Vedolizumab
Highest phase reached
Approved
Drug type
Antibody
First approval year
2014
- First approval year
- 2014
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Antibody
- Drug name
- Vedolizumab
- entyvio
- Entyvio
- adalimumab infliximab ustekinumab golimumab and vedolizumab
- Entyvio (Vedolizumab)
- immunoglobulin g1 anti human integrin lpam 1 lymphocyte peyer s patch adhesion molecule 1 human mus musculus heavy chain disulfide with human mus musculus kappa chain dimer
- IMMUNOGLOBULIN G1, ANTI-(HUMAN INTEGRIN LPAM-1 (LYMPHOCYTE PEYER'S PATCH ADHESION MOLECULE 1)) (HUMAN-MUS MUSCULUS HEAVY CHAIN), DISULFIDE WITH HUMAN-MUS MUSCULUS .KAPPA.-CHAIN, DIMER
- ldp 02
- LDP-02
- ldp02
- LDP02
- mln 0002
- mln 02
- MLN-0002
- MLN-02
- mln0002
- MLN0002
- mln02
- MLN02
- Subcutaneous vedolizumab
- vedolizumab
- Vedolizumab
- VEDOLIZUMAB
- Vedolizumab (brand name Entyvio)
- Vedolizumab (VDZ)
- vedolizumab [INN]
- VEDOLIZUMAB [JAN]
- VEDOLIZUMAB [MART.]
And 20 more, listed on the interactive page.
- ATC classification codes
- L04AG05
Sources for recorded values
- CAS registry numbers
- 943609-66-3
- ChEMBL ID
- CHEMBL1743087
- RxNorm IDs (RxCUI)
- 1538097
- FDA ingredient codes (UNII)
- 9RV78Q2002
- Applicant
- TAKEDA PHARMS USA
- Approval date
- 20 May 2014
- Application number
- BLA125476
- Status
- Authorised
- Status date
- 22 May 2014
- Authorisation date
- 22 May 2014
- Approved indications
- Ulcerative colitis Entyvio is indicated for the treatment of adult patients with moderately to severely active ulcerative colitis who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor alpha (TNF?) antagonist. Crohn’s disease Entyvio is indicated for the treatment of adult patients with moderately to severely active Crohn’s disease who have had an inadequate response with, lost response to, or were intolerant to either conventional therapy or a tumour necrosis factor alpha (TNF?) antagonist. Pouchitis Entyvio is indicated for the treatment of adult patients with moderately to severely active chronic pouchitis, who have undergone proctocolectomy and ileal pouch anal anastomosis for ulcerative colitis, and have had an inadequate response with or lost response to antibiotic therapy.
- Product number
- EMEA/H/C/002782
- Authorisation holder
- Takeda Pharma A/S
- 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
- Colitis, Ulcerative
- Crohn Disease
European medicines record
- Patents
- 0
- Designations
- 4
- First in class
- Yes
- Fast track
- Yes
- Breakthrough designation
- No
- Orphan designation
- No
- Priority review
- Yes
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Prescription only
- Pharmacology name
- vedolizumab
- Type
- Antibody
- Drug name stem
- -mab; -mab
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Parenteral
- Action
- Antagonist
- Action type
- Antagonist
- Target
- integrin α4β7
- Gene symbol
- ITGA4
- Protein identifier
- P13612
- Median affinity
- 8.27
- Affinity units
- pIC50
- Primary target
- Yes
- Action
- Antagonist
- Action type
- Antagonist
- Target
- integrin α4β7
- Gene symbol
- ITGB7
- Protein identifier
- P26010
- Median affinity
- 8.27
- Affinity units
- pIC50
- Primary target
- Yes
- Mechanism
- Integrin alpha-4/beta-7 inhibitor
- Action type
- Inhibitor
- Target
- Integrin alpha-4/beta-7
- Protein identifier
- P13612
- Mechanism
- Integrin alpha-4/beta-7 inhibitor
- Action type
- Inhibitor
- Target
- Integrin alpha-4/beta-7
- Protein identifier
- P26010
Open Targets mechanisms
- Mechanism
- Integrin alpha-4/beta-7 inhibitor
- Action type
- Inhibitor
- Target
- Integrin alpha-4/beta-7
- Condition
- HIV Infections
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000180
- Subject identifier
- D015658
- Condition
- Crohn Disease
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000384
- Subject identifier
- D003424
- Condition
- Infections
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000544
- Subject identifier
- D007239
- Condition
- Colitis, Ulcerative
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000729
- Subject identifier
- D003093
- Condition
- Melanoma
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000756
- Subject identifier
- D008545
- Condition
- HIV Infections
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000764
- Subject identifier
- D015658
- Condition
- Celiac Disease
- Highest recorded phase
- 2
- Condition identifier
- EFO:0001060
- Subject identifier
- D002446
- Condition
- Inflammatory Bowel Diseases
- Highest recorded phase
- 1
- Condition identifier
- EFO:0003767
- Subject identifier
- D015212
- Condition
- Colitis
- Highest recorded phase
- 2
- Condition identifier
- EFO:0003872
- Subject identifier
- D003092
- Condition
- Pouchitis
- Highest recorded phase
- 3
- Condition identifier
- EFO:0003921
- Subject identifier
- D019449
- Condition
- Salivary Gland Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0000521
- Subject identifier
- D012468
- Condition
- Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- MONDO:0004992
- Subject identifier
- D009369
- Condition
- Diabetes Mellitus, Type 1
- Highest recorded phase
- 0.5
- Condition identifier
- MONDO:0005147
- Subject identifier
- D003922
- Condition identifier
- EFO_0000180
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000384
- Condition identifier
- EFO_0000544
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000729
- Condition identifier
- EFO_0000756
- Highest recorded phase
- 1
- Condition identifier
- EFO_0000764
- Condition identifier
- EFO_0001060
- Highest recorded phase
- 2
- Condition identifier
- EFO_0003767
- Highest recorded phase
- 1
- Condition identifier
- EFO_0003921
- Highest recorded phase
- 3
- Condition identifier
- HP_0002014
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0004992
- Condition identifier
- MONDO_0005011
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0005101
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0005105
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0005147
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0005265
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0005292
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0005312
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0013730
- Highest recorded phase
- 2
- Condition identifier
- MONDO_0018646
- Highest recorded phase
- 3
- Condition identifier
- MONDO_0020546
- Highest recorded phase
- 2
- Event
- abdominal pain
- Reports
- 671
- Reporting signal score
- 378.576
- Event
- anal abscess
- Reports
- 150
- Reporting signal score
- 360.694
- Event
- anal fistula
- Reports
- 95
- Reporting signal score
- 209.247
- Event
- clostridium difficile infection
- Reports
- 234
- Reporting signal score
- 409.98
- Event
- colectomy
- Reports
- 145
- Reporting signal score
- 406.462
- Event
- colitis
- Reports
- 189
- Reporting signal score
- 179.158
- Event
- colitis ulcerative
- Reports
- 1,666
- Reporting signal score
- 5,674.09
- Event
- crohn's disease
- Reports
- 1,409
- Reporting signal score
- 3,605.65
- Event
- defaecation urgency
- Reports
- 86
- Reporting signal score
- 219.496
- Event
- diarrhoea haemorrhagic
- Reports
- 118
- Reporting signal score
- 206.205
- Event
- faecal calprotectin increased
- Reports
- 189
- Reporting signal score
- 653.446
- Event
- frequent bowel movements
- Reports
- 351
- Reporting signal score
- 840.274
- Event
- haematochezia
- Reports
- 401
- Reporting signal score
- 600.734
- Event
- intestinal obstruction
- Reports
- 201
- Reporting signal score
- 248.256
- Event
- loss of therapeutic response
- Reports
- 83
- Reporting signal score
- 305.214
- Event
- mucous stools
- Reports
- 105
- Reporting signal score
- 291.297
- Event
- poor venous access
- Reports
- 157
- Reporting signal score
- 370.899
- Event
- pregnancy
- Reports
- 432
- Reporting signal score
- 818.76
- Event
- rectal haemorrhage
- Reports
- 205
- Reporting signal score
- 201.353
- Event
- therapeutic reaction time decreased
- Reports
- 284
- Reporting signal score
- 1,401.57
- NCT00619489
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And 43 more, listed on the interactive page.
- Dose
- 300 mg
- Route
- Intravenous
- How often
- Every 8 weeks after initial doses
- Administer by a healthcare provider
- Infuse over approximately 30 minutes
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
- Component
- Heavy chain
- Type
- Protein
- Sequence
- QVQLVQSGAEVKKPGASVKVSCKGSGYTFTSYWMHWVRQAPGQRLEWIGEIDPSESNTNYNQKFKGRVTLTVDISASTAYMELSSLRSEDTAVYYCARGGYDGWDYAIDYWGQGTLVTVSSASTKGPSVFPLAPSSKSTSGGTAALGCLVKDYFPEPVTVSWNSGALTSGVHTFPAVLQSSGLYSLSSVVTVPSSSLGTQTYICNVNHKPSNTKVDKKVEPKSCDKTHTCPPCPAPELAGAPSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSRDELTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK
- Component
- Light chain
- Type
- Protein
- Sequence
- DVVMTQSPLSLPVTPGEPASISCRSSQSLAKSYGNTYLSWYLQKPGQSPQLLIYGISNRFSGVPDRFSGSGSGTDFTLKISRVEAEDVGVYYCLQGTHQPYTFGQGTKVEIKRTVAAPSVFIFPPSDEQLKSGTASVVCLLNNFYPREAKVQWKVDNALQSGNSQESVTEQDSKDSTYSLSSTLTLSKADYEKHKVYACEVTHQGLSSPVTKSFNRGEC
- 64764-107
- 64764-108
- 64764-300
Related records
Trials (132)
- A Dose-Finding Study of Vedolizumab for Treatment of Steroid-Refractory Acute Intestinal Graft-Versus-Host Disease (GvHD) in Participants Who Have Undergone Allogeneic Hematopoietic Stem Cell Transplantation (Allo-HSCT)
- A HIV Vaccine Trial in Individuals Who Started Antiretrovirals During Primary or Chronic Infection (EHVA T02)
- A Long-Term Extension Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis (UC) or Crohn's Disease (CD)
- A Multicentered Prospective Cohort Study of Chinese IBD Patients
- A Pilot Study to Compare the Pharmacokinetics (PK) of Single Subcutaneous (SC) Injections of Vedolizumab Administered in Prefilled Syringe (PFS) Versus (vs) Prefilled Syringe in Autoinjector (PFS+AI) in Healthy Participants
- A Pilot Study to Compare the Pharmacokinetics (PK) of Single Subcutaneous (SC) Injections of Vedolizumab Administered in Prefilled Syringe (PFS) Versus (vs) Prefilled Syringe in Needle Safety Device (PFS+NSD) in Healthy Participants
- A Study of Intravenous Vedolizumab Administered Every 4 Weeks in Japanese Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease
- A Study of Long-term Effects of Vedolizumab Subcutaneous in Adults With Ulcerative Colitis and Crohn's Disease
- A Study of Mirikizumab (LY3074828) in Participants With Ulcerative Colitis
- A Study of Vedolizumab in Adult Participants With Moderate to Severe Crohn's Disease
- A Study of Vedolizumab in Adults With Ulcerative Colitis or Crohn's Disease in the Community Setting
- A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Crohn's Disease (CD)
- A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Ulcerative Colitis (UC)
- A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease
- A Study of Vedolizumab in Children With Ulcerative Colitis (UC) or Crohn's Disease (CD)
- A Study of Vedolizumab in People With Ulcerative Colitis and Crohn's Disease
- A Study of Vedolizumab Intravenous (IV) and Adalimumab or Vedolizumab and Ustekinumab in Adults With Crohn's Disease
- A Study of Vedolizumab With and Without Upadacitinib in Adults With Crohn's Disease
- A Study of Vedolizumab With Tofacitinib in Adults With Ulcerative Colitis (UC)
- A Study to Assess the Change in Disease Activity in Adult Participants With Moderate to Severe Ulcerative Colitis Treated With Risankizumab Compared to Vedolizumab
Approved for (2)
In development for (9)
- Cancer Phase 2
- Celiac disease Phase 2
- Colitis Phase 2
- HIV infectious disease Phase 2
- Inflammatory bowel disease Phase 1
- Melanoma Phase 1
- Pouchitis Phase 3
- Salivary gland carcinoma Phase 2
- Type 1 diabetes mellitus Early phase 1