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# Sanofi Scraps Phase 2 Study of Lademirsen
- URL: https://www.fdaweb.com/sanofi-scraps-phase-2-study-of-lademirsen/
- Published: 2022-07-18T12:00:00.000Z
- Updated: 2026-09-14T17:52:17.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152297

Sanofi has told Regulus Therapeutics that it is terminating a Phase 2 clinical study (HERA Study) of lademirsen (RG-012) for treating Alport syndrome after data failed to meet Sanofi’s pre-defined futility criteria. Previously, Sanofi acquired from Regulus the rights for developing and marketing RG-012.

Regulus says that Sanofi also notified the company that it is currently evaluating different opportunities involving RG-012\. Under their agreement, Regulus was eligible to receive a $25 million milestone payment upon the successful completion of the HERA study. Regulus says it still remains eligible for the milestone payment in the event of successfully completing a Phase 2 fibrosis proof of concept study

Lademirsen was designed to block the activity of a small RNA molecule called miR-21, which is believed to be associated in the development of kidney tissue scarring (fibrosis) and damage. The drug has been granted orphan drug status by FDA as a potential therapy for Alport syndrome.