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Praliciguat

Phase 2

Focal Segmental Glomerulosclerosis | Small molecule | Nephrology |Akebia Therapeutics, Inc.|Last Updated: Aug 13, 2026

Target and mechanism

Molecular targetGUCY1B1, GUCY1A2, GUCY1A1
Target classActivator
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment60

FDA Designations

No designations recorded

Clinical trial landscape

Praliciguat · 1 trial · 1 indication

Phase 2 1
NCT07268638A Study of Praliciguat in Participants With Focal Segmental Glomerulosclerosis (FSGS)Focal Segmental Glomerulosclerosis
RECRUITING60 Analytics
PHASE2RECRUITING
A Study of Praliciguat in Participants With Focal Segmental Glomerulosclerosis (FSGS)
Focal Segmental GlomerulosclerosisUnlock trial analytics

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
Plasma concentrations of praliciguat
Week 24, Week 32, and Week 36
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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 to N/A
SexALL
Healthy VolunteersNo
Study Sites25

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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Competitive Landscape -Focal Segmental Glomerulosclerosis 6 trials

Recent Changes (Last 90 Days)

LOWAug 14, 2026NCT07268638lastUpdatePostDate: changed
LOWAug 14, 2026NCT07268638lastUpdatePostDate: changed
LOWAug 14, 2026NCT07268638lastUpdatePostDate: changed
LOWJul 13, 2026NCT07268638lastUpdatePostDate: changed
LOWJul 13, 2026NCT07268638lastUpdatePostDate: changed

Frequently asked questions about Praliciguat

What is Praliciguat used for?

Praliciguat is an investigational small molecule being developed for the treatment of Focal Segmental Glomerulosclerosis (FSGS), a kidney disorder. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.

Who makes Praliciguat?

Praliciguat is being developed by Akebia Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AKBA. The company is conducting clinical trials to evaluate the drug's safety and efficacy in patients with FSGS.

What phase is Praliciguat in?

Praliciguat is currently in Phase 2 clinical development. It is an investigational drug and has not yet received regulatory approval. The ongoing Phase 2 study is actively recruiting participants with Focal Segmental Glomerulosclerosis.

What clinical trials is Praliciguat in?

Praliciguat is being studied in a Phase 2 clinical trial with the identifier NCT07268638. This randomized, double-blind, placebo-controlled study is enrolling approximately 60 participants with Focal Segmental Glomerulosclerosis in the United States. The trial is currently recruiting adults aged 18 years and older.

Is Praliciguat the same as any other drug?

No alternative names for Praliciguat have been reported. It is a distinct investigational compound being developed by Akebia Therapeutics for the treatment of Focal Segmental Glomerulosclerosis.