Ascorbic Acid

Evidence Level: L5 Predicted Indications: 9

Table of Contents

  1. Ascorbic Acid
    1. Pharmacist Assessment Report
    2. Ascorbic Acid: From Ascorbic Acid Deficiency (Scurvy) to Non-syndromic Esophageal Malformation
    3. One-Sentence Summary
    4. Quick Overview
    5. Why is This Prediction Reasonable?
    6. Clinical Trial Evidence
    7. Literature Evidence
    8. India Market Information
    9. Safety Considerations
    10. Conclusion and Next Steps
    11. Disclaimer

Pharmacist Assessment Report

Ascorbic Acid: From Ascorbic Acid Deficiency (Scurvy) to Non-syndromic Esophageal Malformation

One-Sentence Summary

Ascorbic acid (vitamin C) is originally used to prevent and treat vitamin C deficiency and scurvy. The TxGNN model predicts it may be effective for non-syndromic esophageal malformation, but this is a model prediction only, with no clinical trials and no publications currently supporting it.


Quick Overview

Item Content
Original Indication Ascorbic acid deficiency; scurvy
Predicted New Indication Non-syndromic esophageal malformation
TxGNN Prediction Score 0.9996
Evidence Level L5
India Market Status Listed in a compiled Indian medicine price dataset (at least 20) – CDSCO approval status is not included in this data
Number of Listed Products at least 20
Recommended Decision Hold

Why is This Prediction Reasonable?

Currently, detailed mechanism of action data is not available. Based on known information, ascorbic acid is a single-ingredient vitamin. Its efficacy in correcting vitamin C deficiency and scurvy is well established. It is also known as an antioxidant and as a cofactor in collagen synthesis.

Non-syndromic esophageal malformation is a structural congenital defect that arises during embryonic development. No plausible mechanism has been identified by which ascorbic acid could correct or treat such a defect. The very high score (0.9996) reflects how the model links this drug to the disease, not biological or clinical support. The reliability of this prediction is therefore low, and it should be treated only as a hypothesis for screening.


Clinical Trial Evidence

Currently no related clinical trials registered.


Literature Evidence

Currently no related literature available.


India Market Information

Ascorbic acid is widely marketed in India as a single-ingredient product. There are 20 valid registrations, none cancelled. Dosage forms include injections, chewable tablets and oral drops. The data compiled for this report do not include approved indication text. The five main authorizations are listed below.

Authorization Number Product Name Dosage Form Manufacturer
Registration No. 246648 Zascor Chewable Tablet Lemon & Honey Sugar Free Chewable tablet (strip of 15) Franco-Indian Pharmaceuticals Pvt Ltd
Registration No. 242077 W-Vit-Plus Injection Combipack Injection (box of 1) Woriox Pharma Private Limited
Registration No. 246805 Zincee Chewable Tablet Chewable tablet (strip of 20) Zydus Healthcare Limited
Registration No. 203069 Scornix Injection Injection (vial of 6 ml) Nixi Laboratories Private Limited
Registration No. 24614 Ascorcee 1500mg Injection Injection (vial of 1) Scotmed Care Pvt Ltd

Safety Considerations

  • Disease associations from the TxGNN model (deep learning), not label text: The TxGNN model (deep learning) may reflect similarities it learned between related diseases, not biological evidence. It lists contraindication relationships between ascorbic acid and several conditions. Examples include kidney disease, anuria, nephrocalcinosis, primary hyperoxaluria, hereditary hemochromatosis, sickle cell anemia, diabetes mellitus, peptic ulcer disease, liver disease, and hypercalcemia. These should be confirmed against the official package insert.
  • Drug Interactions: 25 interactions were recorded in total. The moderate-level interactions among those listed are:
    • Amphetamine
    • Dextroamphetamine
    • Lisdexamfetamine
    • Metamfetamine
    • Benzphetamine
    • Aluminum hydroxide
    • Bortezomib
    • Deferoxamine

    Minor interactions include paclitaxel, cisplatin, doxorubicin, ethinylestradiol, and pseudoephedrine.

Please refer to the package insert for complete warnings and contraindications.


Conclusion and Next Steps

Decision: Hold

Rationale: The prediction for non-syndromic esophageal malformation rests solely on the model score. There are no clinical trials, no literature, and no plausible mechanism for correcting a congenital structural defect with ascorbic acid.

Other predictions for this drug: Several other predicted indications have more supporting evidence and may be better candidates.

  • Perinatal disease: L3, a small trial in neonatal hypoxic-ischemic encephalopathy.
  • Injury: L2, with Phase 2 trials in sepsis- and COVID-19-related lung injury.

To proceed, the following is needed:

  • Mechanism of action data for ascorbic acid
  • Package insert warnings and contraindications from the India Pharma source
  • A biological rationale connecting ascorbic acid to esophageal development, if this indication is to be pursued
  • Prioritization of better-supported indications before any further work on this one

    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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