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TNFSF11

TNFSF11 Overview

English NameTumor necrosis factor ligand superfamily member 11Approved Drugs19
Drugs in Clinical Trials12Target SynonymOsteoclast differentiation factor,TRANCE,TNFSF11,TNF-related activation-induced cytokine,Tumor necrosis factor ligand superfamily member 11,CD254,TNF Superfamily Member 11,Osteoprotegerin Ligand,Receptor Activator Of Nuclear Factor Kappa B Ligand,Tumor Necrosis Factor Superfamily Member 11,ODF,RANKL,OPGL,CD254 Antigen,HRANKL2,TNLG6B,OPTB2,SOdf,RANK Ligand,Tumor Necrosis Factor (Ligand) Superfamily, Member 11,Receptor Activator Of Nuclear Factor Kappa-B Ligand,Tumor Necrosis Factor Ligand 6B
Highest Development StageApproved
English NameTumor necrosis factor ligand superfamily member 11
Target SynonymOsteoclast differentiation factor,TRANCE,TNFSF11,TNF-related activation-induced cytokine,Tumor necrosis factor ligand superfamily member 11,CD254,TNF Superfamily Member 11,Osteoprotegerin Ligand,Receptor Activator Of Nuclear Factor Kappa B Ligand,Tumor Necrosis Factor Superfamily Member 11,ODF,RANKL,OPGL,CD254 Antigen,HRANKL2,TNLG6B,OPTB2,SOdf,RANK Ligand,Tumor Necrosis Factor (Ligand) Superfamily, Member 11,Receptor Activator Of Nuclear Factor Kappa-B Ligand,Tumor Necrosis Factor Ligand 6B
Approved Drugs19
Drugs in Clinical Trials12
Highest Development StageApproved

TNFSF11 Background

Receptor activator of nuclear factor kappa-B ligand (RANKL), also known as tumor necrosis factor ligand superfamily member 11 (TNFSF11), TNF-related activation-induced cytokine (TRANCE), osteoprotegerin ligand (OPGL), and osteoclast differentiation factor (ODF), is known as a type II membrane protein and is a member of the tumor necrosis factor (TNF) superfamily. RANKL, through its ability to stimulate osteoclast formation and activity, is a critical mediator of bone resorption and overall bone density. Some findings also suggestion some cancer cells, particularly prostate cancer cells, can activate an increase in bone remodeling and ultimately increase overall bone production.[17] This increase in bone remodeling and bone production increases the overall growth of bone metastasizes. The overall control of bone remodeling is regulated by the binding of RANKL with its receptor or its decoy receptor, respectively, RANK and OPG.

TNFSF11 Synonyms

RANKL,CD254,TRANCE,OPGL,ODF

Clinical Drug Information

English NameResearch CodeHighest Development StageCompanyIndicationClinical Trial
Denosumab biosimilar(Shanghai Hansoh)HS-20090; HS-20090-2Phase 3 ClinicalJiangsu Hansoh Pharmaceutical Group Co Ltd, Shanghai Hansoh Biomedical Co LtdBone Diseases; Bone metastases; Giant Cell Tumor of Bone; Hypercalcemia; Multiple Myeloma; Neoplasms; Nutritional and Metabolic Diseases; Osteoporosis, Postmenopausal; Solid tumours
Details
Recombinant human anti-RANKL momoclonal antibody (Qilu Pharmaceutical)Phase 3 ClinicalQilu Pharmaceutical Co LtdNeoplasms; Osteoporosis, Postmenopausal
Details
Denosumab biosimilar (GlycoNex)SPD8; SPD-8Phase 3 ClinicalGlyconex IncNeoplasms; Osteoporosis
Details
Denosumab biosimilar (Hetero Biopharma)Phase 3 ClinicalHetero Biopharma LtdSolid tumours
Details
Denosumab biosimilar(Curateq Biologics)BP-16Phase 3 ClinicalCuraTeQ Biologics Pvt LtdOsteoporosis, Postmenopausal
Details
Recombinant anti-RANKL monoclonal antibody(Jiangsu Pacific-Meinuoke)Phase 3 ClinicalJiangsu Pacific Minok Biopharmaceutical Co., Ltd.Osteoporosis, Postmenopausal
Details
SHR-2017SHR-2017; SHR2017Phase 2 ClinicalSuzhou Suncadia Biopharmaceuticals Co LtdBone metastases; Multiple Myeloma; Osteoporosis; Solid tumours
Details
LZM-004LZM-004Phase 1 ClinicalLivzon(Group) Pharmaceutical FactoryBone metastases
Details
Recombinant human anti-RANKL antibody (Innovent Biologics)IBI-307Phase 1 ClinicalOsteoporosis
Details
GB-223GB-223; GB223Phase 1 ClinicalGenor Biopharma Co LtdBone metastases; Bone Neoplasms; Giant Cell Tumor of Bone; Osteoporosis, Postmenopausal; Solid tumours
Details
Denosumab biosimilar (Kpc Pharmaceuticals)MV-088Phase 1 ClinicalKpc Pharmaceuticals IncOsteoporosis, Postmenopausal
Details
Denosumab biosimilar (Zhejiang Hisun)HS629Phase 1 ClinicalZhejiang Hisun Pharmaceutical Co LtdBone metastases; Solid tumours
Details

Marketed Drug Information

English NameResearch CodeHighest Development StageCompanyEarliest Brand NameEarliest Approval CountryEarliest IndicationEarliest Approval CompanyEarliest Approval DateIndicationClinical Trial
Denosumab biosimilar (Teva Pharmaceutical)TVB-009P; TVB-009ApprovedTeva Pharmaceutical Industries LtdPONLIMSI, DEGEVMAEUBone Resorption; Osteoporosis, Postmenopausal; Osteoporosis; Giant Cell Tumor of Bone; Neoplasms, Bone TissueTeva Gmbh2025-11-17Bone Neoplasms; Bone Resorption; Giant Cell Tumor of Bone; Neoplasms, Bone Tissue; Osteoporosis; Osteoporosis, Postmenopausal
Details
Denosumab biosimilar (Henlius)HLX14; HLX-14ApprovedBilprevda, BildyosUnited StatesHypercalcemia; Giant Cell Tumors; Bone metastases; Osteoporosis, PostmenopausalShanghai Henlius Biotech Inc2025-08-29Arthritis, Rheumatoid; Bone metastases; Bone Neoplasms; Bone Resorption; Breast Neoplasms; Fractures, Bone; Giant Cell Tumor of Bone; Giant Cell Tumors; Glucocorticoid-induced osteoporosis; Hypercalcemia; Multiple Myeloma; Neoplasm Metastasis; Neoplasms, Bone Tissue; Osteoporosis; Osteoporosis, Postmenopausal; Prostatic Neoplasms
Details
NarlumosbartJMT-103ApprovedShanghai Jmt-Bio Inc津立泰, 津立生Mainland ChinaGiant Cell Tumor of BoneShanghai Jmt-Bio Inc2023-09-05Bone Diseases; Bone metastases; Giant Cell Tumor of Bone; Glucocorticoid-induced osteoporosis; Hypercalcemia; Multiple Myeloma; Neoplasms; Osteoporosis; Osteoporosis, Postmenopausal; Solid tumours
Details
Denosumab biosimilar (Mabwell)9-MW-0311; 9MW0321; 9-MW0321; 9MW-0321; 9-MW-0321; TK-006; MW-032; MW-031; 9MW0311; 9-MW0311; 9MW-0311ApprovedJiangsu T-Mab Bio-Pharmaceuticals Co Ltd迈利舒, 迈卫健, MAIWEIJIAN, MAILISHUMainland ChinaOsteoporosis, PostmenopausalJiangsu T-Mab Bio-Pharmaceuticals Co Ltd2023-03-28Bone metastases; Bone Neoplasms; Breast Neoplasms; Giant Cell Tumor of Bone; Osteoporosis; Osteoporosis, Postmenopausal; Solid tumours
Details
Denosumab biosimilar (Qilu Pharma)QL-1206ApprovedQilu Pharmaceutical Co Ltd鲁可欣Mainland ChinaOsteoporosis, PostmenopausalQilu Pharmaceutical Co Ltd2023-09-28Bone metastases; Giant Cell Tumor of Bone; Osteoporosis, Postmenopausal; Solid tumours
Details
Denosumab biosimilar (Boan Biopharma/Luye)LY-01011; BA-1102; BA-6101; LY-06006ApprovedShandong Boan Biotechnology Co Ltd博洛加, Boluojia, Boyoubei, 博优倍Mainland ChinaOsteoporosis, PostmenopausalShandong Boan Biotechnology Co Ltd2022-11-08Bone metastases; Bone Neoplasms; Giant Cell Tumor of Bone; Neoplasm Metastasis; Neoplasms; Osteoporosis; Osteoporosis, Postmenopausal; Solid tumours
Details
Denosumab biosimilar (Accord Healthcare)ApprovedAccord Healthcare SluJubereq, OsvyrtiEUOsteoporosis; Neoplasms, Bone Tissue; Giant Cell Tumor of Bone; Bone Resorption; Osteoporosis, PostmenopausalAccord Healthcare Slu2025-05-26Bone metastases; Bone Resorption; Giant Cell Tumor of Bone; Hypercalcemia; Neoplasms, Bone Tissue; Osteoporosis; Osteoporosis, Postmenopausal
Details
DenosumabNSC-744010; AMG-162ApprovedAmgen IncProlia, Xgeva, Pralia, Ranmark, 普罗力EUOsteoporosis, PostmenopausalAmgen Europe Bv2010-05-26Anorexia Nervosa; Arthritis, Rheumatoid; Arthropathy, Neurogenic; Bone Cysts, Aneurysmal; Bone Diseases; Bone Diseases, Metabolic; Bone metastases; Bone Neoplasms; Breast Diseases; Breast Neoplasms; Carcinoma; Carcinoma, Non-Small-Cell Lung; Carcinoma, Ovarian Epithelial; Carcinoma, Squamous Cell; Cataract; Chondroblastoma; Colonic Neoplasms; Crohn Disease; Endocrine Gland Neoplasms; Feeding and Eating Disorders; Fibroma; Fibrous Dysplasia of Bone; Fractures, Bone; Giant Cell Tumor of Bone; Giant Cell Tumors; Glucocorticoid-induced osteoporosis; Granuloma, Giant Cell; Head and Neck Neoplasms; Hematologic Neoplasms; Hematopoietic stem cell transplantation (HSCT); Hodgkin Disease; Hormone-Resistant Prostate Neoplasms; Hypercalcemia; Kidney Neoplasms; Lung Neoplasms; Lymphoma; Lymphoma, Non-Hodgkin; Metastatic breast cancer; Multiple Myeloma; Neoplasm Metastasis; Neoplasms; Neoplasms, Germ Cell and Embryonal; Osteoarthritis; Osteoarthritis, Knee; Osteoblastoma; Osteogenesis Imperfecta; Osteoporosis; Osteoporosis
Details
Denosumab biosimilar(Enzene Biosciences)ENZ-215ApprovedEnzene Biosciences LtdOsqayEUBone ResorptionTheramex Ireland Ltd2026-01-08Bone Resorption; Osteoporosis, Postmenopausal
Details
Denosumab biosimilar (Alvotech Swiss)AVT-03; AVT03ApprovedAlvotech Swiss AgAcvybra, XbonzyEUGiant Cell Tumor of Bone; Osteoporosis, Postmenopausal; Bone Resorption; Neoplasms, Bone Tissue; OsteoporosisStada Arzneimittel Ag, Reddy Holding Gmbh2025-11-17Bone Resorption; Giant Cell Tumor of Bone; Neoplasms, Bone Tissue; Osteoporosis; Osteoporosis, Postmenopausal
Details
Denosumab biosimilar(Mabxience)MB-09ApprovedMabxience SaZadenvi, Izamby, Enwylma, DenbrayceEUNeoplasms, Bone Tissue; Bone Resorption; Osteoporosis, Postmenopausal; Osteoporosis; Giant Cell Tumor of BoneZentiva Ks, Mabxience Research SL2025-06-26Bone Diseases; Bone Resorption; Fractures, Bone; Giant Cell Tumor of Bone; Glucocorticoid-induced osteoporosis; Hypercalcemia; Neoplasms, Bone Tissue; Osteoporosis; Osteoporosis, Postmenopausal
Details
Denosumab biosimilar (Biocon Biologics)Bmab-1000ApprovedBiocon LtdVevzuo, EvfraxyEUNeoplasms, Bone Tissue; Giant Cell Tumor of BoneBiosimilar Collaborations Ireland Ltd2025-06-25Bone metastases; Bone Resorption; Giant Cell Tumor of Bone; Glucocorticoid-induced osteoporosis; Neoplasms, Bone Tissue; Osteoporosis; Osteoporosis, Postmenopausal; Prostatic Neoplasms
Details
Denosumab biosimilar(Reliance Life Sciences)R-TPR-045ApprovedReliance Life SciencesDenosuRelIndiaOsteoporosis, Postmenopausal; Bone metastasesReliance Life Sciences2022-02-01Bone metastases; Osteoporosis, Postmenopausal
Details
Denosumab biosimilar (Gedeon Richter)RGB-14-PApprovedGedeon Richter PlcENOBY, XTRENBO, Yaxwer, JunodEUBone Resorption; Osteoporosis, Postmenopausal; Osteoporosis; Giant Cell Tumor of Bone; Neoplasms, Bone TissueGedeon Richter Plc2025-06-23Bone metastases; Bone Resorption; Breast Neoplasms; Giant Cell Tumor of Bone; Glucocorticoid-induced osteoporosis; Neoplasms, Bone Tissue; Osteoporosis; Osteoporosis, Postmenopausal; Prostatic Neoplasms
Details
Denosumab biosimilar(Fresenius Kabi)FKS-518ApprovedFresenius Kabi Swissbiosim GmbhBOMYNTRA, CONEXXENCEUnited StatesGiant Cell Tumor of Bone; Hypercalcemia; Bone metastasesFresenius Kabi Usa Llc2025-03-25Bone metastases; Bone Resorption; Giant Cell Tumor of Bone; Hypercalcemia; Neoplasms, Bone Tissue; Osteoporosis; Osteoporosis, Postmenopausal
Details
Denosumab biosimilar (Samsung Bioepis)SB-16ApprovedSamsung Bioepis Co LtdOspomyv, Xbryk, XBRYK, OBODENCEEUNeoplasms, Bone Tissue; Giant Cell Tumor of Bone; Bone Resorption; Osteoporosis; Osteoporosis, PostmenopausalSamsung Bioepis Nl Bv2025-02-12Bone Resorption; Giant Cell Tumor of Bone; Glucocorticoid-induced osteoporosis; Neoplasms, Bone Tissue; Osteoporosis; Osteoporosis, Postmenopausal
Details
Denosumab biosimilar (Celltrion)CT-P41ApprovedCelltrion IncStoboclo, OsenveltEUBone Resorption; Osteoporosis, Postmenopausal; Osteoporosis; Neoplasms, Bone Tissue; Giant Cell Tumor of BoneCelltrion Healthcare Hungary Kft2025-02-14Bone Resorption; Breast Neoplasms; Giant Cell Tumor of Bone; Glucocorticoid-induced osteoporosis; Neoplasms, Bone Tissue; Osteoporosis; Osteoporosis, Postmenopausal; Prostatic Neoplasms
Details
Denosumab biosimilar (Sandoz)GP-2411ApprovedNovartis Pharma Ag, SandozJubbonti®, Wyost®United StatesOsteoporosis, Postmenopausal; Osteoporosis; Glucocorticoid-induced osteoporosisSandoz, Sandoz Inc2024-03-05Bone Resorption; Giant Cell Tumor of Bone; Glucocorticoid-induced osteoporosis; Neoplasms, Bone Tissue; Osteoporosis; Osteoporosis, Postmenopausal
Details
Denosumab biosimilar (Alphamab)KN-012ApprovedSuzhou Alphamab Co LtdMainland ChinaOsteoporosis, PostmenopausalPhilippine Biological Technology (Jilin) ​​Co Ltd, Alphamab Jilin Co Ltd2024-09-03Osteoporosis, Postmenopausal
Details
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