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SEP-479

Phase 1

Healthy Volunteers | Small molecule | Other |Septerna, Inc.|Last Updated: Apr 22, 2026

Target and mechanism

Molecular targetPTH1R
Target classGpcr
ModalitySmall molecule

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

Clinical trial landscape

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
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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-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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Recent Changes (Last 90 Days)

LOWMay 26, 2026NCT07433179Status: NOT_YET_RECRUITING → RECRUITING
LOWMay 24, 2026NCT07433179studyFirstPostDate: changed

Frequently asked questions about SEP-479

What is SEP-479 used for?

SEP-479 is an investigational small molecule being studied in healthy volunteers. It is currently in Phase 1 clinical development, with a trial evaluating single and multiple doses in healthy adult participants. The drug is not yet approved and is still in clinical testing.

What does SEP-479 target?

SEP-479 targets the parathyroid hormone 1 receptor (PTH1R), which is a G protein-coupled receptor (GPCR). By targeting this receptor, the drug is designed to modulate its activity, though the specific therapeutic application is still under investigation in early-stage trials.

Who is developing SEP-479?

SEP-479 is being developed by Septerna, Inc., a biopharmaceutical company. The company is conducting a Phase 1 clinical trial of SEP-479 in healthy volunteers, with the study currently recruiting participants in Australia.

What phase is SEP-479 in?

SEP-479 is in Phase 1 clinical development. The ongoing trial, NCT07433179, is a randomized, double-blind, controlled study evaluating single and multiple doses of SEP-479 in healthy adult participants. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is SEP-479 in?

SEP-479 is being studied in one active Phase 1 clinical trial, NCT07433179, titled 'A Study to Evaluate Single and Multiple Doses of SEP-479 in Healthy Adult Participants.' This trial is recruiting 150 healthy adults aged 21 years and older in Australia and is randomized, double-blind, and controlled.