A multinational clinical study of Methylthioninium-chloride for COVID-19 infections
Latest Information Update: 06 Jun 2021
At a glance
- Drugs Methylthioninium chloride (Primary)
- Indications COVID 2019 infections
- Focus Therapeutic Use
- 06 Jun 2021 New trial record
- 13 Apr 2021 According to a Prexa Pharmaceuticals media release, the company expects to initiate this study within the next several months.
- 13 Apr 2021 According to a Prexa Pharmaceuticals media release, the company had submitted a Pre-IND meeting request to the U.S. FDA, on which a written response-providing the understanding on the requirements for opening an IND for the filing of a New Drug Application (NDA) and eventual Product approval was received. The company has incorporated this guidance into Product-118 program and planning for manufacturing and filing of the NDA, for a multi-national clinical study of Product-118.