Last update 28 Jun 2024

Molgramostim inhalation(Savara Pharmaceuticals)

Overview

Basic Info

Drug Type
Biosimilar, Colony-stimulating factors
Synonyms
Molgramostim Biosimilar (Savara, Inc.), NPC-23, Molgradex
Target
Mechanism
CSF-2R stimulants(Granulocyte-macrophage colony-stimulating factor receptor stimulants)
Originator Organization
Active Organization
Inactive Organization
Drug Highest PhasePhase 3
First Approval Date-
RegulationBreakthrough Therapy (US), Fast Track (US), Orphan Drug (US), Orphan Drug (EU), Promising Innovative Medicine (GB)

R&D Status

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IndicationHighest PhaseCountry/LocationOrganizationDate
Pulmonary Alveolar Proteinosis, AcquiredPhase 3
US
30 Aug 2022
Pulmonary Alveolar ProteinosisPhase 3
JP
10 May 2021
Pulmonary Alveolar ProteinosisPhase 3
AU
10 May 2021
Pulmonary Alveolar ProteinosisPhase 3
FR
10 May 2021
Pulmonary Alveolar ProteinosisPhase 3
DE
10 May 2021
Pulmonary Alveolar ProteinosisPhase 3
GR
10 May 2021
Pulmonary Alveolar ProteinosisPhase 3
IT
10 May 2021
Pulmonary Alveolar ProteinosisPhase 3
NL
10 May 2021
Pulmonary Alveolar ProteinosisPhase 3
PT
10 May 2021
Pulmonary Alveolar ProteinosisPhase 3
RO
10 May 2021
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2
139
PARI eFlow nebulizer system+Molgramostim
(Double-blind Molgramostim Once Daily)
fpypviocxj(hmivyifyon) = gwbvvwwgxf lddjadbobk (iwingqtncl, fhzftpmsmr - vtagiwbwku)
-
15 Apr 2022
PARI eFlow nebulizer system+Molgramostim
(Double-blind Molgramostim Intermittent)
fpypviocxj(hmivyifyon) = fiknxghszo lddjadbobk (iwingqtncl, qfzznkdtsw - hlpvglsraj)
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Clinical Trial

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Approval

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Regulation

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