Chengdu Suncadia opens rollover safety study for HRS-5965 in IgA nephropathy
The Phase 2 extension trial enrolls patients who completed a prior HRS-5965 study, feeding into a crowded oral IgA nephropathy field led by Novartis and Vera Therapeutics assets already in Phase 3.
Executive Summary
- A Phase 2 long-term safety trial for HRS-5965 in primary IgA nephropathy moved into active recruitment, enrolling patients who already completed an earlier study of the same drug.
- The trial is built to track adverse events over time, not to establish whether HRS-5965 works, leaving the efficacy case to a separate, larger placebo-controlled trial already underway.
- HRS-5965 enters a field where several oral and biologic mechanisms targeting IgA nephropathy have already reached Phase 3, meaning the safety data from this extension will matter most in supporting an eventual filing rather than differentiating the drug on efficacy.
- Chengdu Suncadia Medicine has completed all of its prior trials, a pattern consistent with routine execution rather than heightened operational risk.
The status change
NCT07582133 moved from Not yet recruiting to Recruiting on July 22, 2026, with the trial's start date recorded as July 6, 2026. The study is designed to evaluate the long-term safety and tolerability of HRS-5965 in patients with primary IgA nephropathy, an autoimmune kidney disease, and its population is defined explicitly as patients from Study HRS-5965-305 who completed treatment or discontinued during the maintenance phase after starting rescue therapy. NCT07582133A Trial to Evaluate the Long-term Safety and Tolerability of HRS-5965 in Patients With Primary IgA NephropathyNCT07582133
Probability of SuccessBased on the AppliedXL Probability of Success model. For more information about the methodology, read the research here.
What the endpoint measures
The registered primary endpoint is the incidence and severity of adverse events over a 2-year follow-up window, an open-label, single-arm design with no comparator arm. Secondary measures track the ratio of 24-hour urine protein excretion to baseline, change in estimated glomerular filtration rate, change in serum creatinine, and the proportion of participants reaching protein excretion thresholds of under 0.3 g/d and under 0.5 g/d. Because the design is a rollover safety cohort rather than a placebo-controlled comparison, it is built to characterize tolerability over time in patients already exposed to the drug, not to establish a new efficacy signal. NCT07582133A Trial to Evaluate the Long-term Safety and Tolerability of HRS-5965 in Patients With Primary IgA NephropathyNCT07582133
Enrollment and stability
The trial's anticipated enrollment held flat at 380 patients with no change from its original target, which the trial's own operational model flags as within the routine band for enrollment shifts. The registry shows a single status update since the trial's initial posting on May 12, 2026, with no changes to endpoints, eligibility criteria, or the primary completion date, which is set for July 1, 2029. NCT07582133A Trial to Evaluate the Long-term Safety and Tolerability of HRS-5965 in Patients With Primary IgA NephropathyNCT07582133
The HRS-5965 program
HRS-5965 is being tested in three registered trials for IgA nephropathy under Chengdu Suncadia Medicine: this safety extension, an earlier Phase 2 tablet study (NCT06137768) that is now active but not recruiting, and a placebo-controlled Phase 3 trial (NCT07014826) enrolling 378 patients with a primary completion date of October 1, 2027. The Phase 3 trial carries the efficacy question for the program; this extension supplies the safety record that would sit alongside it. NCT07582133A Trial to Evaluate the Long-term Safety and Tolerability of HRS-5965 in Patients With Primary IgA NephropathyNCT07582133
The competitive field
IgA nephropathy has drawn multiple Phase 3 programs testing distinct mechanisms: Novartis's zigakibart (targeting APRIL) and iptacopan (targeting Complement Factor B), Vera Therapeutics' atacicept (targeting BAFF), and Takeda's mezagitamab (targeting CD38), among others. None of these shares HRS-5965's mechanism, since HRS-5965's target is not established in available trial data, so the comparison rests on modality and phase rather than mechanism class. With several oral and biologic candidates already past mid-stage development, a safety record this extension generates would need to hold up cleanly through 2-year follow-up for HRS-5965 to compete on tolerability once its Phase 3 efficacy data mature.
Sponsor context
Chengdu Suncadia Medicine has completed 12 of its 21 registered trials with no terminations on record, and its broader pipeline currently includes 4 recruiting and 2 active-not-recruiting studies. That completion pattern supports the trial's operational credibility but does not bear on whether HRS-5965 will differentiate clinically from the mechanisms already in Phase 3 testing.
This analysis was produced using AI-assisted reporting systems, AppliedXL data, and official public records. These systems undergo editorial review, quality checks, and regular audits by human experts. Errors may still occur, as with any automated system. Always consult the linked primary sources. Read our AI Editorial Policy.