TheraRadar
Data updated: May 26, 2026

VIBISONE (cyanocobalamin)

Other Approved 1973-06-20

VIBISONE is indicated for the treatment of Nutritional Deficiency.

Source: FDA Label • Fresenius Kabi
1
Indication
--
Phase 3 Trials
52
Years on Market

Details

Status
Prescription
First Approved
1973-06-20
Routes
INJECTION
Dosage Forms
INJECTABLE

Companies

Active Ingredient: CYANOCOBALAMIN

VIBISONE Approval History

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Original
New Indication
New Form
Label Update
11 FDA actions from 1973 to 2005
Jul 2005 SUPPL
Label · Labeling
Jun 2001 SUPPL
Mfg · Manufacturing (CMC)
Jan 1999 SUPPL
Mfg · Manufacturing (CMC)

What VIBISONE Treats

1 indications

VIBISONE is approved for 1 conditions since its original approval in 1973. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Nutritional Deficiency
Source: FDA Label

VIBISONE Boxed Warning

Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately....

VIBISONE Competitive Set

Pro

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

Indication competitors

1

Same indication, different mechanism — what else might this patient receive?

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

2 trials
Trial Sponsor ID Phase Status Title
NCT04387201 results posted HSC-MS-19-0787 R21DK122234 Ph 4 completed GLP-1 Therapy: The Role of IL-6 Signaling and Adipose Tissue Remodeling in Metabolic Response
NCT05005897 RART 9305-150426 U1111-1267-0112 Ph 2, Ph 3 recruiting Early Infant Micronutrition and Development
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Active Pipeline

Pro

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.

VIBISONE FDA Label Details

Indications & Usage

VIBISONE is indicated for the treatment of Nutritional Deficiency.

⚠️ BOXED WARNING

WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately....

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Data Sources

Data sourced from official FDA and NIH databases. Click links to verify on original sources.