🇸
Thomas C. Marbury, Orlando, Florida, United States
🇺🇸Eric J. Lawitz, MD, San Antonio, Texas, United States
🇭🇺Geza Lakner, Kistarcsa, Hungary
Open-label Study of the Absorption, Metabolism, and Excretion of [14C]TVB-2640 Following a Single Oral Dose in Healthy Male Subjects
- First Posted Date
- 2022-12-20
- Last Posted Date
- 2022-12-28
- Lead Sponsor
- Sagimet Biosciences Inc.
- Target Recruit Count
- 8
- Registration Number
- NCT05657834
- Locations
- 🇺🇸
Celerion Inc., Lincoln, Nebraska, United States
- Prev
- 1
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News
Ascletis' First-in-Class Acne Drug Denifanstat Meets All Phase III Endpoints, Outperforms FDA-Approved Treatments
Denifanstat (ASC40), a first-in-class oral fatty acid synthase inhibitor, achieved statistically significant improvements in all primary and secondary endpoints in a Phase III trial for moderate to severe acne vulgaris.
Ascletis Completes Enrollment in Phase III Trial of Denifanstat for Acne
• Ascletis Pharma has completed enrollment of 480 patients in a Phase III clinical trial for ASC40 (denifanstat), an oral tablet for moderate to severe acne. • The trial is a randomized, double-blind, placebo-controlled study evaluating the safety and efficacy of once-daily ASC40 over 12 weeks. • Topline results from the Phase III trial are anticipated in the second quarter of 2025, potentially offering a novel acne treatment option. • ASC40, a first-in-class FASN inhibitor, has previously demonstrated efficacy and a good safety profile in a Phase II clinical trial.
Ascletis Completes Enrollment in Phase III Trial of Denifanstat for Moderate to Severe Acne
• Ascletis Pharma has completed enrollment of 480 patients in its Phase III clinical trial for ASC40 (denifanstat), an oral tablet for moderate to severe acne. • The Phase III trial is a randomized, double-blind, placebo-controlled, multicenter study in China evaluating the safety and efficacy of once-daily oral denifanstat. • Topline results from the Phase III trial are anticipated in the second quarter of 2025, potentially offering a novel treatment option for acne vulgaris. • Denifanstat, a first-in-class FASN inhibitor, has demonstrated promising efficacy and a good safety profile in a Phase II study.
Ascletis Completes Phase III Enrollment of Denifanstat for Moderate to Severe Acne
• Ascletis Pharma has completed enrollment of 480 patients in its Phase III clinical trial for denifanstat (ASC40), an oral tablet for moderate to severe acne. • The Phase III trial is a randomized, double-blind, placebo-controlled, multicenter study evaluating the safety and efficacy of once-daily oral denifanstat. • Topline results from the Phase III trial are anticipated in the second quarter of 2025, building on positive Phase II results. • Denifanstat is a first-in-class, once-daily oral inhibitor of fatty acid synthase (FASN) with a novel mechanism for acne treatment.