Amisulpride
| Evidence Level: L1 | Predicted Indications: 10 |
Table of Contents
Amisulpride: From an Unspecified Registered Indication to Schizophrenia
One-Sentence Summary
Amisulpride is a selective dopamine D2/D3 receptor antagonist (an atypical antipsychotic) registered in Singapore as Solian tablets. The approved indication text is not available in the data compiled for this report. The TxGNN model predicts it may be effective for schizophrenia, with 37 clinical trials and 20 publications listed. The prediction is best read as confirmation of an established use rather than a true repurposing finding.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not available (the approved indication text is blank in the registration record) |
| Predicted New Indication | Schizophrenia |
| TxGNN Prediction Score | 96.05% |
| Evidence Level | L1 |
| Singapore Market Status | ✓ Marketed |
| Number of Registrations | 1 |
| Recommended Decision | Proceed with Guardrails |
Why is This Prediction Reasonable?
Detailed mechanism-of-action data is not available in the compiled drug record. Based on the clinical literature, amisulpride is a selective D2/D3 dopamine receptor antagonist, with 5-HT7 antagonism at higher doses. Blocking D2 receptors is the core pharmacology behind antipsychotic efficacy in schizophrenia.
Amisulpride is a long-established antipsychotic, so schizophrenia is a known, marketed use rather than a new one. The empty original-indication field appears to be a data gap in the registration record, not evidence that the drug has another primary use. The model's high score is consistent with the mechanism and the existing clinical evidence.
Other predictions in the list are weaker:
- Psychotic disorder (rank 5) is supported mainly by the same trials as schizophrenia, so the evidence is not independent.
- Dysthymic disorder (rank 8) has a plausible mechanism and literature, including double-blind comparisons with other antidepressants. Low-dose amisulpride is thought to increase dopaminergic transmission by blocking presynaptic autoreceptors. However, no registered trials are present and the key evidence dates from around 2002, so it is a research question rather than a ready candidate.
- Anxiety disorder (rank 10) has only indirect support, and no efficacy trials in anxiety are listed.
- The remaining predictions (retinal dystrophy, X-linked myopias, hydranencephaly, polymicrogyria) have no trials or literature and no plausible mechanistic link. These should be held.
Clinical Trial Evidence
The table shows the most relevant trials for schizophrenia.
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT01609153 | Phase 4 | Completed | 328 | Randomized double-blind COMBINE trial: olanzapine plus amisulpride in acutely ill schizophrenia |
| NCT01105481 | Phase 4 | Completed | 273 | 14-week randomized, double-blind, placebo-controlled amisulpride augmentation in clozapine-resistant schizophrenia |
| NCT01246232 | Phase 4 | Completed | 69 | Amisulpride augmentation in clozapine-unresponsive schizophrenia |
| NCT00331981 | Phase 4 | Completed | 138 | Long-term efficacy and safety on positive and negative symptoms, quality of life and cognition |
| NCT01795183 | Phase 4 | Completed | 316 | Open-label multicentre study of effectiveness and safety in Chinese patients |
| NCT00245674 | Phase 4 | Completed | 300 | Amisulpride oral solution in acute episodes of schizophrenia |
| NCT01615185 | Phase 4 | Terminated | 96 | Double-blind: amisulpride 800 mg/day vs low-dose amisulpride plus sulpiride in acute exacerbation |
| NCT01446328 | Phase 4 | Completed | 151 | Head-to-head comparison of aripiprazole, amisulpride and olanzapine over 12 months |
| NCT03510325 | Phase 3 | Completed | 762 | Sequential randomized trial comparing antipsychotics in first-episode schizophrenia |
| NCT00761670 | Phase 4 | Completed | 37 | Amisulpride vs risperidone on cognition in chronic schizophrenia |
Several other registered trials are small, mechanistic or withdrawn (for example NCT05956600 and NCT01448499, both withdrawn with no enrollment). They provide no efficacy evidence and are not listed above.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 23810019 | 2013 | Network meta-analysis | Lancet | Comparative efficacy and tolerability of 15 antipsychotics in schizophrenia |
| 31838873 | 2020 | Dose-response meta-analysis | Am J Psychiatry | Dose-response relationships of antipsychotics in acute schizophrenia |
| 19058842 | 2009 | Meta-analysis | Lancet | Second- vs first-generation antipsychotics in schizophrenia |
| 29368205 | 2018 | Systematic review/meta-analysis | Eur Arch Psychiatry Clin Neurosci | Antipsychotics for schizophrenia with prominent negative symptoms |
| 40056667 | 2025 | Dose-response meta-analysis | Eur Neuropsychopharmacol | Antipsychotic dosing and study discontinuation |
| 41811299 | 2026 | RCT | JAMA Psychiatry | Clozapine after one failed antipsychotic trial in first-episode psychosis |
| 32421188 | 2020 | Expert guideline/review | Schizophr Bull | Recommendations for clozapine combination and augmentation strategies |
| 12076408 | 2002 | Cochrane review | Cochrane Database Syst Rev | Amisulpride for schizophrenia |
| 12418608 | 2002 | Review | Curr Med Res Opin | Amisulpride's D2/D3 blockade addresses both positive and negative symptoms |
| 20121655 | 2010 | Review | Curr Med Res Opin | Functional outcome and quality of life with amisulpride |
Singapore Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| SIN09773P | SOLIAN TABLET 200 mg | Tablet (oral) | Not stated in the registration record |
The product is manufactured by Delpharm Dijon and is currently valid as a single-ingredient product.
Safety Considerations
- Drug Interactions: The interaction screen returned 100 interacting drugs, of which 20 are listed in the compiled data. Several are rated Major: cisapride, clarithromycin, dolasetron, granisetron, levofloxacin and metoclopramide. Many of these are QT-prolonging or related agents, which is consistent with amisulpride's known QTc risk. Moderate interactions include famotidine, epinephrine, hydrocortisone, amphotericin B, and several laxatives and antidiarrhoeals (bisacodyl, castor oil, glycerin, lactitol, lactulose, loperamide, magnesium citrate and hydroxide). Metronidazole is rated Minor.
- Other safety signals in the literature: hyperprolactinaemia and QTc prolongation are the main concerns. Renal impairment requires dose adjustment. Amisulpride has a relatively favourable metabolic and weight profile compared with olanzapine and clozapine.
The package insert warnings and contraindications were not available for this report. Please refer to the package insert for the full safety information.
Conclusion and Next Steps
Decision: Proceed with Guardrails
Rationale: Schizophrenia is supported by many Phase 3/4 trials, several randomized and double-blind, and by multiple high-tier meta-analyses (L1). This is an established antipsychotic use rather than a new indication. The guardrails are needed because the package-insert safety data is missing and the interaction list includes several major QT-related interactions.
To proceed, the following is needed:
- Retrieve the Singapore package insert (warnings, contraindications and approved indication text) and correct the empty indication record
- Add mechanism-of-action data to the drug record
- A monitoring plan covering prolactin, QTc/ECG, metabolic parameters and renal function, with a review of co-medications that have major interactions
- For dysthymic disorder (rank 8), adequately powered modern RCTs before it can move beyond a research question; anxiety disorder and the rare genetic and structural conditions should remain on hold
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.