Albendazole
As of the edition of 20 October 2026, Albendazole is a small molecule: marketed, first approved in 1987 (FR).
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 1996
- Kind
- Small molecule
- Brand name
- Albenza
- First approved
- 1 July 1987 (FR)
- Approvals on record
- 6 in 4 regions
- Holder of the most recent approval
- AMEDRA PHARMACEUTICALS LLC; 3 holders in all
- Registered trials
- 87, 7 stopped early
- Disease areas
- Infections; Blood and lymph; Skin and connective tissue; Eye; Nutrition and metabolism; Digestive system
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 | 35 | 24 | 2 | 1 |
| Phase 1 | 3 | 3 | 0 | 0 |
| Phase 2 | 13 | 9 | 2 | 2 |
| Phase 3 | 18 | 15 | 1 | 2 |
| Phase 4 | 18 | 13 | 3 | 2 |
| All trials | 87 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| GSK | Applicant and Lead sponsor of trials | 1993 to now |
| Amneal Pharmaceuticals | Acquired holder | 2017 to now |