Pyridoxine

Evidence Level: L5 Predicted Indications: 10

Table of Contents

  1. Pyridoxine
  2. Pyridoxine: From Pyridoxine Deficiency Anemia to Gonococcal Urethritis
    1. One-Sentence Summary
    2. Quick Overview
    3. Why is This Prediction Reasonable?
    4. Clinical Trial Evidence
    5. Literature Evidence
    6. Singapore Market Information
    7. Safety Considerations
    8. Conclusion and Next Steps
    9. Disclaimer

## Pharmacist Assessment Report

Pyridoxine: From Pyridoxine Deficiency Anemia to Gonococcal Urethritis

One-Sentence Summary

Pyridoxine (vitamin B6) was originally used to treat pyridoxine deficiency anemia. The TxGNN model predicts it may be effective for gonococcal urethritis, but currently there are 0 clinical trials and 0 publications supporting this direction, so the prediction rests on the model score alone.

Quick Overview

Item Content
Original Indication Pyridoxine deficiency anemia
Predicted New Indication Gonococcal urethritis
TxGNN Prediction Score 93.87%
Evidence Level L5
Singapore Market Status ✓ Marketed
Number of Registrations 14
Recommended Decision Hold

Why is This Prediction Reasonable?

Currently, detailed mechanism of action data is not available. Pyridoxine is a vitamin B6 supplement, and its efficacy in correcting pyridoxine deficiency is well established.

However, no mechanistic link to gonococcal urethritis has been established. Pyridoxine has no known antibacterial activity against Neisseria gonorrhoeae, and standard treatment for this infection is antibiotic-based. Another predicted indication, Ureaplasma urethritis, has the identical score (93.87%), which suggests the prediction comes from a shared neighbourhood in the knowledge graph rather than a real pharmacological relationship. This prediction is most likely a model artifact.

Clinical Trial Evidence

Currently no related clinical trials registered.

Literature Evidence

Currently no related literature available.

Singapore Market Information

All 14 registrations are valid single-entity licences, with no cancelled licences. The registration data do not state approved indication text. Five of them are shown below.

Authorization Number Product Name Dosage Form Approved Indication
SIN15301P Diclectin Delayed Release Tablets 10mg/10mg Tablet, delayed release Not stated in registration data
SIN16865P Bonjesta Extended-Release Tablets 20mg/20mg Tablet, film coated, extended release Not stated in registration data
SIN06258P Neurobion Tablet Tablet, sugar coated Not stated in registration data
SIN12077P Daneuron Tablet Tablet, film coated Not stated in registration data
SIN06262P Neurobion Injection Injection Not stated in registration data

Available dosage forms cover both oral (tablets) and injectable (injection, powder for solution) routes.

Safety Considerations

  • Contraindications (knowledge-graph associations, not label text): The knowledge graph links pyridoxine to a number of conditions, including liver disease and liver failure, kidney disease and impaired renal function, peptic ulcer disease, diabetes mellitus and diabetic ketoacidosis, gout, systemic lupus erythematosus, peripheral neuropathy, and Wilson disease. These should be verified against the official package insert.
  • Drug Interactions: 13 interactions were identified.
    • Moderate: altretamine, phenobarbital, levodopa, phenytoin.
    • Minor: mainly barbiturates (amobarbital, butabarbital, butalbital, methohexital, pentobarbital, secobarbital, thiopental, methylphenobarbital) and primidone.

For label warnings and contraindications, please refer to the package insert.

Conclusion and Next Steps

Decision: Hold

Rationale: The prediction has a high model score but no clinical trials or literature, and pyridoxine has no known activity against Neisseria gonorrhoeae. Standard antibiotic therapy remains the appropriate treatment, so this prediction is unlikely to be actionable.

To proceed, the following is needed:

  • Any plausible mechanistic or in vitro evidence of pyridoxine activity against the pathogen, plus detailed MOA data
  • Clinical or observational data in urethritis patients
  • Package insert warnings and contraindications from the Singapore regulator (HSA) to support safety screening
  • Consideration of better-supported predictions for pyridoxine instead, such as vitamin deficiency disorder. That prediction has a completed Phase 2/3 trial (NCT01128244) and sits close to the approved indication. It would need dose monitoring, since chronic high-dose pyridoxine can cause sensory neuropathy, and attention to the levodopa interaction.

    Disclaimer

This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.



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