CYANOKIT (hydroxocobalamin)
Cyanokit is an antidote used for patients who have known or suspected cyanide poisoning. Because cyanide is a fast-acting toxin that can cause death within minutes, this medication is used to quickly neutralize the poison in the body. It helps patients by preventing the severe cellular damage and metabolic issues that occur during a poisoning event.
How CYANOKIT Works
This drug works by binding directly to cyanide ions, replacing its own hydroxo ligand with the toxin to form cyanocobalamin. This process prevents cyanide from inhibiting the mitochondria's ability to use oxygen for cellular respiration. Once the cyanide is bound to the medication, the resulting compound is safely excreted from the body through the urine.
Details
- Status
- Prescription
- First Approved
- 2006-12-15
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
CYANOKIT Approval History
What CYANOKIT Treats
1 indicationsCYANOKIT is approved for 1 conditions since its original approval in 2006. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Cyanide Poisoning
CYANOKIT Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Clinical Trial Registry
6 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07469189 Shrimp | 2022P003028 | Ph 1 | completed | A Study on Hydroxocobalamin Given to Healthy Individual to Monitor Symptoms |
| NCT03783091 B12 | 32950 | Ph 2 | completed | A Trial of Vitamin B12 in Septic Shock |
| NCT04054999 results posted | 18-006247 | Ph 4 | completed | Methylene Blue vs Cyanokit for Intraoperative Vasoplegic Syndrome in Liver Transplant Patients |
| NCT03735316 results posted | 17-011130 | Ph 2 | terminated | Vitamin B12a Vasoplegic Syndrome |
| NCT02270749 | VITAALII | Ph 4 | completed | Vitamin Deficiencies and Suppletion in Morbid Obesity |
| NCT03446599 | D17173 | Ph 2 | withdrawn | Hemodynamic Effects of Methylene Blue vs Hydroxocobalamin in Patients at Risk of Vasoplegia During Cardiac Surgery |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
CYANOKIT FDA Label Details
Indications & Usage
FDA Label (PDF)CYANOKIT is indicated for the treatment of Cyanide Poisoning.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.