Trial Profile

A Phase 3 randomized, controlled pivotal study of 4D-710 in patients with cystic fibrosis.

Status: Planning

Phase of Trial: Phase III

Latest Information Update: 01 Apr 2024

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At a glance

Drugs 4D 710 (Primary)
Indications Cystic fibrosis
Focus Registrational; Therapeutic Use

Most Recent Events

01 Apr 2024 New trial record
28 Mar 2024 According to a 4DMT media release, company recently had discussions with the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA), regarding the registrational path for 4D-710 for treatment of CF lung disease in pwCF who are ineligible for or cannot tolerate approved CF modulator therapies. Company is preparing for initiation of a Phase 3 clinical trial in H2 2025.

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