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Sargramostim - Bayer HealthCare Pharmaceuticals

Drug Profile

Sargramostim - Bayer HealthCare Pharmaceuticals

Alternative Names: BI 61012; GZ 402664; Leukine; Leukine Liquid; Prokine; Recombinant human GM‑CSF; rhuGM-CSF; sargramostim-biosimilar

Latest Information Update: 03 Sep 2020

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At a glance

  • Originator Amgen
  • Developer Bayer HealthCare Pharmaceuticals Inc.; Cincinnati Children's Hospital Medical Center; National Cancer Institute (USA); National Institute on Aging; Partner Therapeutics; Sanofi Genzyme; University of California at Irvine; University of California at San Francisco; University of Colorado at Denver; University of Texas M. D. Anderson Cancer Center; Virginia Commonwealth University
  • Class Adjuvants; Chemoprotectants; Granulocyte-macrophage colony-stimulating factors
  • 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

Highest Development Phases

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

Most Recent Events

  • 21 Aug 2020 Phase-II clinical trials in Acute hypoxia (Adjunctive treatment) in USA (IV) (NCT04411680)
  • 04 Aug 2020 Partner Therapeutics plans a phase II trial for Acute Hypoxia (Adjunctive treatment) (IV) in the US in August 2020 (NCT04411680)
  • 27 Jul 2020 Efficacy and adverse events data from a phase II trial in Alzheimer’s disease presented at the Alzheimer's Association International Conference 2020 (AAIC-2020)
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