Tremelimumab
Highest phase reached
Approved
Drug type
Antibody
First approval year
2022
- First approval year
- 2022
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Antibody
- Drug name
- Tremelimumab
- imjudo
- Imjudo
- tremelimumab astrazeneca
- Tremelimumab astrazeneca
- cp 675 206
- cp 675206
- CP-675,206
- CP-675206
- durvalumab medi4736 and tremelimumab
- durvalumab tremelimumab
- immunoglobulin g2 anti human ctla 4 antigen human monoclonal cp 675206 clone 11 2 1 heavy chain disulfide with human monoclonal cp 675206 clone 11 2 1 light chain dimer
- immunoglobulin g2 anti human ctla 4 antigen human monoclonal cp 675206 clone 11 2 1 heavy chain disulphide with human monoclonal cp 675206 clone 11 2 1 light chain dimer
- IMMUNOGLOBULIN G2, ANTI-(HUMAN CTLA-4 (ANTIGEN)) (HUMAN MONOCLONAL CP-675206 CLONE 11.2.1 HEAVY CHAIN) DISULFIDE WITH HUMAN MONOCLONAL CP-675206 CLONE 11.2.1 LIGHT CHAIN, DIMER
- IMMUNOGLOBULIN G2, ANTI-(HUMAN CTLA-4 (ANTIGEN)) (HUMAN MONOCLONAL CP-675206 CLONE 11.2.1 HEAVY CHAIN) DISULPHIDE WITH HUMAN MONOCLONAL CP-675206 CLONE 11.2.1 LIGHT CHAIN, DIMER
- pf 06753388
- PF-06753388
- ticilimumab
- TICILIMUMAB
- tremelimumab
- Tremelimumab
- Tremelimumab (genetical recombination)
- TREMELIMUMAB (GENETICAL RECOMBINATION) [JAN]
- tremelimumab (treme)
- tremelimumab [INN]
- TREMELIMUMAB [JAN]
- Tremelimumab [MI]
- TREMELIMUMAB [USAN]
- Tremelimumab [WHO-DD]
- tremelimumab actl
And 12 more, listed on the interactive page.
- ATC classification codes
- L01FX20
Sources for recorded values
- CAS registry numbers
- 745013-59-6
- ChEMBL ID
- CHEMBL2108658
- FDA ingredient codes (UNII)
- QEN1X95CIX
- 2619312
- 2619313
- Applicant
- ASTRAZENECA AB
- Approval date
- 21 Oct 2022
- Application number
- BLA761289
- Status
- Authorised
- Status date
- 20 Feb 2023
- Authorisation date
- 20 Feb 2023
- Approved indications
- Imjudo in combination with durvalumab is indicated for the first line treatment of adults with advanced or unresectable hepatocellular carcinoma (HCC). Imjudo in combination with durvalumab and platinum-based chemotherapy is indicated for the first-line treatment of adults with metastatic non-small cell lung cancer (NSCLC) with no sensitising EGFR mutations or ALK positive mutations.
- Product number
- EMEA/H/C/006016
- Authorisation holder
- AstraZeneca AB
- Priority medicines scheme
- No
- Generic
- No
- Biosimilar
- No
- Generic medicines
- 0
- Biosimilar medicines
- 0
- Advanced therapy
- No
- Conditional approval
- No
- Additional monitoring
- Yes
- Accelerated assessment
- No
- Exceptional circumstances
- No
Therapeutic areas
- Carcinoma, Hepatocellular
- Carcinoma, Non-Small-Cell Lung
European medicines record
- Patents
- 0
- Designations
- 2
- Earliest recorded loss of exclusivity
- 21 Oct 2029
- First in class
- No
- Fast track
- No
- Breakthrough designation
- No
- Orphan designation
- No
- Priority review
- No
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Prescription only
- Pharmacology name
- tremelimumab
- 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
- 8.91
- Affinity units
- pKd
- Primary target
- Yes
- 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
- Carcinoma, Squamous Cell
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000181
- Subject identifier
- D002294
- Condition
- Carcinoma, Hepatocellular
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000182
- Subject identifier
- D006528
- Condition
- Myelodysplastic Syndromes
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000198
- Subject identifier
- D009190
- Condition
- Squamous Cell Carcinoma of Head and Neck
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000199
- Subject identifier
- D000077195
- Condition
- Breast Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000305
- Subject identifier
- D001943
- Condition
- Carcinoma, Renal Cell
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000349
- Subject identifier
- D002292
- Condition
- Colorectal Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000365
- Subject identifier
- D015179
- Condition
- Melanoma
- Highest recorded phase
- 3
- 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
- Adenocarcinoma, Follicular
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000501
- Subject identifier
- D018263
- Condition
- Stomach Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000503
- Subject identifier
- D013274
- Condition
- Neoplasms, Germ Cell and Embryonal
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000514
- Subject identifier
- D009373
- Condition
- Glioblastoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000519
- Subject identifier
- D005909
- Condition
- Lymphoma
- Highest recorded phase
- 1
- Condition identifier
- EFO:0000574
- Subject identifier
- D008223
- Condition
- Mesothelioma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000588
- Subject identifier
- D008654
- Condition
- Neoplasms
- Highest recorded phase
- 4
- Condition identifier
- EFO:0000616
- Subject identifier
- D009369
- Condition
- Thyroid Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000641
- Subject identifier
- D013964
- Condition
- Prostatic Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000673
- Subject identifier
- D011471
- Condition
- Carcinoma, Renal Cell
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000681
- Subject identifier
- D002292
- Condition
- Sarcoma
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000691
- Subject identifier
- D012509
- Condition
- Small Cell Lung Carcinoma
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000702
- Subject identifier
- D055752
- Condition
- Carcinoma, Squamous Cell
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000708
- Subject identifier
- D002294
- Condition
- Melanoma
- Highest recorded phase
- 3
- Condition identifier
- EFO:0000756
- Subject identifier
- D008545
- Condition
- HIV Infections
- Highest recorded phase
- 2
- Condition identifier
- EFO:0000764
- Subject identifier
- D015658
- Condition
- Ovarian Neoplasms
- Highest recorded phase
- 2
- Condition identifier
- EFO:0001075
- Subject identifier
- D010051
And 36 more, listed on the interactive page.
- Condition identifier
- EFO_0000181
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000182
- Condition identifier
- EFO_0000199
- Condition identifier
- EFO_0000389
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000503
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000514
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000588
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000616
- Condition identifier
- EFO_0000673
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000681
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000691
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000702
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000708
- Highest recorded phase
- 2
- Condition identifier
- EFO_0000756
- Highest recorded phase
- 3
- Condition identifier
- EFO_0000764
- Highest recorded phase
- 2
- Condition identifier
- EFO_0002618
- Highest recorded phase
- 2
- Condition identifier
- EFO_0003060
- Condition identifier
- EFO_0003860
- Condition identifier
- EFO_0003863
- Highest recorded phase
- 3
- Condition identifier
- EFO_0003891
- Highest recorded phase
- 2
- Condition identifier
- EFO_0004142
- Highest recorded phase
- 2
- Condition identifier
- EFO_0008528
- Highest recorded phase
- 2
- Condition identifier
- EFO_1000355
- Highest recorded phase
- 3
- Condition identifier
- EFO_1000616
- Highest recorded phase
- 2
- Condition identifier
- EFO_1001331
- Highest recorded phase
- 2
And 99 more, listed on the interactive page.
- Event
- adrenal insufficiency
- Reports
- 12
- Reporting signal score
- 21.3427
- Event
- appendicitis
- Reports
- 9
- Reporting signal score
- 15.7876
- Event
- asthenia
- Reports
- 4
- Reporting signal score
- 8.45602
- Event
- autoimmune hepatitis
- Reports
- 12
- Reporting signal score
- 25.271
- Event
- autoimmune nephritis
- Reports
- 6
- Reporting signal score
- 28.0924
- Event
- autoimmune pancreatitis
- Reports
- 5
- Reporting signal score
- 19.4324
- Event
- bacillus infection
- Reports
- 3
- Reporting signal score
- 10.3677
- Event
- bile duct stenosis
- Reports
- 15
- Reporting signal score
- 61.0911
- Event
- biliary tract infection
- Reports
- 35
- Reporting signal score
- 203.104
- Event
- cauda equina syndrome
- Reports
- 3
- Reporting signal score
- 8.68181
- Event
- cholangitis infective
- Reports
- 3
- Reporting signal score
- 12.6104
- Event
- colitis
- Reports
- 54
- Reporting signal score
- 118.935
- Event
- dizziness
- Reports
- 3
- Reporting signal score
- 15.6638
- Event
- drug-induced liver injury
- Reports
- 17
- Reporting signal score
- 20.2001
- Event
- embolism
- Reports
- 12
- Reporting signal score
- 25.2596
- Event
- endocrine disorder
- Reports
- 3
- Reporting signal score
- 8.72653
- Event
- endocrine toxicity
- Reports
- 2
- Reporting signal score
- 10.9964
- Event
- enterocolitis
- Reports
- 7
- Reporting signal score
- 13.052
- Event
- enterocolitis infectious
- Reports
- 9
- Reporting signal score
- 33.8381
- Event
- febrile neutropenia
- Reports
- 27
- Reporting signal score
- 24.2461
- Event
- gallbladder obstruction
- Reports
- 3
- Reporting signal score
- 13.3802
- Event
- headache
- Reports
- 5
- Reporting signal score
- 15.8908
- Event
- hepatic function abnormal
- Reports
- 14
- Reporting signal score
- 11.688
- Event
- hepatic infection
- Reports
- 11
- Reporting signal score
- 48.9033
- Event
- hepatitis
- Reports
- 14
- Reporting signal score
- 14.7353
And 24 more, listed on the interactive page.
- NCT00086489
- NCT00254579
- NCT00257205
- NCT00431275
- NCT00585000
- NCT01103635
- NCT02535078
- NCT04223648
- NCT00312975
- NCT02000947
- NCT02040064
- NCT02179671
- NCT02352948
- NCT02453282
- NCT02542293
- NCT03130764
- NCT03164616
- NCT03164772
- NCT03237377
- NCT03275597
- NCT03319316
- NCT03581487
- NCT03965468
- NCT03975114
- NCT03994393
And 137 more, listed on the interactive page.
- Dose
- 75 mg
- Route
- Intravenous
- How often
- Every 3 weeks
Conditions of use
- Administer over 60 minutes after dilution
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
- 0310-4505
- 0310-4535
Related records
Trials (249)
- ......SMARTEST Trial......
- A Clinical Study With Tremelimumab as Monotherapy in Malignant Mesothelioma
- A Clinical Trial of Durvalumab and Tremelimumab, Administered With Radiation Therapy or Ablation in Patients With Colorectal Cancer
- A Global Study to Assess the Effects of MEDI4736 (Durvalumab), Given as Monotherapy or in Combination With Tremelimumab Determined by PD-L1 Expression Versus Standard of Care in Patients With Locally Advanced or Metastatic Non Small Cell Lung Cancer
- A Phase 1 Study of MEDI4736 in Combination With Tremelimumab in Subjects With Advanced Solid Tumors
- A Phase 1 Study Testing CP-675,206 In Combination With Gemcitabine In Patients With Previously Untreated, Advanced Pancreatic Cancer
- A Phase 1 Study To Evaluate Escalating Doses Of A Vaccine-Based Immunotherapy Regimen For Prostate Cancer (PrCa VBIR)
- A Phase 1 Study to Evaluate MEDI4736 in Combination With Tremelimumab
- A Phase 1/2 Study of Durvalumab(MEDI4736) and Tremelimumab in Chinese Patients With Advanced Malignancies
- A Phase 1b Study of MEDI4736 in Combination With Tremelimumab in Subjects With Advanced Non-small Cell Lung Cancer
- A Phase 1b/2 Safety and Tolerability Study of MEDI6469 in Combination With Therapeutic Immune Agents or Monoclonal Antibodies
- A Phase 1b/2 Study of MEDI4736 With Tremelimumab, MEDI4736 or Tremelimumab Monotherapy in Gastric or GEJ Adenocarcinoma
- A Phase 2 Study of Durvalumab in Combination With Tremelimumab in Malignant Pleural Mesothelioma
- A Phase I Dose Escalation and Dose Expansion Study to Investigate the Pharmacokinetics and Safety of Subcutaneous Durvalumab
- A Phase I Study to Evaluate the Safety, Tolerability and Efficacy of MEDI4736 (Durvalumab) With Tremelimumab in Head and Neck Cancer
- A Phase I, Open-Label, Multicentre Study to Evaluate the Safety, Tolerability and Pharmacokinetics of MEDI4736 in Patients With Advanced Solid Tumours
- A Phase I/II Study of Pexa-Vec Oncolytic Virus in Combination With Immune Checkpoint Inhibition in Refractory Colorectal Cancer
- A Phase II Study of Durvalumab Treatment - Substudy A: In Patients Who Discontinued Prior Checkpoint Therapy Due to Immune Related Toxicity - Substudy B: For Continued Treatment (+/- Tremelimumab) of Patients Previously Enrolled to Completed CCTG Studies
- A Phase II Study of Neoadjuvant Chemotherapy Plus Durvalumab (MEDI4736) and Tremelimumab in Advanced-stage Ovarian Cancer (TRU-D)
- A Phase II Study of Single Tremelimumab With Regular Interval Durvalumab Plus Gemcitabine and Cisplatin in Locally Advanced Unresectable/Metastatic Combined Hepatocellular-cholangiocarcinoma
Approved for (4)
In development for (58)
- Bile duct cancer Phase 2
- Biliary tract cancer Phase 2
- Biliary tract neoplasm Phase 2
- Breast cancer Phase 2
- Breast carcinoma Phase 2
- Cholangiocarcinoma Phase 2
- Clear cell renal carcinoma Phase 3
- Colorectal adenocarcinoma Phase 2
- Colorectal cancer Phase 2
- Colorectal neoplasm Phase 2
- Cutaneous melanoma Phase 3
- Diffuse large B-cell lymphoma Phase 1
- Dysgerminoma Phase 2
- Esophageal cancer Phase 1
- Exocrine pancreatic carcinoma Phase 2
- Fallopian tube cancer Phase 2
- Fallopian tube carcinoma Phase 2
- Female reproductive organ cancer Phase 2
- Gastric adenocarcinoma Phase 2
- Gastric cancer Phase 2
Targets (1)
- CTLA4 Cytotoxic T-lymphocyte protein 4 inhibitor