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Drug

Hydroxocobalamin

Established medicine
ResearchOngoing clinical research
Also known as Calafol Rx, Cyanokit, Folpace Rx, Hydro Cobex+7 more

Calafol Rx, Cyanokit, Folpace Rx, Hydro Cobex, Hydro-Cobex, Hydroxy Cobal, Hydroxy-Cobal, OH-Cbl, Vitamin B12a, Hydroxocobalamine, Hydroxycobalamin.

1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Study on Hydroxocobalamin Given to Healthy Individual to Monitor Symptoms

Clinical trial2023-06-30Completed · ClinicalTrials.gov

Vitamin Deficiencies and Suppletion in Morbid Obesity

Clinical trial2016-06-01Completed · ClinicalTrials.gov

Approval: Cyanokit (EMA)

Regulatory2007-11-23EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Hydroxocobalamin
Aliases & brands
Calafol RxCyanokitFolpace RxHydro CobexHydro-CobexHydroxy CobalHydroxy-CobalOH-CblVitamin B12aHydroxocobalamineHydroxycobalamin
RxNorm CUI
5514
ChEMBL ID
CHEMBL2103737
ATC codes
B03BA03B03BA53V03AB33
UNII
Q40X8H422O
Regulatory jurisdictions
ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2007-11-23
Latest approval
2007-11-23
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2007-11-23Approval
Approval: Cyanokit (EMA)

Indication: Treatment of known or suspected cyanide poisoning. Cyanokit is to be administered together with appropriate decontamination and supportive measures.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

10 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
10
registered trials across all phases
LATEST COMPLETION 2024
6
Late-stage (III+)
6
Completed
4
Discontinued
PHASE DISTRIBUTIONn = 10
Phase 11Phase 23Phase 2 / 32Phase 43Phase N / A1

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Recent completions

Trials that read out recently, adding to the completed evidence base.

References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.