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Molgramostim

DRUG10 trials

Sponsors

Oslo University Hospital HF, Region Sjaelland, Reponex Pharmaceuticals A/S, Savara Inc., Second Affiliated Hospital of Soochow University, Oslo University Hospital

Conditions

Acute Respiratory Distress SyndromeAutoimmune Pulmonary Alveolar ProteinosisBronchiectasisCystic FibrosisMalignant AscitesPouchitisPseudomyxoma PeritoneiPulmonary Alveolar Proteinosis

Early Phase 1

Pseudovax - A Cancer Vaccine for Patients With Pseudomyxoma Peritonei
RecruitingNCT07341360
Oslo University HospitalPseudomyxoma Peritonei
Start: 2025-10-13End: 2034-12-31Target: 10Updated: 2026-01-14

Phase 1

Inhaled Molgramostim (rhGM-CSF) in Healthy Adult Subjects
CompletedNCT02468908
Savara Inc.Acute Respiratory Distress Syndrome, Bronchiectasis, Cystic Fibrosis +1
Start: 2015-05-31End: 2015-10-31Updated: 2017-02-23
PD-1 Inhibitor Intraperitoneal Perfusion Combined With PRaG Therapy for Malignant Ascites
NCT05501340
Second Affiliated Hospital of Soochow UniversityMalignant Ascites
Start: 2022-09-01End: 2024-09-01Target: 40Updated: 2022-08-15
A combined treatment with GM-CSF, fosfomycin and metronidazole for pouchitis in ulcerative colitis patients after restorative ileal pouch anal anastomosis surgery. A clinical safety and proof-of-concept study
Not yet recruitingCTIS2024-517764-38-00
Region Sjaelland, Reponex Pharmaceuticals A/SPouchitis
Target: 18Updated: 2024-11-14
Intraperitoneal treatment with fosfomycin, metronidazole and recombinant human granulocyte-macrophage colony-stimulating factor in patients with multi-quadrant peritonitis undergoing abdominal surgery: A randomized placebo-controlled trial (TRIPLE)
WithdrawnCTIS2024-520317-49-00
Region Sjaelland, Reponex Pharmaceuticals A/Speritonitis
Target: 32Updated: 2025-06-12
PSEUDOVAX – A CANCER VACCINE TARGETING MUTATED GNAS COMBINED WITH IMMUNE CHECKPOINT INHIBITION FOR PATIENTS WITH PSEUDOMYXOMA PERITONEI
RecruitingCTIS2024-517047-30-01
Oslo University Hospital HFPseudomyxoma Peritonei
Start: 2025-09-01Target: 10Updated: 2025-09-01

Phase 2

Efficacy and Safety of Inhaled Molgramostim (rhGM-CSF) in Autoimmune Pulmonary Alveolar Proteinosis
CompletedNCT02702180
Savara Inc.Autoimmune Pulmonary Alveolar Proteinosis
Start: 2016-03-21End: 2019-09-27Updated: 2023-04-12

Phase 3

Safety Extension Trial of Inhaled Molgramostim in Autoimmune Pulmonary Alveolar Proteinosis
TerminatedNCT03482752
Savara Inc.Autoimmune Pulmonary Alveolar Proteinosis
Start: 2018-04-16End: 2021-01-14Updated: 2024-07-03
Clinical Trial of Inhaled Molgramostim Nebulizer Solution in Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
Active, not recruitingNCT04544293
Savara Inc.Autoimmune Pulmonary Alveolar Proteinosis
Start: 2021-05-19End: 2027-05-30Updated: 2025-08-07
Inhaled Molgramostim in Pediatric Participants With Autoimmune Pulmonary Alveolar Proteinosis (aPAP).
RecruitingNCT06431776
Savara Inc.Autoimmune Pulmonary Alveolar Proteinosis
Start: 2025-10-22End: 2027-12-01Target: 5Updated: 2026-02-19

Related Papers

Pharmacokinetics and pharmacodynamics of inhaled molgramostim in healthy people
BMJ Open Respiratory Research2025-09-01
Phase 3 Trial of Inhaled Molgramostim in Autoimmune Pulmonary Alveolar Proteinosis
New England Journal of Medicine2025-08-206 citations
Efficacy and Safety of PRaG Therapy in Elderly Patients with Advanced Malignant Tumors: A Prospective, Multicenter Clinical Study Protocol (PRaG 9.0 Study)
Technology in Cancer Research & Treatment2025-06-01
IMPALA-2: choice of DLCO as a primary endpoint in aPAP
05.01 - Airway pharmacology and treatment2022-09-04
IMPALA: efficacy measures in patients who required whole lung lavage
05.01 - Airway pharmacology and treatment2022-09-04
Safety and tolerability of inhaled molgramostim in autoimmune pulmonary alveolar proteinosis (aPAP)
05.01 - Airway pharmacology and treatment2022-09-04
Inhaled Molgramostim Therapy in Autoimmune Pulmonary Alveolar Proteinosis
New England Journal of Medicine2020-09-07104 citations