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Also known as Praliciguat (Part A)
Praliciguat · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Praliciguat (Part A) | EXPERIMENTAL | Praliciguat 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. |
| Placebo (Part A) | PLACEBO_COMPARATOR | Matching placebo will be administered daily for 24 weeks |
| Experimental: Long-term safety extension praliciguat (Part B) | EXPERIMENTAL | Praliciguat will be administered daily |
| Name | Type | Description |
|---|---|---|
| Praliciguat (Part A) | DRUG | Oral Tablet |
| Placebo (Part A) | OTHER | Oral Tablet |
| Praliciguat (Part B) | DRUG | Oral Tablet |
Inclusion Criteria (Part A): 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 Epidemi...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Apellis Pharmaceuticals, Inc. | APLS | 1 | PHASE2 | APL-2 |
| Sanofi SA Sponsored ADR | SNY | 1 | PHASE2 | Frexalimab, Brivekimig, rilzabrutinib |
| Novartis AG Sponsored ADR | NVS | 1 | PHASE2 | Atrasentan |
| Akebia Therapeutics, Inc. | AKBA | 1 | PHASE2 | Praliciguat |
| Travere Therapeutics, Inc. | TVTX | 1 | PHASE2 | Sparsentan |
| Vera Therapeutics, Inc. Class A | VERA | 1 | PHASE2 | Atacicept |
Praliciguat is being studied for the treatment of focal segmental glomerulosclerosis (FSGS), a kidney condition. It is an investigational small molecule in Phase 2 clinical development and is not approved for any indication. The ongoing study is enrolling adults with FSGS in the United States.
Praliciguat targets GUCY1B1, GUCY1A2, and GUCY1A1 and acts as an activator of these targets. This small molecule is designed to act on the soluble guanylate cyclase pathway. It is being evaluated in focal segmental glomerulosclerosis, a nephrology indication.
Praliciguat is being developed by Akebia Therapeutics, Inc., which trades under the ticker AKBA. The company is sponsoring the Phase 2 clinical program evaluating the drug in patients with focal segmental glomerulosclerosis. Akebia Therapeutics is a biopharmaceutical company focused on kidney disease.
Praliciguat is in Phase 2 clinical development. It is an investigational drug and has not been approved by the FDA for any indication. The Phase 2 study in focal segmental glomerulosclerosis is currently recruiting participants.
Praliciguat is being evaluated in one clinical trial, NCT07268638, titled A Study of Praliciguat in Participants With Focal Segmental Glomerulosclerosis (FSGS). The Phase 2 trial is recruiting, is randomized, double-blind, and placebo-controlled, and plans to enroll 60 participants aged 18 years and older in the United States.
Yes, Praliciguat (Part A) refers to the same drug as Praliciguat. The parenthetical designation distinguishes a portion of the clinical program rather than a different compound. Both names refer to the small molecule being developed by Akebia Therapeutics for focal segmental glomerulosclerosis.