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Last Updated: March 26, 2025

CLINICAL TRIALS PROFILE FOR CYANOKIT


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All Clinical Trials for CYANOKIT

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT04054999 ↗ Methylene Blue vs Cyanokit for Intraoperative Vasoplegic Syndrome in Liver Transplant Patients Recruiting Mayo Clinic Phase 4 2021-12-30 This study will evaluate if Hydroxocobalamin may be a new and possibly superior treatment for refractory vasoplegic syndrome during liver transplant surgery.
NCT06160219 ↗ Prophylactic Use of Hydroxycobolamin in Vasoplegic Syndrome in Adult Patients Undergoing Cardiopulmonary Bypass Completed Ain Shams University Phase 2/Phase 3 2019-08-28 Several studies have described the use of alternative drugs as methylene blue (MB) (3) other than the standard limited options of the use of vasopressors and systemic corticosteroids (4) especially in the face of increasing incidence of vasoplegic syndrome. Hydroxycobolamin (HCO) has been used for treating cyanide poisoning for more than 40 years. Persistant and significant hypertension occurred as a result of the ability of (HCO) to bind nitric oxide (NO) to form nitrocobalamin. In this prospective randomized controlled trial, we hypothesized that the prophylactic use of HCO in high risk patients after CPB may decrease the incidence of vasoplegia.
NCT03783091 ↗ A Trial of Vitamin B12 in Septic Shock Recruiting Medical College of Wisconsin Phase 2 2019-08-05 This study will randomize 30 septic shock patients to receive either a single 5 gram dose of IV vitamin B12 (Cyanokit® Meridian Medical Technologies, Columbia, MD) versus placebo in addition to standard of care to reduce vasopressor dose at 3 hours.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 3 of 3 entries

Clinical Trial Conditions for CYANOKIT

Condition Name

2110-0.200.20.40.60.811.21.41.61.822.2Vasoplegic SyndromeLiver Transplant; ComplicationsSeptic Shock[disabled in preview]
Condition Name for CYANOKIT
Intervention Trials
Vasoplegic Syndrome 2
Liver Transplant; Complications 1
Septic Shock 1
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Condition MeSH

22110-0.200.20.40.60.811.21.41.61.822.2VasoplegiaSyndromeShock, SepticShock[disabled in preview]
Condition MeSH for CYANOKIT
Intervention Trials
Vasoplegia 2
Syndrome 2
Shock, Septic 1
Shock 1
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Clinical Trial Locations for CYANOKIT

Trials by Country

+
Trials by Country for CYANOKIT
Location Trials
United States 2
Egypt 1
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Trials by US State

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Trials by US State for CYANOKIT
Location Trials
Florida 1
Wisconsin 1
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Clinical Trial Progress for CYANOKIT

Clinical Trial Phase

33.3%33.3%33.3%0-0.100.10.20.30.40.50.60.70.80.911.1Phase 4Phase 2/Phase 3Phase 2[disabled in preview]
Clinical Trial Phase for CYANOKIT
Clinical Trial Phase Trials
Phase 4 1
Phase 2/Phase 3 1
Phase 2 1
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Clinical Trial Status

66.7%33.3%0-0.200.20.40.60.811.21.41.61.822.2RecruitingCompleted[disabled in preview]
Clinical Trial Status for CYANOKIT
Clinical Trial Phase Trials
Recruiting 2
Completed 1
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Clinical Trial Sponsors for CYANOKIT

Sponsor Name

trials000001111111Medical College of WisconsinMayo ClinicAin Shams University[disabled in preview]
Sponsor Name for CYANOKIT
Sponsor Trials
Medical College of Wisconsin 1
Mayo Clinic 1
Ain Shams University 1
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Sponsor Type

100.0%000.511.522.53Other[disabled in preview]
Sponsor Type for CYANOKIT
Sponsor Trials
Other 3
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CYANOKIT: Clinical Trials, Market Analysis, and Projections

Introduction to CYANOKIT

CYANOKIT, containing the active ingredient hydroxocobalamin, is a critical antidote for the treatment of known or suspected cyanide poisoning. Here, we will delve into the clinical trials, market analysis, and projections for this life-saving medication.

Clinical Trials and Efficacy

Challenges in Human Trials

Due to ethical considerations, randomized clinical trials in humans to assess the efficacy of hydroxocobalamin for cyanide poisoning are not feasible. Instead, evidence is primarily derived from animal studies and open-label, uncontrolled clinical studies in humans[3][4].

Open-Label Clinical Studies

Four open-label clinical studies were conducted on patients with known or suspected cyanide poisoning. These studies showed that hydroxocobalamin can rapidly resolve cyanide-induced lactic acidemia and improve survival rates. For instance, in a study on smoke inhalation, the response to CYANOKIT was positive in 45% of patients, partial in 22%, and absent in 15%, with 50 patients surviving[4].

Ongoing Research

An ongoing clinical trial is investigating the use of hydroxocobalamin (CYANOKIT) in septic shock patients. This study aims to assess the feasibility of using a single 5-gram dose of IV vitamin B12 in addition to standard care, focusing on hydrogen sulfide levels and vasopressor dependence[5].

Mechanism of Action

How CYANOKIT Works

CYANOKIT works by binding to cyanide ions, forming a stable complex that prevents cyanide from inhibiting the cytochrome oxidase enzyme. This enzyme is crucial for cellular respiration, and its inhibition by cyanide can lead to rapid cell death and systemic failure. By neutralizing cyanide, hydroxocobalamin restores the body's ability to use oxygen, thereby preventing the fatal consequences of cyanide poisoning[3].

Safety and Adverse Reactions

Common Adverse Reactions

The most common adverse reactions to CYANOKIT include transient chromaturia, erythema, oxalate crystals in urine, rash, increased blood pressure, nausea, headache, and infusion site reactions. More severe reactions can include allergic reactions such as anaphylaxis and angioneurotic edema[1].

Risk of Renal Injury and Increased Blood Pressure

CYANOKIT therapy is associated with risks of acute renal failure, renal impairment, and the formation of urine calcium oxalate crystals. Monitoring of renal function for 7 days post-therapy is recommended. Additionally, substantial increases in blood pressure may occur, necessitating blood pressure monitoring during treatment[1].

Market Analysis

Global Market Size and Growth

The global cyanocobalamin market, which includes CYANOKIT, was valued at USD 283.2 million in 2022 and is projected to reach USD 411.6 million by 2032, growing at a CAGR of 4.1% during the forecast period. This growth is driven by increasing awareness of vitamin B12's health benefits, the rising adoption of plant-based diets, and the use of cyanocobalamin as a food fortifier[2].

Regional Market Trends

  • Asia Pacific: Expected to lead the global market due to growing demand for food and pharmaceutical products, increasing healthcare spending, and a dense concentration of manufacturers in countries like China and India[2].
  • North America: Anticipated to experience significant growth driven by the expanding popularity of veganism and the rising need for vitamin B12 supplements. The United States is the largest market in this region due to the presence of numerous pharmaceutical and food companies[2].
  • Europe: Expected to grow at a moderate rate, driven by the demand for dietary supplements and the increasing trend of veganism. The region is home to a significant number of food and pharmaceutical companies, further fueling market growth[2].

Market Projections

Key Drivers

The market growth for CYANOKIT and other cyanocobalamin products is driven by several key factors:

  • Increasing Health Awareness: Rising public knowledge of vitamin B12's health advantages and its role in preventing and treating various diseases.
  • Dietary Trends: Growing adoption of plant-based diets, particularly vegan and vegetarian lifestyles, which increase the demand for vitamin B12 supplements.
  • Food Fortification: Use of cyanocobalamin to fortify foods such as infant formula, dairy products, and breakfast cereals, driven by government regulations and consumer demand for healthier products[2].

Future Outlook

The global cyanocobalamin market is expected to expand significantly over the forecast period, with the Asia Pacific region leading the growth. The North American and European markets will also see substantial growth, driven by the factors mentioned above. The increasing availability of low-cost sources and raw materials for cyanocobalamin production in developing countries will further support market expansion[2].

Key Takeaways

  • CYANOKIT is a critical antidote for treating known or suspected cyanide poisoning, with efficacy supported by open-label clinical studies.
  • The drug's mechanism involves binding to cyanide ions to restore cellular respiration.
  • Common adverse reactions include transient chromaturia, erythema, and increased blood pressure, with risks of renal injury and severe allergic reactions.
  • The global cyanocobalamin market is projected to grow at a CAGR of 4.1% from 2022 to 2032, driven by health awareness, dietary trends, and food fortification.
  • Regional markets in Asia Pacific, North America, and Europe are expected to see significant growth.

FAQs

What is CYANOKIT used for?

CYANOKIT is used as an antidote for the treatment of known or suspected cyanide poisoning.

How does CYANOKIT work?

CYANOKIT works by binding to cyanide ions, forming a stable complex that prevents cyanide from inhibiting the cytochrome oxidase enzyme, thereby restoring the body's ability to use oxygen.

What are the common adverse reactions to CYANOKIT?

Common adverse reactions include transient chromaturia, erythema, oxalate crystals in urine, rash, increased blood pressure, nausea, headache, and infusion site reactions.

What are the risks associated with CYANOKIT therapy?

CYANOKIT therapy is associated with risks of acute renal failure, renal impairment, and substantial increases in blood pressure.

What is the projected growth of the global cyanocobalamin market?

The global cyanocobalamin market is projected to grow from USD 283.2 million in 2022 to USD 411.6 million by 2032, at a CAGR of 4.1%.

Sources

  1. CYANOKIT-Training-Presentation_Nov2021.pdf - CYANOKIT Training Presentation.
  2. Reports and Data - Cyanocobalamin Market Size 2023, Forecast By 2032.
  3. Cyanokit.com - Treat Cyanide Poisoning With CYANOKIT® (hydroxocobalamin).
  4. European Medicines Agency - Cyanokit | European Medicines Agency (EMA).
  5. ClinicalTrials.Veeva - A Trial of Vitamin B12 in Septic Shock.

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