Bcg vaccine
As of the edition of 20 October 2026, Bcg vaccine is a vaccine component: marketed, first approved in 1989 (US); US protection ended in 2001.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1989
- Kind
- Vaccine component
- Brand name
- Mycobax
- First approved
- 21 June 1989 (US)
- Approvals on record
- 2 in 1 region
- Holder of the most recent approval
- Sanofi; 2 holders in all
- Registered trials
- 42, 6 stopped early
- Disease areas
- Cancer; Infections; Lungs and airways; Urinary and reproductive; Pregnancy and women's health; Digestive system
US protection
US protection ended in 2001.
US protection ended in 2001, computed as 12 years from the first US licence because FDA publishes no date for this product. The application that gives this date is held by Merck & Co.. The date is computed, not published.
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 product1 listing counts towards this date. The exact date and each listing are in the product.
See the exact date and the 1 listing behind itRequest access. Nothing is shown until you do.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 2 | 1 | 0 | 0 |
| Phase 1 | 5 | 4 | 1 | 0 |
| Phase 2 | 11 | 5 | 0 | 3 |
| Phase 3 | 14 | 9 | 0 | 3 |
| Phase 4 | 10 | 4 | 4 | 0 |
| All trials | 42 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Sanofi | Later holder | 2000 to now |
| Merck & Co. | Acquired holder | 2022 to now |