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Praliciguat

Phase 2

Focal Segmental Glomerulosclerosis | Small molecule | Other |Akebia Therapeutics, Inc.|Last Updated: Jun 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
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment60
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07268638A Study of Praliciguat in Participants With Focal Segmental Glomerulosclerosis (FSGS)PHASE2 RECRUITING 60Dec 3, 2025Jan 1, 2028Jun 5, 202614 United States
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Study Endpoints
Primary Endpoints
Change from Baseline in urine protein-to-creatinine ratio (UPCR)
Baseline (Day 1) and up to Week 24
Secondary Endpoints
Percentage of Participants with Partial Remission at Week 24
Up to Week 24
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
PraliciguatEXPERIMENTALPraliciguat will be administered daily with dose escalation to a target dose during a 24-week double-blind period, followed by a 24-week open-label treatment period.
PlaceboPLACEBO_COMPARATORMatching placebo will be administered daily for 24 weeks
Interventions
NameTypeDescription
PraliciguatDRUGOral Tablet
PlaceboOTHEROral Tablet
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites14

Inclusion Criteria: 1. UPCR ≥1 (g/g) during screening. 2. On maximally tolerated ACEi or ARB per principal investigator discretion within 1 month of informed consent. 3. Estimated glomerular filtration rate ≥25 milliliters per minute per 1.73 square meters by Chronic Kidney Disease Epidemiology Col...

Countries:United States
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Recent Changes (Last 90 Days)
LOWJun 5, 2026NCT07268638lastUpdatePostDate: changed
LOWJun 5, 2026NCT07268638lastUpdatePostDate: changed
LOWJun 5, 2026NCT07268638lastUpdatePostDate: changed
LOWJun 5, 2026NCT07268638lastUpdatePostDate: changed
LOWMay 26, 2026NCT07268638primaryCompletionDate: changed
LOWMay 24, 2026NCT07268638studyFirstPostDate: changed