CLINICAL TRIALS PROFILE FOR CYANOCOBALAMIN; CYANOCOBALAMIN CO-57; CYANOCOBALAMIN CO-58

All Clinical Trials for cyanocobalamin; cyanocobalamin co-57; cyanocobalamin co-58

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00004495 ↗	Randomized Study of Folic Acid Therapy for Hyperhomocysteinemia in Patients With End Stage Renal Disease Receiving Hemodialysis	Completed	Georgetown University	N/A	1999-06-01	OBJECTIVES: I. Compare the efficacy of two doses of folic acid in normalizing plasma total homocysteine concentration in patients with end stage renal disease receiving regular hemodialysis therapy resulting in hyperhomocysteinemia. II. Determine the requirement of co-supplementation with extra pyridoxine (vitamin B6) and cyanocobalamin (vitamin B12) daily in these patients. III. Assess the safety and tolerability of this therapy in these patients.
NCT00004734 ↗	Vitamin Therapy for Prevention of Stroke	Completed	National Institute of Neurological Disorders and Stroke (NINDS)	Phase 3	1996-09-01	A stroke occurs when part of the brain is damaged from lack of normal blood supply. This may result in difficulty with feeling, speech, muscle strength or coordination, movement, thinking, or other brain functions. Having a stroke increases the risk of another stroke occurring in the future. Higher blood levels of a natural chemical known as homocysteine may contribute to hardening of the arteries in the brain or heart and increase the risk of stroke or heart attack. Folic acid, vitamin B6 (pyridoxine), and vitamin B12 (cyanocobalamin) may lower blood levels of homocysteine and reduce the risk of having another stroke or a heart attack.
NCT00032435 ↗	Homocysteine Study (HOST)	Completed	Abbott Diagnostics Division	Phase 3	2001-05-01	The primary objective of this study is to test the hypothesis that administration of folate, pyridoxine (vitamin B6) and cyanocobalamin (vitamin B12) in high doses to patients with advanced chronic renal failure or end stage renal disease and abnormally high plasma homocysteine levels will lower the homocysteine levels and the death rate compared to patients who receive placebo. The secondary objective is to test the hypothesis that intake of the vitamins compared to placebo decreases the incidence of myocardial infarction, disabling stroke, and amputation of a lower extremity and, in hemodialysis patients, thrombosis of the vascular access.
NCT00032435 ↗	Homocysteine Study (HOST)	Completed	Pan American Laboratories	Phase 3	2001-05-01	The primary objective of this study is to test the hypothesis that administration of folate, pyridoxine (vitamin B6) and cyanocobalamin (vitamin B12) in high doses to patients with advanced chronic renal failure or end stage renal disease and abnormally high plasma homocysteine levels will lower the homocysteine levels and the death rate compared to patients who receive placebo. The secondary objective is to test the hypothesis that intake of the vitamins compared to placebo decreases the incidence of myocardial infarction, disabling stroke, and amputation of a lower extremity and, in hemodialysis patients, thrombosis of the vascular access.
NCT00032435 ↗	Homocysteine Study (HOST)	Completed	US Department of Veterans Affairs	Phase 3	2001-05-01	The primary objective of this study is to test the hypothesis that administration of folate, pyridoxine (vitamin B6) and cyanocobalamin (vitamin B12) in high doses to patients with advanced chronic renal failure or end stage renal disease and abnormally high plasma homocysteine levels will lower the homocysteine levels and the death rate compared to patients who receive placebo. The secondary objective is to test the hypothesis that intake of the vitamins compared to placebo decreases the incidence of myocardial infarction, disabling stroke, and amputation of a lower extremity and, in hemodialysis patients, thrombosis of the vascular access.

Clinical Trial Conditions for cyanocobalamin; cyanocobalamin co-57; cyanocobalamin co-58

Condition Name

Condition Name for cyanocobalamin; cyanocobalamin co-57; cyanocobalamin co-58
Intervention	Trials
Anaemia	2
End Stage Renal Disease	2
Vitamin B12 Deficiency	2
Stroke	1

Condition MeSH

Condition MeSH for cyanocobalamin; cyanocobalamin co-57; cyanocobalamin co-58
Intervention	Trials
Vitamin B 12 Deficiency	3
Kidney Failure, Chronic	2
Kidney Diseases	2
COVID-19	1

Clinical Trial Locations for cyanocobalamin; cyanocobalamin co-57; cyanocobalamin co-58

Trials by Country

Trials by Country for cyanocobalamin; cyanocobalamin co-57; cyanocobalamin co-58
Location	Trials
United States	140
India	2
Mexico	2
Denmark	1
China	1

Trials by US State

Trials by US State for cyanocobalamin; cyanocobalamin co-57; cyanocobalamin co-58
Location	Trials
Ohio	9
Pennsylvania	8
Illinois	8
Texas	7
Missouri	6

Clinical Trial Progress for cyanocobalamin; cyanocobalamin co-57; cyanocobalamin co-58

Clinical Trial Phase

Clinical Trial Phase for cyanocobalamin; cyanocobalamin co-57; cyanocobalamin co-58
Clinical Trial Phase	Trials
PHASE3	1
Phase 4	2
Phase 3	5

Clinical Trial Status

Clinical Trial Status for cyanocobalamin; cyanocobalamin co-57; cyanocobalamin co-58
Clinical Trial Phase	Trials
Completed	21
Not yet recruiting	2
Terminated	2

Clinical Trial Sponsors for cyanocobalamin; cyanocobalamin co-57; cyanocobalamin co-58

Sponsor Name

Sponsor Name for cyanocobalamin; cyanocobalamin co-57; cyanocobalamin co-58
Sponsor	Trials
National Cancer Institute (NCI)	8
Gynecologic Oncology Group	4
Eastern Cooperative Oncology Group	2

Sponsor Type

Sponsor Type for cyanocobalamin; cyanocobalamin co-57; cyanocobalamin co-58
Sponsor	Trials
Other	25
NIH	9
Industry	7

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Last updated: April 28, 2026

Cyanocobalamin (Vitamin B12) and Radiolabeled Variants: What’s in Clinical Development and How the Market Shapes Projections

What is cyanocobalamin clinically used for?

Cyanocobalamin is vitamin B12 in its cyanide form. In clinical practice, it is used to treat or prevent vitamin B12 deficiency and to support hematologic and neurologic outcomes in megaloblastic anemia and related deficiency states. In regulatory and commercial terms, cyanocobalamin is a mature, widely marketed ingredient across oral and injectable formulations. Radiolabeled cyanocobalamin products (including Co-57 and Co-58 variants) target diagnostic and research use where tracking of biodistribution, absorption, and metabolism matters.

Because cyanocobalamin has broad, historical clinical use, the more actionable development activity typically clusters around:

• Radiolabeled derivatives used for specific diagnostic or metabolic studies.
• Formulation and dosing delivery improvements that can support label expansion rather than reinvent the core active ingredient.

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Where are cyanocobalamin and Co-57/Co-58 variants in clinical trials right now?

No complete, source-verifiable, up-to-date clinical-trials status (trial phase, sponsor, recruitment status, and timelines) for cyanocobalamin, cyanocobalamin Co-57, and cyanocobalamin Co-58 can be provided from the information available in this chat.

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What is the market structure for cyanocobalamin (base vitamin) versus radiolabeled derivatives?

Cyanocobalamin (base ingredient): demand drivers

Cyanocobalamin demand tracks vitamin deficiency epidemiology and prescribing patterns in:

• Megaloblastic anemia due to B12 deficiency
• Neurologic injury associated with deficiency (as part of supportive management)
• Long-term supplementation programs (dietary deficiency risk, malabsorption risk)

Commercial supply is largely driven by:

• Generic and long-standing branded products
• Broad route coverage (oral, subcutaneous, intramuscular)
• Formulation diversity (tablets, sublingual, injectables)

Radiolabeled cyanocobalamin (Co-57 and Co-58): niche demand drivers

Cyanocobalamin labeled with cobalt isotopes is used where radio-tracing provides value beyond non-radioactive B12 measurement. The commercial base is smaller and depends on:

• Availability of radiochemistry supply chains
• Access to specialized handling and imaging or assay workflows
• Institutional and research procurement cycles

In practice, the radiolabeled market is constrained by:

• Regulatory and radiation-safety requirements
• Supply constraints for specific isotopes
• Limited volumes compared with commodity vitamin B12

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How should you project market size and revenue for these assets?

Projection framework (fit for investment or R&D planning)

For cyanocobalamin and its radiolabeled variants, revenue projection should be built on separate layers:

1. Base cyanocobalamin (global)

   • Volume projection: deficiency-treatment and supplementation programs (public health and clinical prescribing)
   • Price projection: generic price erosion plus formulation premium where relevant
   • Channel: pharmacy, hospital, and long-term care procurement

2. Cyanocobalamin radiolabeled (Co-57, Co-58)

   • Unit economics: isotope availability, radiolabeling service cost, and dose kit pricing
   • Adoption: diagnostic or research protocol penetration per institution
   • Contract structure: tenders and multi-year supply agreements with nuclear/radiopharmacy providers

What a realistic market projection typically looks like

• Base vitamin B12 (cyanocobalamin) behaves like a mature commodity with modest growth tied to treatment incidence and population coverage.
• Radiolabeled cyanocobalamin behaves like a specialized supply business where growth depends on trial/research demand and institutional adoption cycles.

However, producing a quantified, defensible projection with numbers (market size, CAGR, unit volumes, and price bands) requires external market datasets and current clinical pipeline evidence. That content is not present in the information available here.

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Clinical development implications for investors

Base cyanocobalamin

Most “clinical updates” for base cyanocobalamin tend to be incremental:

• Comparative efficacy or formulation bioavailability
• Label refinement by administration route
• Safety and adherence-focused studies

Co-57 and Co-58 radiolabeled cyanocobalamin

Radiolabeled variants often have development that looks like:

• Diagnostic performance studies
• Biodistribution or metabolic assays
• Protocol validation in defined indications (malabsorption states, deficiency diagnostics, or research protocols)

For business planning, the differentiator is less about “new biology” and more about:

• Reliable radiochemistry supply
• Consistent kit manufacturing and dose reproducibility
• A clear clinical workflow that reduces institutional friction

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Competitive landscape: what matters commercially

For cyanocobalamin (non-radioactive)

Key competitive forces:

• Generic competition dominates
• Route-of-administration convenience affects brand stickiness more than unique IP
• Regulatory reuse of long-known safety data makes new entrants harder to justify unless they differentiate on delivery or labeling

For radiolabeled cyanocobalamin (Co-57/Co-58)

Key competitive forces:

• Radiolabeling capability and isotope supply continuity
• Institutional adoption and protocol standardization
• Availability of radiopharmacy infrastructure

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Key Takeaways

• Cyanocobalamin is a mature, widely used vitamin B12 product with demand tied to B12 deficiency treatment and supplementation patterns.
• Cyanocobalamin Co-57 and Co-58 are niche radiolabeled derivatives that primarily serve diagnostic or research workflows where radio-tracing adds value.
• A defensible market and clinical-trials projection requires current trial registry and market dataset inputs; those are not present in the information available in this chat.

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FAQs

1) Is cyanocobalamin considered a pipeline opportunity or a mature market?

It is a mature market for base vitamin B12 use. Development opportunities generally center on formulation, route optimization, or label refinement.

2) What differentiates radiolabeled cyanocobalamin products from base cyanocobalamin?

Radiolabeled variants use cobalt isotopes to enable tracing and measurement in diagnostic or research protocols, which changes the commercial model to niche, infrastructure-dependent procurement.

3) What typically drives adoption of Co-57/Co-58 cyanocobalamin in institutions?

Protocol fit, radiopharmacy capability, isotope availability, and workflow integration are usually the adoption determinants.

4) Why do base cyanocobalamin markets often show pricing pressure?

Long product history and generic competition typically compress prices and shift value toward volume and formulation convenience.

5) What is the most practical projection approach for these assets?

Build separate layers for base cyanocobalamin (commodity treatment and supplementation volumes) and radiolabeled variants (institutional adoption and dose kit economics tied to isotope supply).

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References

[1] No cited sources are available from the information provided in this chat.