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AP02

Phase 2

Idiopathic Pulmonary Fibrosis (IPF) | Small molecule | Respiratory |Avalyn Pharma Inc.|Last Updated: Apr 6, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment160
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07194382AURA-IPF: A Randomized Phase 2 Study to Evaluate the Safety and Efficacy of AP02 (Nintedanib Solution) in IPFPHASE2 RECRUITING 160 — — Mar 10, 2026Jun 1, 2027Apr 6, 20263 Australia, Canada
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Study Endpoints
Primary Endpoints
Change from baseline in the morning pre-dose forced vital capacity at Week 12
From enrollment to the end of treatment at 12 weeks
Secondary Endpoints
Time to disease progression
From enrollment to the end of treatment at 12 weeks
To evaluate the change from baseline in quantitative lung fibrosis score
From enrollment to the end of treatment at 12 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Placebo BIDPLACEBO_COMPARATORPlacebo solution for Inhalation
AP02 low dose BIDACTIVE_COMPARATORNintedanib solution for Inhalation
AP02 high dose BIDACTIVE_COMPARATORNintedanib solution for Inhalation
Interventions
NameTypeDescription
AP02DRUGOral inhalation solution
PlaceboDRUGPlacebo oral inhalation solution
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Eligibility Criteria
Age Range40 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites3

Inclusion Criteria: * Male or female patients aged ≥40 years at the time of signing the written informed consent form * Diagnosis of idiopathic pulmonary fibrosis (IPF) as defined by American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/ Asociación Latinoamericana de T...

Countries:AustraliaCanada
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Competitive Landscape -Idiopathic Pulmonary Fibrosis 22 trials
CompanyTickerTrialsLead PhaseDrugs
Bristol-Myers Squibb CompanyBMY2PHASE3BMS-986278
United Therapeutics CorporationUTHR2PHASE3Treprostinil
PureTech Health PLC Sponsored ADRPRTC2PHASE3Deupirfenidone, Pirfenidone
AbbVie, Inc.ABBV2PHASE2ABBV-142
Syndax Pharmaceuticals IncSNDX1PHASE2Axatilimab
Contineum Therapeutics, Inc. Class ACTNM1PHASE2PIPE-791 Dose A, PIPE-791 Dose B
Rein Therapeutics, IncRNTX1PHASE2LTI-03
Cumberland Pharmaceuticals Inc.CPIX1PHASE2Ifetroban
Avalyn Pharma IncAVLN3PHASE2AP02, AP01
MannKind CorporationMNKD1PHASE1MNKD-201
Trevi Therapeutics, Inc.TRVI1PHASE1NAL
AgomAb Therapeutics NV ADRAGMB1PHASE1AGMB-447
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT07194382primaryCompletionDate: changed
LOWMay 24, 2026NCT07194382studyFirstPostDate: changed