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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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Recent Changes (Last 90 Days)

MEDIUMJun 9, 2026NCT06989840primaryCompletionDate: changed
MEDIUMJun 9, 2026NCT06989840primaryCompletionDate: changed
MEDIUMJun 9, 2026NCT06989840primaryCompletionDate: changed
MEDIUMJun 9, 2026NCT06989840primaryCompletionDate: changed
MEDIUMMay 26, 2026NCT06989840primaryCompletionDate: changed
LOWMay 24, 2026NCT06989840studyFirstPostDate: changed

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, with a study evaluating its safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy participants with or without acne.

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.

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 of TVB-3567 for acne, with the study currently recruiting participants.

What phase is TVB-3567 in?

TVB-3567 is in Phase 1 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 1 trial is evaluating the drug's safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy participants with or without acne.

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.

Is TVB-3567 the same as any other drug?

TVB-3567 is a unique investigational compound developed by Sagimet Biosciences. No alternative names for TVB-3567 have been reported. It is a small molecule targeting FASN, and it is being studied specifically for the treatment of acne.