Trial Profile

A Randomized, Double-Blind, Placebo-Controlled, Phase 2b Study Evaluating the Safety and Efficacy of Pirfenidone Solution for Inhalation (AP01) in Participants With PPF

Status: Active, no longer recruiting

Phase of Trial: Phase II

Latest Information Update: 21 Aug 2026

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At a glance

18 Jun 2026 Status changed from recruiting to active, no longer recruiting.
17 Jun 2026 According to Avalyn Pharma media release, topline data expected in the second half of 2027.
17 Jun 2026 According to Avalyn Pharma media release, company announced that it has completed target enrollment of 375 patients in the Phase 2b MIST clinical trial of AP01 (inhaled pirfenidone) in patients with progressive pulmonary fibrosis (PPF). Additional patients currently in screening remain eligible for randomization and may be enrolled in the trial over the next several weeks.

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