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TEV-53408

Phase 1

Vitiligo | Small molecule | Immunology |Teva Pharmaceutical Industries Limited|Last Updated: Feb 5, 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
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment38
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06625177A Trial to Test the Safety and Efficacy of TEV-53408 in Treating VitiligoPHASE1 ACTIVE NOT_RECRUITING 38 — — Nov 11, 2024Jun 5, 2027Feb 5, 202613 United States
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Study Endpoints
Primary Endpoints
Number of Participants With at Least One Treatment-Emergent Adverse Event
Up to Week 40
Number of Participants With at Least One Serious Treatment-Emergent Adverse Event
Up to Week 40
Number of Participants With at Least One Protocol-Defined Adverse Event of Special Interest
Up to Week 40
Number of Participants With at Least One Treatment-Related Adverse Event
Up to Week 40
Number of Participants who Discontinued Treatment due to an Adverse Event
Up to Week 40
Secondary Endpoints
Number of Participants With at Least One Protocol-Defined Adverse Event of Special Interest
Week 40 to Week 80
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
TEV-53408EXPERIMENTALsolution administered subcutaneously
Interventions
NameTypeDescription
TEV-53408DRUGTEV-53408 injection administered subcutaneously
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Eligibility Criteria
Age Range18 Years — 75 Years
SexALL
Healthy VolunteersNo
Study Sites13

Inclusion Criteria: * The participant has a diagnosis of active or stable vitiligo for at least 3 months. * The participant has a body mass index (BMI) within the range of 18.5 to 40.0 kg/m2 * A female participant is eligible if she is not pregnant or breastfeeding AND is a woman of nonchildbearing...

Countries:United States
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Competitive Landscape -Vitiligo 14 trials
CompanyTickerTrialsLead PhaseDrugs
Incyte CorporationINCY5PHASE3Povorcitinib, Ruxolitinib, Vehicle
Pfizer Inc.PFE2PHASE3Ritlecitinib
AbbVie, Inc.ABBV2PHASE3Upadacitinib
Takeda Pharmaceutical Co. Ltd. Sponsored ADRTAK1PHASE2Zasocitinib
Novartis AG Sponsored ADRNVS1PHASE2GIA632
Arcutis Biotherapeutics IncARQT1PHASE2Roflumilast 0.3% foam
Forte Biosciences Inc.FBRX1PHASE1FB102
Teva Pharmaceutical Industries Limited Sponsored ADRTEVA1PHASE1TEV-53408
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT06625177studyFirstPostDate: changed