Paroxetine
| Evidence Level: L5 | Predicted Indications: 1 |
Table of Contents
Paroxetine: From SSRI Antidepressant to Ohdo Syndrome and Variants
One-Sentence Summary
Paroxetine is a selective serotonin reuptake inhibitor (SSRI) marketed in South Africa. The SAHPRA registration records supplied do not state its approved indications. The TxGNN model predicts it may be relevant to Ohdo syndrome and variants, a group of rare congenital disorders. There are currently 0 clinical trials and 0 publications supporting this direction, so it rests on the model score alone.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not stated in the SAHPRA registration records provided (paroxetine is an SSRI antidepressant) |
| Predicted New Indication | Ohdo syndrome and variants |
| TxGNN Prediction Score | 99.11% |
| Evidence Level | L5 |
| South Africa Market Status | Marketed |
| Number of SAHPRA Registrations | 6 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data is not available in the input. Based on known information, paroxetine is an SSRI that acts on the serotonin transporter. Its original approved indications are not listed in the records supplied.
Ohdo syndrome and its variants (for example, the KAT6B-related Say-Barber-Biesecker-Young-Simpson type) are rare congenital disorders. They are linked to chromatin and histone acetyltransferase dysfunction. Typical features include blepharophimosis, intellectual disability and developmental delay.
No supported mechanistic link was identified. The candidate rests only on a high knowledge-graph score (0.991). There is no plausible way for serotonin reuptake inhibition to correct a developmental epigenetic defect, and no rationale for treating a congenital structural syndrome. Any benefit would at most be symptomatic, such as for comorbid anxiety or depression, and would not be disease-modifying. A high model score alone should therefore be read with caution.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
Currently no related literature available.
South Africa Market Information
Six registrations are recorded. The five product entries below are listed; two of them share registration number A38/1.2/0612. The approved indication text was not provided for any of them.
| Registration Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| Reg. No. 42/1.2/0208 | Lenio | Tablet | Not stated in the record |
| Reg. No. 36/1.2/0160 | Hexal-Paroxetine | Film-coated tablet (Fct) | Not stated in the record |
| Reg. No. A39/1.2/0216 | Xet | Tablet | Not stated in the record |
| Reg. No. A38/1.2/0612 | Aropax CR 12,5 | Tablet | Not stated in the record |
| Reg. No. A38/1.2/0612 | Aropax CR | Tablet | Not stated in the record |
All listed forms are oral.
Safety Considerations
Please refer to the SAHPRA-approved Professional Information (PI) for safety information. Report adverse drug reactions to SAHPRA.
No drug interaction records were found in the data supplied. Two known risks are relevant to a disorder that presents in childhood. Paroxetine carries risks in pregnancy, and a boxed warning for suicidality in young patients applies to the pediatric population.
Conclusion and Next Steps
Decision: Hold
Rationale: The candidate has a very high TxGNN score but no clinical trials, no literature and no plausible mechanistic link to a congenital chromatin-related disorder. Known pregnancy and paediatric risks further weaken any case for proceeding.
To proceed, the following is needed:
- Mechanism of action data (MOA), to test whether any biological link to KAT6B/histone acetylation pathways exists
- The SAHPRA Professional Information (PI), covering approved indications, warnings and contraindications
- Preclinical or mechanistic evidence, or at least case-level clinical reports, supporting the prediction
- A defined target outcome (for example, symptom management of comorbid anxiety or depression) and a paediatric safety assessment, if this direction is pursued
This report is for research reference only and does not constitute medical advice. Predicted repurposing candidates require clinical validation before any clinical use.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.