Hydroxocobalamin
As of the edition of 20 October 2026, Hydroxocobalamin is a small molecule: marketed, first approved in 1968 (ES).
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2007
- Kind
- Small molecule
- Brand name
- Cyanokit
- First approved
- 1 June 1968 (ES)
- Approvals on record
- 5 in 4 regions
- Holder of the most recent approval
- Btg; 4 holders in all
- Registered trials
- 10, 2 stopped early
- Disease areas
- Heart and blood vessels; Nutrition and metabolism; Blood and lymph; Bones, joints and muscles; Infections; Inherited and neonatal
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 | 1 | 1 | 0 | 0 |
| Phase 1 | 1 | 1 | 0 | 0 |
| Phase 2 | 3 | 1 | 0 | 2 |
| Phase 3 | 2 | 0 | 1 | 0 |
| Phase 4 | 3 | 2 | 0 | 0 |
| All trials | 10 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Merck KGaA | Earlier holder | 2006 to now |
| Serb | Applicant | 2007 to now |
| Btg | Acquired holder | 2022 to now |