tremelimumab
Trade name: Imjudo
mAbapprovedOrphan Drug FDA
Approved
Oct 21, 2022
Tremelimumab, sold under the brand name Imjudo, is a fully human monoclonal antibody used for the treatment of hepatocellular carcinoma. Tremelimumab is designed to attach to and block CTLA-4, a protein that controls the activity of T cells, which are part of the immune system. — Wikipedia
Clinical trial activity
281 trials · 204 clinical orgs · 1 marketing orgs
Phase 1
92
Phase 2
205
Phase 3
35
Phase 4
3
Earliest trial started Aug 1, 2003 (NCT00086489)
Timeline
2000s
- Jan 1, 2003
AstraZeneca — Earliest Phase 2 Sponsor(trial)
- Jan 1, 2004
AstraZeneca — Earliest Phase 1 Sponsor(trial)
- Jan 1, 2006
AstraZeneca — Earliest Phase 3 Sponsor(trial)
2020s
- Jan 15, 2020
Orphan Drug Designation
- Oct 21, 2022
AstraZeneca — Earliest FDA Approval
- Oct 21, 2022
AstraZeneca — Marketing Organization
- Oct 21, 2022
AstraZeneca — NDA Secondary Org
- Oct 21, 2022
AstraZeneca — NDA Organization
Indications
Approved for
Studied for
- Bile Duct Neoplasms · Phase 1/Phase 2
- Biliary Tract Neoplasms · Phase 2
- BRCA1 Protein · Phase 1/Phase 2
- Breast Neoplasms · Phase 2
- Carcinoma · Phase 2
- Carcinoma, Hepatocellular · Phase 4
- Carcinoma, Merkel Cell · Phase 1/Phase 2
- Carcinoma, Non-Small-Cell Lung · Phase 3
- Carcinoma, Ovarian Epithelial · Phase 2
- Carcinoma, Pancreatic Ductal · Phase 1
- Carcinoma, Renal Cell · Phase 3
- Carcinoma, Squamous Cell · Phase 2
- Carcinoma, Transitional Cell · Phase 3
- Cholangiocarcinoma · Phase 2
- Colorectal Neoplasms · Phase 2
- COVID-19 · Phase 2
- Digestive System Diseases · Phase 1
- Drug Interactions · Phase 2
- Drugs, Investigational · Phase 2
- Dysgerminoma · Phase 2
- Endometrial Neoplasms · Phase 2
- Esophageal Neoplasms · Phase 2
- Esophageal Squamous Cell Carcinoma · Phase 1
- Fallopian Tube Neoplasms · Phase 2
- Fibrosis · Phase 2
- Gallbladder Neoplasms · Phase 2
- Genital Neoplasms, Female · Phase 1
- Glioblastoma · Phase 2
- Glioma · Phase 2
- Hamartoma · Phase 2
- Head and Neck Neoplasms · Phase 2
- Hematologic Neoplasms · Phase 1/Phase 2
- Hepatitis B virus · Phase 2
- Hepatitis C, Chronic · Phase 2
- HIV · Phase 2
- Hormones · Phase 2
- Hydronephrosis · Early Phase 1
- Hypertension, Portal · Phase 2
- Hypopharynx · Phase 2
- Immunotherapy · Phase 2
- Kidney Neoplasms · Phase 1/Phase 2
- Klatskin Tumor · Phase 2
- Larynx · Phase 2
- Lip · Phase 1
- Liver Cirrhosis · Phase 2
- Liver Neoplasms · Phase 2
- Lung Neoplasms · Phase 2
- Lymphoma · Phase 1/Phase 2
- Lymphoma, B-Cell · Phase 1/Phase 2
- Lymphoma, Large B-Cell, Diffuse · Phase 1
- Lymphoma, T-Cell, Cutaneous · Phase 1/Phase 2
- Melanoma · Phase 3
- Menopause · Phase 2
- Mesothelioma · Phase 2
- Mesothelioma, Malignant · Phase 2
- Microsatellite Instability · Phase 2
- Mouth Neoplasms · Phase 1
- Multiple Myeloma · Phase 1
- Multiple Sclerosis · Phase 2
- Mutation · Phase 1/Phase 2
- Myelodysplastic Syndromes · Phase 1
- Neoplasm Metastasis · Phase 2/Phase 3
- Neoplasms · Phase 3
- Neoplasms, Germ Cell and Embryonal · Phase 2
- Neoplastic Cells, Circulating · Phase 4
- Neuroendocrine Tumors · Phase 2
- Oropharyngeal Neoplasms · Phase 1/Phase 2
- Oropharynx · Phase 2
- Ovarian Neoplasms · Phase 2
- Pancreatic Neoplasms · Phase 2
- Papillomavirus Infections · Phase 1/Phase 2
- Peritoneal Neoplasms · Phase 2
- Prostatic Neoplasms · Phase 2
- Prostatic Neoplasms, Castration-Resistant · Phase 2
- Radiotherapy · Phase 2
- Rare Diseases · Phase 2
- Sarcoma · Phase 2
- Seminoma · Phase 2
- Sepsis · Phase 1
- Small Cell Lung Carcinoma · Phase 3
- Squamous Cell Carcinoma of Head and Neck · Phase 3
- Stomach Neoplasms · Phase 2
- Testicular Neoplasms · Phase 1/Phase 2
- Thyroid Neoplasms · Phase 2
- Triple Negative Breast Neoplasms · Phase 2
- Ureteral Neoplasms · Early Phase 1
- Urethral Neoplasms · Early Phase 1
- Urinary Bladder Diseases · Phase 2
- Urinary Bladder Neoplasms · Phase 3
- Uterine Cervical Neoplasms · Phase 1/Phase 2
- Vaginal Neoplasms · Phase 1
- Vulvar Neoplasms · Phase 1
Mechanism of action
- Cytotoxic T-lymphocyte protein 4INHIBITOR
CTLA4 inhibitor
Blocks the binding of the antigen-presenting cell ligands B7.1 and B7.2 to CTLA-4, resulting in inhibition of B7-CTLA-4-mediated downregulation of T-cell activation.
Approval history
- approvedOct 21, 2022
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
- Multi-specific
- No
Oral
No
Parenteral
Yes
Topical
No
Sources
- WikipediaTremelimumab ↗
- ChEMBLCHEMBL2108658 ↗
Also known as
- cp 675
- cp-675
- cp-675
- cp675206
- cp 675206
- cp 675,206
- cp-675206
- cp-675206
- cp-675206
- cp-675,206
- cp-675,206
- cp675 cpd
- eadm
- eadm
- ticilimumab
- ticilimumab
- ticilimumab
- ticilimumab
- tremelimumab
- tremelimumab
- tremelimumab
- tremelimumab
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07288034 | Phase 2 | Sep 21, 2026 | City of Hope National Medical Center, National Cancer Institute (NCI) |
| NCT07122089 | Phase 2 | Jan 2, 2026 | Boston Scientific Corporation, Center Eugene Marquis |
| NCT06904170 | Phase 2/Phase 3 (Phase 3) | Nov 30, 2025 | AstraZeneca, Center Eugene Marquis, UNICANCER |
| NCT07174570 | Phase 2 | Nov 28, 2025 | Emory University, National Cancer Institute (NCI) |
| NCT07166406 | Phase 3 | Nov 27, 2025 | NRG Oncology |
| NCT07175441 | Phase 2 | Oct 31, 2025 | Riboscience, LLC. |
| NCT06880523 | Phase 2 | Oct 21, 2025 | AstraZeneca, Canadian Cancer Trials Group, Fondazione Giovanni Pascale |
| NCT06994299 | Phase 2 | Oct 1, 2025 | Cornell University |
| NCT07168668 | Phase 2 | Sep 15, 2025 | Chang Gung University |
| NCT07081633 | Phase 2 | Aug 5, 2025 | AstraZeneca |
| NCT06855225 | Phase 2 | Jun 30, 2025 | AstraZeneca, Hoosier Cancer Research Network, University of Alabama, Birmingham |
| NCT06999707 | Phase 2 | May 22, 2025 | Chang Gung University |
| NCT06999694 | Phase 2 | May 22, 2025 | Chang Gung University |
| NCT06921785 | Phase 3 | May 6, 2025 | AstraZeneca |
| NCT06911255 | Phase 1/Phase 2 (Phase 2) | Apr 18, 2025 | AstraZeneca, Seoul National University |
| NCT06824363 | Early Phase 1 (Phase 1) | Mar 31, 2025 | University of California, Irvine |
| NCT06564623 | Phase 1 | Jan 31, 2025 | AstraZeneca, Johns Hopkins University |
| NCT06710223 | Phase 1 | Dec 31, 2024 | TriSalus Life Sciences, University of California, San Diego |
| NCT06698250 | Phase 2 | Dec 31, 2024 | Exelixis, University of Pittsburgh |
| NCT06608940 | Phase 1/Phase 2 (Phase 2) | Dec 1, 2024 | Case Western Reserve University |
Showing 20 of 281 trials
Page 1 / 15
Organizations
Research & Development (204)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| AstraZeneca | For profit | 120 | 42 | 4 | 2003 |
| MedImmune | For profit | 30 | 10 | 3 | 2012 |
| National Cancer Institute (NCI) | Government | 21 | 6 | 3 | 2004 |
| University of Texas at Houston | Academic/Hospital | 13 | 10 | 2 | 2015 |
| Canadian Cancer Trials Group | Academic/Hospital | 9 | 9 | 2 | 2015 |
| Cornell University | Academic/Hospital | 9 | 6 | 3 | 2013 |
| University of Toronto | Academic/Hospital | 9 | 3 | 2 | 2010 |
| Harvard University | Academic/Hospital | 8 | 6 | 2 | 2014 |
| Pfizer | For profit | 8 | 3 | 3 | 2006 |
| Seoul National University | Academic/Hospital | 8 | 6 | 1 | 2012 |
| University of Milan | Academic/Hospital | 6 | 1 | 1 | 2017 |
| Eastern Hepatobiliary Surgery Hospital | Academic/Hospital | 5 | 4 | 3 | 2008 |
| Institut Gustave Roussy | Academic/Hospital | 5 | 3 | 2 | 2014 |
| Johns Hopkins University | Academic/Hospital | 5 | 4 | 2 | 2014 |
| University of California, Los Angeles | Academic/Hospital | 5 | 5 | 2 | 2004 |
| Chang Gung University | Academic/Hospital | 4 | 4 | 2 | 2015 |
| Columbia University | Academic/Hospital | 4 | 3 | 3 | 2015 |
| Ludwig Institute for Cancer Research | Academic/Hospital | 4 | 4 | 2 | 2013 |
| People's Liberation Army of China | Government | 4 | 3 | 3 | 2008 |
| Sun Yat-Sen University | Academic/Hospital | 4 | 4 | 2 | 2014 |
204 organizations
Page 1 / 11
Marketing (3)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| AstraZeneca | For profit | MKTG | Oct 21, 2022 |
| AstraZeneca | For profit | NDA2 | Oct 21, 2022 |
| AstraZeneca | For profit | NDA | Oct 21, 2022 |