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BHV-1400

Phase 1

IgA Nephropathy | Small molecule | Nephrology |Biohaven Ltd.|Last Updated: Jun 2, 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 Enrollment20
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07054684Study of BHV-1400 in IgA NephropathyPHASE1 RECRUITING 20Jul 30, 2025Jul 1, 2027Jun 2, 202615 United States, United Kingdom
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Study Endpoints
Primary Endpoints
Number of participants with Serious AEs (SAEs), AEs leading to discontinuation, deaths
Up to 1 year

To assess the safety and tolerability of BHV-1400. This objective will be measured by assessing the number of unique subjects with SAEs, moderate or severe AEs, AEs leading to discontinuation or deaths

Number of participants with Grade 3-4 treatment-emergent laboratory abnormalities
Up to 1 year

To assess the safety and tolerability of BHV-1400. This objective will be measured by assessing the number of unique subjects with Grade 3 or 4 treatment-emergent laboratory abnormalities.

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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
BHV-1400EXPERIMENTAL -
Interventions
NameTypeDescription
BHV-1400DRUGBHV-1400 is delivered subcutaneously (SC)
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites15

Key Inclusion Criteria: 1\. Participants must have biopsy-confirmed IgA Nephropathy Key Exclusion Criteria: 1. Any secondary IgAN 2. Any cause of chronic kidney disease not diagnosed as IgAN or due to non-IgAN cause

Countries:United StatesUnited Kingdom
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Recent Changes (Last 90 Days)
LOWJun 2, 2026NCT07054684lastUpdatePostDate: changed
LOWJun 2, 2026NCT07054684lastUpdatePostDate: changed
LOWJun 2, 2026NCT07054684lastUpdatePostDate: changed
LOWMay 26, 2026NCT07054684primaryCompletionDate: changed
LOWMay 24, 2026NCT07054684studyFirstPostDate: changed