Salubris starts Phase 2 test of oral SAL0120 for proteinuric kidney disease
The 320-patient trial will measure whether SAL0120 lowers urine albumin at 12 weeks, entering a chronic kidney disease field already dense with small-molecule programs.
Executive Summary
- Salubris has registered a Phase 2, placebo-controlled dose-ranging study of its oral drug SAL0120 in chronic kidney disease, sized to compare urine albumin reduction across several dose groups.
- The design targets a change in a kidney-damage biomarker over 12 weeks, a marker regulators and drug developers commonly use to gauge whether a kidney drug is working before committing to larger outcome trials.
- Chronic kidney disease already has an active small-molecule field spanning SGLT2 inhibitors, GLP-1 receptor agonists, and mineralocorticoid receptor antagonists, several of them in Phase 3, which sets a high bar for a new entrant's biomarker data to carry any weight.
- Salubris brings a clean completion record from its broader trial portfolio into a novel program whose molecular target has not been disclosed, meaning the read here rests on modality and design rather than a differentiated mechanism story.
The trial
The study, listed under NCT07716618, is a quadruple-masked, randomized, four-arm trial comparing multiple SAL0120 dose groups against placebo in 320 patients with chronic kidney disease. Patients must show an estimated glomerular filtration rate of at least 20 mL/min/1.73 m2 and a urine albumin-to-creatinine ratio (UACR) between 300 and 5,000 mg/g at screening, a population with established, moderate-to-severe proteinuria. The trial started enrollment on January 17, 2025, and is now Active, not recruiting, meaning enrollment has closed and the trial has moved into its treatment and follow-up phase. NCT07716618A Phase II Clinical Trial of the Safety and Efficacy of SAL0120 in Patients With Chronic Kidney Disease (CKD)NCT07716618
The endpoint
The primary endpoint is the change from baseline in UACR at 12 weeks, compared across SAL0120 dose groups relative to placebo. UACR is a standard biomarker of kidney damage: a larger reduction signals the drug is lowering the protein leakage that marks disease progression. The trial's primary completion date is listed as May 27, 2026, with overall study completion targeted for August 31, 2026. No results have posted to ClinicalTrials.gov as of this writing, and the amendment history shows a single registry event, the initial registration itself, with no protocol changes since. NCT07716618A Phase II Clinical Trial of the Safety and Efficacy of SAL0120 in Patients With Chronic Kidney Disease (CKD)NCT07716618
The competitive field
Chronic kidney disease is not short of active development. AstraZeneca is running Phase 3 or Phase 4 programs for dapagliflozin and the mineralocorticoid receptor antagonist balcinrenone in the same indication, Boehringer Ingelheim has empagliflozin in Phase 3, and Shandong Suncadia Medicine has two separate Phase 3 CKD programs, HRS-1780 and HRS-7535, running with total enrollment above 5,000 and 3,600 patients respectively. All of these are small molecules, matching SAL0120's modality, but each works through a different target, SGLT2, mineralocorticoid receptor, or GLP-1 receptor, rather than SAL0120's undisclosed mechanism. That leaves SAL0120 competing on the same UACR-driven proteinuria endpoint as a mechanism-diverse field, where the informative test is not whether one more mechanism drops the biomarker, but whether it does so with a magnitude or tolerability profile that stands apart from the SGLT2 and mineralocorticoid classes already advancing toward Phase 3 outcome data.
Sponsor track record
Salubris has completed all 13 of its prior trials with no terminations on record, and its broader 33-trial portfolio includes 15 completed studies against 3 in an unknown status. That gives the sponsor an execution record to draw on as it runs SAL0120 through Phase 2, even though the trial's molecular target is not identified in available registry data, which limits how far any mechanism-based competitive comparison can be pushed.
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