Drugs / AP01
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT06329401 | Apr 2024 → Jun 2027 expected | hypersensitivity pneumonitis, pulmonary fibrosis, pulmonary systemic sclerosis, rheumatoid arthritis-associated interstitial lung disease | Avalyn Pharma Inc. | Active not recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2026-09-08 | Avalyn Pharma Inc. | Results Avalyn Presents New Data at ERS Congress 2026 Supporting AP01 Lung Distribution and Patient-Centered Trial Design in Pulmonary Fibrosis avalynpharma.com ↗
today announced new data demonstrating predicted aerosol distribution of AP01 and survey data highlighting patient perspectives on participation in clinical studies for idiopathic pulmonary fibrosis (IPF). |
| 2026-05-05 | Avalyn Pharma Inc. | Results Avalyn to Present Patient-Centered Research on AP01 Delivery and Supportive Care Experiences at American Thoracic Society 2026 International Conference avalynpharma.com ↗
Avalyn will present findings from a usability study of the eFlow® Nebulizer System designed to deliver AP01 (inhaled pirfenidone), demonstrating how patient, care partner, and clinician experience and feedback informed improvements to instructional materials. |
| 2026-04-13 | Avalyn Pharma Inc. | Results Avalyn Showcases Clinical Data Across Multiple Pulmonary Fibrosis Programs at ATS 2025 avalynpharma.com ↗
AP01 (inhaled pirfenidone) treatment demonstrated long-term antifibrotic effects and continued favorable safety out to over 4.5 years |
| 2026-04-13 | Avalyn Pharma Inc. | Results Avalyn Announces Publication Demonstrating Correlation Between Imaging, Improved Lung Function, and Quality of Life with AP01 in Patients with Idiopathic Pulmonary Fibrosis avalynpharma.com ↗ |
All press releases naming this drug 8 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | AP01 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06329401 ↗ |
| Known as | pirfenidone | “assessed safety, tolerability and efficacy of inhaled pirfenidone (AP01) in IPF.” PMID 36948586 ↗ Mar 2023 |
| Route | Inhaled | “by oral inhalation using the investigational eFlow Nebuliser System” PMID 41448793 ↗ Dec 2025 |