MedPath

Sargramostim

Generic Name
Sargramostim
Brand Names
Leukine
Drug Type
Biotech
CAS Number
123774-72-1
Unique Ingredient Identifier
5TAA004E22

Overview

Sargramostim is a human recombinant granulocyte macrophage colony-stimulating factor (GM-CSF) expressed in yeast. It is a glycoprotein that is 127 residues. Substitution of Leu23 leads to a difference from native protein.

Background

Sargramostim is a human recombinant granulocyte macrophage colony-stimulating factor (GM-CSF) expressed in yeast. It is a glycoprotein that is 127 residues. Substitution of Leu23 leads to a difference from native protein.

Indication

For the treatment of cancer and bone marrow transplant

Associated Conditions

  • Acute Lymphoblastic Leukemia (ALL)
  • Hematopoietic Subsyndrome of Acute Radiation Syndrome
  • Hodgkin's Lymphoma
  • Neutropenia
  • Non-Hodgkin's Lymphoma (NHL)
  • Severe Infection

Clinical Trials

Title
Posted
Study ID
Phase
Status
Sponsor
N10: A Study of Reduced Chemotherapy and Monoclonal Antibody (mAb)-Based Therapy in Children With Neuroblastoma
2024/07/30
NCT06528496
Phase 2
Recruiting
Memorial Sloan Kettering Cancer Center
Temozolomide and Survivin Long Peptide Vaccine (SurVaxM) for the Treatment of Patients With Progressing Metastatic Neuroendocrine Tumors
2024/01/11
NCT06202066
Phase 2
Not yet recruiting
Roswell Park Cancer Institute
Aerosolized Sargramostim Added to Immunotherapy for the Treatment of Patients With Metastatic Melanoma to the Lung
2023/02/08
NCT05717140
Phase 1
Suspended
Mayo Clinic
Biomarker Validation Following Sargramostim Treatment in Parkinson's Disease
2023/01/10
NCT05677633
Phase 1
Completed
University of Nebraska
Trial to Evaluate Safety and Efficacy of GM-CSF /Sargramostim in Down Syndrome
2022/08/01
NCT05482334
Phase 2
Withdrawn
University of Colorado, Denver
STEMVAC in Patients With Early Stage Triple Negative Breast Cancer
2022/07/13
NCT05455658
Phase 2
Recruiting
University of Washington
A Multiple Antigen Vaccine (STEMVAC) for the Treatment of Patients With Stage IV Non-Small Cell Lung Cancer
2022/02/16
NCT05242965
Phase 2
Active, not recruiting
University of Washington
Tolerability and Efficacy of UV1 Vaccine in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma Planned for First-line Treatment With Pembrolizumab
2021/10/12
NCT05075122
Phase 2
Recruiting
Martin-Luther-Universität Halle-Wittenberg
Phase II Trial to Evaluate Safety and Efficacy of GM-CSF/Sargramostim in Alzheimer's Disease
2021/05/26
NCT04902703
Phase 2
Recruiting
University of Colorado, Denver
Sargramostim Use in COVID-19 to Recover Patient Health
2021/01/13
NCT04707664
Phase 2
Completed
Partner Therapeutics, Inc.

FDA Drug Approvals

Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
Leukine
Partner Therapeutics, Inc.
71837-5843
SUBCUTANEOUS, INTRAVENOUS
250 ug in 1 mL
8/31/2023

EMA Drug Approvals

Approved Product
Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product
Manufacturer
Approval Number
Dosage Form
Strength
Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product
Company
Approval Number
Drug Type
Dosage Form
Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product
Registration No.
Company
Licence No.
Strength
Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product
ARTG ID
Sponsor
Registration Type
Status
Registration Date
No TGA approvals found for this drug.
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