Ozmosi | Molgramostim Drug Profile

Product Description

Mechanisms of Action: Immunostimulant

Novel Mechanism: Yes

Modality: Peptide/Protein

Route of Administration: Inhalant

FDA Designation: *

Approval Status: Not Approved

Approved Indications: None

Known Adverse Events: None

Company: Savara
Company Location: Western America
Company Founding Year: 2007
Additional Commercial Interests: None

Clinical Description

Map of Global Clinical Trials for Molgramostim

Countries in Clinic: Australia, Belgium, Canada, France, Germany, Greece, Ireland, Italy, Japan, Korea, Netherlands, Poland, Portugal, Romania, Spain, Turkey, United Kingdom, United States, Unknown Location

Active Clinical Trial Count: 6

Recent & Upcoming Milestones

Clinical Outcomes Reported - Savara presented P3 Pulmonary Alveolar Proteinosis results on 2025-10-21 for Molgramostim
Clinical Outcomes Reported - Savara presented P3 Pulmonary Alveolar Proteinosis results on 2025-09-29 for Molgramostim
Clinical Outcomes Reported - Savara presented P3 Pulmonary Alveolar Proteinosis results on 2025-08-21 for Molgramostim

Highest Development Phases

Phase 3: Pulmonary Alveolar Proteinosis

Trial ID	Trial	Phase	Trial Status	Disease	Primary Completion Date	Probability of Success	Latest Trial Update Date	Data Updated
NCT06431776	aPAP	P3	Recruiting	Pulmonary Alveolar Proteinosis	2027-06-01	13%	2026-02-20	Primary Completion Date\|Primary Endpoints\|Start Date\|Study Completion Date
2024-512039-66-00	SAV006-04	P3	Not yet recruiting	Pulmonary Alveolar Proteinosis	2027-08-31		2025-04-26	Treatments
2024-511052-41-00	SAV00605	P3	Active, not recruiting	Pulmonary Alveolar Proteinosis	2026-12-31		2025-05-02	Treatments
jRCT2051210036	jRCT2051210036	P3	Recruiting	Pulmonary Alveolar Proteinosis	2024-12-31
NCT04544293	IMPALA-2	P3	Active, not recruiting	Pulmonary Alveolar Proteinosis	2023-11-30	21%	2025-08-08	Primary Endpoints
2020-001263-85	IMPALA-2	P3	Completed	Pulmonary Alveolar Proteinosis	2023-10-19	21%	2025-07-09	Treatments

Recent News Events

Date	Type	Title
02/04/2026	News Article	Savara Announces Participation in Upcoming Investor Healthcare Conferences
01/27/2026	News Article	Savara Announces Amendment to Hercules Capital Debt Facility Providing up to $75M of Additional Debt Funding Upon U.S. Food and Drug Administration (FDA) Approval of MOLBREEVI*
01/16/2026	News Article	Savara Announces New Employment Inducement Grant
01/08/2026	News Article	PANTHERx® Rare Selected by Savara as the U.S. Exclusive Specialty Pharmacy for MOLBREEVI*
04/01/2024	PubMed	OPTIMA: An Open-Label, Noncomparative Pilot Trial of Inhaled Molgramostim in Pulmonary Nontuberculous Mycobacterial Infection.
04/01/2024	PubMed	Nonantibiotic Management of Nontuberculous Mycobacteria in Non-Cystic Fibrosis Bronchiectasis: Natural or Nonsense?
10/22/2020	PubMed	Inhaled Molgramostim Therapy in Autoimmune Pulmonary Alveolar Proteinosis.

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Molgramostim

Alternative Names: molgramostim Clinical Status: Active Latest Update: 2026-02-19 Latest Update Note: Clinical Trial Update