Recent Updates
Recently added Catalysts

AP01

Phase 2

Pulmonary Fibrosis | Small molecule | Immunology |Avalyn Pharma Inc.|Last Updated: Jul 2, 2026

Success Probability
Subscribe to view
Market & Valuation
Subscribe to view
Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment375
FDA Designations
No designations recorded
Clinical trial landscape

AP01 · 2 trials · 11 indications

Phase 2 2
NCT06951217An Extension Study of Subjects Who Received an Avalyn Inhaled Antifibrotic Agent (SAIL)Progressive Pulmonary Fibrosis
RECRUITING340 Analytics
NCT06329401A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary FibrosisPulmonary Fibrosis
ACTIVE NOT_RECRUITING375 Analytics
PHASE2RECRUITING
An Extension Study of Subjects Who Received an Avalyn Inhaled Antifibrotic Agent (SAIL)
Progressive Pulmonary FibrosisUnlock trial analytics
PHASE2ACTIVE NOT_RECRUITING
A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis
Pulmonary FibrosisUnlock trial analytics
Study Endpoints
Primary Endpoints
To evaluate the long-term safety and tolerability outcomes of subjects receiving Avalyn nebulized antifibrotic medications (AP01).
Through end of study; average of 6 years

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.

To evaluate the effect of AP01 high dose twice a day (BID) or AP01 low dose twice a day (BID) compared to placebo twice a day (BID)
Week 52

Change from baseline in forced vital capacity (FVC) (mL)

Secondary Endpoints
To evaluate the long-term effect of Avalyn nebulized antifibrotic medications on lung function the change from baseline in forced vital capacity (FVC) will be evaluated.
Through end of study; average of 6 years
To evaluate the long-term effect of Avalyn nebulized antifibrotic medications on stabilization of disease.
Through end of study; average of 6 years
To evaluate the long-term impact of Avalyn nebulized antifibrotic medications on subject-reported quality of life (QoL).
Through end of study; average of 6 years
Unlock Study Endpoints
Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Open-label AP01 treatment armEXPERIMENTALAll 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 BIDEXPERIMENTALPirfenidone Solution for Inhalation
AP01 Low Dose BIDEXPERIMENTALPirfenidone Solution for Inhalation
Placebo BIDPLACEBO_COMPARATORPlacebo solution for inhalation
Interventions
NameTypeDescription
AP01COMBINATION_PRODUCTAP01 will be administered open-label via the eFlow Nebulizer System
PlaceboOTHERPlacebo oral inhalation solution
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites54

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...

Countries:United StatesAustraliaCanadaCzechiaFranceGermanyItalyNetherlandsNew ZealandPolandSpainUnited KingdomArgentinaBelgiumTurkey (Türkiye)
Unlock Eligibility Criteria
Recent Changes (Last 90 Days)
LOWJul 2, 2026NCT06951217lastUpdatePostDate: changed
LOWJul 2, 2026NCT06329401lastUpdatePostDate: changed
LOWJul 2, 2026NCT06951217lastUpdatePostDate: changed
LOWJul 2, 2026NCT06329401lastUpdatePostDate: changed
LOWJul 2, 2026NCT06951217lastUpdatePostDate: changed
LOWJul 2, 2026NCT06329401lastUpdatePostDate: changed
MEDIUMJun 18, 2026NCT06329401Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMJun 18, 2026NCT06329401Status: RECRUITING → ACTIVE_NOT_RECRUITING
MEDIUMJun 18, 2026NCT06329401Status: RECRUITING → ACTIVE_NOT_RECRUITING
LOWMay 26, 2026NCT06951217primaryCompletionDate: changed
LOWMay 26, 2026NCT06329401primaryCompletionDate: changed
LOWMay 24, 2026NCT06951217studyFirstPostDate: changed
LOWMay 24, 2026NCT06329401studyFirstPostDate: changed