Drug Profile
Molgramostim - Savara Pharmaceuticals
Alternative Names: GM-CSF inhalation - Savara; Molgradex; Nebulised recombinant human GM-CSF - Savara; NPC 23; rh-GM-CSFLatest Information Update: 28 Jun 2023
Price :
$50
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At a glance
- Originator Serendex Pharmaceuticals
- Developer Justus Liebig University Giessen; Savara Pharmaceuticals
- Class Antibacterials; Antibronchitics; Antifibrotics; Antineoplastics; Chemoprotectants; Immunotherapies; Recombinant proteins
- Mechanism of Action Granulocyte-macrophage colony stimulating factor replacements
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Orphan Drug Status
Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.
- New Molecular Entity No
Highest Development Phases
- Phase III Pulmonary alveolar proteinosis
- Phase II Adult respiratory distress syndrome; SARS-CoV-2 acute respiratory disease
- Discontinued Bronchiectasis; Cystic fibrosis; Nontuberculous mycobacterium infections
Most Recent Events
- 26 Jun 2023 Savara Pharmaceuticals completes enrolment in the phase III IMPALA 2 trial in Pulmonary alveolar proteinosis in USA, Australia, Belgium, Canada, France, Germany, Greece, Ireland, Italy, Japan, South Korea, Netherlands, Poland, Portugal, Romania, Spain, Turkey and UK (Inhalation) (NCT04544293)
- 14 Dec 2022 Savara Pharmaceuticals initiates the phase III IMPALA 2 trial in Pulmonary alveolar proteinosis in Australia, France, Greece, Italy, Japan, South Korea, Netherlands, Portugal, Spain, Turkey, UK (Inhalation) before December 2022 (NCT04544293) (EudraCT2020-001263-85)
- 10 Nov 2022 UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) accepts the revised Paediatric Investigation Plan (PIP) for molgramostim, for Pulmonary alveolar proteinosis, before November 2022