Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Sargramostim · 2 trials · 2 indications
| Name | Type | Description |
|---|---|---|
| Sargramostim | DRUG | - |
Inclusion Criteria Patients must have: * Serum antibody to HIV with or without evidence of HIV. * Antigenemia. * Anticipated survival of at least 6 months. * Allowed: * Kaposi's sarcoma. Exclusion Criteria Co-existing Condition: Patients with the following conditions or symptoms are excluded: ...
Top 20 of 28 competitors
Sargramostim is an investigational small molecule being studied for use in HIV Infections, specifically in patients with AIDS virus infection and leukopenia. It is in Phase 1 clinical development and has not been approved by the FDA. Two Phase 1 trials have been completed to evaluate its effects in this patient population.
Sargramostim is a recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF). It works by stimulating the production and function of white blood cells, particularly granulocytes and macrophages, which may help address leukopenia in patients with HIV infection. This mechanism is based on the drug's known class and the trial focus on cytopenias.
Sargramostim is being developed by Novartis AG, a global pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS. The company is conducting clinical research on this drug for the treatment of HIV Infections and associated leukopenia.
Sargramostim is in Phase 1 clinical development. It is an investigational drug and has not received FDA approval. Two Phase 1 trials have been completed, but no active trials are currently listed. The drug remains under investigation for its potential use in HIV Infections with leukopenia.
Sargramostim has been studied in two completed Phase 1 clinical trials: NCT00002008, an open-label study of subcutaneously administered recombinant human GM-CSF in patients with AIDS virus infection and leukopenia, and NCT00002009, a Phase 1/II study of the same drug in a similar patient population. Both trials were conducted in the United States and enrolled male patients aged 18 years and older.
Sargramostim is a recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF), meaning it is a laboratory-made version of the naturally occurring GM-CSF protein. It is designed to mimic the effects of GM-CSF to stimulate white blood cell production, particularly in patients with HIV-related leukopenia.