A Phase III Study of Gemcabene in Patients with Homozygous Familial Hypercholesterolemia
Phase of Trial: Phase III
Latest Information Update: 13 Aug 2018
At a glance
- Drugs Gemcabene (Primary)
- Indications Dyslipidaemias; Hyperlipoproteinaemia type IIa
- Focus Registrational; Therapeutic Use
- Sponsors Gemphire Therapeutics
- 13 Aug 2018 According to a Gemphire Therapeutics media release, the company is working with the FDA to release the partial hold on gemcabene with respect to clinical trials of longer than six months in duration, with the goal of proceeding to an End of Phase 2 meeting and reaching an agreement on the design of this Phase 3 clinical trial in dyslipidemia. It plans to conduct the studies required by the FDA and expects to submit the additional results in the second quarter of 2019.
- 15 Mar 2018 According to a Gemphire Therapeutics media release, company plans to initiate this trial in second half of 2018, once agreement with the FDA is reached.
- 19 Sep 2017 According to a Gemphire Therapeutics media release, company plans to initiate this trial in 2018.