Griseofulvin

Evidence Level: L5 Predicted Indications: 5

Table of Contents

  1. Griseofulvin
    1. Pharmacist Assessment Report
    2. Griseofulvin: Myiasis
    3. One-Sentence Summary
    4. Quick Overview
    5. Why is This Prediction Reasonable?
    6. Clinical Trial Evidence
    7. Literature Evidence
    8. Australia Market Information
    9. Safety Considerations
    10. Conclusion and Next Steps
    11. Disclaimer

Pharmacist Assessment Report

Griseofulvin: Myiasis

One-Sentence Summary

Griseofulvin is an oral antifungal originally used for dermatophyte infections of the skin, hair and nails, such as tinea pedis, tinea corporis, tinea unguium and tinea barbae. The TxGNN model predicts it may be effective for myiasis (a fly larvae infestation), but no clinical trials and no publications currently support this prediction. This is a model-only signal with no demonstrated mechanistic basis, so it should be treated as a hypothesis rather than a lead.


Quick Overview

Item Content
Original Indication Not recorded in the local data
Predicted New Indication Myiasis
TxGNN Prediction Score 0.9941
Evidence Level L5
Australia Market Status Listed on the PBS Schedule (1 of 1 items) – TGA (ARTG) registration status is not included in this data
Number of PBS Items 1 (valid: 1)
Recommended Decision Hold

Why is This Prediction Reasonable?

Currently, detailed mechanism of action data is not available in the data compiled for this report. Based on known information, griseofulvin is an oral antifungal that disrupts fungal microtubules and mitosis, and it is deposited in keratinised tissue. Its efficacy in dermatophyte infections is well established.

For myiasis, however, no plausible mechanistic link can be established. Myiasis is an infestation of tissue by fly larvae (dipterans), not a fungal disease. Griseofulvin has no known antiparasitic or insecticidal activity. Standard management relies on removal of the larvae, not on an antifungal. The high score (0.9941) comes from the TxGNN model (deep learning) and may reflect similarities the model learned between related diseases, not biological evidence.

The same applies to the other top-ranked predictions (wound myiasis, creeping myiasis, furuncular myiasis, toxoplasmosis and Bacteroidaceae infection), which have no trials, no literature and no credible mechanism.

Among lower-ranked predictions, cutaneous candidiasis is biologically closer because it is fungal. Griseofulvin is generally not effective against Candida. The retrieved literature for this indication is indirect.


Clinical Trial Evidence

Currently no related clinical trials registered.


Literature Evidence

Currently no related literature available for myiasis.

For context, the literature retrieved for the lower-ranked prediction of cutaneous candidiasis (20 records, 10 shown) was indirect. It consists mainly of reviews of superficial fungal infections and other antifungals (terbinafine, itraconazole, ketoconazole, tolnaftate), with griseofulvin mentioned as a comparator or a treatment for tinea capitis. It does not show that griseofulvin treats candidiasis.

PMID Year Type Journal Key Findings
8763460 1996 Review Br J Dermatol Cutaneous mycoses in children; griseofulvin has been the main treatment in children but is only fungistatic, may cause interactions and needs prolonged dosing
15571501 2004 Review Dermatol Ther Therapy of superficial fungal infections; onychomycosis often needs systemic griseofulvin, itraconazole or terbinafine
34898894 2021 Review J Obstet Gynaecol India Risks and precautions of common antifungal drugs in pregnancy
10439936 1999 Review Drugs Terbinafine in superficial mycoses; mycological cure above 80% in dermatophyte infections
1372222 1992 Review Drugs Terbinafine pharmacology and efficacy in tinea corporis, cruris and pedis
8706596 1996 Review Drugs Itraconazole in superficial fungal infections, including dermatophytosis and vaginal candidiasis
8077517 1994 Review J Am Acad Dermatol Treatment of tropical mycoses (retrieved for the blastomycosis prediction); general, not griseofulvin-specific

Australia Market Information

ARTG Number Product Name Dosage Form Approved Indication
ARTG 1460W Grisovin Tablet 125 mg (oral) Not recorded in the data compiled for this report

Safety Considerations

No product-label warnings or contraindications were available in the data compiled for this report. Please refer to the TGA-approved Product Information (PI) for full safety information.

Contraindication signals from the knowledge graph (these are not label text and need verification against the PI):

  • Liver failure
  • Porphyria (including inherited porphyria and other porphyrin metabolism disorders)
  • Systemic lupus erythematosus (including the paediatric form)
  • Substance abuse/dependence
  • Neutropenia and agranulocytosis (including congenital and idiopathic forms)

Drug interactions (100 interactions were identified; examples are below, with the most frequent level being Moderate):

  • Anticoagulants and antiplatelets: warfarin, apixaban, rivaroxaban, dicoumarol, ticagrelor (Moderate); acetylsalicylic acid (Minor)
  • Antidiabetic agents: saxagliptin, linagliptin, repaglinide (Moderate); liraglutide (Minor)
  • Antiemetics: aprepitant, rolapitant (Moderate)
  • Antimalarials and antiparasitics: artemether, mefloquine, praziquantel (Moderate)
  • Others: eliglustat, naloxegol, nitisinone, macimorelin, fostamatinib (Moderate)

Conclusion and Next Steps

Decision: Hold

Rationale: The myiasis prediction is a computational output only (evidence level L5). There are no registered trials, no supporting literature, and no biologically plausible mechanism linking an antifungal to fly larvae infestation. The knowledge-graph contraindication signals (hepatic, haematological and porphyria-related) and the large number of interactions add risk without any demonstrated benefit.

To proceed, the following is needed:

  • A credible mechanistic or preclinical rationale for activity against dipteran larvae (none currently exists)
  • Mechanism of action data for griseofulvin from DrugBank
  • The TGA Product Information (warnings, contraindications and approved indication text), as this was not available for the Australian listing
  • If a repurposing direction is still wanted, consider a review of the fungal prediction instead (cutaneous candidiasis). It has a more plausible biological basis but still needs direct comparative evidence, since standard therapies (azoles, nystatin, terbinafine, itraconazole) are already established.

    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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