Words by Jade Williams
Novartis is set to acquire Regulus Therapeutics, a San Diego-based, clinical-stage biopharmaceutical company focused on microRNA-targeting therapeutics.
The acquisition will enhance Novartis’ renal disease portfolio through the addition of a potential first-in-class development for autosomal dominant polycystic kidney disease (ADPKD).
ADPKD is the most common genetic cause of renal failure worldwide and remains a major area of unmet medical need. The acquisition aligns with Novartis’ strategic focus on kidney diseases and builds on its capabilities in RNA-targeting drug development.
The acquisition of this therapeutic “represents a potential first-in-class medicine with a profile that may provide enhanced efficacy, tolerability and safety versus standard of care,” said Shreeram Aradhye, President, Development and Chief Medical Officer, Novartis. “ADPKD is the most common genetic cause of renal failure worldwide. The team at Regulus has done meaningful foundational work with [the drug], and we look forward to investigating its potential further as we aim to bring a better treatment option to patients in need.”
The asset is an investigational microRNA inhibitor designed for preferential kidney exposure. In March 2025, Regulus completed a Phase 1b multiple-ascending dose trial showing promising safety and pharmacodynamic signals.
The transaction is expected to close in the second half of 2025, subject to regulatory approvals and other customary conditions.
Following completion, Regulus will become an indirect wholly owned subsidiary of Novartis. Until then, both companies will continue to operate independently.
