Sargramostim

drug
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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

FieldValue
ChEMBL IDCHEMBL1201670
NameSargramostim
TypeProtein
Max phase4
ATCL03AA09

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).

IndicationTrial phaseMONDOEFO
neoplasm4MONDO:0005070EFO:0000616
acute myeloid leukemia4MONDO:0018874EFO:0000222
Crohn disease3MONDO:0005011EFO:0000384
leukemia3MONDO:0005059EFO:0000565
melanoma3MONDO:0005105EFO:0000756
cutaneous melanoma3MONDO:0005012EFO:0000389
neuroblastoma3MONDO:0005072EFO:0000621
sarcoma3MONDO:0005089EFO:0000691
myelodysplastic syndrome3MONDO:0018881EFO:0000198
chronic myeloid leukemia3MONDO:0011996EFO:0000339
lymphoma3MONDO:0005062EFO:0000574
plasma cell myeloma3MONDO:0009693EFO:0001378
metastatic melanoma3MONDO:0005191EFO:0002617
exocrine pancreatic carcinoma3MONDO:0005192EFO:0002618
rhabdomyosarcoma3MONDO:0005212EFO:0002918
breast neoplasm3MONDO:0021100EFO:0003869
non-Hodgkin lymphoma3MONDO:0018908EFO:0005952
ganglioneuroblastoma3MONDO:0005035EFO:0000502
cytomegalovirus retinitis3MONDO:0000878EFO:1001302
ocular melanoma3MONDO:0006325EFO:1000403
soft tissue sarcoma3MONDO:0018078EFO:1001968
prostate carcinoma2MONDO:0005159EFO:0001663
pulmonary alveolar proteinosis2MONDO:0001437Orphanet:264675
male breast carcinoma2MONDO:0005628EFO:0006861
B-cell chronic lymphocytic leukemia2MONDO:0004948EFO:0000095
HIV infectious disease2MONDO:0005109EFO:0000180
osteosarcoma2MONDO:0009807EFO:0000637
prostate adenocarcinoma2MONDO:0005082EFO:0000673
renal cell carcinoma2MONDO:0005086EFO:0000681
ovarian carcinoma2MONDO:0005140EFO:0001075
non-small cell lung carcinoma2MONDO:0005233EFO:0003060
kidney disorder2MONDO:0005240EFO:0003086
biliary tract neoplasm2MONDO:0005304EFO:0003891
ovarian neoplasm2MONDO:0021068EFO:0003893
cutaneous leishmaniasis2MONDO:0005446EFO:0005046
inflammatory breast carcinoma2MONDO:0006804EFO:1000984
gliosarcoma2MONDO:0016681EFO:1001465
colorectal carcinoma2MONDO:0024331EFO:1001951
acute lymphoblastic leukemia2MONDO:0004967EFO:0000220
endometrioid adenocarcinoma2MONDO:0005026EFO:0000466
glioblastoma2MONDO:0018177EFO:0000519
fallopian tube carcinoma2MONDO:0006206EFO:1000251
Hodgkins lymphoma2MONDO:0004952EFO:0000183
ductal breast carcinoma in situ2MONDO:0005023EFO:0000432
myeloproliferative neoplasm2MONDO:0020076EFO:0002428
brain neoplasm2MONDO:0021211EFO:0003833
ovarian serous cystadenocarcinoma2MONDO:0006046EFO:1000043
central nervous system neoplasm2MONDO:0006130EFO:1000158
gastric neoplasm2MONDO:0021085MONDO:0001056
peritoneal neoplasm2MONDO:0006901MONDO:0002087
fallopian tube neoplasm2MONDO:0021092MONDO:0002158
kidney cancer2MONDO:0002367MONDO:0002367
gallbladder neoplasm2MONDO:0021253MONDO:0005411
ovarian cancer2MONDO:0008170MONDO:0008170
lung neoplasm2MONDO:0021117MONDO:0008903
follicular lymphoma2MONDO:0018906MONDO:0018906
hematopoietic and lymphoid system neoplasm2MONDO:0002334MONDO:0044881
oral cavity squamous cell carcinoma2MONDO:0004958EFO:0000199
severe acute respiratory syndrome2MONDO:0005091EFO:0000694
triple-negative breast carcinoma2MONDO:0005494EFO:0005537
myelodysplastic/myeloproliferative disease2MONDO:0020077MONDO:0020077
head and neck squamous cell carcinoma2MONDO:0010150EFO:0000181
Down syndrome2MONDO:0008608EFO:0001064
Alzheimer disease2MONDO:0004975MONDO:0004975
plasma cell neoplasm2MONDO:0004959EFO:0000200
colorectal neoplasm2MONDO:0005335MONDO:0005575
adenocarcinoma1MONDO:0004970EFO:0000228
periodontitis1MONDO:0005076EFO:0000649
myelodysplastic syndrome with excess blasts1MONDO:0019454EFO:0003811
chronic hepatitis B virus infection1MONDO:0005366EFO:0004239
plasma cell leukemia1MONDO:0018689EFO:0006475
Parkinson disease1MONDO:0005180MONDO:0005180
pancreatic ductal adenocarcinoma1MONDO:0005184MONDO: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

PhaseTrials
PHASE2173
PHASE177
PHASE331
PHASE1/PHASE222
Not specified10
PHASE2/PHASE33
PHASE41
EARLY_PHASE11

Top trials by phase / activity

NCTPhaseStatusTitle
NCT04326920PHASE4COMPLETEDSargramostim in Patients With Acute Hypoxic Respiratory Failure Due to COVID-19 (SARPAC)
NCT02339571PHASE2/PHASE3ACTIVE_NOT_RECRUITINGA Phase II/III Trial of Nivolumab, Ipilimumab, and GM-CSF in Patients With Advanced Melanoma
NCT03126916PHASE3RECRUITINGTesting the Addition of 131I-MIBG or Lorlatinib to Intensive Therapy in People With High-Risk Neuroblastoma (NBL)
NCT00000658PHASE3COMPLETEDA Phase III Randomized Trial of Low-Dose Versus Standard-Dose mBACOD Chemotherapy With rGM-CSF for Treatment of AIDS-Associated Non-Hodgkin’s Lymphoma
NCT00002070PHASE3COMPLETEDPhase III Ganciclovir +/- rGM-CSF for AIDS-Related CMV Retinitis
NCT00002514PHASE3COMPLETEDStem Cell Transplantation Compared With Standard Chemotherapy in Treating Patients With Acute Lymphoblastic Leukemia in First Remission
NCT00002599PHASE3UNKNOWNCombination Chemotherapy and Interferon Alfa With or Without Bone Marrow or Peripheral Stem Cell Transplantation in Treating Patients With Myeloma
NCT00002766PHASE3COMPLETEDComparison of Two Combination Chemotherapy Regimens in Treating Adults With Previously Untreated Leukemia or Lymphoma
NCT00002995PHASE3COMPLETEDCombination Chemotherapy With or Without Radiation Therapy in Treating Patients With Newly Diagnosed Rhabdomyosarcoma
NCT00003093PHASE3COMPLETEDCombination Chemotherapy in Treating Children With Neuroblastoma
NCT00003119PHASE3COMPLETEDSurgery in Treating Children With Neuroblastoma
NCT00003315PHASE3COMPLETEDLiposomal Amphotericin B With or Without Sargramostim in Treating Patients With Invasive Fungal Infection
NCT00003958PHASE3COMPLETEDCombination Chemotherapy in Treating Patients With Previously Untreated Rhabdomyosarcoma
NCT00003972PHASE3COMPLETEDCombination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Stage II or Stage IIIA Breast Cancer
NCT00008398PHASE3COMPLETEDSargramostim in Decreasing Mucositis in Patients Receiving Radiation Therapy for Head and Neck Cancer
NCT00017290PHASE3UNKNOWNCombination Chemotherapy Followed By Vaccine Therapy Plus Sargramostim in Treating Patients With Stage III or Stage IV Non-Hodgkin’s Lymphoma
NCT00026312PHASE3COMPLETEDIsotretinoin With or Without Dinutuximab, Aldesleukin, and Sargramostim Following Stem Cell Transplant in Treating Patients With Neuroblastoma
NCT00046930PHASE3COMPLETEDDaunorubicin & Cytarabine +/- Zosuquidar inTreating Older Patients With Newly Diagnosed Acute Myeloid Leukemia or Refractory Anemia
NCT00049517PHASE3COMPLETEDCombination Chemotherapy With or Without Monoclonal Antibody Therapy in Treating Patients With AML Leukemia
NCT00050531PHASE3COMPLETEDHigh-Dose Gleevec Alone or in Combination With Peg-Intron and GM-CSF in Early Phase Chronic Myelogenous Leukemia (CML)
NCT00089115PHASE3TERMINATEDVaccine Therapy and Sargramostim Compared With Placebo and Sargramostim Following Rituximab in Treating Patients With Non-Hodgkin’s Lymphoma
NCT00206674PHASE3COMPLETEDEfficacy (Induction of Response/Remission) and Safety Study in Patients With Moderate to Severe Crohn’s Disease
NCT00206713PHASE3TERMINATEDEfficacy Study of Sargramostim in the Retreatment of Patients Who Have Crohn’s Disease Who Have Previously Responded to Treatment With Sargramostim
NCT00237575PHASE3TERMINATEDRandomized Phase III Trial of Leukine® vs Neupogen® in Patients Receiving Cisplatin & Gemcitabine for Urothelial Cancer
NCT00293462PHASE3COMPLETEDGM-CSF Mouthwash for Preventing and Treating Mucositis in Patients Undergoing Radiation Therapy for Head and Neck Cancer
NCT00295165PHASE3TERMINATEDEfficacy (Induction of Response/Remission) and Safety Study in Patients With Moderate to Severe Crohn’s Disease
NCT00324831PHASE3SUSPENDEDGM-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
NCT00425360PHASE3COMPLETEDGemcitabine and Capecitabine With or Without Vaccine Therapy in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
NCT00454168PHASE3UNKNOWNVaccine Therapy and GM-CSF in Treating Patients With Acute Myeloid Leukemia in Remission
NCT00630565PHASE2/PHASE3TERMINATEDStem Cell Transplant in Treating Patients With Acute Myeloid Leukemia
NCT01041638PHASE3COMPLETEDMonoclonal Antibody Ch14.18, Sargramostim, Aldesleukin, and Isotretinoin After Autologous Stem Cell Transplant in Treating Patients With Neuroblastoma
NCT01324063PHASE3COMPLETEDA Randomized Phase III Study of Intensive Consolidation With High Dose Cytosine Arabinoside in Acute Myelogenous Leukemia (AML-8B)
NCT01826864PHASE3WITHDRAWNSargramostim or Hypertonic Saline Before Sentinel Lymph Node Biopsy in Treating Patients With Stage IB-II Melanoma
NCT01989572PHASE3COMPLETEDSargramostim, Vaccine Therapy, or Sargramostim and Vaccine Therapy in Preventing Disease Recurrence in Patients With Melanoma That Has Been Removed By Surgery
NCT04642950PHASE2/PHASE3COMPLETEDA Phase II/III Study of Sargramostim
NCT01134614PHASE2ACTIVE_NOT_RECRUITINGIpilimumab With or Without Sargramostim in Treating Patients With Stage III or Stage IV Melanoma That Cannot Be Removed by Surgery
NCT02455557PHASE2ACTIVE_NOT_RECRUITINGSurVaxM Vaccine Therapy and Temozolomide in Treating Patients With Newly Diagnosed Glioblastoma
NCT03012100PHASE2ACTIVE_NOT_RECRUITINGMulti-epitope Folate Receptor Alpha Peptide Vaccine, GM-CSF, and Cyclophosphamide in Treating Patients With Triple Negative Breast Cancer
NCT03786783PHASE2ACTIVE_NOT_RECRUITINGDinutuximab, Sargramostim, and Combination Chemotherapy in Treating Patients With Newly Diagnosed High-Risk Neuroblastoma
NCT03794349PHASE2ACTIVE_NOT_RECRUITINGIrinotecan 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.

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).