Odronextamab
Highest phase reached
Phase 3
Drug type
Antibody
- Listing at source
- Listed
- Highest phase reached
- Phase 3
- Drug type
- Antibody
- Drug name
- Odronextamab
- anti cd20 cd3 monoclonal antibody regn1979
- anti cd20 x anti cd3 bispecific monoclonal antibody regn1979
- ANTI-CD20 X ANTI-CD3 BISPECIFIC MONOCLONAL ANTIBODY REGN1979
- ANTI-CD20/CD3 MONOCLONAL ANTIBODY REGN1979
- immunoglobulin g4 anti human cd20 antigen human regn1979 gamma chain disulfide with human regn1979 kappa chain dimer with immunoglobulin g4 anti human cd3 antigen human regn1979 gamma chain disulfide with human regn1979 kappa chain
- immunoglobulin g4 kappa anti homo sapiens b lymphocyte antigen cd20 hetero dimer with immunoglobulin g4 kappa anti homo sapiens t cell surface glycoprotein cd3 epsilon chain human monoclonal antibody gamma 4 heavy chain 1 453 homo sapiens vh ighv3 9 01 95 ighd ighj6 01 95 8 8 20 1 127 homo sapiens ighg4 01 hinge s10 p 235 ch2 e3 p 240 f4 v 241 l5 del g6 a 242 128 453 141 214 disulfide with kappa light chain 1 214 homo sapiens v kappa igkv3 15 01 98 igkj4 01 6 3 9 1 107 homo sapiens igkc 01 108 214 hetero dimer with gamma 4 heavy chain 1 449 homo sapiens vh ighv3 9 01 98 ighd ighj6 01 90 8 8 16 1 123 homo sapiens ighg4 01 hinge s10 p 231 ch2 e3 p 236 f4 v 237 l5 del g6 a 238 124 449 137 214 disulfide with kappa light chain 1 214 homo sapiens v kappa igkv3 15 01 98 igkj4 01 6 3 9 1 107 homo sapiens igkc 01 108 214 229 233 232 236 bisdisulfide
- IMMUNOGLOBULIN G4-KAPPA ANTI-(HOMO SAPIENS B-LYMPHOCYTE ANTIGEN CD20), HETERO DIMER WITH IMMUNOGLOBULIN G4-KAPPA ANTI-(HOMO SAPIENS T-CELL SURFACE GLYCOPROTEIN CD3 EPSILON CHAIN) HUMAN MONOCLONAL ANTIBODY .GAMMA.4 HEAVY CHAIN (1-453) (HOMO SAPIENS VH (IGHV3-9*01 (95%) (IGHD)-IGHJ6*01 (95%)) (8.8.20) (1-127) -HOMO SAPIENS IGHG4*01 (HINGE(S10>P(235)), CH2(E3>P(240),F4>V(241),L5>DEL,G6>A(242))) (128-453)) (141-214')-DISULFIDE WITH .KAPPA. LIGHT CHAIN (1'-214') (HOMO SAPIENS V-KAPPA (IGKV3-15*01 (98%) IGKJ4*01)(6.3.9) (1'-107') -HOMO SAPIENS IGKC*01 (108'-214')), HETERO DIMER WITH .GAMMA.4 HEAVY CHAIN (1''-449'') (HOMO SAPIENS VH (IGHV3-9*01 (98%) (IGHD)-IGHJ6*01 (90%)) (8.8.16) (1''-123'')-HOMO SAPIENS IGHG4*01 (HINGE(S10>P(231'')), CH2(E3>P(236''),F4>V(237''),L5>DEL,G6>A(238''))) (124''-449'')) (137''-214''')-DISULFIDE WITH .KAPPA. LIGHT CHAIN (1'''-214''') (HOMO SAPIENS V-KAPPA (IGKV3-15*01 (98%) IGKJ4*01)(6.3.9) (1'''-107''') -HOMO SAPIENS IGKC*01 (108'''-214''')), (229''-233:232''-236)-BISDISULFIDE
- IMMUNOGLOBULIN G4, ANTI-(HUMAN CD20 ANTIGEN) (HUMAN REGN1979 .GAMMA.-CHAIN), DISULFIDE WITH HUMAN REGN1979 .KAPPA.-CHAIN, DIMER WITH IMMUNOGLOBULIN G4, ANTI-(HUMAN CD3 ANTIGEN) (HUMAN REGN1979 .GAMMA.-CHAIN), DISULFIDE WITH HUMAN REGN1979 .KAPPA.-CHAIN
- MAB HUMAN (IGG4) ANTI P11836 (CD20_HUMAN) & ANTI P07766 (CD3E_HUMAN) (REGN1979)
- mab human igg4 anti p11836 cd20 human anti p07766 cd3e human regn1979
- odronextamab
- Odronextamab
- odronextamab [INN]
- ODRONEXTAMAB [USAN]
- Odronextamab [WHO-DD]
- odronextamab inn
- odronextamab usan
- odronextamab who dd
- regn 1979
- REGN-1979
- regn1979
- Regn1979
- REGN1979
- CAS registry numbers
- 1801338-64-6
- ChEMBL ID
- CHEMBL4298084
- FDA ingredient codes (UNII)
- 8R5CM46UIO
- L01FX34
- Not yet assigned
Sources for recorded values
- Status
- Authorised
- Status date
- 22 Aug 2024
- Authorisation date
- 22 Aug 2024
- Approved indications
- Ordspono as monotherapy is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (r/r FL) after two or more lines of systemic therapy. Ordspono as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL) after two or more lines of systemic therapy.
- Product number
- EMEA/H/C/006215
- Authorisation holder
- Regeneron Ireland Designated Activity Company (DAC)
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 0
- Biosimilar medicines
- 0
- Advanced therapy
- No
- Conditional approval
- Yes
- Additional monitoring
- Yes
- Accelerated assessment
- No
- Exceptional circumstances
- No
Therapeutic areas
- Lymphoma, Follicular
European medicines record
- Patents
- 0
- Designations
- 1
- First in class
- No
- Fast track
- No
- Breakthrough designation
- No
- Orphan designation
- Yes
- Priority review
- No
- Orphan exclusivity
- No
- Accelerated approval
- No
- European Union (EMA)
- Authorised
- Pharmacology name
- odronextamab
- Type
- Antibody
- Drug name stem
- -mab
- Approval recorded by Guide to Pharmacology
- Yes
- Mechanism
- B-lymphocyte antigen CD20 binding agent
- Action type
- BINDING_AGENT
- Target
- B-lymphocyte antigen CD20
- Protein identifier
- P11836
- Mechanism
- T cell surface glycoprotein CD3 binding agent
- Action type
- BINDING_AGENT
- Target
- T cell surface glycoprotein CD3
- Protein identifier
- P04234
- Mechanism
- T cell surface glycoprotein CD3 binding agent
- Action type
- BINDING_AGENT
- Target
- T cell surface glycoprotein CD3
- Protein identifier
- P07766
- Mechanism
- T cell surface glycoprotein CD3 binding agent
- Action type
- BINDING_AGENT
- Target
- T cell surface glycoprotein CD3
- Protein identifier
- P09693
- Action
- Binding
- Action type
- Binding
- Target
- CD20 (membrane-spanning 4-domains, subfamily A, member 1)
- Gene symbol
- MS4A1
- Protein identifier
- P11836
- Mechanism
- B-lymphocyte antigen CD20 binding agent
- Action type
- BINDING AGENT
- Target
- B-lymphocyte antigen CD20
- Mechanism
- T cell surface glycoprotein CD3 binding agent
- Action type
- BINDING AGENT
- Target
- T cell surface glycoprotein CD3
- Condition
- Leukemia, B-Cell
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000094
- Subject identifier
- D015448
- Condition
- Leukemia, Lymphocytic, Chronic, B-Cell
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000095
- Subject identifier
- D015451
- Condition
- Lymphoma, Follicular
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000096
- Subject identifier
- D008224
- Condition
- Lymphoma, Large B-Cell, Diffuse
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000403
- Subject identifier
- D016403
- Condition
- Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000616
- Subject identifier
- D009369
- Condition
- Lymphoma, Non-Hodgkin
- Highest recorded phase
- 2
- Condition identifier
- EFO:0005952
- Subject identifier
- D008228
- Condition
- Lymphoma, B-Cell
- Highest recorded phase
- 1
- Condition identifier
- EFO:1001938
- Subject identifier
- D016393
- Condition
- Lymphoma, Follicular
- Highest recorded phase
- 3
- Condition identifier
- MONDO:0018906
- Subject identifier
- D008224
- Condition identifier
- EFO_0000094
- Condition identifier
- EFO_0000095
- Highest recorded phase
- 1
- Condition identifier
- EFO_0000616
- Condition identifier
- EFO_1001938
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0002083
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0004947
- Condition identifier
- MONDO_0004948
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0005070
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0005556
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0015759
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0017604
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0018905
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0018906
- Condition identifier
- MONDO_0018906
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0018908
- Highest recorded phase
- 3
- NCT02290951
- NCT02651662
- NCT03888105
- NCT06230224
- NCT05685173
- NCT05991388
- NCT06091254
- NCT06097364
- NCT06091865
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
- Component
- Heavy chain: (anti-CD20)
- Type
- Protein
- Sequence
- EVQLVESGGGLVQPGRSLRLSCVASGFTFNDYAMHWVRQAPGKGLEWVSVISWNSDSIGYADSVKGRFTISRDNAKNSLYLQMHSLRAEDTALYYCAKDNHYGSGSYYYYQYGMDVWGQGTTVTVSSASTKGPSVFPLAPCSRSTSESTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTKTYTCNVDHKPSNTKVDKRVESKYGPPCPPCPAPPVAGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSQEDPEVQFNWYVDGVEVHNAKTKPREEQFNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKGLPSSIEKTISKAKGQPREPQVYTLPPSQEEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSRLTVDKSRWQEGNVFSCSVMHEALHNHYTQKSLSLSLGK
- Component
- Light chain
- Type
- Protein
- Sequence
- EIVMTQSPATLSVSPGERATLSCRASQSVSSNLAWYQQKPGQAPRLLIYGASTRATGIPARFSGSGSGTEFTLTISSLQSEDFAVYYCQHYINWPLTFGGGTKVEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
- Component
- Heavy chain: (anti-CD3)
- Type
- Protein
- Sequence
- EVQLVESGGGLVQPGRSLRLSCAASGFTFDDYTMHWVRQAPGKGLEWVSGISWNSGSIGYADSVKGRFTISRDNAKKSLYLQMNSLRAEDTALYYCAKDNSGYGHYYYGMDVWGQGTTVTVASASTKGPSVFPLAPCSRSTSESTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTKTYTCNVDHKPSNTKVDKRVESKYGPPCPPCPAPPVAGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSQEDPEVQFNWYVDGVEVHNAKTKPREEQFNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKGLPSSIEKTISKAKGQPREPQVYTLPPSQEEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSRLTVDKSRWQEGNVFSCSVMHEALHNRFTQKSLSLSLGK
- Component
- Glycosylation sites (N)
- Sequence
- Asn-299'''' $ Asn-303
- Component
- Glycosylation sites (N)
- Sequence
- Asn-299'' $ Asn-303
- Component
- Disulfide bridges
- Sequence
- 22-96 $ 22''-96'' $ 23'-88' $ 23'''-88''' $ 134'-194' $ 134'-194' $ 134'''-194''' $ 137''-214''' $ 141-214' $ 150''-206'' $ 154-210 $ 229''-233 $ 232''-236 $ 263''-323'' $ 267-327 $ 369''-427'' $ 373-431
Related records
Trials (17)
- A Compassionate Use (CU) Program of Odronextamab
- A Global Study of Novel Agents in Paediatric and Adolescent Relapsed and Refractory B-cell Non-Hodgkin Lymphoma
- A Study to Assess the Anti-Tumor Activity and Safety of Odronextamab in Adult Patients With B-cell Non-Hodgkin Lymphoma Who Have Been Previously Treated With Other Cancer Therapies
- A Study to Compare How Well Odronextamab Combined With Chemotherapy Works and How Safe it is Against Rituximab Combined With Chemotherapy, in Adult Patients With Previously Untreated Diffuse Large B-cell Lymphoma
- A Study to Learn How Safe and Tolerable Odronextamab and Cemiplimab Are in Adult Patients With B-cell Malignancies
- A Trial to Find Out if Odronextamab Combined With Lenalidomide is Safe and Works Better Than Rituximab Combined With Lenalidomide in Adult Participants With Follicular Lymphoma and Marginal Zone Lymphoma
- A Trial to Learn How Effective and Safe Odronextamab is Compared to Standard of Care for Adult Participants With Previously Treated Aggressive B-cell Non-Hodgkin Lymphoma
- A Trial to Learn if Odronextamab Combined With Chemotherapy is Safe and Well-Tolerated and How Well it Works Compared to Rituximab Combined With Chemotherapy for Adult Participants With Follicular Lymphoma
- A Trial to Learn if Odronextamab is Safe and Well-Tolerated and How Well it Works Compared to Rituximab Combined With Different Types of Chemotherapy for Adult Participants With Previously Untreated Follicular Lymphoma
- A Trial to Study if REGN5837 in Combination With Odronextamab is Safe for Adult Participants With Aggressive B-cell Non-Hodgkin Lymphomas
- Dose Escalation Study With Bispecific Antibodies in Adult Participants With Lupus Nephritis
- Odronextamab for Relapsed and Refractory Large B-cell Lymphomas Before CAR-T
- Odronextamab for the Treatment of Relapsed and Refractory Diffuse Large B-cell Lymphoma Before and After Chimeric Antigen Receptor T-cell Therapy
- Odronextamab in Low Tumor Volume Advanced FL
- REGN9220 in Combination With Odronextamab in Adult Participants With Relapsed or Refractory Aggressive B-Cell Non-Hodgkin Lymphomas (BCNHLs)
- Study to Investigate the Safety and Tolerability of Odronextamab in Patients With CD20+ B-Cell Malignancies
- Zanubrutinib in Combination With Odronextamab for the Treatment of Patients With Richter's Transformation
In development for (11)
- B-cell acute lymphoblastic leukemia Phase 1
- B-cell chronic lymphocytic leukemia Phase 1
- B-cell non-Hodgkin lymphoma Phase 1
- Diffuse large B-cell lymphoma Phase 3
- Follicular lymphoma Phase 3
- Lupus nephritis Phase 1
- Marginal zone lymphoma Phase 3
- Neoplasm Phase 2
- Neoplasm of mature B-cells Phase 3
- Non-Hodgkin lymphoma Phase 2
- Richter transformation Phase 1