Dosulepin

Evidence Level: N/A Predicted Indications: 0

Table of Contents

  1. Dosulepin
    1. Pharmacist Assessment Report
    2. Dosulepin: Known uses and market status in Australia
    3. Summary
    4. Quick overview
    5. Known uses among the model’s candidates
      1. Approved (supported by a licence or label)
      2. Related to an approved indication (same disease category)
      3. Relations recorded in the knowledge graph (no approval found)
    6. Australia Market Information
    7. Safety Considerations
    8. Disclaimer

Pharmacist Assessment Report

Dosulepin: Known uses and market status in Australia

Summary

The TxGNN deep-learning model (score ≥ 0.99) produced candidates for Dosulepin, but every candidate that can be traced to a source is already a known use. There is therefore currently no new predicted indication for this drug. The two known uses below are recorded as knowledge graph relations, and no approval was found for them in the data used here.

Quick overview

Item Content
New predicted indications None (all traceable model candidates are known uses)
Known uses among model candidates 2
Evidence level Not applicable
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)

Known uses among the model’s candidates

Approved (supported by a licence or label)

Indication Source
none none
Indication Approved category
none none

Relations recorded in the knowledge graph (no approval found)

Indication
anxiety disorder
endogenous depression

Australia Market Information

Licence Product Dosage form Status
1357K Dosulepin Viatris Capsule containing dosulepin hydrochlori Valid

Safety Considerations

  • Cardiac effects: Two ECG studies in patients treated with dosulepin reported changes in QT dispersion, suggesting cardiotoxicity.
  • Anticholinergic and sedative effects: Dosulepin binds muscarinic M1–M5 and histamine H1 receptors, which accounts for anticholinergic and sedative effects. This is a particular concern in infants and for ocular surface disease.
  • Overdose and seizure risk: The compiled assessments flag overdose toxicity and lowered seizure threshold as concerns, especially in paediatric and rare neurodevelopmental populations.
  • Pharmacological targets: SERT, NET, M1–M5 and H1 receptors (an 8-target pharmacology profile, not a list of drug–drug interactions with specific agents).

Please refer to the TGA-approved Product Information (PI) for full warnings, contraindications and drug interaction information.


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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