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Povetacicept

Phase 3

Immunoglobulin A Nephropathy | Small molecule | Other |Vertex Pharmaceuticals Incorporated|Last Updated: May 15, 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 Enrollment605
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06564142Evaluation of Efficacy of Povetacicept in Adults With Immunoglobulin A Nephropathy (IgAN)PHASE3 ACTIVE NOT_RECRUITING 605 — — Aug 30, 2024Jan 30, 2028May 15, 2026318 United States, Australia +31
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Study Endpoints
Primary Endpoints
Change From Baseline in 24-hour Urine Protein to Creatinine Ratio (uPCR) at Week 36
From Baseline at Week 36
Total Estimated Glomerular Filtration Rate (eGFR) Slope Through Week 104
From Baseline Through Week 104
Secondary Endpoints
Change from Baseline in Serum Gd-IgA1 at Week 36
From Baseline at Week 36
Proportion of Participants to Achieve Hematuria Resolution at Week 36 (Among Participants With Hematuria at Baseline)
From Baseline at Week 36
Change From Baseline in eGFR at Week 104
From Baseline at Week 104
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PovetaciceptEXPERIMENTALParticipants will be randomized to receive Povetacicept.
PlaceboPLACEBO_COMPARATORParticipants will be randomized to receive placebo matched to Povetacicept.
Interventions
NameTypeDescription
PovetaciceptDRUGSubcutaneous injection administration.
Placebo (matched to Povetacicept)DRUGPlacebo matched to Povetacicept subcutaneous injection administration.
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites318

Key Inclusion Criteria: * Diagnosed IgAN, with biopsy confirmation * 24-hr proteinuria excretion ≥1.0 g/day or 24-hour uPCR ≥0.75 g/g * Estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73m\^2 * Stable angiotensin converting enzyme inhibitor (ACEi) or angiotensin II receptor blocker (ARBs) ...

Countries:United StatesAustraliaAustriaBelgiumBrazilCanadaChinaCroatiaCzechiaDenmarkEstoniaFinlandFranceGermanyHong KongHungaryIrelandIsraelItalyJapanLatviaLithuaniaMexicoNetherlandsNorwayPolandSaudi ArabiaSouth KoreaSpainSwedenTaiwanTurkey (Türkiye)United Kingdom
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06564142primaryCompletionDate: changed
LOWMay 24, 2026NCT06564142studyFirstPostDate: changed