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Denifanstat

Phase 1

Healthy | Small molecule | Other |Sagimet Biosciences Inc. - Series A|Last Updated: Jan 23, 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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment40
FDA Designations
BREAKTHROUGH_THERAPY
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07216313A Drug-Drug Interaction Study of Denifanstat and Resmetirom in Healthy Adult ParticipantsPHASE1 COMPLETED 40Sep 30, 2025Oct 20, 2025Jan 23, 20261 United States
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Study Endpoints
Primary Endpoints
Area under the concentration-time curve during a dosing interval (tau) at steady state (AUC0-tau)
7 days
Maximum observed concentration at steady-state (Cmax,ss)
7 days
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Cohort 1EXPERIMENTALEffect of resmetirom on pharmacokinetics of denifanstat
Cohort 2EXPERIMENTALEffect of denifanstat on pharmacokinetics of resmetirom
Interventions
NameTypeDescription
DenifanstatDRUGOnce daily
ResmetiromDRUGOnce daily
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Additional inclusion and exclusion criteria may apply. Inclusion Criteria: * Seated blood pressure is ≥ 90/40 mmHg and ≤ 140/90 mmHg at the screening visit. * Seated pulse rate is ≥ 40 bpm and ≤ 99 bpm at the screening visit. * QTcF interval is ≤ 460 msec (males) and ≤ 470 msec (females) and has E...

Countries:United States
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