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Regulus Therapeutics

San Diego, California, United Statesregulusrx.com ↗

Ownership: Public · RGLS
Development stage: Other

Overview

Farabursen (RGLS8429) successfully completed Phase 1b multiple-ascending dose clinical trial for ADPKD in March 2025, showing promising clinical efficacy and safety, including consistent impact on urinary polycystin (PC) and height-adjusted total kidney volume (htTKV). The company has received FDA alignment on key elements of a Phase 3 trial design as a single pivotal study, with a 12-month htTKV endpoint planned to support Accelerated Approval and a 24-month eGFR endpoint to support Full Approval[9].

Therapeutic areas: Nephrology
Modalities: Oligonucleotide therapeuticsmicroRNA inhibitors
Industry: Biotech

Drug pipeline

13 assets

farabursen

12 more assets in the full pipeline.

Partnerships

Sanofi (2010)AstraZeneca (2014)

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