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Rezpegaldesleukin

Phase 2

Alopecia Areata | Small molecule | Immunology |Nektar Therapeutics|Last Updated: Mar 31, 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-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment94
FDA Designations
FAST_TRACK
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06340360A Phase 2b Study to Evaluate Rezpegaldesleukin (Rezpeg) in the Treatment of Severe to Very Severe Alopecia Areata in Adult Patients (Rezolve AA)PHASE2 ACTIVE NOT_RECRUITING 94Apr 2, 2024Aug 1, 2026Mar 31, 202626 United States, Canada +1
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Study Endpoints
Primary Endpoints
Percent change from baseline in Severity of Alopecia Tool (SALT) score at Week 36
Baseline and Week 36

The SALT score is the sum of percentage of hair loss in all areas with a maximum score of 100 (higher score indicates greater hair loss).

Secondary Endpoints
Percent change from baseline in SALT score
Baseline and Weeks 12, 16, 20, 24, 28, and 32
Proportion of patients achieving improvement in Severity of Alopecia Tool (SALT) ≥ 50%/75%/90%
Baseline and Weeks 12, 16, 20, 24, 28, 32, and 36
Proportion of patients achieving an absolute SALT score ≤ 10/20/30/50
Baseline and Weeks 12, 16, 20, 24, 28, 32, and 36
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Low DoseEXPERIMENTALRezpegaldesleukin Low Dose Every 2 weeks
High DoseEXPERIMENTALRezpegaldesleukin High Dose Every 2 weeks
PlaceboPLACEBO_COMPARATORPlacebo Every 2 weeks
Interventions
NameTypeDescription
RezpegaldesleukinDRUGPharmaceutical form: Injection solution Route of administration: subcutaneous
PlaceboDRUGPharmaceutical form: Injection solution Route of administration: subcutaneous
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Eligibility Criteria
Age Range18 Years — 70 Years
SexALL
Healthy VolunteersNo
Study Sites26

Inclusion Criteria: * Adults who are at least 18 years and ≤60 years for males (≤70 years of age for females) old at the time of informed consent * Diagnosis of Alopecia Areata (AA) severity at screening and baseline: 1. severe to very severe AA (≥ 50% scalp involvement) as measured using the SA...

Countries:United StatesCanadaPoland
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06340360primaryCompletionDate: changed
LOWMay 24, 2026NCT06340360studyFirstPostDate: changed