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Data updated: May 26, 2026

CYANOKIT (hydroxocobalamin)

Other Approved 2006-12-15

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.

Source: FDA Label • BTG INTL • Antidote

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.

1
Indication
--
Phase 3 Trials
1
Priority Reviews
19
Years on Market

Details

Status
Prescription
First Approved
2006-12-15
Routes
INJECTION
Dosage Forms
INJECTABLE

Companies

Active Ingredient: HYDROXOCOBALAMIN

CYANOKIT Approval History

2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
24 FDA actions from 2006 to 2018
Dec 2018 SUPPL
Label · Labeling
Feb 2016 SUPPL Priority
Mfg · Manufacturing (CMC)
Jul 2014 SUPPL Priority
Mfg · Manufacturing (CMC)

What CYANOKIT Treats

1 indications

CYANOKIT is approved for 1 conditions since its original approval in 2006. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Cyanide Poisoning
Source: FDA Label

CYANOKIT Competitive Set

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Three rings of competition based on shared molecular targets and treated indications.

MoA expansion candidates

2

Same target(s), different indications — where else is this mechanism being explored?

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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to CYANOKIT

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

NITHIODOTE
SODIUM NITRITE
1 shared
HOPE PHARMS
Shared indications:
Cyanide Poisoning
SODIUM NITRITE
SODIUM NITRITE
1 shared
HOPE PHARMS
Shared indications:
Cyanide Poisoning
SODIUM THIOSULFATE
SODIUM THIOSULFATE
1 shared
US ARMY
Shared indications:
Cyanide Poisoning
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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
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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

Full development history with FDA approval milestones

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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.