Melphalan
As of the edition of 20 October 2026, Melphalan is a small molecule: marketed, first approved in 1964 (CH); no US protection of its own is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2017
- Kind
- Small molecule
- Brand name
- Alkeran
- First approved
- 17 September 1964 (CH)
- Approvals on record
- 9 in 5 regions
- Holder of the most recent approval
- Apotex; 7 holders in all
- Registered trials
- 651, 113 stopped early
- Disease areas
- Cancer; Blood and lymph; Immune system; Heart and blood vessels; Inherited and neonatal; Nutrition and metabolism
US protection
No US protection of its own is listed.
The FDA registers list no drug-substance patent or exclusivity of its own that counts for this drug.
Delcath Systems holds a later exclusivity on its own new formulation or combination product, ending 2030; it does not protect the original drug.
This is the US only.
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 43 | 19 | 7 | 6 |
| Phase 1 | 119 | 65 | 17 | 27 |
| Phase 2 | 395 | 226 | 62 | 71 |
| Phase 3 | 91 | 49 | 17 | 8 |
| Phase 4 | 3 | 1 | 1 | 1 |
| All trials | 651 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Acrotech Biopharma | Acquired holder and Lead sponsor of trials | 2010 to now |
| Delcath Systems | Later holder and Lead sponsor of trials | 2014 to now |
| Zydus Worldwide DMCC | Later holder | 2016 to now |
| Apotex | Acquired holder | 2016 to now |
| GSK | Earlier holder |