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SEP-631

Phase 1

Healthy Volunteers | Small molecule | Other |Septerna, Inc.|Last Updated: Apr 21, 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-BlindCONTROLLED
Total Trials1
Total Enrollment120
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07069036A Study to Evaluate Single and Multiple Doses of SEP-631 in Healthy Adult VolunteersPHASE1 COMPLETED 120 — — Jul 15, 2025Dec 18, 2025Apr 21, 20261 Australia
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Study Endpoints
Primary Endpoints
Frequency of treatment emergent adverse events
From enrollment to end of follow up visit, up to approximately 2 months
Secondary Endpoints
Plasma PK of SEP-631 after single and multiple doses
From enrollment to end of treatment period, up to approximately 14 days
Plasma PK of SEP-631 under fed and fasted conditions
From enrollment to end of treatment period, up to approximately 14 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Single Ascending DoseEXPERIMENTAL -
Multiple Ascending DoseEXPERIMENTAL -
Food EffectEXPERIMENTAL -
Interventions
NameTypeDescription
SEP-631DRUGOral, tablet
PlaceboOTHEROral, tablet
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Subjects who are able and willing to provide informed consent 2. Aged 18 to 60 years at the time of consent 3. Have a BMI within the range 18.5 to 32.0 kg/m2 4. In general good health Exclusion Criteria: 1. Any condition, which in the investigator's opinion might jeopardize...

Countries:Australia
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Recent Changes (Last 90 Days)
MEDIUMMay 26, 2026NCT07069036TRIAL_REMOVED: changed
LOWMay 24, 2026NCT07069036studyFirstPostDate: changed