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Sargramostim - Bayer HealthCare Pharmaceuticals/Partner Therapeutics

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Drug Profile

Sargramostim - Bayer HealthCare Pharmaceuticals/Partner Therapeutics

Alternative Names: BI 61012; GZ 402664; IMREPLYS; Leukine; Leukine Liquid; NPC-26; Prokine; Recombinant human GM‑CSF; rhuGM-CSF; Sargmalin; Sargramostim - Bayer HealthCare Pharmaceuticals; sargramostim-biosimilar

Latest Information Update: 25 Jun 2025

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At a glance

  • Originator Amgen
  • Developer Bayer HealthCare Pharmaceuticals Inc.; Cincinnati Children's Hospital Medical Center; Dana-Farber Cancer Institute; National Institute on Aging; Niigata University; Nobelpharma; Partner Therapeutics; Sanofi; University of California at Irvine; University of California at San Francisco; University of Colorado at Denver; University of Nebraska Medical Center; University of Texas M. D. Anderson Cancer Center; Virginia Commonwealth University
  • Class Adjuvants; Anti-infectives; Antidementias; Antineoplastics; Antiparkinsonians; Chemoprotectants; Granulocyte-macrophage colony-stimulating factors; Radioprotectives
  • Mechanism of Action Granulocyte stimulants; Haematopoiesis stimulants; Macrophage stimulants; Neutrophil stimulants
  • Orphan Drug Status

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

    Yes - Malignant melanoma; Pulmonary alveolar proteinosis
  • New Molecular Entity Yes
  • Available For Licensing Yes - Sepsis

Highest Development Phases

  • Marketed Acute radiation syndrome; Bone marrow disorders; Neutropenia; Pneumococcal infections; Stem cell mobilisation
  • Registered Pulmonary alveolar proteinosis
  • Phase III COVID 2019 infections
  • Phase II Acute hypoxia; Alzheimer's disease; Chronic lymphocytic leukaemia; Haematological malignancies; Malignant melanoma; Mycobacterial infections; Prostate cancer; Skin cancer
  • Phase I Unspecified
  • Preclinical Down syndrome; Sepsis
  • No development reported Ovarian cancer; Parkinson's disease
  • Discontinued Crohn's disease; Follicular lymphoma; Non-Hodgkin's lymphoma

Most Recent Events

  • 20 Jun 2025 Preregistration for Acute radiation syndrome (In children, In adolescents, In infants, In neonates, In adults) in European Union (SC)
  • 20 Jun 2025 CHMP recommends approval of Sargramostim for Acute radiation syndrome in European Union
  • 09 Jan 2025 Partner Therapeutics establishes BARDA with Biomedical Advanced Research and Development Authority for the development of Sargramostim in Sepsis

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