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Molgramostim - Savara Pharmaceuticals

Drug Profile

Molgramostim - Savara Pharmaceuticals

Alternative Names: GM-CSF inhalation - Savara; Molgradex; Nebulised recombinant human GM-CSF - Savara; NPC 23; rh-GM-CSF

Latest Information Update: 28 Jun 2023

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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
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Pulmonary alveolar proteinosis; Adult respiratory distress syndrome
  • 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
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