trastuzumab
Trade name: herceptin
mAbapproved
Approved
Sep 25, 1998
Trastuzumab, sold under the brand name Herceptin among others, is a monoclonal antibody used to treat breast cancer and stomach cancer. It is specifically used for cancer that is HER2 receptor positive. It may be used by itself or together with other chemotherapy medication. Trastuzumab is given by slow injection into a vein and injection just under the skin. — Wikipedia
Clinical trial activity
963 trials · 532 clinical orgs · 9 marketing orgs
Phase 1
225
Phase 2
756
Phase 3
197
Phase 4
18
Earliest trial started Dec 31, 1992
Timeline
1990s
- Jan 1, 1992
Genentech — Earliest Phase 1 Sponsor
- Jan 1, 1998
Earliest Phase 2 Sponsor(trial)
- Jan 1, 1998
Earliest Phase 3 Sponsor(trial)
- Sep 25, 1998
Genentech — Earliest FDA Approval
- Sep 25, 1998
Genentech — Marketing Organization
- Sep 25, 1998
Genentech — NDA Secondary Org
- Sep 25, 1998
Genentech — NDA Organization
2010s
- Dec 1, 2017
Mylan — Marketing Organization
- Dec 1, 2017
Biocon Limited — NDA Secondary Org
- Dec 14, 2018
Celltrion — Marketing Organization
- Dec 14, 2018
Celltrion — NDA Secondary Org
- Jan 18, 2019
Samsung — Marketing Organization
- Jan 18, 2019
Samsung — NDA Secondary Org
- Feb 28, 2019
Roche — NDA Secondary Org
- Mar 11, 2019
Pfizer — Marketing Organization
- Mar 11, 2019
Pfizer — NDA Secondary Org
- Jun 13, 2019
Amgen — Marketing Organization
- Jun 13, 2019
Amgen — NDA Secondary Org
2020s
- Apr 25, 2024
Accord Research — Marketing Organization
Indications
Approved for
Studied for
- Adenocarcinoma · Phase 2
- Adrenocortical Carcinoma · Phase 1
- Antibodies, Monoclonal · Phase 3
- Antineoplastic Agents · Phase 1
- Appendix · Phase 1
- Arthritis, Psoriatic · Phase 3
- Bile Duct Neoplasms · Phase 2
- Biliary Tract Neoplasms · Phase 3
- Brain Neoplasms · Phase 4
- Breast Carcinoma In Situ · Phase 2
- Breast Diseases · Phase 2
- Breast Neoplasms, Male · Phase 3
- Carcinoma · Phase 2
- Carcinoma, Adenoid Cystic · Phase 1
- Carcinoma, Ductal, Breast · Phase 2
- Carcinoma, Hepatocellular · Phase 1
- Carcinoma, Islet Cell · Phase 1
- Carcinoma, Mucoepidermoid · Phase 1
- Carcinoma, Non-Small-Cell Lung · Phase 2
- Carcinoma, Renal Cell · Phase 2
- Carcinoma, Squamous Cell · Phase 1
- Carcinoma, Transitional Cell · Phase 2
- Cardiotoxicity · Phase 3
- Central Nervous System Diseases · Phase 1/Phase 2
- Chemotherapy-Induced Febrile Neutropenia · Phase 3
- Cholangiocarcinoma · Phase 2
- Cognition Disorders · Phase 1/Phase 2
- Colonic Neoplasms · Phase 3
- Colorectal Neoplasms · Phase 3
- Depression · Phase 2
- Dihydropyrimidine Dehydrogenase Deficiency · Phase 2
- Drug-Related Side Effects and Adverse Reactions · Phase 3
- Drugs, Investigational · Phase 2
- Drug Therapy, Combination · Phase 1/Phase 2
- Endometrial Neoplasms · Phase 2/Phase 3
- Ependymoma · Phase 1
- Epidermal Growth Factor · Phase 2
- ErbB Receptors · Phase 2
- Esophageal Neoplasms · Phase 3
- Esophageal Squamous Cell Carcinoma · Phase 2
- Fallopian Tube Neoplasms · Phase 1
- Gallbladder Neoplasms · Phase 2/Phase 3
- Gastrinoma · Phase 1
- Gastrointestinal Neoplasms · Phase 2
- Genes, erbB-2 · Phase 2
- Glioma · Phase 1/Phase 2
- Glucagonoma · Phase 1
- Hamartoma · Phase 1
- Head and Neck Neoplasms · Phase 2
- Health Services for the Aged · Phase 2
- Healthy Volunteers · Phase 1
- Heart Failure · Phase 2
- Helicobacter pylori · Phase 4
- Hemangiosarcoma · Phase 2
- Hematologic Neoplasms · Phase 1
- Hodgkin Disease · Phase 1
- Hypertrophy, Left Ventricular · Phase 2
- Immunotherapy · Phase 2
- Inflammatory Breast Neoplasms · Phase 3
- Infusions, Intravenous · Phase 4
- Insulinoma · Phase 1
- Intestinal Neoplasms · Phase 2
- Leukemia · Phase 2
- Leukemia, Myeloid, Acute · Phase 2
- Liver Neoplasms · Phase 1
- Lung Neoplasms · Phase 2/Phase 3
- Lymphoma, B-Cell, Marginal Zone · Phase 1
- Lymphoma, Non-Hodgkin · Phase 2
- Melanoma · Phase 1/Phase 2
- Meningeal Carcinomatosis · Phase 1/Phase 2
- Meninges · Phase 2
- Menopause · Phase 1
- Multiple Myeloma · Phase 2
- Mutation · Phase 2
- Mycosis Fungoides · Phase 1
- Neoadjuvant Therapy · Phase 2
- Neoplasm Metastasis · Phase 4
- Neoplastic Cells, Circulating · Phase 2
- Neuromuscular Diseases · Phase 2
- Osteosarcoma · Phase 2
- Ovarian Neoplasms · Phase 2/Phase 3
- Oxaliplatin · Phase 2
- Paget Disease, Extramammary · Phase 2
- Pancreatic Neoplasms · Phase 2/Phase 3
- Peritoneal Neoplasms · Phase 1
- Pharmacokinetics · Phase 2
- Pleural Effusion, Malignant · Phase 1
- Postmenopause · Phase 1/Phase 2
- Progression-Free Survival · Phase 2
- Prostatic Neoplasms · Phase 2/Phase 3
- Prostatic Neoplasms, Castration-Resistant · Phase 2
- Psoriasis · Phase 3
- Radiotherapy · Phase 2
- Rectal Neoplasms · Phase 2
- Renal Colic · Phase 2
- Rocky Mountain Spotted Fever · Phase 3
- Salivary Gland Neoplasms · Phase 2/Phase 3
- Sarcoma · Phase 2
- Skin Neoplasms · Phase 2/Phase 3
- Small Cell Lung Carcinoma · Phase 2
- Somatostatinoma · Phase 1
- Spinal Muscular Atrophies of Childhood · Phase 1/Phase 2
- Squamous Cell Carcinoma of Head and Neck · Phase 2
- Stomach Neoplasms · Phase 4
- Testicular Neoplasms · Phase 1
- Thyroid Carcinoma, Anaplastic · Phase 1
- Thyroid Neoplasms · Phase 1
- Trastuzumab · Phase 3
- Treatment Outcome · Phase 2
- Triple Negative Breast Neoplasms · Phase 2
- Tumor Burden · Phase 3
- Urethral Neoplasms · Phase 2
- Urinary Bladder Neoplasms · Phase 2/Phase 3
- Urological Manifestations · Early Phase 1
- Urologic Neoplasms · Phase 2
- Uterine Cervical Neoplasms · Phase 2
- Uterine Neoplasms · Phase 2/Phase 3
- Vaginal Neoplasms · Phase 1
- Vipoma · Phase 1
- Vulvar Neoplasms · Phase 1
Mechanism of action
ERBB2 inhibitor
Approval history
- approvedSep 25, 1998
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
- Multi-specific
- No
Oral
No
Parenteral
Yes
Topical
No
Black box warning
Sources
- WikipediaTrastuzumab ↗
- NCATSP188ANX8CK ↗
- ChEMBLCHEMBL1201585 ↗
Also known as
- 4d5v8
- abp 980
- anti her2
- cipterbin
- herceptin
- herceptin
- herceptin
- herceptin
- r-597
- trastuzuamb
- trastuzumab
- trastuzumab
- trastuzumab
- trastuzumab
- trastuzumab
- trastuzumab
- trastuzumab
- trastuzumab
- trastuzumab
- trastuzumab
- trastuzumab
- trastuzumab-dkst
- trastuzumab-dttb
- trastuzumab-pkrb
- trastuzumab-qyyp
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07299955 | Phase 1 | Jan 9, 2026 | Biocon Limited |
| NCT07299890 | Phase 2 | Dec 20, 2025 | Anhui Medical University |
| NCT07246317 | Phase 2 | Dec 15, 2025 | Tianjin Medical University |
| NCT07245797 | Phase 2 | Dec 15, 2025 | Fudan University |
| NCT07193394 | Phase 2 | Dec 5, 2025 | Curie Institute, Eurofins, Pfizer, UNICANCER |
| NCT07136428 | Phase 1/Phase 2 (Phase 2) | Nov 30, 2025 | Duke University, Novartis |
| NCT07220135 | Phase 2 | Nov 14, 2025 | University of Kansas |
| NCT07216105 | Phase 1 | Nov 4, 2025 | Fate Therapeutics |
| NCT07070999 | Phase 1/Phase 2 (Phase 2) | Oct 31, 2025 | Gemma Biotherapeutics |
| NCT07263425 | Phase 2 | Oct 27, 2025 | Nanjing Medical University |
| NCT07196774 | Phase 3 | Oct 23, 2025 | Hengrui Therapeutics, Inc. |
| NCT07214766 | Phase 1 | Oct 17, 2025 | Genentech |
| NCT07176702 | Phase 2 | Sep 30, 2025 | Fudan University |
| NCT07187752 | N/A | Sep 30, 2025 | Shandong University |
| NCT07102381 | Phase 2 | Sep 24, 2025 | Jazz Pharmaceuticals |
| NCT07053085 | Phase 2 | Sep 17, 2025 | Gateway for Cancer Research, Memorial Sloan-Kettering Cancer Center |
| NCT07116824 | Phase 2 | Sep 15, 2025 | Shijiazhuang Pharma Group (CSPC) |
| NCT07043725 | Phase 3 | Sep 15, 2025 | Jiangsu Chia-tai Tianqing Pharmaceutical Co.,Ltd |
| NCT07179939 | Phase 2 | Sep 10, 2025 | Fudan University, Hengrui Therapeutics, Inc., People's Liberation Army of China |
| NCT07136974 | Phase 2 | Sep 1, 2025 | Henan Medical University |
Showing 20 of 963 trials
Page 1 / 49
Organizations
Research & Development (532)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Roche | For profit | 128 | 77 | 4 | 1999 |
| National Cancer Institute (NCI) | Government | 125 | 50 | 5 | 1997 |
| Genentech | For profit | 69 | 12 | 4 | 1992 |
| Novartis | For profit | 43 | 24 | 4 | 2000 |
| Harvard University | Academic/Hospital | 39 | 30 | 3 | 1999 |
| Fudan University | Academic/Hospital | 32 | 25 | 2 | 2005 |
| GlaxoSmithKline | For profit | 27 | 7 | 3 | 2001 |
| Pfizer | For profit | 22 | 8 | 3 | 2001 |
| Merck | For profit | 20 | 8 | 3 | 2005 |
| Seattle Genetics | For profit | 19 | 7 | 4 | 2013 |
| Sun Yat-Sen University | Academic/Hospital | 19 | 16 | 3 | 2011 |
| Cornell University | Academic/Hospital | 18 | 14 | 2 | 1998 |
| Sanofi | For profit | 18 | 8 | 3 | 2001 |
| Chinese Academy of Medical Sciences | Academic/Hospital | 17 | 13 | 3 | 2005 |
| University of Texas at Houston | Academic/Hospital | 17 | 11 | 4 | 2000 |
| AstraZeneca | For profit | 14 | 4 | 3 | 2005 |
| Amgen | For profit | 13 | 2 | 3 | 2001 |
| Hengrui Therapeutics, Inc. | For profit | 13 | 5 | 3 | 2018 |
| Bristol-Myers Squibb | For profit | 12 | 2 | 2 | 1999 |
| Eli Lilly | For profit | 12 | 4 | 3 | 2001 |
532 organizations
Page 1 / 27
Marketing (16)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Accord Research | For profit | MKTG | Apr 25, 2024 |
| Amgen | For profit | MKTG | Jun 13, 2019 |
| Amgen | For profit | NDA2 | Jun 13, 2019 |
| Biocon Limited | For profit | NDA2 | Dec 1, 2017 |
| Celltrion | For profit | MKTG | Dec 14, 2018 |
| Celltrion | For profit | NDA2 | Dec 14, 2018 |
| Genentech | For profit | MKTG | Sep 25, 1998 |
| Genentech | For profit | SYN | Feb 28, 2019 |
| Genentech | For profit | NDA2 | Sep 25, 1998 |
| Genentech | For profit | NDA | Sep 25, 1998 |
| Mylan | For profit | MKTG | Dec 1, 2017 |
| Pfizer | For profit | MKTG | Mar 11, 2019 |
| Pfizer | For profit | NDA2 | Mar 11, 2019 |
| Roche | For profit | NDA2 | Feb 28, 2019 |
| Samsung | For profit | MKTG | Jan 18, 2019 |
| Samsung | For profit | NDA2 | Jan 18, 2019 |