Novartis posts ASSIST Phase 2 results; two pediatric studies listed

Novartis Pharmaceuticals had three registry updates during the week of July 20-21, 2026, spanning a completed adult kidney disease trial and two pediatric studies at different stages.

• Novartis posted results for its completed Phase 2 ASSIST trial (NCT05834738), which evaluated the safety and efficacy of atrasentan vs. placebo in subjects with IgA nephropathy while on background standard of care therapy and an SGLT2 inhibitor.¹ The study enrolled 54 participants¹ and its primary outcome was percentage change in proteinuria (UPCR from a 24-hour urine collection) from baseline to week 12¹, with results first posted July 20, 2026.
• Novartis registered a Phase 4 study (NCT07713602) of Coartem® Baby, artemether/lumefantrine 5 mg/60 mg, in neonates and infants weighing ≥2 kg to <5 kg with uncomplicated malaria due to Plasmodium falciparum or mixed infections under real-world conditions.² The trial, performed in response to requests from Swissmedic and African National Regulatory Authorities following the approval of Coartem® Baby to generate additional post-marketing data², is not yet recruiting and plans to enroll 20 participants (estimated)².
• Novartis is recruiting for an observational study (NCT07716410) designed to characterize the pediatric cryptosporidiosis disease profile with respect to clinical presentation³ in children 6 months to 59 months³ old. The study plans to enroll 30 participants (estimated)³ across 4 sites in 3 countries: Kenya, Malaysia, Zambia³, with primary completion estimated for May 19, 2027.