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SEP-479

Phase 1

Undisclosed | Small Molecules | Other |Septerna, Inc.|Trials Updated: Apr 22, 2026

SEP-479 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Feb 2026

SEP-479 target and mechanism

Molecular targetPTH1R
Target classGpcr
ModalitySmall Molecules

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials1
Total Enrollment150

FDA Designations

No designations recorded

SEP-479 clinical trials

SEP-479 · 1 trial · 1 indication

Phase 1 1
NCT07433179A Study to Evaluate Single and Multiple Doses of SEP-479 in Healthy Adult ParticipantsHealthy Volunteers
RECRUITING150 Analytics
PHASE1RECRUITING
A Study to Evaluate Single and Multiple Doses of SEP-479 in Healthy Adult Participants
Healthy VolunteersUnlock trial analytics

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-479 after single and multiple doses
From enrollment to end of treatment period, up to approximately 14 days
Plasma PK of SEP-479 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
MaskingTRIPLE
ModelSEQUENTIAL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Single Ascending DoseEXPERIMENTAL -
Multiple Ascending DoseEXPERIMENTAL -
Food EffectEXPERIMENTAL -

Interventions

NameTypeDescription
SEP-479DRUGOral, capsule
PlaceboOTHEROral, capsule
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Eligibility Criteria

Age Range21 Years to 60 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: 1. Subjects who are able and willing to provide informed consent 2. Aged 21 to 60 years at the time of consent 3. Have a BMI within the range 18.0 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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Frequently asked questions about SEP-479

What is SEP-479?

SEP-479 is an investigational small molecule drug being developed by Septerna, Inc. It is currently in Phase 1 clinical development and is being studied in healthy adult volunteers. Its therapeutic indications have not been disclosed.

What does SEP-479 target?

SEP-479 targets PTH1R, the parathyroid hormone 1 receptor, which is a G protein-coupled receptor (GPCR). It is a small molecule designed to act on this receptor. Targeting PTH1R places SEP-479 in the GPCR-targeted class of therapeutics.

Who makes SEP-479?

SEP-479 is being developed by Septerna, Inc., a biotechnology company that trades under the ticker symbol SEPN. Septerna is the sponsor of the clinical program evaluating SEP-479.

What phase is SEP-479 in?

SEP-479 is in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The ongoing Phase 1 study is evaluating single and multiple doses in healthy adult participants.

What clinical trials is SEP-479 in?

SEP-479 is being evaluated in one active clinical trial, NCT07433179, titled A Study to Evaluate Single and Multiple Doses of SEP-479 in Healthy Adult Participants. The trial is currently recruiting, is randomized, double-blind, and controlled, and plans to enroll 150 participants in Australia.