Lomustine
As of the edition of 20 October 2026, Lomustine is a small molecule: marketed, first approved in 1976 (CA).
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2022
- Kind
- Small molecule
- Brand name
- Gleostine
- First approved
- 31 December 1976 (CA)
- Approvals on record
- 7 in 3 regions
- Holder of the most recent approval
- MEDAC GESELLSCHAFT FUR KLINISCHE SPEZIALPRAPARATE (ALLEMAGNE); 3 holders in all
- Registered trials
- 81, 14 stopped early
- Disease areas
- Cancer; Nervous system; Blood and lymph; Immune system; Lungs and airways; Skin and connective tissue
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 | 7 | 3 | 1 | 1 |
| Phase 1 | 14 | 7 | 2 | 5 |
| Phase 2 | 37 | 16 | 8 | 8 |
| Phase 3 | 23 | 12 | 6 | 0 |
| All trials | 81 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Azurity Pharmaceuticals | Acquired holder | 2025 to now |
| Bristol Myers Squibb | Earlier holder |