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Recombinant GM-CSF
Recombinant GM-CSF stimulates the production and activation of granulocytes and macrophages to enhance immune response.
Recombinant GM-CSF stimulates the production and activation of granulocytes and macrophages to enhance immune response. Used for Cancer immunotherapy (various malignancies in phase 3 development), Mobilization of hematopoietic stem cells.
At a glance
| Generic name | Recombinant GM-CSF |
|---|---|
| Sponsor | University of Arkansas |
| Drug class | Cytokine; Colony-stimulating factor |
| Target | GM-CSF receptor (CD116/CD131) |
| Modality | Small molecule |
| Therapeutic area | Oncology; Immunology |
| Phase | Phase 3 |
Mechanism of action
GM-CSF (granulocyte-macrophage colony-stimulating factor) is a cytokine that promotes the differentiation and proliferation of hematopoietic progenitor cells into granulocytes and macrophages. By increasing the number and activity of these immune cells, it enhances the body's ability to fight infections and potentially tumors. This mechanism makes it useful as an immunostimulatory agent in cancer therapy and infectious disease contexts.
Approved indications
- Cancer immunotherapy (various malignancies in phase 3 development)
- Mobilization of hematopoietic stem cells
Common side effects
- Fever
- Bone pain
- Fatigue
- Injection site reactions
- Leukocytosis
Key clinical trials
- Isotretinoin With or Without Dinutuximab, Aldesleukin, and Sargramostim Following Stem Cell Transplant in Treating Patients With Neuroblastoma (PHASE3)
- Inhaled Molgramostim in Pediatric Participants With Autoimmune Pulmonary Alveolar Proteinosis (aPAP). (PHASE3)
- N10: A Study of Reduced Chemotherapy and Monoclonal Antibody (mAb)-Based Therapy in Children With Neuroblastoma (PHASE2)
- Pseudovax - A Cancer Vaccine for Patients With Pseudomyxoma Peritonei (EARLY_PHASE1)
- Molgramostim Nebulizer Solution Expanded Access Program Protocol
- Biomarker Assessments of Leukine During Treatment of Parkinson's Disease (PHASE1)
- Tebentafusp-tebn With LDT in Metastatic UM (PHASE1, PHASE2)
- A Clinical Trial Assessing BT-001 Alone and in Combination With Pembrolizumab in Metastatic or Advanced Solid Tumors (PHASE1, PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Recombinant GM-CSF CI brief — competitive landscape report
- Recombinant GM-CSF updates RSS · CI watch RSS
- University of Arkansas portfolio CI