Trial Profile

A first-in-human trial of RVL001 in Rett syndrome

Status: Recruiting

Phase of Trial: Phase I

Latest Information Update: 07 May 2025

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At a glance

29 Apr 2025 According to an Unravel Biosciences media release, Company announced the submission of clinical study applications for RVL-001 under a pilot program by the Colombian Health Regulatory Agency ("INVIMA"), allowing for priority review and fast track approval for orphan and high unmet need diseases.
24 Oct 2024 According to an Unravel Biosciences media release, initiation of patient dosing for the RVL-001 trial in RTT and extension trial in PTHS are both anticipated in early 2025.
19 Mar 2024 According to an Unravel Biosciences media release, the company announced a manufacturing and development partnership with Quality Chemical Laboratories, Inc. (QCL) to manufacture RVL001 clinical trial material for use in upcoming Rett syndrome clinical trials in the US and Colombia.

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