tislelizumab
mAbapprovedOrphan Drug FDA
Approved
Mar 13, 2024
Tislelizumab, sold under the brand name Tevimbra among others, is an anti-cancer medication used for the treatment of various forms of cancer. It is a humanized monoclonal antibody directed against programmed death receptor-1. It is being developed by BeOne Medicines. — Wikipedia
Clinical trial activity
529 trials · 193 clinical orgs · 1 marketing orgs
Phase 1
104
Phase 2
442
Phase 3
63
Phase 4
6
Earliest trial started Jun 1, 2015 (NCT02407990)
Timeline
2010s
- Jan 1, 2015
BeOne Medicines — Earliest Phase 1 Sponsor(trial)
- Jan 1, 2017
BeOne Medicines — Earliest Phase 2 Sponsor(trial)
- Jan 1, 2017
BeOne Medicines — Earliest Phase 3 Sponsor(trial)
- Nov 6, 2019
Orphan Drug Designation
2020s
- Mar 13, 2024
BeOne Medicines — Earliest FDA Approval
- Mar 13, 2024
BeOne Medicines — NDA Organization
Indications
Approved for
Studied for
- Adenocarcinoma · Phase 1/Phase 2
- Adolescent · Phase 2/Phase 3
- Angiogenesis Inhibitors · Phase 2
- Anterior Cruciate Ligament Injuries · Phase 2
- Antineoplastic Agents · Phase 1/Phase 2
- Antineoplastic Agents, Immunological · Phase 2
- Anus Neoplasms · Phase 1
- Apoptosis · Phase 2
- Ascites · Phase 1
- BCG Vaccine · Phase 3
- Bevacizumab · Phase 2
- Bile Duct Neoplasms · Phase 2
- Biliary Tract Neoplasms · Phase 2
- Biomarkers · Phase 2
- Brain Neoplasms · Phase 2
- Breast Neoplasms · Phase 4
- Brentuximab Vedotin · Phase 2/Phase 3
- Capecitabine · Phase 2
- Carcinoma · Phase 2
- Carcinoma, Adenoid Cystic · Phase 1
- Carcinoma, Hepatocellular · Phase 3
- Carcinoma, Non-Small-Cell Lung · Phase 4
- Carcinoma, Ovarian Epithelial · Phase 1
- Carcinoma, Pancreatic Ductal · Phase 2
- Carcinoma, Renal Cell · Phase 2
- Carcinoma, Small Cell · Phase 2
- Carcinoma, Squamous Cell · Phase 2
- Carcinoma, Transitional Cell · Phase 3
- Chemoradiotherapy · Phase 2
- Chemotherapy, Adjuvant · Phase 2
- Child · Phase 2/Phase 3
- Cholangiocarcinoma · Phase 3
- Colonic Neoplasms · Phase 3
- Colorectal Neoplasms · Phase 3
- Colorectal Neoplasms, Hereditary Nonpolyposis · Early Phase 1
- Dendritic Cells · Phase 2
- Desmoplastic Small Round Cell Tumor · Phase 2
- Digestive System Neoplasms · Phase 2
- DNA Mismatch Repair · Phase 2
- Drug-Related Side Effects and Adverse Reactions · Phase 2
- Drugs, Investigational · Phase 2
- Drug Therapy · Phase 3
- Electroconvulsive Therapy · Phase 2
- Endodermal Sinus Tumor · Phase 1
- Endometrial Neoplasms · Phase 1/Phase 2
- Epirubicin · Phase 2
- Esophageal Neoplasms · Phase 3
- Esophageal Squamous Cell Carcinoma · Phase 3
- Esophagogastric Junction · Phase 2
- Fibrosarcoma · Phase 2
- Gallbladder Neoplasms · Phase 2
- Genes, erbB-2 · Phase 2
- Genes, ras · Phase 2
- Glioblastoma · Phase 2
- Head and Neck Neoplasms · Phase 2
- Hemangiosarcoma · Phase 2
- Hodgkin Disease · Phase 4
- Hypopharyngeal Neoplasms · Phase 3
- Immune Checkpoint Inhibitors · Phase 3
- Immunotherapy · Phase 2
- Immunotherapy, Active · Phase 3
- Immunotherapy, Adoptive · Phase 2
- Intestinal Neoplasms · Phase 1/Phase 2
- Kidney Neoplasms · Phase 2
- Kidney Transplantation · Phase 2
- Killer Cells, Natural · Phase 2
- Klatskin Tumor · Phase 2
- Laryngeal Neoplasms · Phase 3
- Leiomyosarcoma · Phase 2
- Leukemia · Phase 1
- Leukemia, Lymphocytic, Chronic, B-Cell · Phase 2
- Leukemia-Lymphoma, Adult T-Cell · Phase 2
- Leukemia, Myeloid, Acute · Phase 2
- Linitis Plastica · Phase 2
- Liposarcoma · Phase 2
- Liver Neoplasms · Phase 2
- Lung Neoplasms · Phase 3
- Lymphoma · Phase 3
- Lymphoma, B-Cell, Marginal Zone · Phase 1/Phase 2
- Lymphoma, Extranodal NK-T-Cell · Phase 2
- Lymphoma, Follicular · Phase 2
- Lymphoma, Large B-Cell, Diffuse · Phase 3
- Lymphoma, Large-Cell, Anaplastic · Phase 2
- Lymphoma, Large-Cell, Immunoblastic · Phase 2
- Lymphoma, Mantle-Cell · Phase 1/Phase 2
- Lymphoma, Non-Hodgkin · Phase 2
- Lymphoma, T-Cell · Phase 2
- Lymphoma, T-Cell, Cutaneous · Phase 2
- Lymphoma, T-Cell, Peripheral · Phase 2
- Melanoma · Phase 2
- Mesothelioma · Phase 1
- Mesothelioma, Malignant · Phase 2
- Metabolism · Phase 2/Phase 3
- Microsatellite Instability · Phase 3
- Multicenter Study · Phase 3
- Mutation · Phase 2
- Nasopharyngeal Carcinoma · Phase 3
- Nasopharyngeal Neoplasms · Phase 2
- Neoadjuvant Therapy · Phase 4
- Neoplasm Metastasis · Phase 2/Phase 3
- Neoplasm Recurrence, Local · Phase 3
- Neoplasm, Residual · Phase 2
- Neoplasms · Phase 2
- Nerve Sheath Neoplasms · Phase 2
- Neuroendocrine Tumors · Phase 2
- Oropharyngeal Neoplasms · Phase 2
- Osteosarcoma · Early Phase 1
- Ovarian Neoplasms · Phase 2
- Oxaliplatin · Phase 2
- Pancreatic Neoplasms · Phase 3
- Pathology · Phase 2
- Patient Reported Outcome Measures · Phase 2
- Peritoneal Neoplasms · Phase 2
- Positron-Emission Tomography · Phase 2/Phase 3
- Prostatic Neoplasms · Phase 2
- Prostatic Neoplasms, Castration-Resistant · Phase 2
- Radiation · Phase 2
- Radiation Oncology · Phase 2
- Radiotherapy · Phase 2
- Rectal Neoplasms · Phase 3
- Recurrence · Phase 3
- Safety · Phase 2
- Sarcoma · Phase 3
- Simplexvirus · Phase 1/Phase 2
- Small Cell Lung Carcinoma · Phase 4
- Squamous Cell Carcinoma of Head and Neck · Phase 3
- Stomach · Phase 2
- Stomach Neoplasms · Phase 3
- Survival · Phase 2/Phase 3
- Testicular Neoplasms · Phase 1
- Therapeutics · Phase 2/Phase 3
- Thymoma · Phase 2
- Thyroid Carcinoma, Anaplastic · Phase 1/Phase 2
- Thyroid Neoplasms · Phase 2
- Transplantation · Phase 3
- Treatment Outcome · Phase 3
- Triple Negative Breast Neoplasms · Phase 2
- Tumor Escape · Phase 2
- Urinary Bladder Diseases · Phase 1/Phase 2
- Urinary Bladder Neoplasms · Phase 4
- Urogenital Neoplasms · Phase 1/Phase 2
- Urologic Neoplasms · Phase 1/Phase 2
- Uterine Cervical Neoplasms · Phase 2
- Uterine Neoplasms · Early Phase 1
- Young Adult · Phase 2/Phase 3
Mechanism of action
- Programmed cell death protein 1INHIBITOR
PDCD1 inhibitor
Approval history
- approvedMar 13, 2024
Chemistry & pharmacology
Loading structure…
SMILES
COCCNCc1ccc(-c2cc3nccc(Oc4ccc(NC(=O)C5(C(=O)Nc6ccc(F)cc6)CC5)cc4F)c3s2)nc1- Mol. weight
- 629.69 g/mol
- Lipinski Ro5
- 2 violation(s)
- Rule of 3
- No
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Availability
- Prescription Only
- Multi-specific
- No
Oral
No
Parenteral
No
Topical
No
Sources
- ChEMBLCHEMBL4297840 ↗
- WikipediaTislelizumab ↗
- ChEMBLCHEMBL3989926 ↗
Also known as
- bgb-a317
- sitravatinib tislelizumab
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07290985 | Phase 2 | Mar 1, 2026 | American Association for Cancer Research, Jazz Pharmaceuticals |
| NCT07300891 | Phase 2 | Jan 31, 2026 | Sungkyunkwan University |
| NCT07243938 | Phase 2 | Jan 15, 2026 | Huazhong University of Science and Technology |
| NCT07304258 | Phase 2 | Dec 12, 2025 | Hebei University |
| NCT07243691 | N/A | Dec 1, 2025 | Zhejiang University |
| NCT07244705 | Phase 1/Phase 2 (Phase 2) | Nov 30, 2025 | Anbogen Therapeutics, Inc., Fortrea |
| NCT07172412 | Phase 2 | Nov 30, 2025 | Tianjin Medical University |
| NCT07166263 | Early Phase 1 (Phase 1) | Nov 30, 2025 | Base Therapeutics (Shanghai) Co., Ltd. |
| NCT07233252 | Phase 2 | Nov 25, 2025 | Tianjin Medical University |
| NCT07205731 | Phase 2 | Oct 31, 2025 | BeOne Medicines, Federation Francophone de Cancerologie Digestive, University Clermont Auvergne |
| NCT07131319 | Phase 2/Phase 3 (Phase 3) | Oct 30, 2025 | Nanchang University |
| NCT07296705 | Phase 2 | Oct 25, 2025 | BeOne Medicines, Fujian Medical University |
| NCT07170995 | Phase 3 | Oct 22, 2025 | Suzhou Suncadia Biopharmaceuticals Co., Ltd. |
| NCT07119996 | Phase 1 | Oct 1, 2025 | Sun Yat-Sen University |
| NCT07132008 | Phase 3 | Oct 1, 2025 | Hacettepe University, University of South China, Xiamen University |
| NCT06883552 | Phase 2 | Oct 1, 2025 | Sichuan University |
| NCT07099547 | Phase 2 | Sep 30, 2025 | Suzhou Zelgen Biopharmaceuticals Co.,Ltd |
| NCT07128693 | Phase 2 | Sep 30, 2025 | Zhengzhou University |
| NCT07196540 | Phase 2 | Sep 26, 2025 | Sun Yat-Sen University |
| NCT07145931 | Phase 2 | Sep 20, 2025 | Sun Yat-Sen University |
Showing 20 of 529 trials
Page 1 / 27
Organizations
Research & Development (193)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| BeOne Medicines | For profit | 108 | 70 | 3 | 2015 |
| Fudan University | Academic/Hospital | 55 | 49 | 3 | 2017 |
| Sun Yat-Sen University | Academic/Hospital | 51 | 41 | 3 | 2019 |
| Jiao Tong University | Academic/Hospital | 38 | 31 | 5 | 2020 |
| Chinese Academy of Medical Sciences | Academic/Hospital | 35 | 26 | 3 | 2020 |
| Tianjin Medical University | Academic/Hospital | 29 | 24 | 3 | 2020 |
| Fujian Medical University | Academic/Hospital | 24 | 22 | 3 | 2021 |
| Sichuan University | Academic/Hospital | 22 | 18 | 4 | 2020 |
| Huazhong University of Science and Technology | Academic/Hospital | 21 | 15 | 4 | 2020 |
| Peking University | Academic/Hospital | 17 | 11 | 3 | 2021 |
| Zhejiang University | Academic/Hospital | 17 | 12 | 4 | 2020 |
| Nanjing Medical University | Academic/Hospital | 11 | 11 | 2 | 2020 |
| People's Liberation Army of China | Government | 11 | 9 | 4 | 2020 |
| Shandong University | Academic/Hospital | 10 | 5 | 2 | 2021 |
| Zhengzhou University | Academic/Hospital | 10 | 6 | 2 | 2021 |
| Capital Medical University | Academic/Hospital | 8 | 7 | 3 | 2021 |
| Henan Medical University | Academic/Hospital | 8 | 5 | 2 | 2021 |
| Novartis | For profit | 8 | 5 | 3 | 2022 |
| Anhui Medical University | Academic/Hospital | 7 | 3 | 3 | 2022 |
| China Medical University | Academic/Hospital | 7 | 4 | 3 | 2021 |
193 organizations
Page 1 / 10
Marketing (1)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| BeOne Medicines | For profit | NDA | Mar 13, 2024 |