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JANX011

Phase 1

Autoimmune | Small molecule | Immunology |Janux Therapeutics, Inc.|Last Updated: Apr 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
UNCONTROLLEDDMC
Total Trials1
Total Enrollment60
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07291323Study of JANX011 in Healthy Adult Volunteers to Assess Safety and Tolerability.EARLY_PHASE1 RECRUITING 60Feb 16, 2026Dec 1, 2026Apr 23, 20261 Australia
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Study Endpoints
Primary Endpoints
Incidence, severity, and relatedness of TEAEs, treatment-emergent SAEs, and treatment-emergent AESIs.
Up to 85 days
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Dose EscalationEXPERIMENTALDosage per cohort will increase to determine the maximum tolerable dose.
Interventions
NameTypeDescription
JANX011DRUGJANX011 is administered subcutaneously, one time.
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy men and women, in the opinion of the PI or designee and as determined by physical examination, laboratory screening tests, and medical history. * Aged 18 to 65 years, with a body weight between 50 to 120 kg and a body mass index (BMI) between 18 to 32 kg/m2 (all inclus...

Countries:Australia
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07291323Status: NOT_YET_RECRUITING → RECRUITING
LOWMay 24, 2026NCT07291323studyFirstPostDate: changed