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Inaxaplin

Phase 2

Proteinuric Kidney Disease | Small molecule | Nephrology |Vertex Pharmaceuticals Incorporated|Last Updated: May 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 Enrollment42
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06794996Inaxaplin in Participants With Proteinuric APOL1 Mediated Kidney Disease With or Without ComorbiditiesPHASE2 ACTIVE NOT_RECRUITING 42Feb 4, 2025Dec 30, 2026May 5, 202635 United States
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Study Endpoints
Primary Endpoints
Percent Change in Urine Albumin-Creatinine Ratio (UACR)
Baseline and At Week 13
Secondary Endpoints
Safety and Tolerability as Assessed by Number of Participants with Adverse Events (AEs) and Serious Adverse Events (SAEs)
From Baseline Up To Week 17
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
IXP (Inaxaplin)EXPERIMENTALParticipants with proteinuric APOL1-mediated kidney disease (AMKD) with or without the comorbidity of Type 2 diabetes mellitus (T2DM) will receive a single dose of IXP once daily, for 13 weeks.
Interventions
NameTypeDescription
InaxaplinDRUGTablets for Oral Administration.
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Eligibility Criteria
Age Range18 Years — 67 Years
SexALL
Healthy VolunteersNo
Study Sites35

Key Inclusion Criteria: * Participant has an APOL1 genotype of G1/G1, G2/G2, or G1/G2 obtained with a Vertex designated investigational clinical study assay * Estimated Glomerular Filtration Rate (eGFR) of greater than or equal to (≥) 25 milliliter per minute (mL/min)/1.73m\^2 at screening Key Exc...

Countries:United States
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Recent Changes (Last 90 Days)
MEDIUMMay 26, 2026NCT06794996Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWMay 24, 2026NCT06794996studyFirstPostDate: changed