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TVB-3567

Phase 1

Acne | Small molecule | Dermatology |Sagimet Biosciences Inc. - Series A|Last Updated: Jun 9, 2026

Target and mechanism

Molecular targetFASN
Target classProtein
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLEDDMC
Total Trials1
Total Enrollment128

FDA Designations

No designations recorded

Clinical trial landscape

TVB-3567 · 1 trial · 1 indication

Phase 1 1
NCT06989840Phase 1 Study to Evaluate the Safety, Tolerability, PK, and PD of TVB-3567 in Healthy Participants With or Without AcneAcne
RECRUITING128 Analytics
PHASE1RECRUITING
Phase 1 Study to Evaluate the Safety, Tolerability, PK, and PD of TVB-3567 in Healthy Participants With or Without Acne
AcneUnlock trial analytics

Study Endpoints

Primary Endpoints

Part A - Incidence of adverse events (AEs) and serious adverse events (SAEs)
Baseline to 7 to 8 days after dosing
Part B - Plasma AUC0-t in fasted and fed conditions
Baseline to Day 4

Area under the concentration-time curve from time zero until the last observed concentration

Part B - Plasma AUC0-inf in fasted and fed conditions
Baseline to Day 4

Area under the concentration-time curve from time zero to infinity

Part B - Plasma Cmax in fasted and fed conditions
Baseline to Day 4

Maximum concentration measurement in plasma

Part B - Incidence of adverse events (AEs) and serious adverse events (SAEs) under fasted and fed conditions
Baseline to 7 to 8 days after dosing
Part C - Incidence of adverse events (AEs) and serious adverse events (SAEs)
Baseline to 13 to 15 days after the last dose
Part D - Incidence of adverse events (AEs) and serious adverse events (SAEs)
Baseline to 13 to 15 days after the last dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
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 -

Interventions

NameTypeDescription
TVB-3567DRUGOrally administered capsule
PlaceboDRUGOrally administered capsule
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites2

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)...

Countries:United StatesAustralia
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Competitive Landscape -Acne 9 trials

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Frequently asked questions about TVB-3567

What is TVB-3567 used for?

TVB-3567 is an investigational small molecule being developed for the treatment of acne. It is currently in Phase 1 clinical development and has not been approved by the FDA. The drug is being studied in healthy participants with or without acne to evaluate its safety, tolerability, pharmacokinetics, and pharmacodynamics.

What does TVB-3567 target?

TVB-3567 targets FASN, a protein involved in fatty acid synthesis. By inhibiting FASN, the drug may reduce sebum production, which is a key factor in the development of acne. This mechanism is being investigated in early-stage clinical trials to determine its safety and efficacy.

Who makes TVB-3567?

TVB-3567 is being developed by Sagimet Biosciences Inc., a biopharmaceutical company. The company is conducting a Phase 1 clinical trial to evaluate the drug's safety and tolerability in healthy participants with or without acne.

What phase is TVB-3567 in?

TVB-3567 is in Phase 1 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The ongoing Phase 1 trial is recruiting participants to assess the drug's safety, tolerability, pharmacokinetics, and pharmacodynamics.

What clinical trials is TVB-3567 in?

TVB-3567 is being studied in a Phase 1 clinical trial with the identifier NCT06989840. This randomized, double-blind, controlled study is evaluating the safety, tolerability, pharmacokinetics, and pharmacodynamics of TVB-3567 in healthy participants with or without acne. The trial is recruiting 128 participants in the United States and Australia.