Pivotal study of RG-101 and GSK2878175 in patients chronically infected with hepatitis C virus.
Phase of Trial: Phase III
Latest Information Update: 27 Jan 2017
At a glance
- Drugs GSK 2878175 (Primary) ; RG 101 (Primary)
- Indications Hepatitis C
- Focus Therapeutic Use
- 27 Jan 2017 According to a Regulus Therapeutics media release, company received written communication from the U.S. Food and Drug Administration (FDA) to continue clinical hold on RG-101 clinical development program. FDA has requested the final safety and efficacy data from on-going RG-101 studies before reconsidering the clinical hold. Company is planning an additional requests with US FDA to seek the release of the clinical hold.
- 27 Jun 2016 According to a Regulus Therapeutics media release, the company plans to work with US FDA to seek the release of the clinical hold.
- 27 Jun 2016 According to a Regulus Therapeutics media release, based on a second serious adverse event (SAE) of jaundice observed from a phase I trial (Profile 266977), the company has received a verbal notice from the U.S. Food and Drug Administration that its Investigational New Drug for RG-101 for the treatment of chronic hepatitis C virus infection has been placed on clinical hold and anticipates to receive a formal clinical hold letter from the FDA within 30 days.