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# FDA Clinical Hold on Regulus Hepatitis C Therapy
- URL: https://www.fdaweb.com/fda-clinical-hold-on-regulus-hepatitis-c-therapy/
- Published: 2016-06-28T12:00:00.000Z
- Updated: 2026-09-14T21:12:06.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5136073

FDA has placed a clinical hold on a Regulus Therapeutics IND for RG-101 for treating chronic hepatitis C virus (HCV) infection after the company reported a second serious adverse event involving jaundice. The event occurred in a HCV patient with end-stage renal disease on dialysis who was enrolled in an on-going Phase 1 study 117 days after receiving a single RG-101 dose.

“Timelines for Regulus' three on-going studies of RG-101 are not expected to be impacted as all patients have been enrolled and completed their dosing of RG-101 and will continue with protocol scheduled visits,” the company says. Regulus says it remains on track to deliver follow-up results from these studies at upcoming relevant scientific meetings.

Regulus is also developing RG-012, an anti-miR targeting microRNA-21, for treating Alport syndrome, a life-threatening kidney disease driven by genetic mutations with no approved therapy. In addition, RG-125, a GalNAc-conjugated anti-miR targeting microRNA-103/107, is under development for treating nonalcoholic steatohepatitis in patients with Type 2 diabetes/pre-diabetes.