Drugs / Molgramostim

Trials 14 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 11 trial
Phase 1 NCT02468908 May → Oct 2015 acute respiratory distress syndrome, bronchiectasis, cystic fibrosis, pulmonary alveolar proteinosis Savara Inc. Completed No outcome recorded
Phase 1/21 trial
Phase 1/2 NCT05501340 Sep → Dec 2022 peritoneal neoplasm Second Affiliated Hospital of Soochow University Unknown No outcome recorded
Phase 27 trials
Phase 2 NCT04823962 Mar 2021 → Dec 2023 ulcer of lower limbs Reponex Pharmaceuticals A/S Unknown No outcome recorded
Phase 2 NCT04569877 Sep 2020 → Jun 2022 pneumonia, severe acute respiratory syndrome University of Giessen Completed No outcome recorded
Phase 2 NCT03597347 Jun 2019 → Oct 2020 cystic fibrosis, pulmonary non-tuberculous mycobacterial infection Savara Inc. Terminated No outcome recorded
Phase 2 NCT03421743 Mar 2018 → Oct 2019 pulmonary non-tuberculous mycobacterial infection Savara Inc. Completed No outcome recorded
Phase 2 NCT03435900 Feb → Jul 2018 appendicitis Herlev Hospital Completed No outcome recorded
Phase 2 NCT02595060 Jun 2016 → Sep 2021 acute respiratory distress syndrome University of Giessen Completed No outcome recorded
Phase 2 NCT02702180 Mar 2016 → Apr 2019 autoimmune pulmonary alveolar proteinosis Savara Inc. Completed No outcome recorded
Phase 2/31 trial
Phase 2/3 NCT01729663 Apr 2009 → Dec 2018 cutaneous melanoma Laboratorio Pablo Cassará S.R.L. Unknown No outcome recorded
Phase 33 trials
Phase 3 NCT06431776 Oct 2025 → Jun 2027 expected autoimmune pulmonary alveolar proteinosis Savara Inc. Recruiting No outcome recorded
Phase 3 NCT04544293 May 2021 → Nov 2023 overdue autoimmune pulmonary alveolar proteinosis Savara Inc. Active not recruiting No outcome recorded
Phase 3 NCT03482752 Apr 2018 → Jan 2021 autoimmune pulmonary alveolar proteinosis Savara Inc. Terminated No outcome recorded
Phase not stated1 trial
NCT06546098 autoimmune pulmonary alveolar proteinosis Savara Inc. Available No outcome recorded
Also used as a comparator or background therapy in 3 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT07341360 Background Oct 2025 → Dec 2029 expected pseudomyxoma peritonei Oslo University Hospital Recruiting No outcome recorded
Phase 31 trial
Phase 3 NCT00925873 Comparator Jun 1996 → Apr 2000 acute myeloid leukemia French Innovative Leukemia Organisation Completed No outcome recorded
Phase 41 trial
Phase 4 NCT00464217 Background Oct 1998 → Dec 2008 acute myeloid leukemia PETHEMA Foundation Completed No outcome recorded

Evidence & citations 7 cited values

Every value below carries the sentence it was read from. 18 sources stand behind the page.

FieldValueCited text
Known as Molgramostim “Shorter Total Length of Stay After Intraperitoneal Fosfomycin, Metronidazole, and Molgramostim for Complicated Appendicitis” PMID 32432123 May 2020
15

“The active substance: molgramostim (rhGM-CSF)” NCT04823962

“GM-CSF (molgramostim, Novartis)” NCT00925873

“Drug: MolgramostimNCT05501340

NCT04569877

NCT07341360

NCT06431776

NCT02595060

NCT01729663

NCT02468908

NCT03482752

NCT02702180

NCT06546098

NCT04544293

NCT03597347

NCT03421743

Known as Leucomax ClinicalTrials.gov intervention name — accepted as the source's own label NCT00464217
Known as rhGM-CSF “This trial evaluates efficacy and safety of inhaled molgramostim (rhGM-CSF) in 45 patients with pneumonia associated acute respiratory distress syndrome (ARDS).” NCT02595060
2

“300 mcg molgramostim (rhGM-CSF) nebulizer solution for inhalation” NCT02702180

“The active substance: molgramostim (rhGM-CSF)” NCT04823962

Action Activate “Savara is studying an investigational drug called molgramostim nebulizer solution to see if it activates the cells that help clear surfactant from the lungs” NCT06546098
Modality Protein / enzyme biologic “Inhaled molgramostim, a form of recombinant human granulocyte-macrophage colony stimulating factor (GM-CSF)” PMID 40973220 Sep 2025
Route Intravenous “5 mcg/kg subcutaneous or endovenous” NCT00464217
Route Subcutaneous “5 mcg/kg subcutaneous or endovenous” NCT00464217