Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT06329401 | A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis | PHASE2 | RECRUITING | 375 | — | — | Apr 3, 2024 | Jun 1, 2027 | Apr 6, 2026 | 152 | United States, Argentina +12 |
Change from baseline in forced vital capacity (FVC) (mL)
| Arm | Type | Description |
|---|---|---|
| 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 | DRUG | Oral inhalation solution |
| Placebo | OTHER | Placebo oral inhalation solution |
Inclusion Criteria: * Participant meets criteria for PPF, as follows: * In subjects with interstitial lung disease (ILD) of known or unknown etiology other than idiopathic pulmonary fibrosis (IPF) who have radiological evidence of pulmonary fibrosis, PPF is defined as: Physiological evidence of di...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Bristol-Myers Squibb Company | BMY | 2 | PHASE3 | BMS-986278 |
| United Therapeutics Corporation | UTHR | 2 | PHASE3 | Treprostinil |
| PureTech Health PLC Sponsored ADR | PRTC | 2 | PHASE3 | Deupirfenidone, Pirfenidone |
| AbbVie, Inc. | ABBV | 2 | PHASE2 | ABBV-142 |
| 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 |
| Cumberland Pharmaceuticals Inc. | CPIX | 1 | PHASE2 | Ifetroban |
| Avalyn Pharma Inc | AVLN | 3 | PHASE2 | AP02, AP01 |
| MannKind Corporation | MNKD | 1 | PHASE1 | MNKD-201 |
| Trevi Therapeutics, Inc. | TRVI | 1 | PHASE1 | NAL |
| AgomAb Therapeutics NV ADR | AGMB | 1 | PHASE1 | AGMB-447 |