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 CEO: Matthew Pauls
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	Not yet recruiting	Pulmonary Alveolar Proteinosis	2027-01-01	11%	2024-05-30	Primary Endpoints\|Treatments
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
01/08/2026	News Article	PANTHERx® Rare Selected by Savara as the U.S. Exclusive Specialty Pharmacy for MOLBREEVI*
12/22/2025	News Article	Savara Resubmits the Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for MOLBREEVI* for the Potential Treatment of Autoimmune Pulmonary Alveolar Proteinosis (Autoimmune PAP)
12/17/2025	News Article	Savara Announces Participation in the 44th Annual J.P. Morgan Healthcare Conference
12/11/2025	News Article	Savara Announces European Patent Office (EPO) Intends to Grant a Patent for the Liquid Formulation of MOLBREEVI*
04/01/2024	PubMed	Nonantibiotic Management of Nontuberculous Mycobacteria in Non-Cystic Fibrosis Bronchiectasis: Natural or Nonsense?
04/01/2024	PubMed	OPTIMA: An Open-Label, Noncomparative Pilot Trial of Inhaled Molgramostim in Pulmonary Nontuberculous Mycobacterial Infection.
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: 2026-01-14 Latest Update Note: Clinical Trial Update