Chlorambucil
As of the edition of 20 October 2026, Chlorambucil is a small molecule: marketed, first approved in 1957 (CH).
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
- Leukeran
- First approved
- 1 June 1957 (CH)
- Approvals on record
- 4 in 4 regions
- Holder of the most recent approval
- Aspen Pharma Trading Limited; 4 holders in all
- Registered trials
- 36, 5 stopped early
- Disease areas
- Cancer; Blood and lymph; Immune system; Digestive system; Heart and blood vessels; Pregnancy and women's health
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 | 3 | 1 | 0 | 0 |
| Phase 1 | 3 | 2 | 0 | 1 |
| Phase 2 | 12 | 6 | 1 | 3 |
| Phase 3 | 17 | 11 | 0 | 1 |
| Phase 4 | 1 | 1 | 0 | 0 |
| All trials | 36 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Waylis Therapeutics | Acquired holder | 2023 to now |
| GSK | Earlier holder |