Disitamab vedotin
Highest phase reached
Phase 3
Drug type
Antibody drug conjugate
- Listing at source
- Listed
- Highest phase reached
- Phase 3
- Drug type
- Antibody drug conjugate
- Drug name
- Disitamab vedotin
- disitamab vedotin
- Disitamab vedotin
- Disitamab Vedotin
- disitamab vedotin [INN]
- DISITAMAB VEDOTIN [USAN]
- Disitamab Vedotin [WHO-DD]
- Disitamab Vedotin for injection
- Disitamab Vedotin for Injection
- Disitamab Vedotin Injection
- disitamab vedotin inn
- disitamab vedotin usan
- disitamab vedotin who dd
- Drug: Disitamab Vedotin
- immunoglobulin g1 anti human tyrosine kinase receptor erbb2 human mus musculus monoclonal rc48 270a4023 γ1 chain disulfide with human mus musculus monoclonal rc48 270a4023 κ chain dimer thioether with n 4 n 6 3 mercapto 2 5 dioxo 1 pyrrolidinyl 1 oxohexyl l valyl n5 aminocarbonyl l ornithyl amino phenyl methoxy carbonyl n methyl l valyl n 1s 2r 4 2s 2 1r 2r 3 1r 2s 2 hydroxy 1 methyl 2 phenylethyl amino 1 methoxy 2 methyl 3 oxopropyl 1 pyrrolidinyl 2 methoxy 1 1s 1 methylpropyl 4 oxobutyl n methyl l valinamide
- immunoglobulin g1 kappa anti homo sapiens erbb2 epidermal growth factor receptor 2 receptor tyrosine protein kinase erbb 2 egfr2 her2 her 2 p185c erbb2 neu cd340 humanized monoclonal antibody conjugated to auristatin e gamma1 heavy chain humanized 1 445 vh homo sapiens ighv1 69 2 01 83 5 ighd ighj1 01 92 9 8 8 8 1 115 homo sapiens ighg1 03v g1m3 g1m17 ng1m1 ch1 r120 k 212 116 213 hinge 214 228 ch2 229 338 ch3 e12 354 m14 357 339 443 chs 444 445 116 445 218 212 disulfide with kappa light chain humanized 1 212 v kappa homo sapiens igkv1 39 01 83 3 igkj4 01 100 6 3 7 1 105 homo sapiens igkc 01 100 km3 a45 1 151 v101 189 106 212 dimer 224 224 227 227 bisdisulfide conjugated on an average of 4 cysteinyl to monomethylauristatin e mmae via a cleavable maleimidocaproyl valyl citrullinyl paminobenzyloxycarbonyl mc val cit pabc type linker
- Immunoglobulin G1-kappa, anti-[Homo sapiens ERBB2 (epidermal growth factor receptor 2, receptor tyrosine-protein kinase erbB-2, EGFR2, HER2, HER-2, p185c-erbB2, NEU, CD340)], humanized monoclonal antibody conjugated to auristatin E; gamma1 heavy chain humanized (1-445) [VH (Homo sapiens IGHV1-69-2*01 (83.5%) -(IGHD) -IGHJ1*01 (92.9%)) [8.8.8] (1-115) -Homo sapiens IGHG1*03v, G1m3>G1m17, nG1m1 (CH1 R120>K (212) (116-213), hinge (214-228), CH2 (229-338), CH3 E12 (354), M14 (357) (339-443), CHS (444-445)) (116-445)] (218-212')-disulfide with kappa light chain humanized (1'-212') [V-KAPPA (Homo sapiens IGKV1-39*01 (83.3%) -IGKJ4*01 (100%))[6.3.7] (1'-105') -Homo sapiens IGKC*01 (100%) Km3 A45.1 (151), V101 (189) (106'-212')]; dimer (224-224'':227-227'')-bisdisulfide; conjugated on an average of 4 cysteinyl to monomethylauristatin E (MMAE), via a cleavable maleimidocaproyl-valyl-citrullinyl-paminobenzyloxycarbonyl (mc-val-cit-PABC) type linker
- Immunoglobulin G1, anti-(human tyrosine kinase receptor ErbB2) (human-Mus musculus monoclonal RC48-270A4023 γ1-chain), disulfide with human-Mus musculus monoclonal RC48-270A4023 κ-chain, dimer, thioether with N-[[[4-[[N-[6-(3-mercapto-2,5-dioxo-1-pyrrolidinyl)-1-oxohexyl]-L-valyl-N5-(aminocarbonyl)-L-ornithyl]amino]phenyl]methoxy]carbonyl]-N-methyl-L-valyl-N-[(1S,2R)-4-[(2S)-2-[(1R,2R)-3-[[(1R,2S)-2-hydroxy-1-methyl-2-phenylethyl]amino]-1-methoxy-2-methyl-3-oxopropyl]-1-pyrrolidinyl]-2-methoxy-1-[(1S)-1-methylpropyl]-4-oxobutyl]-N-methyl-L-valinamide
- r48 adc
- R48-ADC
- rc48 adc
- RC48- ADC
- RC48-ADC
- CAS registry numbers
- 2136633-23-1
- ChEMBL ID
- CHEMBL5095273
- FDA ingredient codes (UNII)
- RB3U3A1S27
- Patents
- 0
- Designations
- 1
- First in class
- No
- Fast track
- No
- Breakthrough designation
- No
- Orphan designation
- No
- Priority review
- No
- Orphan exclusivity
- No
- Accelerated approval
- No
- Pharmacology name
- disitamab vedotin
- Type
- Antibody
- Drug name stem
- -dotin; -mab
- Approval recorded by Guide to Pharmacology
- Yes
- Mechanism
- Receptor tyrosine-protein kinase erbB-2 binding agent
- Action type
- BINDING_AGENT
- Target
- Receptor tyrosine-protein kinase erbB-2
- Protein identifier
- P04626
- Mechanism
- Tubulin disrupting agent
- Action type
- DISRUPTING_AGENT
- Target
- Tubulin
- Protein identifier
- P04350
- Mechanism
- Tubulin disrupting agent
- Action type
- DISRUPTING_AGENT
- Target
- Tubulin
- Protein identifier
- P07437
- Mechanism
- Tubulin disrupting agent
- Action type
- DISRUPTING_AGENT
- Target
- Tubulin
- Protein identifier
- P0DPH7
- Mechanism
- Tubulin disrupting agent
- Action type
- DISRUPTING_AGENT
- Target
- Tubulin
- Protein identifier
- P68363
- Mechanism
- Tubulin disrupting agent
- Action type
- DISRUPTING_AGENT
- Target
- Tubulin
- Protein identifier
- P68366
- Mechanism
- Tubulin disrupting agent
- Action type
- DISRUPTING_AGENT
- Target
- Tubulin
- Protein identifier
- P68371
- Mechanism
- Tubulin disrupting agent
- Action type
- DISRUPTING_AGENT
- Target
- Tubulin
- Protein identifier
- Q13509
- Mechanism
- Tubulin disrupting agent
- Action type
- DISRUPTING_AGENT
- Target
- Tubulin
- Protein identifier
- Q13885
- Mechanism
- Tubulin disrupting agent
- Action type
- DISRUPTING_AGENT
- Target
- Tubulin
- Protein identifier
- Q3ZCM7
- Mechanism
- Tubulin disrupting agent
- Action type
- DISRUPTING_AGENT
- Target
- Tubulin
- Protein identifier
- Q6PEY2
- Mechanism
- Tubulin disrupting agent
- Action type
- DISRUPTING_AGENT
- Target
- Tubulin
- Protein identifier
- Q71U36
- Mechanism
- Tubulin disrupting agent
- Action type
- DISRUPTING_AGENT
- Target
- Tubulin
- Protein identifier
- Q9BQE3
- Mechanism
- Tubulin disrupting agent
- Action type
- DISRUPTING_AGENT
- Target
- Tubulin
- Protein identifier
- Q9BUF5
- Mechanism
- Tubulin disrupting agent
- Action type
- DISRUPTING_AGENT
- Target
- Tubulin
- Protein identifier
- Q9BVA1
- Mechanism
- Tubulin disrupting agent
- Action type
- DISRUPTING_AGENT
- Target
- Tubulin
- Protein identifier
- Q9H4B7
- Action
- Inhibition
- Action type
- Inhibitor
- Target
- erb-b2 receptor tyrosine kinase 2
- Gene symbol
- ERBB2
- Protein identifier
- P04626
- Primary target
- Yes
- Mechanism
- Receptor tyrosine-protein kinase erbB-2 binding agent
- Action type
- BINDING AGENT
- Target
- Receptor tyrosine-protein kinase erbB-2
- Mechanism
- Tubulin disrupting agent
- Action type
- DISRUPTING AGENT
- Target
- Tubulin
- Condition
- Neoplasms
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000616
- Subject identifier
- D009369
- Condition
- Pancreatic Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0002618
- Subject identifier
- D010190
- Condition
- Breast Neoplasms
- Highest recorded phase
- 3
- Condition identifier
- EFO:0003869
- Subject identifier
- D001943
- Condition
- Colorectal Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0004142
- Subject identifier
- D015179
- Condition
- Urinary Bladder Neoplasms
- Highest recorded phase
- 3
- Condition identifier
- EFO:0008528
- Subject identifier
- D001749
- Condition
- Stomach Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0001056
- Subject identifier
- D013274
- Condition
- Urinary Bladder Neoplasms
- Highest recorded phase
- 3
- Condition identifier
- MONDO:0001187
- Subject identifier
- D001749
- Condition
- Uterine Cervical Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0002974
- Subject identifier
- D002583
- Condition
- Colorectal Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0005575
- Subject identifier
- D015179
- Condition
- Breast Neoplasms
- Highest recorded phase
- 3
- Condition identifier
- MONDO:0007254
- Subject identifier
- D001943
- Condition
- Prostatic Neoplasms, Castration-Resistant
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0008315
- Subject identifier
- D064129
- Condition identifier
- EFO_0000616
- Highest recorded phase
- 1
- Condition identifier
- EFO_0002618
- Highest recorded phase
- 2
- Condition identifier
- EFO_0003869
- Condition identifier
- EFO_0004142
- Highest recorded phase
- 2
- Condition identifier
- EFO_0008528
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0000521
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0000548
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0001056
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0001187
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0001402
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0001528
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0002158
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0002447
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0002974
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0003060
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0003193
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0003219
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0004986
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0004992
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0005036
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0005070
- Condition identifier
- MONDO_0005105
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0005140
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0005192
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0005233
- Highest recorded phase
- 2
And 16 more, listed on the interactive page.
Reported adverse events
- Event
- metastasis
- Reports
- 2
- Reporting signal score
- 13.0536
- NCT04879329
- NCT05911295
- NCT05912205
- NCT06210490
- NCT05113459
- NCT05586061
- NCT05627414
- NCT05720533
- NCT05928897
- NCT05982834
- NCT05333809
- NCT05493683
- NCT05578287
- NCT05726175
- NCT05904964
- NCT06000033
- NCT06178159
- NCT06278870
- NCT06389006
- NCT05940896
- NCT06105008
- NCT06155396
- NCT06187506
- NCT06378242
- NCT06227156
And 1 more, listed on the interactive page.
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
- Component
- Heavy chain
- Type
- Protein
- Sequence
- EVQLVQSGAEVKKPGATVKISCKVSGYTFTDYYIHWVQQAPGKGLEWMGRVNPDHGDSYYNQKFKDKATITADKSTDTAYMELSSLRSEDTAVYFCARNYLFDHWGQGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELLGGPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSREEMTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK
- Component
- Glycosylation sites (N)
- Sequence
- 295 $ 295''
- Component
- Disulfide bridges
- Sequence
- 22-96 $ 22''-96'' $ 23'-88' $ 23'''-88''' $ 132'-191' $ 132'''-192''' $ 142-198 $ 142''-198'' $ 218-212' $ 218'''-212''' $ 224-224' $ 227-227' $ 259-319 $ 259''-319'' $ 4365-423 $ 365''-423''
- Component
- Light chain
- Type
- Protein
- Sequence
- DIQMTQSPSSVSASVGDRVTITCKASQDVGTAVAWYQQKPGKAPKLLIYWASIRHTGVPSRFSGSGSGTDFTLTISSLQPEDFATYYCHQFATYTFGGGTKVEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
Related records
Trials (120)
- A Clinical Study Evaluating the Efficacy and Safety of Disitamab Vedotin Combined With PD-1 Inhibitor and Radiotherapy as Bladder-preserving Therapy in Patients With Localized HER2-high Expressing Muscle-invasive Bladder Urothelial Carcinoma Following Maximal Transurethral Resection
- A Clinical Study of Disitamab Vedotin for Injection Combined With Penpulimab Injection in Neoadjuvant Therapy for Patients With HER2-expressing Cisplatin-intolerant cT2-T4aNxM0 Bladder Urothelial Carcinoma
- A Clinical Study of RC48-ADC Combined With Triplizumab For Treatment of Myometrial Invasive Bladder Cancer
- A Clinical Study of the Efficacy and Safety of Disitamab Vedotin in Combination With Radiotherapy for the Adjuvant Treatment of HER2 Overexpressing UTUC Patients With High Risk Factors for Recurrence After Radical Surgery
- A Open-label, Single-arm, Multicenter, Phase II Study of RC48-ADC to Evaluate the Efficacy and Safety of Subjects With HER2 Overexpressing Locally Advanced or Metastatic Urothelial Cancer
- A Phase II Study of RC48-ADC in Subjects With HER2 Positive Metastatic or Unresectable Urothelial Cancer
- A Phase II Study of Toripalimab Plus RC48-ADC With Radiotherapy for Bladder Preservation in HER2-Positive Muscle-Invasive Bladder Cancer
- A Single-Arm Study of Sintilimab and Disitamab Vedotin for Locally Advanced Eyelid Sebaceous Gland Carcinoma
- A Study of Disitamab Vedotin + Bicalutamide in HER2/AR-Positive Scrotal Paget's Disease
- A Study of Disitamab Vedotin Alone or With Pembrolizumab in Urothelial Cancer That Expresses HER2
- A Study of Disitamab Vedotin Combined With Tislelizumab and Chemotherapy Versus Tislelizumab Combined With Chemotherapy in HER2-Low Advanced Gastric or Gastroesophageal Junction Adenocarcinoma
- A Study of Disitamab Vedotin Combined With Trastuzumab and Tislelizumab Versus Chemotherapy Combined With Trastuzumab With or Without Pembrolizumab in HER2-high Expression Advanced Gastric or Gastroesophageal Junction Adenocarcinoma.
- A Study of Disitamab Vedotin in Adults With HER2 Expressing Advanced Breast Cancer
- A Study of Disitamab Vedotin in Previously Treated Solid Tumors That Express HER2
- A Study of Disitamab Vedotin With Other Anticancer Drugs in Solid Tumors
- A Study of RC48-ADC Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer With or Without Liver Metastases
- A Study of RC48-ADC Combination Therapies as First-line Treatment in Advanced Metastatic Gastric Cancer
- A Study of RC48-ADC Combination With Zimberelimab Injection Therapies at Least First-line Platinum-containing Standard Therapy Failed With Recurrent or Metastatic Cervical Cancer
- A Study of RC48-ADC Combined With AK104 For Perioperative Treatment of Muscle-Invasive Bladder Cancer
- A Study of RC48-ADC Combined With Cadonilimab（AK104）in the Treatment of HER2-expression Locally Advanced or Metastatic Urothelial Carcinoma
In development for (12)
- Breast cancer Phase 3
- Breast neoplasm Phase 3
- Cervical cancer Phase 2
- Colorectal cancer Phase 2
- Colorectal neoplasm Phase 2
- Exocrine pancreatic carcinoma Phase 2
- Gastric cancer Phase 2
- Neoplasm Phase 1
- Ovarian cancer Phase 2
- Prostate cancer Phase 2
- Urinary bladder cancer Phase 3
- Urothelial carcinoma Phase 3
Targets (16)
- ERBB2 Receptor tyrosine-protein kinase erbB-2 binding agent
- TUBA1A Tubulin disrupting agent
- TUBA1B Tubulin disrupting agent
- TUBA1C Tubulin disrupting agent
- TUBA3C Tubulin disrupting agent
- TUBA3E Tubulin disrupting agent
- TUBA4A Tubulin disrupting agent
- TUBB Tubulin disrupting agent
- TUBB1 Tubulin disrupting agent
- TUBB2A Tubulin disrupting agent
- TUBB2B Tubulin disrupting agent
- TUBB3 Tubulin disrupting agent
- TUBB4A Tubulin disrupting agent
- TUBB4B Tubulin disrupting agent
- TUBB6 Tubulin disrupting agent
- TUBB8 Tubulin disrupting agent