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TVB-3567

Phase 1

Acne | Small molecule | Dermatology |Sagimet Biosciences Inc. - Series A|Last Updated: Feb 6, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment128
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06989840Phase 1 Study to Evaluate the Safety, Tolerability, PK, and PD of TVB-3567 in Healthy Participants With or Without AcnePHASE1 RECRUITING 128 — — Jun 3, 2025Jun 1, 2026Feb 6, 20262 United States, Australia
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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 — 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 12 trials
CompanyTickerTrialsLead PhaseDrugs
AbbVie, Inc.ABBV1PHASE3Undisclosed
Biofrontera, Inc.BFRI1PHASE21h Incubation Photodynamic therapy, 3h Incubation Photodynamic therapy
Sanofi SA Sponsored ADRSNY3PHASE1Acne mRNA vaccine
Hoth Therapeutics, Inc.HOTH1PHASE2HT-001 2%, HT-001 1%, HT-001 0.5%
Sagimet Biosciences Inc. Class ASGMT1PHASE1TVB-3567
Bausch Health Companies Inc.BHC1 — clindamycin , adapalene and benzoyl peroxide
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Recent Changes (Last 90 Days)
MEDIUMMay 26, 2026NCT06989840primaryCompletionDate: changed
LOWMay 24, 2026NCT06989840studyFirstPostDate: changed