Carmustine
As of the edition of 20 October 2026, Carmustine is a small molecule: marketed, first approved in 1975 (CA); acts on GSR.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2016
- Kind
- Small molecule
- Brand name
- Bicnu
- First approved
- 31 December 1975 (CA)
- Approvals on record
- 9 in 6 regions
- Holder of the most recent approval
- Accord Healthcare; 8 holders in all
- Registered trials
- 200, 36 stopped early
- Disease areas
- Cancer; Immune system; Blood and lymph; Nervous system; Heart and blood vessels; Infections
US protection
No US approval on record.
With no US approval on record there are no listed US patents or exclusivities.
This is the US only.
Companies that need a new molecule because of this drug
1 company on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Carmustine.
See the 1 company on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| GSR | Glutathione reductase, mitochondrial | P00390 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 9 | 3 | 0 | 2 |
| Phase 1 | 33 | 23 | 3 | 6 |
| Phase 2 | 125 | 82 | 10 | 24 |
| Phase 3 | 33 | 19 | 1 | 4 |
| All trials | 200 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Sanofi | Later holder | 1996 to now |
| Nobelpharma | Applicant | 2012 to now |
| Avet Lifesciences | Acquired holder | 2021 to now |
| Accord Healthcare | Later holder | 2022 to now |
| Azurity Pharmaceuticals | Acquired holder | 2022 to now |