Belatacept

Highest phase reached
Approved
www.ebi.ac.uk
Drug type
Protein
www.ebi.ac.uk
First approval year
2011
www.ebi.ac.uk

First approval year
2011
www.ebi.ac.uk
Listing at source
Listed
Highest phase reached
Approved
www.ebi.ac.uk

Drug type
Protein
www.ebi.ac.uk
Drug name
Belatacept
www.ebi.ac.uk

  • nujolix
  • Nujolix
  • nulojix
  • Nulojix

  • belatacept
  • Belatacept
  • BELATACEPT [EMA EPAR]
  • belatacept [INN]
  • BELATACEPT [MART.]
  • BELATACEPT [MI]
  • BELATACEPT [PURPLE BOOK CDER]
  • BELATACEPT [USAN]
  • BELATACEPT [VANDF]
  • Belatacept [WHO-DD]
  • belatacept ema epar
  • Belatacept Injection
  • belatacept inn
  • belatacept mart
  • belatacept mi
  • Belatacept MI (more intensive)
  • belatacept purple book cder
  • belatacept usan
  • belatacept vandf
  • belatacept who dd
  • bms 224818
  • BMS-224818
  • ctla 4 antigen 29 tyrosine 104 glutamic acid human extracellular domain containing fragment fusion protein with immunoglobulin g1 human monoclonal fc domain containing fragment bimol 120 120 disulfide
  • CTLA-4 (ANTIGEN) (29-TYROSINE,104-GLUTAMIC ACID) (HUMAN EXTRACELLULAR DOMAIN-CONTAINING FRAGMENT) FUSION PROTEIN WITH IMMUNOGLOBULIN G1 (HUMAN MONOCLONAL FC DOMAIN-CONTAINING FRAGMENT), BIMOL. (120->120')-DISULFIDE
  • lea29y

And 3 more, listed on the interactive page.

ATC classification codes
  • L04AA28
Sources for recorded values
www.ebi.ac.uk
CAS registry numbers
  • 706808-37-9
ChEMBL ID
CHEMBL1742990
www.ebi.ac.uk
RxNorm IDs (RxCUI)
  • 1112973
FDA ingredient codes (UNII)
  • E3B2GI648A

Applicant
BRISTOL MYERS SQUIBB
Approval date
15 Jun 2011
Application number
BLA125288

Status
Authorised
Status date
17 Jun 2011
Authorisation date
17 Jun 2011
Approved indications
Nulojix, in combination with corticosteroids and a mycophenolic acid (MPA), is indicated for prophylaxis of graft rejection in adult recipients of a renal transplant.
Product number
EMEA/H/C/002098
Authorisation holder
Bristol-Myers Squibb Pharma EEIG
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

  • Graft Rejection
  • Kidney Transplantation
European medicines record
www.ema.europa.eu

Patents
0
Designations
2
Earliest recorded loss of exclusivity
15 Jun 2018
First in class
Yes
Fast track
Yes
Breakthrough designation
No
Orphan designation
No
Priority review
No
Orphan exclusivity
No
Accelerated approval
No
Availability
Prescription only
Boxed warning
Yes

Pharmacology name
belatacept
Type
Peptide
Drug name stem
-cept
Approval recorded by Guide to Pharmacology
Yes

Administration routes

  • Parenteral

  • Action
    Inhibition
    Action type
    Inhibitor
    Target
    CD80
    Gene symbol
    CD80
    Protein identifier
    P33681
    Primary target
    Yes
  • Action
    Inhibition
    Action type
    Inhibitor
    Target
    CD86
    Gene symbol
    CD86
    Protein identifier
    P42081
    Primary target
    Yes
  • Mechanism
    T-lymphocyte activation antigen CD80 inhibitor
    Action type
    Inhibitor
    Target
    T-lymphocyte activation antigen CD80
    Protein identifier
    P33681
  • Mechanism
    T-lymphocyte activation antigen CD86 inhibitor
    Action type
    Inhibitor
    Target
    T-lymphocyte activation antigen CD86
    Protein identifier
    P42081

  • Mechanism
    T-lymphocyte activation antigen CD80 inhibitor
    Action type
    Inhibitor
    Target
    T-lymphocyte activation antigen CD80
  • Mechanism
    T-lymphocyte activation antigen CD86 inhibitor
    Action type
    Inhibitor
    Target
    T-lymphocyte activation antigen CD86

  • Condition
    Delayed Graft Function
    Highest recorded phase
    4
    Subject identifier
    D051799
  • Condition
    Immune System Diseases
    Highest recorded phase
    4
    Condition identifier
    EFO:0000540
    Subject identifier
    D007154
  • Condition
    Arthritis, Rheumatoid
    Highest recorded phase
    1
    Condition identifier
    EFO:0000685
    Subject identifier
    D001172
  • Condition
    Renal Insufficiency, Chronic
    Highest recorded phase
    1
    Condition identifier
    EFO:0003884
    Subject identifier
    D051436
  • Condition
    Graft vs Host Disease
    Highest recorded phase
    3
    Condition identifier
    EFO:0004599
    Subject identifier
    D006086
  • Condition
    Kidney Transplantation
    Highest recorded phase
    4
    Condition identifier
    EFO:0010134
    Subject identifier
    D016030
  • Condition
    Proteinuria
    Highest recorded phase
    2
    Condition identifier
    HP:0000093
    Subject identifier
    D011507
  • Condition
    Diabetes Mellitus, Type 1
    Highest recorded phase
    2
    Condition identifier
    MONDO:0005147
    Subject identifier
    D003922
  • Condition
    Kidney Failure, Chronic
    Highest recorded phase
    3
    Condition identifier
    MONDO:0024327
    Subject identifier
    D007676

  • Condition identifier
    EFO_0000540
  • Condition identifier
    EFO_0000685
  • Condition identifier
    EFO_0003046
  • Condition identifier
    EFO_0003046
    Highest recorded phase
    3
  • Condition identifier
    EFO_0003884
  • Condition identifier
    EFO_0004599
    Highest recorded phase
    3
  • Condition identifier
    EFO_0008497
    Highest recorded phase
    2
  • Condition identifier
    EFO_0009909
  • Condition identifier
    EFO_0009909
    Highest recorded phase
    1
  • Condition identifier
    EFO_0010134
  • Condition identifier
    EFO_0010134
    Highest recorded phase
    4
  • Condition identifier
    EFO_0010721
    Highest recorded phase
    2
  • Condition identifier
    HP_0000093
    Highest recorded phase
    2
  • Condition identifier
    HP_0001943
    Highest recorded phase
    2
  • Condition identifier
    HP_0003074
    Highest recorded phase
    2
  • Condition identifier
    MONDO_0001106
  • Condition identifier
    MONDO_0005046
    Highest recorded phase
    4
  • Condition identifier
    MONDO_0005132
  • Condition identifier
    MONDO_0005147
    Highest recorded phase
    2
  • Condition identifier
    MONDO_0005300
    Highest recorded phase
    3
  • Condition identifier
    MONDO_0005344
  • Condition identifier
    MONDO_0008383
    Highest recorded phase
    1
  • Condition identifier
    MONDO_0019088
  • Condition identifier
    MONDO_0024327
    Highest recorded phase
    3
  • Condition identifier
    MONDO_0100192

  • Warning
    Black Box Warning
    Effect
    carcinogenicity
  • Warning
    Black Box Warning
    Effect
    immune system toxicity
  • Warning
    Black Box Warning
    Effect
    infectious disease

  • Warning
    Black Box Warning
    Effect
    carcinogenicity
    Country
    United States
  • Warning
    Black Box Warning
    Effect
    immune system toxicity
    Country
    United States
  • Warning
    Black Box Warning
    Effect
    infectious disease
    Country
    United States

  • Event
    acute kidney injury
    Reports
    43
    Reporting signal score
    19.277
  • Event
    adenovirus infection
    Reports
    9
    Reporting signal score
    24.1945
  • Event
    arthralgia
    Reports
    3
    Reporting signal score
    17.7854
  • Event
    aspergillus infection
    Reports
    17
    Reporting signal score
    44.3264
  • Event
    bk virus infection
    Reports
    24
    Reporting signal score
    76.9945
  • Event
    cervicitis
    Reports
    4
    Reporting signal score
    14.4379
  • Event
    clostridium difficile colitis
    Reports
    11
    Reporting signal score
    15.4208
  • Event
    coronavirus infection
    Reports
    9
    Reporting signal score
    19.615
  • Event
    covid-19
    Reports
    33
    Reporting signal score
    38.0462
  • Event
    cytomegalovirus chorioretinitis
    Reports
    14
    Reporting signal score
    44.8053
  • Event
    cytomegalovirus colitis
    Reports
    13
    Reporting signal score
    38.6697
  • Event
    cytomegalovirus gastrointestinal infection
    Reports
    7
    Reporting signal score
    31.0259
  • Event
    cytomegalovirus infection
    Reports
    44
    Reporting signal score
    100.664
  • Event
    cytomegalovirus viraemia
    Reports
    24
    Reporting signal score
    73.4347
  • Event
    disseminated tuberculosis
    Reports
    11
    Reporting signal score
    28.9093
  • Event
    dizziness
    Reports
    5
    Reporting signal score
    20.9969
  • Event
    drug hypersensitivity
    Reports
    1
    Reporting signal score
    18.9465
  • Event
    drug interaction
    Reports
    1
    Reporting signal score
    14.5781
  • Event
    dyspnoea
    Reports
    9
    Reporting signal score
    19.456
  • Event
    epstein-barr viraemia
    Reports
    6
    Reporting signal score
    18.0137
  • Event
    epstein-barr virus infection
    Reports
    16
    Reporting signal score
    35.4994
  • Event
    eye infection toxoplasmal
    Reports
    12
    Reporting signal score
    52.6962
  • Event
    fatigue
    Reports
    9
    Reporting signal score
    27.0485
  • Event
    graft dysfunction
    Reports
    7
    Reporting signal score
    29.5452
  • Event
    graft loss
    Reports
    25
    Reporting signal score
    115.679

And 34 more, listed on the interactive page.

Dose
10 mg per kg (initial), 5 mg per kg (maintenance)
Route
Intravenous
How often
Initial doses on day 1 and day 5, then every 4 weeks after week 16

  • Administer over 30 minutes
  • Use only the enclosed silicone-free disposable syringe for preparation

Prodrug
No
Chirality
Single enantiomer
Inorganic
No
Natural product
No

Sequences

  • Component
    Sequence
    Type
    Protein
    Sequence
    MHVAQPAVVLASSRGIASFVCEYASPGKYTEVRVTVLRQADSQVTEVCAATYMMGNELTFLDDSICTGTSSGNQVNLTIQGLRAMDTGLYICKVELMYPPPYYEGIGNGTQIYVIDPEPCPDSDQEPKSSDKTHTSPPSPAPELLGGSSVFLFPPKPKDTLMISRTPEVTCVVVDVSHEDPEVKFNWYVDGVEVHNAKTKPREEQYNSTYRVVSVLTVLHQDWLNGKEYKCKVSNKALPAPIEKTISKAKGQPREPQVYTLPPSRDELTKNQVSLTCLVKGFYPSDIAVEWESNGQPENNYKTTPPVLDSDGSFFLYSKLTVDKSRWQQGNVFSCSVMHEALHNHYTQKSLSLSPGK

  • 0003-0371

Related records

Trials (282)

Approved for (1)

In development for (6)

Targets (2)