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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05255991 | Multinational Study of Efficacy and Safety of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis | PHASE3 | COMPLETED | 597 | — | — | Oct 4, 2022 | Jun 30, 2025 | Aug 15, 2025 | 108 | Argentina, Australia +14 |
| NCT04905693 | Extension Study of Inhaled Treprostinil in Subjects With Fibrotic Lung Disease | PHASE3 | ENROLLING BY_INVITATION | 1,850 | — | — | Sep 6, 2022 | Jun 1, 2026 | May 22, 2026 | 194 | United States, Argentina +16 |
| NCT04708782 | Study of Efficacy and Safety of Inhaled Treprostinil in Subjects With Idiopathic Pulmonary Fibrosis | PHASE3 | COMPLETED | 598 | — | — | Jun 1, 2021 | Feb 2, 2026 | May 5, 2026 | 98 | United States, Canada +1 |
The FVC measurement indicates the amount of air a person can forcefully and quickly exhale after taking a deep breath.
Incidence of AEs and SAEs, incidence of abnormal clinical laboratory parameters, abnormal vital signs, and abnormal 12-lead ECGs
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Matching placebo inhaled using an ultrasonic nebulizer QID |
| Inhaled Treprostinil | EXPERIMENTAL | Treprostinil for inhalation solution (0.6 mg/mL) delivered via an ultrasonic nebulizer which emits a dose of approximately 6 mcg per breath. Inhaled QID and titrated up to a target of 12 breaths QID or until the subject reaches their maximum clinically tolerated dose. |
| Name | Type | Description |
|---|---|---|
| Placebo | DRUG | Placebo administered QID |
| Inhaled Treprostinil | DRUG | Inhaled treprostinil (6 mcg/breath) administered QID |
| Treprostinil Ultrasonic Nebulizer | DEVICE | Treprostinil ultrasonic nebulizer which emits a dose of approximately 6 mcg per breath. |
Inclusion Criteria: 1. Subject gives voluntary informed consent to participate in the study. 2. Subject is ≥40 years of age, inclusive, at the time of signing informed consent. 3. The subject has a diagnosis of IPF based on the 2018 ATS/ERS/JRS/ALAT Clinical Practice Guideline (Raghu 2018) and conf...
| 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 |