Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Pirfenidone Solution
AP01 · 2 trials · 11 indications
The incidence of adverse events will be evaluated from the time of signing of the informed consent until approximately 2 weeks after the last dose of study drug. Examples of potential adverse events include: respiratory symptoms, liver toxicity, and skin conditions. Study participants will be monitored for adverse events via the following: vital signs (blood pressure assessed using a sphygmomanometer, temperature assessed by thermometer, pulse and respiratory rate assessed by pulse oximeter), oxygen saturation, spirometry, physical exams, blood chemistry, and quality of life assessments.
Change from baseline in forced vital capacity (FVC) (mL)
| Arm | Type | Description |
|---|---|---|
| Open-label AP01 treatment arm | EXPERIMENTAL | All trial participants will enroll from a Sponsor-led parent study of AP01 and receive open-label AP01 for continued evaluation of long-term safety and tolerability. |
| AP01 High Dose BID | EXPERIMENTAL | Pirfenidone Solution for Inhalation |
| AP01 Low Dose BID | EXPERIMENTAL | Pirfenidone Solution for Inhalation |
| Placebo BID | PLACEBO_COMPARATOR | Placebo solution for inhalation |
| Name | Type | Description |
|---|---|---|
| AP01 | COMBINATION_PRODUCT | AP01 will be administered open-label via the eFlow Nebulizer System |
| Placebo | OTHER | Placebo oral inhalation solution |
Inclusion Criteria: * Previously participated in an Avalyn-sponsored inhaled antifibrotic clinical study for subjects with either idiopathic pulmonary fibrosis (IPF) (IPF subjects are excluded from the US and Canada) or progressive pulmonary fibrosis (PPF) and with the approval of the Study Physici...
AP01 is an inhaled small molecule drug in development by Avalyn Pharma Inc. for progressive pulmonary fibrosis and pulmonary fibrosis. It is given by inhalation and is being studied in adults 18 years and older. AP01 is investigational and has not been approved for any indication.
AP01 is being developed to treat progressive pulmonary fibrosis and pulmonary fibrosis, including forms secondary to systemic sclerosis and interstitial lung disease associated with connective tissue disease or rheumatoid arthritis. The clinical program enrolls adults with these fibrotic lung conditions. AP01 remains investigational and is not approved for use.
AP01 is being developed by Avalyn Pharma Inc., ticker AVLN. The company sponsors the Phase 2 clinical program for the inhaled small molecule in progressive pulmonary fibrosis and related fibrotic lung diseases. Avalyn Pharma is the sole developer named for this asset.
AP01 is in Phase 2 clinical development. Both of its listed studies are Phase 2 trials in progressive pulmonary fibrosis and related interstitial lung diseases. AP01 is investigational and is not FDA approved; it remains in clinical testing for its proposed indications.
AP01 is being studied in two Phase 2 trials. NCT06329401 evaluates the safety and efficacy of inhaled AP01 in progressive pulmonary fibrosis and is active but not recruiting, with 398 participants. NCT06951217, the SAIL extension study, is recruiting 340 participants across the United States, Europe, and other countries.
The SAIL extension study, NCT06951217, enrolls adults 18 years and older of all sexes who previously received an Avalyn inhaled antifibrotic agent. It is recruiting across the United States, Argentina, Australia, Canada, Czechia, France, Germany, Italy, Netherlands, New Zealand, Poland, Spain, and the United Kingdom, and does not enroll healthy volunteers.