Mogamulizumab
Highest phase reached
Approved
Drug type
Antibody
First approval year
2018
- First approval year
- 2018
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Antibody
- Drug name
- Mogamulizumab
- poteligeo
- Poteligeo
- amg 761
- AMG 761
- AMG-761
- immunoglobulin g1 anti cc chemokine receptor ccr4 human mouse monoclonal kw 0761 heavy chain disulfide with human mouse monoclonal kw 0761 kappa chain dimer
- IMMUNOGLOBULIN G1, ANTI-(CC CHEMOKINE RECEPTOR CCR4) (HUMAN-MOUSE MONOCLONAL KW-0761 HEAVY CHAIN), DISULFIDE WITH HUMAN-MOUSE MONOCLONAL KW-0761 .KAPPA.-CHAIN, DIMER
- km 8761
- KM-8761
- km8761
- KM8761
- kw 0761
- KW-0761
- KW-0761 (mogamulizumab)
- mogamulizumab
- Mogamulizumab
- Mogamulizumab (genetical recombination)
- MOGAMULIZUMAB (GENETICAL RECOMBINATION) [JAN]
- Mogamulizumab (KW-0761)
- Mogamulizumab (subsequent cycles post TSEB)
- mogamulizumab [INN]
- MOGAMULIZUMAB [JAN]
- MOGAMULIZUMAB [MI]
- MOGAMULIZUMAB [USAN]
- Mogamulizumab [WHO-DD]
- mogamulizumab genetical recombination
- mogamulizumab genetical recombination jan
And 15 more, listed on the interactive page.
- CAS registry numbers
- 1159266-37-1
- ChEMBL ID
- CHEMBL1743041
- FDA ingredient codes (UNII)
- YI437801BE
- L01FX09
- L01XC25
Sources for recorded values
- 2054068
- 2054077
- Applicant
- KYOWA KIRIN
- Approval date
- 8 Aug 2018
- Application number
- BLA761051
- Status
- Authorised
- Status date
- 22 Nov 2018
- Authorisation date
- 22 Nov 2018
- Approved indications
- Poteligeo is indicated for the treatment of adult patients with mycosis fungoides (MF) or Sézary syndrome (SS) who have received at least one prior systemic therapy.
- Product number
- EMEA/H/C/004232
- Authorisation holder
- Kyowa Kirin Holdings B.V.
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 0
- Biosimilar medicines
- 0
- Advanced therapy
- No
- Conditional approval
- No
- Additional monitoring
- No
- Accelerated assessment
- No
- Exceptional circumstances
- No
Therapeutic areas
- Mycosis Fungoides
- Sezary Syndrome
European medicines record
- Patents
- 0
- Designations
- 5
- Earliest recorded loss of exclusivity
- 26 Nov 2028
- First in class
- Yes
- Fast track
- No
- Breakthrough designation
- Yes
- Orphan designation
- Yes
- Priority review
- Yes
- Orphan exclusivity
- No
- Accelerated approval
- No
- Pharmacology name
- mogamulizumab
- Type
- Antibody
- Drug name stem
- -mab; -mab
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Parenteral
- Mechanism
- C-C chemokine receptor type 4 cross-linking agent
- Action type
- CROSS_LINKING_AGENT
- Target
- C-C chemokine receptor type 4
- Protein identifier
- P51679
- Action
- Inhibition
- Action type
- Inhibitor
- Target
- CCR4
- Gene symbol
- CCR4
- Protein identifier
- P51679
- Primary target
- Yes
Open Targets mechanisms
- Mechanism
- C-C chemokine receptor type 4 cross-linking agent
- Action type
- CROSS-LINKING AGENT
- Target
- C-C chemokine receptor type 4
- Condition
- Carcinoma, Hepatocellular
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000182
- Subject identifier
- D006528
- Condition
- Carcinoma
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000313
- Subject identifier
- D002277
- Condition
- Lymphoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000574
- Subject identifier
- D008223
- Condition
- Neoplasms
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000616
- Subject identifier
- D009369
- Condition
- Lymphoma, T-Cell, Cutaneous
- Highest recorded phase
- 3
- Condition identifier
- EFO:0002913
- Subject identifier
- D016410
- Condition
- Carcinoma, Non-Small-Cell Lung
- Highest recorded phase
- 1
- Condition identifier
- EFO:0003060
- Subject identifier
- D002289
- Condition
- Paraparesis, Tropical Spastic
- Highest recorded phase
- 3
- Condition identifier
- EFO:0007527
- Subject identifier
- D015493
- Condition
- Sezary Syndrome
- Highest recorded phase
- 4
- Condition identifier
- EFO:1000785
- Subject identifier
- D012751
- Condition
- Mycosis Fungoides
- Highest recorded phase
- 4
- Condition identifier
- EFO:1001051
- Subject identifier
- D009182
- Condition
- Lymphoma, T-Cell, Peripheral
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0000430
- Subject identifier
- D016411
- Condition
- Asthma
- Highest recorded phase
- 1
- Condition identifier
- MONDO:0004979
- Subject identifier
- D001249
- Condition
- Leukemia-Lymphoma, Adult T-Cell
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0019471
- Subject identifier
- D015459
- Condition identifier
- EFO_0000616
- Condition identifier
- EFO_0002913
- Highest recorded phase
- 3
- Condition identifier
- EFO_0003060
- Highest recorded phase
- 1
- Condition identifier
- EFO_0007527
- Highest recorded phase
- 3
- Condition identifier
- EFO_1000785
- Condition identifier
- EFO_1001051
- Condition identifier
- MONDO_0000430
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0000607
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0002367
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0004979
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0005070
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0005233
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0007576
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0008039
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0008903
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0009691
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0017844
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0018905
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0019471
- Condition identifier
- MONDO_0019471
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0023644
- Highest recorded phase
- 1
- Event
- autoimmune dermatitis
- Reports
- 2
- Reporting signal score
- 10.0395
- Event
- autoimmune hepatitis
- Reports
- 6
- Reporting signal score
- 11.8374
- Event
- chills
- Reports
- 19
- Reporting signal score
- 16.1712
- Event
- cutaneous t-cell lymphoma recurrent
- Reports
- 3
- Reporting signal score
- 19.7754
- Event
- cytomegalovirus viraemia
- Reports
- 6
- Reporting signal score
- 15.5655
- Event
- diffuse large b-cell lymphoma
- Reports
- 10
- Reporting signal score
- 28.046
- Event
- disease progression
- Reports
- 63
- Reporting signal score
- 125.111
- Event
- epstein-barr virus associated lymphoma
- Reports
- 5
- Reporting signal score
- 22.5003
- Event
- epstein-barr virus infection
- Reports
- 6
- Reporting signal score
- 12.9228
- Event
- erythema
- Reports
- 26
- Reporting signal score
- 21.667
- Event
- graft versus host disease
- Reports
- 10
- Reporting signal score
- 27.7642
- Event
- graft versus host disease in eye
- Reports
- 3
- Reporting signal score
- 14.2347
- Event
- graft versus host disease in gastrointestinal tract
- Reports
- 4
- Reporting signal score
- 11.8691
- Event
- graft versus host disease in skin
- Reports
- 6
- Reporting signal score
- 18.7163
- Event
- headache
- Reports
- 3
- Reporting signal score
- 8.90798
- Event
- hepatic cytolysis
- Reports
- 5
- Reporting signal score
- 12.3784
- Event
- infusion related reaction
- Reports
- 30
- Reporting signal score
- 47.9265
- Event
- lymphopenia
- Reports
- 14
- Reporting signal score
- 27.7501
- Event
- mycobacterium chelonae infection
- Reports
- 6
- Reporting signal score
- 26.5276
- Event
- peripheral t-cell lymphoma unspecified stage iii
- Reports
- 5
- Reporting signal score
- 37.7298
- Event
- pruritus
- Reports
- 28
- Reporting signal score
- 14.4792
- Event
- rash
- Reports
- 94
- Reporting signal score
- 105.611
- Event
- skin disorder
- Reports
- 12
- Reporting signal score
- 21.069
- Event
- skin lesion
- Reports
- 11
- Reporting signal score
- 16.8567
- Event
- suspected covid-19
- Reports
- 3
- Reporting signal score
- 8.92958
And 4 more, listed on the interactive page.
- NCT00888927
- NCT01611142
- NCT00920790
- NCT01173887
- NCT01626664
- NCT01514981
- NCT01728805
- NCT04128072
- NCT04745234
- NCT01929486
- NCT02281409
- NCT02301130
- NCT02444793
- NCT02476123
- NCT02358473
- NCT02705105
- NCT02867007
- NCT03191526
- NCT04256018
- NCT04541017
- NCT04676087
- NCT04930653
- NCT05414500
- NCT06235281
- NCT05996185
- Dose
- 1 mg/kg
- Route
- Intravenous
- How often
- Days 1, 8, 15, and 22 of the first 28-day cycle, then days 1 and 15 of subsequent cycles
- Administer over at least 60 minutes
- Do not administer subcutaneously or by rapid IV infusion
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
- Component
- Heavy chain
- Type
- Protein
- Sequence
- QAQVVESGGGVVQSGRSLRLSCAASGFAFSSYGMHWVRQAPGKGLEWVAVIWYDGSNKYYADSVRGRFTISRDNSENTLYLQMNSLRAEDTAVYYCARDHYGSGVHHYFYYGLDVWGQGTTVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKRVEPKSCDKTHTCPPCPAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK
- Component
- Light chain
- Type
- Protein
- Sequence
- EIVLTQSPGTLSLSPGERATLSCRASQSVSSSYLAWYQQKPGQAPRLLIYGASSRATGIPDRFSGSGSGTDFTLTISRLEPEDFAVYYCQQYGSSPLTFGGGTKVEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
- 42747-761
Related records
Trials (38)
- A Study of KW-0761 in Subjects With HTLV-1 Associated Myelopathy (HAM)
- A Study of Mogamulizumab to Prevent Adult T-cell Leukemia/Lymphoma in People With HTLV-1
- A Study of PF-05082566 In Combination With Mogamulizumab In Patients With Advanced Solid Tumors
- A Study of VG712 in Patients With Mycosis Fungoides
- A Study to Evaluate the Efficacy and Safety of KW-0761 in Chinese Subjects With Mycosis Fungoides or Sézary Syndrome Previously Treated With Systemic Therapy
- AMG 761 in Adults With Asthma
- Anti-CCR4 Monoclonal Antibody (Mogamulizumab) and Total Skin Electron Beam Therapy (TSEB) in Patients With Stage IB-IIB Cutaneous T-Cell Lymphoma
- Assessment of Safety and Efficacy of Poteligeo Inj. 20 mg (Mogamulizumab) Through Use-result Surveillance
- Extension Study in Subjects Who Relapsed After Complete Response on Study KW-0761-001
- Extracorporeal Photopheresis and Mogamulizumab for the Treatment of Erythrodermic Cutaneous T Cell Lymphoma
- KHK2455 Alone and in Combination With Mogamulizumab in Subjects With Locally Advanced or Metastatic Solid Tumors
- KW-0761 or Investigator's Choice in Subjects With Previously Treated Adult T-cell Leukemia-Lymphoma (ATL)
- Mogamulizumab + Low-Dose Total Skin Electron Beam Tx in Mycosis Fungoides & Sézary Syndrome
- Mogamulizumab and Brentuximab Vedotin in CTCL and Mycosis Fungoides
- Mogamulizumab and Extracorporeal Photopheresis for the Treatment of Sezary Syndrome or Mycosis Fungoides
- Mogamulizumab and Pembrolizumab in Treating Patients With Relapsed or Refractory Diffuse Large B Cell Lymphoma
- Mogamulizumab Q4week Dosing in Participants With R/R CTCL
- Multicenter, Randomized, Open-label, Parallel-group Study to Compare mLSG15 + KW-0761 to mLSG15
- Pembrolizumab and Mogamulizumab in Advanced-stage, Relapsed/Refractory Cutaneous T-cell Lymphomas
- Phase I Study of KW-0761 in Relapsed Patients With CCR4-Positive ATL and PTCL
Approved for (3)
- Mycosis fungoides
- Neoplasm
- Sezary syndrome
In development for (9)
- Adult T-cell leukemia/lymphoma Phase 2
- Asthma Phase 1
- Carcinoma Phase 1
- Hepatocellular carcinoma Phase 1
- Lymphoma Phase 2
- Mature T-cell and NK-cell non-Hodgkin lymphoma Phase 2
- Non-small cell lung carcinoma Phase 1
- Primary cutaneous T-cell non-Hodgkin lymphoma Phase 3
- Tropical spastic paraparesis Phase 3
Targets (1)
- CCR4 C-C chemokine receptor type 4 cross-linking agent