Trial Profile
A Phase III Study of Gemcabene in Patients with Homozygous Familial Hypercholesterolemia
Status:
Suspended
Phase of Trial:
Phase III
Latest Information Update: 21 Aug 2020
Price :
$35 *
At a glance
- Drugs Gemcabene (Primary)
- Indications Dyslipidaemias; Hyperlipoproteinaemia type IIa
- Focus Registrational; Therapeutic Use
- Sponsors Gemphire Therapeutics; MetaVia
- 11 Aug 2020 According to a NeuroBo Pharmaceuticals media release, the company announced that in May 2020, it received written communication from the FDA stating that the clinical development program for Gemcabene remains on a partial clinical hold. The Company is reviewing its options regarding Gemcabene.
- 15 Mar 2019 According to a Gemphire Therapeutics media release, the FDA denied the request to lift partial clinical hold in Q3 2018 and requested additional information in order to resubmit. End of Phase 2 meeting would not take place until the partial clinical hold is lifted. Company expect to submit the additional information to the FDA in the Q4 of 2019. Management need to raise capital to complete additional activities needed to susubmit our request to the FDA to lift the partial clinical hold.
- 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.