Molgramostim inhalation - Savara Pharmaceuticals

Drug Profile

Molgramostim inhalation - Savara Pharmaceuticals

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

Latest Information Update: 18 Apr 2018

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At a glance

  • Originator Serendex Pharmaceuticals
  • Developer Savara Pharmaceuticals
  • Class Chemoprotectants; Granulocyte-macrophage colony-stimulating factors; Recombinant proteins
  • Mechanism of Action Granulocyte macrophage colony stimulating factor agonists
  • Orphan Drug Status

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

    Yes - Pulmonary alveolar proteinosis; Respiratory distress syndrome
  • New Molecular Entity No

Highest Development Phases

  • Phase III Pulmonary alveolar proteinosis
  • Phase II Mycobacterial infections; Respiratory distress syndrome
  • Phase I Bronchiectasis; Cystic fibrosis

Most Recent Events

  • 06 Mar 2018 Savara initiates enrolment in a phase III trial for Pulmonary alveolar proteinosis in Denmark (EudraCT2017-004078-32)
  • 01 Mar 2018 Phase-II clinical trials in Mycobacterial infections in Australia (Inhalation) (NCT03421743)
  • 12 Feb 2018 The US Food and Drug Administration (FDA) approves IND application for molgramostim inhalation in Pulmonary alveolar proteinosis
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