Sargramostim
drugOn this page
Also known as B1 61.012LeukineRHU GM-CSFRHU-GM-CSFSargramostim rdna
Summary
Sargramostim (CHEMBL1201670) is an approved protein (ATC L03AA09); indicated across 87 conditions including neoplasm and acute myeloid leukemia.
At a glance
- Status: Approved (max clinical phase 4)
- Modality: Protein
- ATC class: L03AA09
- Indications: 87 conditions
- Clinical trials: 318
Identifiers
Drug identity and classification
| Field | Value |
|---|---|
| ChEMBL ID | CHEMBL1201670 |
| Name | Sargramostim |
| Type | Protein |
| Max phase | 4 |
| ATC | L03AA09 |
Also known as: B1 61.012, Leukine, RHU GM-CSF, RHU-GM-CSF, Sargramostim, Sargramostim rdna, SARGRAMOSTIM
Targets
Targets
No target linkage available.
Bioactivity
No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).
Target pathways
No target-pathway data for this drug (no mapped target genes).
Indications & clinical
Indications
87 indications (3 at ChEMBL trial phase 4). Phase below is the highest clinical-trial phase recorded for this drug against each disease — not the molecule’s overall approval status (that is in the Summary).
| Indication | Trial phase | MONDO | EFO |
|---|---|---|---|
| neoplasm | 4 | MONDO:0005070 | EFO:0000616 |
| acute myeloid leukemia | 4 | MONDO:0018874 | EFO:0000222 |
| Crohn disease | 3 | MONDO:0005011 | EFO:0000384 |
| leukemia | 3 | MONDO:0005059 | EFO:0000565 |
| melanoma | 3 | MONDO:0005105 | EFO:0000756 |
| cutaneous melanoma | 3 | MONDO:0005012 | EFO:0000389 |
| neuroblastoma | 3 | MONDO:0005072 | EFO:0000621 |
| sarcoma | 3 | MONDO:0005089 | EFO:0000691 |
| myelodysplastic syndrome | 3 | MONDO:0018881 | EFO:0000198 |
| chronic myeloid leukemia | 3 | MONDO:0011996 | EFO:0000339 |
| lymphoma | 3 | MONDO:0005062 | EFO:0000574 |
| plasma cell myeloma | 3 | MONDO:0009693 | EFO:0001378 |
| metastatic melanoma | 3 | MONDO:0005191 | EFO:0002617 |
| exocrine pancreatic carcinoma | 3 | MONDO:0005192 | EFO:0002618 |
| rhabdomyosarcoma | 3 | MONDO:0005212 | EFO:0002918 |
| breast neoplasm | 3 | MONDO:0021100 | EFO:0003869 |
| non-Hodgkin lymphoma | 3 | MONDO:0018908 | EFO:0005952 |
| ganglioneuroblastoma | 3 | MONDO:0005035 | EFO:0000502 |
| cytomegalovirus retinitis | 3 | MONDO:0000878 | EFO:1001302 |
| ocular melanoma | 3 | MONDO:0006325 | EFO:1000403 |
| soft tissue sarcoma | 3 | MONDO:0018078 | EFO:1001968 |
| prostate carcinoma | 2 | MONDO:0005159 | EFO:0001663 |
| pulmonary alveolar proteinosis | 2 | MONDO:0001437 | Orphanet:264675 |
| male breast carcinoma | 2 | MONDO:0005628 | EFO:0006861 |
| B-cell chronic lymphocytic leukemia | 2 | MONDO:0004948 | EFO:0000095 |
| HIV infectious disease | 2 | MONDO:0005109 | EFO:0000180 |
| osteosarcoma | 2 | MONDO:0009807 | EFO:0000637 |
| prostate adenocarcinoma | 2 | MONDO:0005082 | EFO:0000673 |
| renal cell carcinoma | 2 | MONDO:0005086 | EFO:0000681 |
| ovarian carcinoma | 2 | MONDO:0005140 | EFO:0001075 |
| non-small cell lung carcinoma | 2 | MONDO:0005233 | EFO:0003060 |
| kidney disorder | 2 | MONDO:0005240 | EFO:0003086 |
| biliary tract neoplasm | 2 | MONDO:0005304 | EFO:0003891 |
| ovarian neoplasm | 2 | MONDO:0021068 | EFO:0003893 |
| cutaneous leishmaniasis | 2 | MONDO:0005446 | EFO:0005046 |
| inflammatory breast carcinoma | 2 | MONDO:0006804 | EFO:1000984 |
| gliosarcoma | 2 | MONDO:0016681 | EFO:1001465 |
| colorectal carcinoma | 2 | MONDO:0024331 | EFO:1001951 |
| acute lymphoblastic leukemia | 2 | MONDO:0004967 | EFO:0000220 |
| endometrioid adenocarcinoma | 2 | MONDO:0005026 | EFO:0000466 |
| glioblastoma | 2 | MONDO:0018177 | EFO:0000519 |
| fallopian tube carcinoma | 2 | MONDO:0006206 | EFO:1000251 |
| Hodgkins lymphoma | 2 | MONDO:0004952 | EFO:0000183 |
| ductal breast carcinoma in situ | 2 | MONDO:0005023 | EFO:0000432 |
| myeloproliferative neoplasm | 2 | MONDO:0020076 | EFO:0002428 |
| brain neoplasm | 2 | MONDO:0021211 | EFO:0003833 |
| ovarian serous cystadenocarcinoma | 2 | MONDO:0006046 | EFO:1000043 |
| central nervous system neoplasm | 2 | MONDO:0006130 | EFO:1000158 |
| gastric neoplasm | 2 | MONDO:0021085 | MONDO:0001056 |
| peritoneal neoplasm | 2 | MONDO:0006901 | MONDO:0002087 |
| fallopian tube neoplasm | 2 | MONDO:0021092 | MONDO:0002158 |
| kidney cancer | 2 | MONDO:0002367 | MONDO:0002367 |
| gallbladder neoplasm | 2 | MONDO:0021253 | MONDO:0005411 |
| ovarian cancer | 2 | MONDO:0008170 | MONDO:0008170 |
| lung neoplasm | 2 | MONDO:0021117 | MONDO:0008903 |
| follicular lymphoma | 2 | MONDO:0018906 | MONDO:0018906 |
| hematopoietic and lymphoid system neoplasm | 2 | MONDO:0002334 | MONDO:0044881 |
| oral cavity squamous cell carcinoma | 2 | MONDO:0004958 | EFO:0000199 |
| severe acute respiratory syndrome | 2 | MONDO:0005091 | EFO:0000694 |
| triple-negative breast carcinoma | 2 | MONDO:0005494 | EFO:0005537 |
| myelodysplastic/myeloproliferative disease | 2 | MONDO:0020077 | MONDO:0020077 |
| head and neck squamous cell carcinoma | 2 | MONDO:0010150 | EFO:0000181 |
| Down syndrome | 2 | MONDO:0008608 | EFO:0001064 |
| Alzheimer disease | 2 | MONDO:0004975 | MONDO:0004975 |
| plasma cell neoplasm | 2 | MONDO:0004959 | EFO:0000200 |
| colorectal neoplasm | 2 | MONDO:0005335 | MONDO:0005575 |
| adenocarcinoma | 1 | MONDO:0004970 | EFO:0000228 |
| periodontitis | 1 | MONDO:0005076 | EFO:0000649 |
| myelodysplastic syndrome with excess blasts | 1 | MONDO:0019454 | EFO:0003811 |
| chronic hepatitis B virus infection | 1 | MONDO:0005366 | EFO:0004239 |
| plasma cell leukemia | 1 | MONDO:0018689 | EFO:0006475 |
| Parkinson disease | 1 | MONDO:0005180 | MONDO:0005180 |
| pancreatic ductal adenocarcinoma | 1 | MONDO:0005184 | MONDO:0005184 |
14 further indication records had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.
Clinical trials
Total trials: 318.
Phase distribution
| Phase | Trials |
|---|---|
| PHASE2 | 173 |
| PHASE1 | 77 |
| PHASE3 | 31 |
| PHASE1/PHASE2 | 22 |
| Not specified | 10 |
| PHASE2/PHASE3 | 3 |
| PHASE4 | 1 |
| EARLY_PHASE1 | 1 |
Top trials by phase / activity
| NCT | Phase | Status | Title |
|---|---|---|---|
| NCT04326920 | PHASE4 | COMPLETED | Sargramostim in Patients With Acute Hypoxic Respiratory Failure Due to COVID-19 (SARPAC) |
| NCT02339571 | PHASE2/PHASE3 | ACTIVE_NOT_RECRUITING | A Phase II/III Trial of Nivolumab, Ipilimumab, and GM-CSF in Patients With Advanced Melanoma |
| NCT03126916 | PHASE3 | RECRUITING | Testing the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL) |
| NCT00000658 | PHASE3 | COMPLETED | A Phase III Randomized Trial of Low-Dose Versus Standard-Dose mBACOD Chemotherapy With rGM-CSF for Treatment of AIDS-Associated Non-Hodgkin’s Lymphoma |
| NCT00002070 | PHASE3 | COMPLETED | Phase III Ganciclovir +/- rGM-CSF for AIDS-Related CMV Retinitis |
| NCT00002514 | PHASE3 | COMPLETED | Stem Cell Transplantation Compared With Standard Chemotherapy in Treating Patients With Acute Lymphoblastic Leukemia in First Remission |
| NCT00002599 | PHASE3 | UNKNOWN | Combination Chemotherapy and Interferon Alfa With or Without Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Myeloma |
| NCT00002766 | PHASE3 | COMPLETED | Comparison of Two Combination Chemotherapy Regimens in Treating Adults With Previously Untreated Leukemia or Lymphoma |
| NCT00002995 | PHASE3 | COMPLETED | Combination Chemotherapy With or Without Radiation Therapy in Treating Patients With Newly Diagnosed Rhabdomyosarcoma |
| NCT00003093 | PHASE3 | COMPLETED | Combination Chemotherapy in Treating Children With Neuroblastoma |
| NCT00003119 | PHASE3 | COMPLETED | Surgery in Treating Children With Neuroblastoma |
| NCT00003315 | PHASE3 | COMPLETED | Liposomal Amphotericin B With or Without Sargramostim in Treating Patients With Invasive Fungal Infection |
| NCT00003958 | PHASE3 | COMPLETED | Combination Chemotherapy in Treating Patients With Previously Untreated Rhabdomyosarcoma |
| NCT00003972 | PHASE3 | COMPLETED | Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Stage II or Stage IIIA Breast Cancer |
| NCT00008398 | PHASE3 | COMPLETED | Sargramostim in Decreasing Mucositis in Patients Receiving Radiation Therapy for Head and Neck Cancer |
| NCT00017290 | PHASE3 | UNKNOWN | Combination Chemotherapy Followed By Vaccine Therapy Plus Sargramostim in Treating Patients With Stage III or Stage IV Non-Hodgkin’s Lymphoma |
| NCT00026312 | PHASE3 | COMPLETED | Isotretinoin With or Without Dinutuximab, Aldesleukin, and Sargramostim Following Stem Cell Transplant in Treating Patients With Neuroblastoma |
| NCT00046930 | PHASE3 | COMPLETED | Daunorubicin & Cytarabine +/- Zosuquidar inTreating Older Patients With Newly Diagnosed Acute Myeloid Leukemia or Refractory Anemia |
| NCT00049517 | PHASE3 | COMPLETED | Combination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Patients With AML Leukemia |
| NCT00050531 | PHASE3 | COMPLETED | High-Dose Gleevec Alone or in Combination With Peg-Intron and GM-CSF in Early Phase Chronic Myelogenous Leukemia (CML) |
| NCT00089115 | PHASE3 | TERMINATED | Vaccine Therapy and Sargramostim Compared With Placebo and Sargramostim Following Rituximab in Treating Patients With Non-Hodgkin’s Lymphoma |
| NCT00206674 | PHASE3 | COMPLETED | Efficacy (Induction of Response/Remission) and Safety Study in Patients With Moderate to Severe Crohn’s Disease |
| NCT00206713 | PHASE3 | TERMINATED | Efficacy Study of Sargramostim in the Retreatment of Patients Who Have Crohn’s Disease Who Have Previously Responded to Treatment With Sargramostim |
| NCT00237575 | PHASE3 | TERMINATED | Randomized Phase III Trial of Leukine® vs Neupogen® in Patients Receiving Cisplatin & Gemcitabine for Urothelial Cancer |
| NCT00293462 | PHASE3 | COMPLETED | GM-CSF Mouthwash for Preventing and Treating Mucositis in Patients Undergoing Radiation Therapy for Head and Neck Cancer |
| NCT00295165 | PHASE3 | TERMINATED | Efficacy (Induction of Response/Remission) and Safety Study in Patients With Moderate to Severe Crohn’s Disease |
| NCT00324831 | PHASE3 | SUSPENDED | GM-CSF With or Without Vaccine Therapy After Combination Chemotherapy and Rituximab as First-Line Therapy in Treating Patients With Stage II, Stage III, or Stage IV Diffuse Large B-Cell Lymphoma |
| NCT00425360 | PHASE3 | COMPLETED | Gemcitabine and Capecitabine With or Without Vaccine Therapy in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer |
| NCT00454168 | PHASE3 | UNKNOWN | Vaccine Therapy and GM-CSF in Treating Patients With Acute Myeloid Leukemia in Remission |
| NCT00630565 | PHASE2/PHASE3 | TERMINATED | Stem Cell Transplant in Treating Patients With Acute Myeloid Leukemia |
| NCT01041638 | PHASE3 | COMPLETED | Monoclonal Antibody Ch14.18, Sargramostim, Aldesleukin, and Isotretinoin After Autologous Stem Cell Transplant in Treating Patients With Neuroblastoma |
| NCT01324063 | PHASE3 | COMPLETED | A Randomized Phase III Study of Intensive Consolidation With High Dose Cytosine Arabinoside in Acute Myelogenous Leukemia (AML-8B) |
| NCT01826864 | PHASE3 | WITHDRAWN | Sargramostim or Hypertonic Saline Before Sentinel Lymph Node Biopsy in Treating Patients With Stage IB-II Melanoma |
| NCT01989572 | PHASE3 | COMPLETED | Sargramostim, Vaccine Therapy, or Sargramostim and Vaccine Therapy in Preventing Disease Recurrence in Patients With Melanoma That Has Been Removed By Surgery |
| NCT04642950 | PHASE2/PHASE3 | COMPLETED | A Phase II/III Study of Sargramostim |
| NCT01134614 | PHASE2 | ACTIVE_NOT_RECRUITING | Ipilimumab With or Without Sargramostim in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery |
| NCT02455557 | PHASE2 | ACTIVE_NOT_RECRUITING | SurVaxM Vaccine Therapy and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma |
| NCT03012100 | PHASE2 | ACTIVE_NOT_RECRUITING | Multi-epitope Folate Receptor Alpha Peptide Vaccine, GM-CSF, and Cyclophosphamide in Treating Patients With Triple Negative Breast Cancer |
| NCT03786783 | PHASE2 | ACTIVE_NOT_RECRUITING | Dinutuximab, Sargramostim, and Combination Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma |
| NCT03794349 | PHASE2 | ACTIVE_NOT_RECRUITING | Irinotecan Hydrochloride, Temozolomide, and Dinutuximab With or Without Eflornithine in Treating Patients With Relapsed or Refractory Neuroblastoma |
Clinical evidence (CIViC)
No CIViC predictive evidence (expected for non-precision-medicine drugs).
Pharmacology
Pharmacogenomics
No PharmGKB pharmacogenomic data curated for this drug.
Related molecules
Related molecules
No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).
Related Atlas pages
- Diseases: neoplasm, acute myeloid leukemia, Crohn disease, leukemia, melanoma, cutaneous melanoma, neuroblastoma, sarcoma, myelodysplastic syndrome, chronic myeloid leukemia, lymphoma, plasma cell myeloma, metastatic melanoma, exocrine pancreatic carcinoma, rhabdomyosarcoma, breast neoplasm, non-Hodgkin lymphoma, ganglioneuroblastoma, cytomegalovirus retinitis, ocular melanoma, soft tissue sarcoma