Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
AP02 · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Placebo BID | PLACEBO_COMPARATOR | Placebo solution for Inhalation |
| AP02 low dose BID | ACTIVE_COMPARATOR | Nintedanib solution for Inhalation |
| AP02 high dose BID | ACTIVE_COMPARATOR | Nintedanib solution for Inhalation |
| Name | Type | Description |
|---|---|---|
| AP02 | DRUG | Oral inhalation solution |
| Placebo | DRUG | Placebo oral inhalation solution |
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...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Bristol-Myers Squibb Company | BMY | 2 | PHASE3 | BMS-986278 |
| United Therapeutics Corporation | UTHR | 2 | PHASE3 | Treprostinil |
| AbbVie, Inc. | ABBV | 2 | PHASE2 | ABBV-142 |
| PureTech Health PLC Sponsored ADR | PRTC | 2 | PHASE3 | Deupirfenidone, Pirfenidone |
| Syndax Pharmaceuticals Inc | SNDX | 1 | PHASE2 | Axatilimab |
| Contineum Therapeutics, Inc. Class A | CTNM | 1 | PHASE2 | PIPE-791 Dose A, PIPE-791 Dose B |
| Rein Therapeutics, Inc | RNTX | 1 | PHASE2 | LTI-03 |
| Sunshine Biopharma Incorporated | SBFM | 2 | PHASE3 | HEC585, Pirfenidone |
| Cumberland Pharmaceuticals Inc. | CPIX | 1 | PHASE2 | Ifetroban |
| Avalyn Pharma Inc | AVLN | 3 | PHASE2 | AP01 |
AP02 is an investigational small molecule being developed for the treatment of Idiopathic Pulmonary Fibrosis (IPF). It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities. The drug is being studied to evaluate its safety and efficacy in patients with IPF.
AP02 is a nintedanib solution, and nintedanib is a tyrosine kinase inhibitor that targets multiple receptors involved in fibrotic processes. It inhibits receptors such as vascular endothelial growth factor receptor (VEGFR), fibroblast growth factor receptor (FGFR), and platelet-derived growth factor receptor (PDGFR), which play key roles in the progression of IPF.
AP02 is being developed by Avalyn Pharma Inc., a biopharmaceutical company. The company is conducting clinical trials to evaluate the drug's potential as a treatment for Idiopathic Pulmonary Fibrosis. Avalyn Pharma Inc. is publicly traded under the ticker symbol AVLN.
AP02 is currently in Phase 2 clinical development. It is an investigational drug and has not received FDA approval. The ongoing Phase 2 trial is designed to assess the safety and efficacy of AP02 in patients with Idiopathic Pulmonary Fibrosis.
AP02 is being studied in a Phase 2 clinical trial with the identifier NCT07194382, titled 'AURA-IPF: A Randomized Phase 2 Study to Evaluate the Safety and Efficacy of AP02 (Nintedanib Solution) in IPF.' This trial is currently recruiting participants and aims to enroll 160 patients across multiple countries.
AP02 is a nintedanib solution, meaning it contains the active ingredient nintedanib. However, AP02 is a specific formulation being developed by Avalyn Pharma Inc. for the treatment of Idiopathic Pulmonary Fibrosis. It is not the same as other marketed nintedanib products, as it is an investigational formulation under clinical evaluation.