Lurasidone
| Evidence Level: L5 | Predicted Indications: 9 |
Table of Contents
Lurasidone: Retinal dystrophy with or without extraocular anomalies
One-Sentence Summary
Lurasidone is an atypical antipsychotic originally used to treat bipolar disorder and schizophrenia. The TxGNN model predicts it may be effective for retinal dystrophy with or without extraocular anomalies,
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Not recorded in the local data |
| Predicted New Indication | Retinal dystrophy with or without extraocular anomalies |
| TxGNN Prediction Score | 0.9995 |
| Evidence Level | L5 |
| 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) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Detailed mechanism of action data is not available in the data compiled for this report. Based on general pharmacology, lurasidone is an atypical antipsychotic that antagonises D2, 5-HT2A and 5-HT7 receptors and is a partial agonist at 5-HT1A. This profile is inferred from general knowledge, not from the supplied data.
The original indications (bipolar disorder and schizophrenia) overlap closely with the predicted indication. Manic episodes are plausibly responsive to D2/5-HT2A blockade, as seen with other atypical antipsychotics. However, the high TxGNN score is consistent with the known bipolar indication and is not independent evidence for efficacy in mania. Much of the published bipolar literature on lurasidone concerns bipolar depression, which is a different clinical target. One case report describes lurasidone-induced mania.
Clinical Trial Evidence
| Trial Number | Phase | Status | Enrolment | Key Findings |
|---|---|---|---|---|
| NCT01932541 | Phase 4 | Withdrawn | 0 | Planned 8-week open-label study of lurasidone (Latuda) for mania in children and adolescents aged 6-17 with bipolar I, bipolar II or bipolar spectrum disorder. No participants were enrolled, so there are no efficacy or safety data. |
Literature Evidence
Systematic reviews and meta-analyses are listed first, followed by guidelines and other reviews. No randomised controlled trials of lurasidone in mania were identified in the data compiled for this report.
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 39557452 | 2024 | Systematic review / dose-response meta-analysis | BMJ Mental Health | Examines the dose-response relationship of lurasidone for efficacy, acceptability and metabolic/endocrine profile in bipolar depression |
| 37595997 | 2023 | Network meta-analysis | Lancet Psychiatry | Comparative efficacy and tolerability of drug treatments for acute bipolar depression |
| 38487836 | 2024 | Network meta-analysis | European Psychiatry | Compares FDA-approved atypical antipsychotics, including lurasidone, for bipolar depression (16 RCTs, 7,234 patients) |
| 41855620 | 2026 | Network meta-analysis / systematic review | Eur Neuropsychopharmacol | Updated network meta-analysis of treatments for bipolar depression |
| 33177610 | 2021 | Systematic review / network meta-analysis | Molecular Psychiatry | Compares mood stabilisers and antipsychotics for bipolar maintenance treatment |
| 41985753 | 2026 | Systematic review / network meta-analysis | J Affect Disord | Dose-related efficacy and safety of drugs for bipolar maintenance across age groups |
| 38150810 | 2024 | Systematic review / meta-analysis | Psychiatry Research | Efficacy and safety of second-generation antipsychotics for psychiatric disorders other than schizophrenia |
| 29536616 | 2018 | Guideline | Bipolar Disorders | CANMAT/ISBD 2018 guidelines for managing bipolar disorder |
| 34599629 | 2021 | Guideline | Bipolar Disorders | CANMAT/ISBD recommendations for bipolar disorder with mixed presentations |
| 31298818 | 2019 | Case report | Prim Care Companion CNS Disord | Describes lurasidone-induced mania, a safety signal relevant to this prediction |
Australia Market Information
| ARTG Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| ARTG 10526B | Lurasidone Lupin | Tablet containing lurasidone hydrochloride 40 mg (oral) | Not stated in the data compiled for this report |
Safety Considerations
Label-based warnings and contraindications are not available in the data compiled for this report. Please refer to the TGA-approved Product Information (PI) for these.
- Knowledge-graph contraindication signals (not label text): orthostatic hypotension and related autonomic conditions, liver disease and failure, epilepsy, diabetes mellitus and related conditions (hyperglycaemia, diabetic ketoacidosis), hyperlipidaemia, neutropenia, leukopenia and agranulocytosis, cerebrovascular disease (stroke, transient ischaemic attack, cerebral infarction), renal impairment, neuroleptic malignant syndrome, tardive dyskinesia, hyperprolactinaemia and prolactin-producing pituitary tumour, and gallbladder disease.
- Drug interactions: 100 interactions were identified; the first 20 returned include:
- Major: bupropion, aprepitant, morphine, clarithromycin.
- Moderate: antidiabetic agents (acarbose, alogliptin, metformin, pioglitazone, canagliflozin, chlorpropamide, albiglutide), anticholinergics (atropine, hyoscyamine, glycopyrronium), epinephrine, dexamethasone, lorcaserin, cimetidine, and bowel-preparation agents (picosulfuric acid, polyethylene glycol).
- Interaction severities come from the DDInter database; the strong CYP3A4 inhibitor clarithromycin is of particular practical relevance.
Conclusion and Next Steps
Decision: Hold
Rationale: The only trial for this indication was withdrawn with no participants, and the supporting literature mostly addresses bipolar depression or general bipolar management rather than mania. The TxGNN score is not independent evidence, and label safety data are missing. Lower-ranked predictions (ranks 2-10, such as retinal dystrophy and hydranencephaly) have no trials, no literature and no supported mechanism, so they are not pursued.
To proceed, the following is needed:
- Review of the TGA Product Information and the current ARTG-approved indications, including whether mania is covered
- Detailed mechanism of action data (for example, from DrugBank)
- Targeted review of randomised trial data for lurasidone in acute mania, as distinct from bipolar depression
- Safety assessment for manic presentations, given the reported lurasidone-induced mania and the metabolic, cardiovascular and drug-interaction signals above
- If evidence supports it, a prospective trial design, possibly registered with ANZCTR
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.