Molgramostim is under clinical development by Savara and currently in the Phase II and Phase III in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Molgramostim’s likelihood of approval (LoA) and phase transition for Lung Disease took place on 21 Oct 2020, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Molgramostim Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

Molgramostim overview

Molgramostim (Molgradex) is under development for the treatment of autoimmune pulmonary alveolar proteinosis (aPAP), acute respiratory distress syndrome, coronavirus disease 2019 caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and non-tuberculous Mycobacteria (NTM) lung infections. It is administered via inhalational route as a solution. Molgramostim is a recombinant human granulocyte macrophage colony stimulating factor (GM-CSF). The drug candidate acts by targeting granulocyte macrophage colony-stimulating factor (GM-CSF) receptor. The drug development is developed based on veltis technology. It was also under development for the treatment of cystic fibrosis-related lung infection (CF), bronchiectasis (BE) and ventilator-associated pneumonia (VAP).

Savara overview

Savara, formerly Mast Therapeutics Inc, is a clinical-stage biopharmaceutical company, which develops therapies for the treatment of rare respiratory diseases, including cystic fibrosis (CF), and pulmonary alveolar proteinosis (PAP). The company’s lead product candidates include Molgradex, an inhaled formulation of recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) for the treatment of PAP; and AeroVanc, an inhaled formulation of vancomycin for the treatment of CF. The company has subsidiaries in the US, and Denmark. Savara is headquartered in Austin, Texas, the US.

Quick View Molgramostim LOA Data

Report Segments
  • Innovator
Drug Name
  • Molgramostim
Administration Pathway
  • Inhalational
Therapeutic Areas
  • Infectious Disease
  • Respiratory
Key Developers
Highest Development Stage
  • Phase III

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.