Busulfan
As of the edition of 20 October 2026, Busulfan is a small molecule: marketed, first approved in 1954 (CA).
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2020
- Kind
- Small molecule
- Brand name
- Myleran
- First approved
- 31 December 1954 (CA)
- Approvals on record
- 9 in 5 regions
- Holder of the most recent approval
- Otsuka; 5 holders in all
- Registered trials
- 503, 95 stopped early
- Disease areas
- Blood and lymph; Cancer; Immune system; Inherited and neonatal; 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.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 43 | 13 | 9 | 11 |
| Phase 1 | 68 | 35 | 13 | 18 |
| Phase 2 | 320 | 172 | 50 | 60 |
| Phase 3 | 66 | 23 | 11 | 6 |
| Phase 4 | 6 | 2 | 0 | 0 |
| All trials | 503 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Otsuka | Acquired holder and Lead sponsor of trials | 2008 to now |
| Waylis Therapeutics | Acquired holder | 2023 to now |
| GSK | Earlier holder |