Trial Profile

Phase 2b/3 study of AXA1125 for treatment of Long COVID Fatigue

Status: Planning

Phase of Trial: Phase II/III

Latest Information Update: 21 Feb 2023

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At a glance

Drugs AXA 1125 (Primary)
Indications Fatigue; Post acute COVID 19 syndrome
Focus Registrational; Therapeutic Use
Sponsors Axcella Health

Most Recent Events

15 Feb 2023 According to an Axcella Heath media release, an Investigational New Drug (IND) Application has been cleared by the U.S. Food and Drug Administration (FDA). Study design now accepted by U.S. and U.K. regulatory authorities.
30 Jan 2023 New trial record
23 Jan 2023 According to an Axcella Heath media release, the company will be meeting with the MHRA in the near term to discuss the Innovative Licensing and Access Pathway (ILAP) application.

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