Methionine

證據等級: L5 預測適應症: 10

目錄

  1. Methionine
  2. Methionine: From No Established Indication to Acne (disease)
    1. One-Sentence Summary
    2. Quick Overview
    3. Why is This Prediction Reasonable?
    4. Clinical Trial Evidence
    5. Literature Evidence
    6. US Market Information
    7. Safety Considerations
    8. Conclusion and Next Steps
    9. Disclaimer

## 藥師評估報告

Methionine: From No Established Indication to Acne (disease)

One-Sentence Summary

Methionine (DrugBank DB00134) has no recorded original indication or marketing authorization in this dataset — it is currently not marketed and no license records exist. TxGNN predicts potential efficacy for Acne (disease), but this prediction is currently backed only by the model score, with 0 clinical trials and 4 loosely related publications, none of which establish a mechanistic or clinical link to acne.


Quick Overview

Item Content
Original Indication No data available — drug not marketed, no license records on file
Predicted New Indication Acne (disease)
TxGNN Prediction Score 99.9996%
Evidence Level L5
US Market Status Not Marketed
Number of NDAs 0
Recommended Decision Hold

Why is This Prediction Reasonable?

Detailed mechanism-of-action data for methionine is not available in this evidence pack, and no original approved indication is on record to anchor a mechanistic comparison against acne.

Reviewing the supporting literature, none of the four retrieved papers actually connect methionine to acne treatment. One paper reports elevated plasma homocysteine (a downstream metabolite of methionine metabolism) in patients undergoing isotretinoin therapy for cystic acne — this is an adverse-effect biomarker of a different drug’s toxicity profile, not evidence that methionine treats acne. A second paper concerns an MTHFR mutation causing neonatal encephalopathy (with “neonatal acne” as an incidental clinical feature, unrelated to methionine therapy). The remaining two papers discuss neutrophil chemotactic function and Sweet’s syndrome chemoattractants in inflammatory skin disease generally, sharing no direct link to methionine or acne pathophysiology.

In short, this prediction is currently supported only by the TxGNN model’s ranking score. No mechanistic rationale or clinical signal in the retrieved evidence corroborates a therapeutic role for methionine in acne.


Clinical Trial Evidence

Currently no related clinical trials registered.


Literature Evidence

PMID Year Type Journal Key Findings
11277950 2001 Cohort International Journal of Dermatology Elevated plasma homocysteine (a methionine metabolite) observed in cystic acne patients on isotretinoin — reflects a drug side-effect biomarker, not a methionine treatment effect
39357918 2024 Case Report BMJ Case Reports Neonate with MTHFR mutation presenting with encephalopathy; neonatal acne noted as an incidental dysmorphic feature, unrelated to methionine therapy
3161955 1985 Basic Research Journal of Investigative Dermatology Neutrophil C5a chemotactic function studied across several inflammatory skin diseases including acne conglobata; no methionine involvement
3859500 1985 Basic Research Journal of the American Academy of Dermatology Plasma chemoattractant activity in a Sweet’s syndrome patient with cystonodular acne; no methionine involvement

US Market Information

Methionine holds no marketing authorization on record in this dataset (market status: Not Marketed; 0 licenses).


Safety Considerations

Please refer to the package insert for safety information.


Conclusion and Next Steps

Decision: Hold

Rationale: The Acne (disease) prediction is supported only by the TxGNN score — there are no clinical trials, and none of the four available publications provide a mechanistic or clinical basis linking methionine to acne. Combined with the absence of MOA and safety data, there is insufficient evidence to advance this indication.

To proceed, the following is needed:

  • TFDA/FDA label warnings and contraindications (currently blocking — required before any S1 safety review)
  • Methionine’s mechanism of action (currently a data gap; needed to assess biological plausibility)
  • Original, real-world dosing/indication context, since no license or original-indication data exists in this dataset
  • Dedicated preclinical or clinical studies directly testing methionine in acne, rather than incidental literature mentions
  • Separately worth noting: among this drug’s 10 predicted indications, diabetic cataract (rank 10) shows materially stronger, methionine-specific mechanistic evidence (MsrB1/S-adenosylmethionine pathway in lens oxidative defense) and was flagged at decision stage S1 (“Research Question”) — it may merit independent follow-up ahead of the acne candidate.

    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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