Year
DEALS // DEV.
Country
Therapeutic Area
Study Phase
Deal Type
Product Type
Dosage Form
Lead Product
Target
Lead Product(s) : Sargramostim
Therapeutic Area : Pulmonary/Respiratory Diseases
Study Phase : Approved
Recipient : Nobelpharma
Deal Size : Not Applicable
Deal Type : Not Applicable
Partner Therapeutics' Leukine® (sargramostim) Approved in Japan for aPAP
Details : Sargmalin (sargramostim) is a glycosylated recombinant human granulocyte-macrophage colony-stimulating factor (rhu GM-CSF). It is approved for autoimmune pulmonary alveolar proteinosis.
Brand Name : Sargmalin
Molecule Type : Large molecule
Upfront Cash : Not Applicable
April 03, 2024
Lead Product(s) : Sargramostim
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Approved
Recipient : Nobelpharma
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Leukine (sargramostim) is a glycosylated recombinant human granulocyte-macrophage colony-stimulating factor (rhu GM-CSF) produced by recombinant DNA technology in yeast.
Brand Name : Leukine
Molecule Type : Large molecule
Upfront Cash : Not Applicable
December 15, 2022
Lead Product(s) : Sargramostim
Therapeutic Area : Genetic Disease
Study Phase : Preclinical
Sponsor : University of Colorado
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : People with Down syndrome are at higher risk for Alzheimer’s, and showed that GM-CSF improves cognition and brain pathology in AD mice and that Leukine® (sargramostim, glycosylated, yeast-derived rhuGM-CSF) improved cognition and reduced blood biomark...
Brand Name : Leukine
Molecule Type : Large molecule
Upfront Cash : Not Applicable
March 29, 2022
Lead Product(s) : Sargramostim
Therapeutic Area : Genetic Disease
Highest Development Status : Preclinical
Sponsor : University of Colorado
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Sargramostim
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Phase IV
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Safety and efficacy of inhaled sargramostim for the treatment of COVID-19 has not been established and sargramostim is not approved for treatment of COVID-19. Sargramostim has a different mechanism of action from recombinant G-CSFs products and data shou...
Brand Name : Leukine
Molecule Type : Large molecule
Upfront Cash : Not Applicable
June 28, 2021
Lead Product(s) : Sargramostim
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase IV
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Sargramostim
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Phase IV
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : This study will evaluate the role of Leukine in reducing progression and need for hospitalization in COVID-19 patients. Primary study endpoints are: COVID-19-related emergency room visit, COVID-19- related hospitalization, or death.
Brand Name : Leukine
Molecule Type : Large molecule
Upfront Cash : Not Applicable
April 29, 2021
Lead Product(s) : Sargramostim
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase IV
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Sargramostim
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Phase IV
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : SARPAC Clinical Trial of Leukine® met the primary endpoint of improved oxygenation after five days of treatment with inhaled sargramostim in combination with standard of care (SOC) compared with SOC alone.
Brand Name : Leukine
Molecule Type : Large molecule
Upfront Cash : Not Applicable
February 26, 2021
Lead Product(s) : Sargramostim
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase IV
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Sargramostim
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Phase IV
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Data showed that five days of inhaled sargramostim plus standard of care (SOC) treatment improved oxygenation in patients, thereby meeting the primary endpoint.
Brand Name : Leukine
Molecule Type : Large molecule
Upfront Cash : Not Applicable
February 26, 2021
Lead Product(s) : Sargramostim
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase IV
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Sargramostim
Therapeutic Area : Infections and Infectious Diseases
Study Phase : Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : First patient has been enrolled in the iLeukPulm clinical trial, a randomized phase 2 study of inhaled Leukine in hospitalized COVID-19 patients with acute hypoxemia.
Brand Name : Leukine
Molecule Type : Large molecule
Upfront Cash : Not Applicable
August 25, 2020
Lead Product(s) : Sargramostim
Therapeutic Area : Infections and Infectious Diseases
Highest Development Status : Phase II
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Sargramostim
Therapeutic Area : Pulmonary/Respiratory Diseases
Study Phase : Phase II
Sponsor : U.S. Department of Defense
Deal Size : $35.0 million
Deal Type : Agreement
Details : Funding will support two clinical studies of inhaled Leukine® (sargramostim, rhu-Granulocyte Macrophage-Colony Stimulating Factor “GM-CSF”) in patients with COVID-19 associated acute hypoxemia.
Brand Name : Leukine
Molecule Type : Large molecule
Upfront Cash : Undisclosed
August 04, 2020
Lead Product(s) : Sargramostim
Therapeutic Area : Pulmonary/Respiratory Diseases
Highest Development Status : Phase II
Sponsor : U.S. Department of Defense
Deal Size : $35.0 million
Deal Type : Agreement
Details : The trial will evaluate the effectiveness of Leukine compared to a matched control cohort of G-CSF treated patients, as well as evaluate the immune reconstitution profile of the treated patients compared to a contemporaneous cohort of 20 patients who rec...
Brand Name : Leukine
Molecule Type : Large molecule
Upfront Cash : Not Applicable
June 11, 2020
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