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GIA632

Phase 2

Atopic Dermatitis | Small molecule | Immunology |Novartis AG|Last Updated: May 14, 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 Enrollment34
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07220577Phase 2a Study to Assess the Efficacy,Safety and Tolerability of GIA632 in Adult Participants With Moderate to Severe Atopic DermatitisPHASE2 ACTIVE NOT_RECRUITING 34Nov 10, 2025Sep 6, 2027May 14, 202628 United States, Bulgaria +7
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Study Endpoints
Primary Endpoints
IGA response at Week 16 defined as clear (0) or almost clear (1) score with at least a 2 point-reduction from baseline
Baseline, Week 16

To assess the efficacy of GIA632 compared to placebo at week 16

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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
GIA632EXPERIMENTALActive treatment arm
PlaceboPLACEBO_COMPARATORPlacebo treatment arm
Interventions
NameTypeDescription
GIA632DRUGActive treatment arm
PlaceboOTHERPlacebo treatment arm
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Eligibility Criteria
Age Range18 Years — 100 Years
SexALL
Healthy VolunteersNo
Study Sites28

Key Inclusion Criteria: * Able and willing to sign the informed consent form * Patients with a diagnosis of atopic dermatitis and disease for at least 1 year * Moderate to severe atopic dermatitis Key Exclusion Criteria: * Participants with a clinically significant medical condition or infectious...

Countries:United StatesBulgariaCanadaCzechiaFranceGermanyMalaysiaPolandSingapore
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Recent Changes (Last 90 Days)
HIGHMay 26, 2026NCT07220577Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWMay 24, 2026NCT07220577studyFirstPostDate: changed