Threonine

證據等級: L5 預測適應症: 1

目錄

  1. Threonine
  2. Threonine: From Essential Amino Acid to Gastroparesis
    1. One-Sentence Summary
    2. Quick Overview
    3. Why is This Prediction Reasonable?
    4. Clinical Trial Evidence
    5. Literature Evidence
    6. Market Information
    7. Safety Considerations
    8. Conclusion and Next Steps
    9. Disclaimer

## 藥師評估報告

Threonine: From Essential Amino Acid to Gastroparesis

One-Sentence Summary

Threonine is an essential amino acid without an approved therapeutic indication in the current dataset; it is not currently marketed in Taiwan and has no known original mechanism of action. The TxGNN model predicts a possible link to Gastroparesis, but this is supported only by a model score with no clinical trials and a single mechanistic paper whose relevance appears to be a keyword false-positive. Evidence is currently insufficient to support any repurposing action.


Quick Overview

Item Content
Original Indication No approved indication on record (Threonine is an essential amino acid / nutritional substance, not a registered drug with a labeled indication)
Predicted New Indication Gastroparesis
TxGNN Prediction Score 99.32%
Evidence Level L5 (model prediction only)
Market Status Not marketed (未上市) — 0 authorizations on file
Number of Authorizations 0
Recommended Decision Hold

Why is This Prediction Reasonable?

Currently, detailed mechanism of action data is not available (original_moa: [Data Gap]). Threonine is an essential amino acid rather than a conventional pharmacological agent, and no therapeutic indication is on record for it, so there is no established original-indication → new-indication pharmacological rationale to evaluate.

More importantly, the single supporting literature record raises a significant concern about relevance rather than confirming it. The paper (PMID 28627597) studies apoptosis and PI3K-AKT-mTOR / AMPK-mTOR signaling in a rat model of diabetic gastroparesis. AKT is a serine/threonine kinase, and the term “threonine” in this context very likely refers to a phosphorylation residue on the kinase substrate — not to therapeutic use of threonine as an amino acid. This is consistent with the model’s own rationale field, which explicitly flags this as a likely keyword false-positive rather than a genuine mechanistic link. There is no evidence in the pack of threonine supplementation being studied as an intervention for gastroparesis.

Given this, the high TxGNN score (99.32%) should not be interpreted as strong biological plausibility — it reflects a graph-level prediction unsupported by corroborating clinical or mechanistic evidence specific to threonine as a drug candidate.


Clinical Trial Evidence

Currently no related clinical trials registered.


Literature Evidence

PMID Year Type Journal Key Findings
28627597 2017 Mechanistic/Basic Research Molecular Medicine Reports Examined gastric smooth muscle cell apoptosis and PI3K-AKT-mTOR / AMPK-mTOR signaling in a rat model of diabetic gastroparesis; “threonine” here refers to a kinase phosphorylation residue (AKT is a serine/threonine kinase), not to threonine as a therapeutic agent — likely a keyword mismatch rather than genuine supporting evidence

Market Information

No approved authorizations are on file. The drug is currently not marketed (未上市), with 0 total licenses recorded.


Safety Considerations

Please refer to the package insert for safety information. Note: label warnings/contraindications data (TFDA) and full DDI data are currently unavailable and flagged as a Blocking data gap (DG001), meaning a formal safety review (S1 stage) cannot proceed until this is resolved.


Conclusion and Next Steps

Decision: Hold

Rationale: The evidence level is L5 (model prediction only) — there are no clinical trials and only one piece of literature, which itself appears to be a false-positive keyword match (threonine amino acid vs. threonine/serine kinase phosphorylation site) rather than genuine mechanistic support. Combined with the complete absence of safety data, there is no basis to advance this candidate beyond the prediction stage.

To proceed, the following is needed:

  • Resolve DG001 (Blocking): obtain TFDA label warnings/contraindications before any safety review can begin
  • Resolve DG002 (High): obtain confirmed mechanism of action data from DrugBank
  • Independent literature review to confirm whether any genuine evidence exists for threonine (the amino acid) in gastroparesis, distinct from unrelated kinase-signaling studies
  • If no genuine mechanistic or clinical support is found, this candidate should be deprioritized/closed rather than advanced further

    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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