Regramostim

Summary

Regramostim (CHEMBL2107881) is a phase-3 clinical-stage protein; indicated across 28 conditions including melanoma and cutaneous melanoma.

At a glance

• Status: Max clinical phase 3 (not approved)
• Modality: Protein
• Indications: 28 conditions
• Clinical trials: 158

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL2107881
Name	Regramostim
Type	Protein
Max phase	3

Also known as: GM-CSF, GM-CSF (CHO CELL), Regramostim, RHGM-C, RHGM-CSF, REGRAMOSTIM

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

28 indications (0 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
melanoma	3	MONDO:0005105	EFO:0000756
cutaneous melanoma	3	MONDO:0005012	EFO:0000389
colorectal adenocarcinoma	2	MONDO:0005008	EFO:0000365
non-small cell lung carcinoma	2	MONDO:0005233	EFO:0003060
HIV infectious disease	2	MONDO:0005109	EFO:0000180
glioblastoma	2	MONDO:0018177	EFO:0000519
lymphoma	2	MONDO:0005062	EFO:0000574
neuroblastoma	2	MONDO:0005072	EFO:0000621
renal cell carcinoma	2	MONDO:0005086	EFO:0000681
malignant pleural mesothelioma	2	MONDO:0005112	EFO:0000770
nasopharyngeal neoplasm	2	MONDO:0005375	EFO:0004252
peripheral arterial disease	2	MONDO:0005386	EFO:0004265
appendicitis	2	MONDO:0005649	EFO:0007149
Burkitt lymphoma	2	MONDO:0007243	EFO:0000309
diffuse large B-cell lymphoma	2	MONDO:0018905	EFO:0000403
colorectal carcinoma	2	MONDO:0024331	EFO:1001951
pulmonary alveolar proteinosis	2	MONDO:0001437	MONDO:0001437
breast neoplasm	2	MONDO:0021100	MONDO:0007254
ovarian cancer	2	MONDO:0008170	MONDO:0008170
lung neoplasm	2	MONDO:0021117	MONDO:0008903
colonic neoplasm	2	MONDO:0005401	MONDO:0021063
glioma	2	MONDO:0021042	MONDO:0100342
plasma cell myeloma	1	MONDO:0009693	EFO:0001378
kidney cancer	1	MONDO:0002367	MONDO:0002367
neoplasm	1	MONDO:0005070	MONDO:0004992

3 further indication records had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.

Clinical trials

Total trials: 158.

Phase distribution

Phase	Trials
PHASE2	81
PHASE1	32
PHASE1/PHASE2	18
PHASE3	11
PHASE4	7
Not specified	7
EARLY_PHASE1	2

Top trials by phase / activity

NCT	Phase	Status	Title
NCT01232504	PHASE4	COMPLETED	Antifugal Effect of Recombinant Human Granulocyte-macrophage Stimulating Factor (rhGM-CSF) in Patients Post Allo-HSCT
NCT01495637	PHASE4	COMPLETED	GM-CSF for Immunomodulation Following Trauma (GIFT) Study
NCT01718210	PHASE4	COMPLETED	Use of GM-CSF Supplemented IVF Medium in Patients With Recurrent Implantation Failure
NCT02250768	PHASE4	COMPLETED	Effects of Embryogen in RIF Patients
NCT02451488	PHASE4	COMPLETED	Neoadjuvant Granulocyte-Macrophage Colony-Stimulating Factor (GM-CSF) in Cutaneous Stage L-lll Melanoma
NCT02933333	PHASE4	UNKNOWN	G-CSF Alone or Combination With GM-CSF on Prevention and Treatment of Infection in Children With Malignant Tumor
NCT03769844	PHASE4	COMPLETED	GM-CSF for Reversal of immunopAralysis in pediatriC sEpsis-induced MODS Study
NCT04229979	PHASE3	ACTIVE_NOT_RECRUITING	Galinpepimut-S Versus Investigator’s Choice of Best Available Therapy for Maintenance in AML CR2/CRp2
NCT00001561	PHASE3	COMPLETED	Active Immunization of Sibling Bone Marrow Transplant Donors Against Purified Myeloma Protein of the Recipient Undergoing Allogeneic Bone Marrow Transplantation
NCT00083551	PHASE3	COMPLETED	UARK 98-026 TT II: Multiple Myeloma Evaluating Anti-Angiogenesis With Thalidomide and Post-Transplant Consolidation Chemotherapy
NCT00091676	PHASE3	UNKNOWN	Study of the BiovaxId Tumor Derived Idiotype Vaccine in Patients With Follicular Lymphoma
NCT00769704	PHASE3	COMPLETED	Efficacy and Safety Study of Talimogene Laherparepvec Compared to Granulocyte Macrophage Colony Stimulating Factor (GM-CSF) in Melanoma
NCT00880243	PHASE3	COMPLETED	Effect of Priming During Induction and Consolidations in Younger Acute Myeloid Leukemia (AML)
NCT01265901	PHASE3	COMPLETED	IMA901 in Patients Receiving Sunitinib for Advanced/Metastatic Renal Cell Carcinoma
NCT01322490	PHASE3	COMPLETED	A Randomized, Double-blind, Phase 3 Efficacy Trial of PROSTVAC-V/F +/- GM-CSF in Men With Asymptomatic or Minimally Symptomatic Metastatic Castrate-Resistant Prostate Cancer
NCT01715974	PHASE3	UNKNOWN	Use of GM-CSF Treatment in Recurrent Implantation Failure
NCT04446052	PHASE3	COMPLETED	Phase III rhu_GM-CSF + 3 Induction Regimens in Adults With Acute Non-Lymphocytic Leukemia
NCT05266001	PHASE3	COMPLETED	GM-CSF for Reversal of Immunoparalysis in Pediatric Sepsis-induced MODS
NCT00799110	PHASE2	ACTIVE_NOT_RECRUITING	Vaccination of Patients With Ovarian Cancer With Dendritic Cell/Tumor Fusions With Granulocyte Macrophage Colony-stimulating Factor (GM-CSF) and Imiquimod
NCT01903330	PHASE2	ACTIVE_NOT_RECRUITING	ERC1671/GM-CSF/Cyclophosphamide for the Treatment of Glioblastoma Multiforme
NCT02502786	PHASE2	ACTIVE_NOT_RECRUITING	Humanized Monoclonal Antibody 3F8 (Hu3F8) With Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) in the Treatment of Recurrent Osteosarcoma
NCT03363373	PHASE2	RECRUITING	Naxitamab for High-Risk Neuroblastoma Patients With Primary Refractory Disease or Incomplete Response to Salvage Treatment in Bone and/or Bone Marrow
NCT03600350	PHASE2	ACTIVE_NOT_RECRUITING	pTVG-HP and Nivolumab in Patients With Non-Metastatic PSA-Recurrent Prostate Cancer
NCT03630211	PHASE2	RECRUITING	Autologous Stem Cell Transplantation in Patients With Systemic Sclerosis
NCT04713371	PHASE2	ACTIVE_NOT_RECRUITING	A Phase 2 Trial for Patients With Metastatic Solid Cancer
NCT04739618	PHASE2	ACTIVE_NOT_RECRUITING	Metastatic Solid Cancer Clinical Trial
NCT04936529	PHASE2	RECRUITING	A Study of a Vaccine in Combination With β-glucan and GM-CSF in People With Neuroblastoma
NCT05366062	PHASE2	NOT_YET_RECRUITING	ERC1671 to Treat Malignant Gliomas When Given in Combination With GM-CSF, Cyclophosphamide, Bevacizumab and Pembrolizumab
NCT06013618	PHASE2	RECRUITING	Clinical Analysis of Naxitamab (hu3F8) in the Treatment of Pediatric High Risk or Refractory/ Relapsed Neuroblastoma
NCT06450041	PHASE2	RECRUITING	NANT 2021-01 Phase II STING (Sequential Temozolomide, Irinotecan, NK Cells and GD2 mAb) Trial
NCT06472739	PHASE2	RECRUITING	The Effect of GM-CSF to Preventing Oral Mucositis for Patients With Nasopharyngeal Carcinoma Receiving Radiotherapy
NCT06626516	PHASE1/PHASE2	RECRUITING	Tebentafusp-tebn With LDT in Metastatic UM
NCT07327411	PHASE2	NOT_YET_RECRUITING	Cetuximab β Combined With PRaG Regimen in the Treatment of EGFR-positive Advanced Refractory Solid Tumors
NCT00001564	PHASE2	COMPLETED	A Pilot Study of Tumor-Specific Peptide Vaccination and IL-2 With or Without Autologous T Cell Transplantation in Recurrent Pediatric Sarcomas
NCT00005780	PHASE2	COMPLETED	Chemotherapy Plus Vaccination to Treat Mantle Cell Lymphoma
NCT00089219	PHASE1/PHASE2	COMPLETED	Vaccine Therapy in Treating Patients With Stage IIIB, Stage IIIC, or Stage IV Melanoma
NCT00090870	PHASE2	TERMINATED	PEG-Interferon Alfa-2b, Sargramostim, and Thalidomide in Treating Patients With Metastatic Kidney Cancer
NCT00157573	PHASE2	COMPLETED	GM-CSF, Sargramostim in Women With Recurrent Ovarian Cancer
NCT00201409	PHASE2	COMPLETED	A Randomized Trial of GM-CSF in Patients With ALI/ARDS
NCT00204516	PHASE1/PHASE2	COMPLETED	Vaccination With Tumor mRNA in Metastatic Melanoma - Fixed Combination Versus Individual Selection of Targeted Antigens

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).