6 completed, 2 terminated, 1 active not recruiting, 1 available. 4 Phase 2, 4 Phase 3, 2 Phase 1.
| Phase | Trials | Status |
|---|---|---|
| Phase 2 | 4 | Completed 3, Terminated 1 |
| Phase 3 | 4 | Active not recruiting 1, Completed 1, Recruiting 1, Terminated 1 |
| Phase 1 | 2 | Completed 2 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Inhaled Molgramostim in Pediatric Participants With Autoimmune Pulmonary Alveolar Proteinosis (aPAP). Molgramostim - Autoimmune Pulmonary Alveolar Proteinosis | Phase 3 | Recruiting | Savara Inc. | 5 | 2025-10-22 | 2026-02-19 |
| Clinical Trial of Inhaled Molgramostim Nebulizer Solution in Autoimmune Pulmonary Alveolar Proteinosis (aPAP) Molgramostim, Placebo, Molgramostim Open-label - Autoimmune Pulmonary Alveolar Proteinosis | Phase 3 | Active not recruiting | Savara Inc. | 164 | 2021-05-19 | 2026-08-26 |
| Trial of Inhaled Molgramostim in Cystic Fibrosis Subjects With Nontuberculous Mycobacterial Infection Molgramostim nebulizer solution, PARI eFlow nebulizer system - Mycobacterium Infections, Nontuberculous, Cystic Fibrosis (CF) | Phase 2 | Terminated | Savara Inc. | 14 | 2019-06-20 | 2023-01-10 |
| Safety Extension Trial of Inhaled Molgramostim in Autoimmune Pulmonary Alveolar Proteinosis Molgramostim - Autoimmune Pulmonary Alveolar Proteinosis | Phase 3 | Terminated | Savara Inc. | 60 | 2018-04-16 | 2024-07-03 |
| Pilot Trial of Inhaled Molgramostim in Non-tuberculous Mycobacterial (NTM) Infection Inhaled molgramostim, Antimycobacterial regimen - Mycobacterium Infections, Nontuberculous | Phase 2 | Completed | Savara Inc. | 32 | 2018-03-01 | 2024-07-03 |
| AeroVanc in the Treatment of Methicillin-resistant Staphylococcus Aureus Infection in Patients With Cystic Fibrosis Vancomycin inhalation powder, Placebo inhalation powder - MRSA, Cystic Fibrosis | Phase 3 | Completed | Savara Inc. | 188 | 2017-09-20 | 2022-12-16 |
| Efficacy and Safety of Inhaled Molgramostim (rhGM-CSF) in Autoimmune Pulmonary Alveolar Proteinosis Molgramostim, Placebo, PARI eFlow nebulizer system - Autoimmune Pulmonary Alveolar Proteinosis | Phase 2 | Completed | Savara Inc. | 139 | 2016-03-21 | 2023-04-12 |
| Inhaled Molgramostim (rhGM-CSF) in Healthy Adult Subjects Molgramostim, Placebo - Pulmonary Alveolar Proteinosis, Bronchiectasis | Phase 1 | Completed | Savara Inc. | 42 | 2015-05-01 | 2017-02-23 |
| Efficacy and Safety Study of AeroVanc for the Treatment of Persistent MRSA Lung Infection in Cystic Fibrosis Patients Vancomycin hydrochloride inhalation powder, Placebo inhalation powder - Cystic Fibrosis | Phase 2 | Completed | Savara Inc. | 87 | 2013-03-01 | 2020-01-13 |
| Inhaled Vancomycin Tolerability, Safety and Pharmacokinetics AeroVanc, IV vancomycin hydrochloride - Healthy, Cystic Fibrosis | Phase 1 | Completed | Savara Inc. | 25 | 2011-11-01 | 2014-03-31 |
| Molgramostim Nebulizer Solution Expanded Access Program Protocol Molgramostim nebulizer solution - Autoimmune Pulmonary Alveolar Proteinosis | Available | Savara Inc. | 2026-10-13 |
Cystic Fibrosis (5) · Pulmonary Alveolar Proteinosis, Acquired (5) · Pulmonary Alveolar Proteinosis (3) · Mycobacterium Infections, Nontuberculous (2) · Bronchiectasis (1) · Respiratory Distress Syndrome (1)
regramostim (6) · molgramostim (5) · Colony-Stimulating Factors (4) · Granulocyte-Macrophage Colony-Stimulating Factor (1) · Vancomycin (1)
United States (6) · United Kingdom (5) · Australia (4) · Germany (4) · France (3) · Greece (3) · Italy (3) · Netherlands (3) · Turkey (Türkiye) (3) · Canada (2) · Denmark (2) · Israel (2) · Japan (2) · Portugal (2) · Russia (2)
Bruce Trapnell, MD (1) · Cliff Morgan, MD (1) · Elliott Dasenbrook, M.D., MHS (1) · Francesco Bonella, Prof. (1) · Grant Waterer, Prof. (1) · Jerry Nick, MD (1) · Johnston Steward, MD (1) · Matthias Griese, MD, (1) · Patrick Flume, MD (1)
PMID 36511181, PMID 37948736, PMID 40834301, PMID 40973220
2017 (2), 2015 (1)