Trastuzumab
As of the edition of 20 October 2026, Trastuzumab is an antibody: marketed, first approved in 1998 (US); acts on ERBB2; US protection ended in 2017.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2001
- Kind
- Antibody
- Brand name
- Herceptin
- First approved
- 25 September 1998 (US)
- Approvals on record
- 26 in 5 regions
- Holder of the most recent approval
- Prestige Biopharma; 8 holders in all
- Registered trials
- 885, 127 stopped early
- Disease areas
- Cancer; Skin and connective tissue; Digestive system; Urinary and reproductive; Nervous system; Pregnancy and women's health
US protection
US protection ended in 2017.
The orphan exclusivity ended in 2017 (it covers one use only). The application that gives this date is held by Roche.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product3 listings count towards this date. The exact date and each listing are in the product.
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Target
| Gene | Protein | UniProt |
|---|---|---|
| ERBB2 | Receptor tyrosine-protein kinase erbB-2 | P04626 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 68 | 34 | 9 | 6 |
| Phase 1 | 109 | 73 | 14 | 16 |
| Phase 2 | 542 | 250 | 133 | 91 |
| Phase 3 | 150 | 80 | 43 | 12 |
| Phase 4 | 16 | 4 | 8 | 2 |
| All trials | 885 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Roche | Applicant, Later holder and Lead sponsor of trials | 1998 to now |
| Pfizer | Applicant and Lead sponsor of trials | 2001 to now |
| Amgen | Later holder and Lead sponsor of trials | 2009 to now |
| Prestige Biopharma | Later holder and Lead sponsor of trials | 2018 to now |