Ipilimumab
Highest phase reached
Approved
Drug type
Antibody
First approval year
2011
- First approval year
- 2011
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Antibody
- Drug name
- Ipilimumab
- yervoy
- Yervoy
- bms 734016
- BMS-734016
- bms734016
- BMS734016
- enoblituzumab plus ipilimumab
- immunoglobulin g1 anti human ctla 4 antigen human gamma 1 chain disulfide with human kappa chain dimer
- immunoglobulin g1 anti human ctla 4 antigen human gamma 1 chain disulphide with human kappa chain dimer
- IMMUNOGLOBULIN G1, ANTI-(HUMAN CTLA-4 (ANTIGEN)) (HUMAN .GAMMA.1-CHAIN), DISULFIDE WITH HUMAN .KAPPA.-CHAIN, DIMER
- IMMUNOGLOBULIN G1, ANTI-(HUMAN CTLA-4 (ANTIGEN)) (HUMAN .GAMMA.1-CHAIN), DISULPHIDE WITH HUMAN .KAPPA.-CHAIN, DIMER
- ipilimumab
- Ipilimumab
- IPILIMUMAB
- Ipilimumab (BMS-734016)
- IPILIMUMAB [EMA EPAR]
- ipilimumab [INN]
- IPILIMUMAB [JAN]
- IPILIMUMAB [MART.]
- IPILIMUMAB [MI]
- IPILIMUMAB [PURPLE BOOK CDER]
- IPILIMUMAB [USAN]
- IPILIMUMAB [VANDF]
- Ipilimumab [WHO-DD]
- Ipilimumab 2.5 mg
- ipilimumab ema epar
- Ipilimumab infusion
And 24 more, listed on the interactive page.
- ATC classification codes
- L01FX04
Sources for recorded values
- CAS registry numbers
- 477202-00-9
- ChEMBL ID
- CHEMBL1789844
- RxNorm IDs (RxCUI)
- 1094833
- FDA ingredient codes (UNII)
- 6T8C155666
- Applicant
- BRISTOL MYERS SQUIBB
- Approval date
- 25 Mar 2011
- Application number
- BLA125377
- Status
- Authorised
- Status date
- 13 Jul 2011
- Authorisation date
- 13 Jul 2011
- Approved indications
- Melanoma Yervoy as monotherapy or combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults and adolescents 12 years of age and older (see section 4.4). Yervoy in combination with nivolumab is indicated for the treatment of advanced (unresectable or metastatic) melanoma in adults. Relative to nivolumab monotherapy, an increase in progression-free survival (PFS) and overall survival (OS) for the combination of nivolumab with ipilimumab is established only in patients with low tumour PD-L1 expression (see sections 4.4 and 5.1). Renal cell carcinoma (RCC) Yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with intermediate/poor-risk advanced renal cell carcinoma (see section 5.1). Non-small cell lung cancer (NSCLC) Yervoy in combination with nivolumab and 2 cycles of platinum-based chemotherapy is indicated for the first-line treatment of metastatic non-small cell lung cancer in adults whose tumours have no sensitising EGFR mutation or ALK translocation. Malignant pleural mesothelioma (MPM) Yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with unresectable malignant pleural mesothelioma. Mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) colorectal cancer (CRC) Yervoy in combination with nivolumab is indicated for the treatment of adult patients with mismatch repair deficient or microsatellite instability high colorectal cancer in the following settings: first-line treatment of unresectable or metastatic colorectal cancer; treatment of metastatic colorectal cancer after prior fluoropyrimidine based combination chemotherapy (see section 5.1). Oesophageal squamous cell carcinoma (OSCC) Yervoy in combination with nivolumab is indicated for the first-line treatment of adult patients with unresectable advanced, recurrent or metastatic oesophageal squamous cell carcinoma with tumour cell PD-L1 expression ≥ 1%.Hepatocellular carcinoma (HCC) Yervoy in combination with nivolumab is indicated for the first line treatment of adult patients with unresectable or advanced hepatocellular carcinoma.
- Product number
- EMEA/H/C/002213
- 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
- Carcinoma, Non-Small-Cell Lung
- Carcinoma, Renal Cell
- Colorectal Neoplasms
- Melanoma
- Mesothelioma, Malignant
European medicines record
- Patents
- 0
- Designations
- 5
- Earliest recorded loss of exclusivity
- 2 Oct 2027
- First in class
- Yes
- Fast track
- Yes
- Breakthrough designation
- Yes
- Orphan designation
- No
- Priority review
- Yes
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Prescription only
- Pharmacology name
- ipilimumab
- Type
- Antibody
- Drug name stem
- -mab
- Approval recorded by Guide to Pharmacology
- Yes
Administration routes
- Parenteral
- Action
- Binding
- Action type
- Binding
- Target
- cytotoxic T-lymphocyte-associated protein 4 (CD152)
- Gene symbol
- CTLA4
- Protein identifier
- P16410
- Median affinity
- 8.07
- Affinity units
- pKd
- Mechanism
- Cytotoxic T-lymphocyte protein 4 inhibitor
- Action type
- Inhibitor
- Target
- Cytotoxic T-lymphocyte protein 4
- Protein identifier
- P16410
Open Targets mechanisms
- Mechanism
- Cytotoxic T-lymphocyte protein 4 inhibitor
- Action type
- Inhibitor
- Target
- Cytotoxic T-lymphocyte protein 4
- Condition
- Leukemia, Lymphocytic, Chronic, B-Cell
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000095
- Subject identifier
- D015451
- Condition
- Lymphoma, Follicular
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000096
- Subject identifier
- D008224
- Condition
- Carcinoma, Squamous Cell
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000181
- Subject identifier
- D002294
- Condition
- Carcinoma, Hepatocellular
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000182
- Subject identifier
- D006528
- Condition
- Hodgkin Disease
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000183
- Subject identifier
- D006689
- Condition
- Prostatic Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000196
- Subject identifier
- D011471
- Condition
- Myelodysplastic Syndromes
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000198
- Subject identifier
- D009190
- Condition
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000220
- Subject identifier
- D054198
- Condition
- Leukemia, Myeloid, Acute
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000222
- Subject identifier
- D015470
- Condition
- Adenocarcinoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000228
- Subject identifier
- D000230
- Condition
- Breast Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000305
- Subject identifier
- D001943
- Condition
- Carcinoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000313
- Subject identifier
- D002277
- Condition
- Leukemia, Myelogenous, Chronic, BCR-ABL Positive
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000339
- Subject identifier
- D015464
- Condition
- Carcinoma, Renal Cell
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000349
- Subject identifier
- D002292
- Condition
- Colorectal Neoplasms
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000365
- Subject identifier
- D015179
- Condition
- Melanoma
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000389
- Subject identifier
- D008545
- Condition
- Lymphoma, Large B-Cell, Diffuse
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000403
- Subject identifier
- D016403
- Condition
- Stomach Neoplasms
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000503
- Subject identifier
- D013274
- Condition
- Glioblastoma
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000519
- Subject identifier
- D005909
- Condition
- Sarcoma, Kaposi
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000558
- Subject identifier
- D012514
- Condition
- Leiomyosarcoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000564
- Subject identifier
- D007890
- Condition
- Leukemia
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000565
- Subject identifier
- D007938
- Condition
- Adenocarcinoma of Lung
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000571
- Subject identifier
- D000077192
- Condition
- Lymphoma
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000574
- Subject identifier
- D008223
- Condition
- Mesothelioma
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000588
- Subject identifier
- D008654
And 86 more, listed on the interactive page.
- Condition identifier
- EFO_0000181
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000182
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000183
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000220
- Highest recorded phase
- 1
- Condition identifier
- EFO_0000305
- Highest recorded phase
- 1
- Condition identifier
- EFO_0000339
- Highest recorded phase
- 1
- Condition identifier
- EFO_0000349
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000389
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000503
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000519
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000558
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000574
- Condition identifier
- EFO_0000588
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000616
- Condition identifier
- EFO_0000673
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000681
- Condition identifier
- EFO_0000691
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000702
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000708
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000756
- Condition identifier
- EFO_0000764
- Highest recorded phase
- 1
- Condition identifier
- EFO_0000770
- Highest recorded phase
- 3
- Condition identifier
- EFO_0001061
- Condition identifier
- EFO_0001376
- Highest recorded phase
- 2
- Condition identifier
- EFO_0001378
And 217 more, listed on the interactive page.
- Event
- adrenal insufficiency
- Reports
- 369
- Reporting signal score
- 942.017
- Event
- autoimmune colitis
- Reports
- 139
- Reporting signal score
- 588.151
- Event
- autoimmune hepatitis
- Reports
- 165
- Reporting signal score
- 347.246
- Event
- colitis
- Reports
- 1,171
- Reporting signal score
- 3,112.2
- Event
- diabetic ketoacidosis
- Reports
- 165
- Reporting signal score
- 156.948
- Event
- diarrhoea
- Reports
- 1,223
- Reporting signal score
- 458.51
- Event
- drug hypersensitivity
- Reports
- 9
- Reporting signal score
- 184.059
- Event
- drug interaction
- Reports
- 3
- Reporting signal score
- 162.577
- Event
- enterocolitis
- Reports
- 157
- Reporting signal score
- 366.007
- Event
- fulminant type 1 diabetes mellitus
- Reports
- 56
- Reporting signal score
- 173.738
- Event
- hepatitis
- Reports
- 279
- Reporting signal score
- 384.766
- Event
- hyperthyroidism
- Reports
- 220
- Reporting signal score
- 407.913
- Event
- hypophysitis
- Reports
- 690
- Reporting signal score
- 3,149.23
- Event
- hypopituitarism
- Reports
- 166
- Reporting signal score
- 598.517
- Event
- hypothalamo-pituitary disorder
- Reports
- 64
- Reporting signal score
- 204.269
- Event
- hypothyroidism
- Reports
- 284
- Reporting signal score
- 444.22
- Event
- immune-mediated enterocolitis
- Reports
- 234
- Reporting signal score
- 937.593
- Event
- immune-mediated hepatitis
- Reports
- 135
- Reporting signal score
- 514.004
- Event
- lymphocytic hypophysitis
- Reports
- 88
- Reporting signal score
- 385.586
- Event
- malignant neoplasm progression
- Reports
- 769
- Reporting signal score
- 1,295.25
- Event
- meningitis aseptic
- Reports
- 85
- Reporting signal score
- 165.866
- Event
- myocarditis
- Reports
- 151
- Reporting signal score
- 272.141
- Event
- myositis
- Reports
- 121
- Reporting signal score
- 190.703
- Event
- pneumonitis
- Reports
- 408
- Reporting signal score
- 761.406
- Event
- pyrexia
- Reports
- 847
- Reporting signal score
- 351.432
And 5 more, listed on the interactive page.
- NCT00025181
- NCT00032045
- NCT00058279
- NCT00077532
- NCT00084656
- NCT00357461
- NCT01134614
- NCT01176474
- NCT01274338
- NCT01708941
- NCT01950390
- NCT01970527
- NCT02158520
- NCT02339571
- NCT02437279
- NCT02941744
- NCT03396952
- NCT03719131
- NCT03769155
- NCT03949153
- NCT05200143
- NCT05578872
- NCT06377111
- NCT00047164
- NCT00586391
And 504 more, listed on the interactive page.
- Dose
- 3 mg/kg
- Route
- Intravenous
- How often
- Every 3 weeks for 4 doses or until disease progression or unacceptable toxicity
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
- 0003-2327
- 0003-2328
Related records
Trials (837)
- A 2-part Phase 1/2 Open-label Trial on ODM-212
- A BIOmarker Driven Trial With Nivolumab and Ipilimumab or VEGFR tKi in Naïve Metastatic Kidney Cancer
- A Biomarker Study in Advanced Mucosal or Acral Lentiginous Melanoma Receiving Nivolumab in Combination With Ipilimumab
- A Clinical Study Evaluating Nivolumab-containing Treatments in Patients With Advanced Non-small Cell Lung Cancer After Failing Previous PD-1/(L)1 Therapy and Chemotherapy
- A Clinical Trial of Influenza Virus Split Vaccine for Individuals Aged 60 Years and Above
- A Clinical Trial: Adjuvant Low-dose Ipilimumab + Nivolumab After Resection of Melanoma Macrometastases
- A Combination of Ipilimumab and Fotemustine for Treat Unresectable Locally Advanced or Metastatic Melanoma
- A Companion Study for Patients Enrolled in Prior/Parent Ipilimumab Studies
- A Comparative Study in Chinese Subjects With Chemotherapy Naïve Stage IV Melanoma Receiving Ipilimumab (3 mg/kg) vs. Dacarbazine
- A DNAJB1-PRKACA Fusion Kinase Peptide Vaccine Combined With Glutamine Antagonist DRP-104, Nivolumab, and Ipilimumab in Patients With Advanced Stage Fibrolamellar Carcinoma (FLC)
- A Dose Escalation and Cohort Expansion Study of NKTR-214 in Combination With Nivolumab and Other Anti-Cancer Therapies in Patients With Select Advanced Solid Tumors
- A Dose Escalation and Combination Immunotherapy Study to Evaluate BMS-986226 Alone or in Combination With Nivolumab or Ipilimumab in Patients With Advanced Solid Tumors
- A Dose-Escalation Study of MDX-010 Administered Monthly as Immunotherapy in Subjects Infected With Human Immunodeficiency Virus (HIV)
- A First-in-Human Study of BMS-986506 in Participants With Advanced Clear Cell Renal Cell Carcinoma (ccRCC)
- A First-in-human, Dose Escalation and Dose Expansion Study of SAR445877 in Adult Participants With Advanced Solid Tumors
- A Longitudinal Assessment of Tumor Evolution in Patients With Brain Cancer
- A Multicenter Clinical Study of Combined Therapy for Unresectable Hepatocellular Carcinoma
- A Multicenter Open-label Phase II Trial to Evaluate Nivolumab and Ipilimumab for 2nd Line Therapy in Elderly Patients With Advanced Esophageal Squamous Cell Cancer
- A National Phase IV Study With Ipilimumab for Patients With Advanced Malignant Melanoma.
- A Neoadjuvant Study of Nivolumab Plus Ipilimumab or Nivolumab Plus Chemotherapy Versus Chemotherapy Alone in Early Stage Non-Small Cell Lung Cancer (NSCLC)
Approved for (15)
- Cancer
- Clear cell renal carcinoma
- Colorectal adenocarcinoma
- Colorectal cancer
- Colorectal carcinoma
- Colorectal neoplasm
- Cutaneous melanoma
- Malignant mesothelioma
- Melanoma
- Metastatic melanoma
- Neoplasm
- Non-small cell lung carcinoma
- Renal carcinoma
- Renal cell adenocarcinoma
- Renal cell carcinoma
In development for (95)
- Acute lymphoblastic leukemia Phase 1
- Acute myeloid leukemia Phase 1
- Adenocarcinoma Phase 2
- B-cell chronic lymphocytic leukemia Phase 1
- Basal cell carcinoma Phase 2
- Biliary tract neoplasm Phase 2
- Breast cancer Phase 2
- Breast carcinoma Phase 2
- Carcinoid tumor Phase 2
- Carcinoma Phase 2
- Carcinoma of esophagus Phase 2
- Cervical adenocarcinoma Phase 2
- Cervical cancer Phase 2
- Cervical carcinoma Phase 2
- Cholangiocarcinoma Phase 1
- Chronic myeloid leukemia Phase 1
- Classic Hodgkin lymphoma Phase 2
- Colon carcinoma Phase 2
- Colonic neoplasm Phase 2
- Cutaneous neuroendocrine carcinoma Phase 2
Targets (1)
- CTLA4 Cytotoxic T-lymphocyte protein 4 inhibitor