Trial Profile

Phase I clinical trial of TNX-601 CR for major depressive disorder (depression)

Status: Planning

Phase of Trial: Phase I

Latest Information Update: 25 Mar 2021

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At a glance

22 Mar 2021 According to a Tonix Pharmaceuticals Holding Corp media release; based on the official minutes, Tonix expects to submit the IND to conduct a human abuse potential study and meet with FDA controlled substances staff (CSS) to reach agreement on the details of the abuse potential study
22 Mar 2021 According to a Tonix Pharmaceuticals Holding Corp media release, the company has received the official minutes from a Type B pre-investigational new drug (IND) meeting with the USFDA on its development plan for TNX-601 CR (tianeptine oxalate and naloxone controlled-release) tablet for the treatment of major depressive disorder
24 Mar 2020 According to a Tonix Pharmaceuticals Holding Corp media release, company plans to start the first efficacy trial ex-U.S. in 2021.

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