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.
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 |
| Canada Market Status | Marketed (marketed DINs on record: at least 17; cancelled: 3) |
| Number of DINs | at least 20 |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data compiled for this report is not available. Lurasidone is known to be an atypical antipsychotic that antagonises D2, 5-HT2A and 5-HT7 receptors and is a partial agonist at 5-HT1A. This profile plausibly supports antimanic activity, but it should be confirmed against a primary source.
The other eight predicted indications (for example hydranencephaly, several myopia subtypes and Charcot-Marie-Tooth disease type 1G) have similarly high TxGNN model (deep learning) scores (between 0.9992 and 0.9995), but no clinical trials or literature and no plausible mechanistic link. These scores may reflect similarities the model learned between related diseases, not biological evidence. They remain model predictions only and are not recommended for follow-up at this stage.
Clinical Trial Evidence
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT01932541 | Phase 4 | Withdrawn | 0 | 8-week open-label study of lurasidone (Latuda) for mania in children and adolescents aged 6-17 with bipolar I, II or spectrum disorders. Withdrawn before enrolment, so no efficacy or safety data exist. |
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 37595997 | 2023 | Network meta-analysis | Lancet Psychiatry | Comparative efficacy and tolerability of drug treatments for acute bipolar depression in adults |
| 39557452 | 2024 | Systematic review / dose-response meta-analysis | BMJ Ment Health | Dose-response of lurasidone for bipolar depression: efficacy, acceptability, metabolic and endocrine profile |
| 38487836 | 2024 | Network meta-analysis | Eur Psychiatry | Efficacy and tolerability of five FDA-approved atypical antipsychotics, including lurasidone, in bipolar depression (16 RCTs, 7,234 patients) |
| 33177610 | 2021 | Systematic review / network meta-analysis | Mol Psychiatry | Antipsychotics and mood stabilisers for maintenance-phase bipolar disorder |
| 29536616 | 2018 | Guideline | Bipolar Disord | CANMAT/ISBD 2018 guidelines for managing bipolar disorder |
| 34599629 | 2021 | Guideline | Bipolar Disord | CANMAT/ISBD recommendations for bipolar disorder with mixed presentations |
| 37815563 | 2023 | Review | JAMA | Overview of diagnosis and treatment of bipolar disorder |
| 36472471 | 2022 | Review | J Child Adolesc Psychopharmacol | Treatment algorithms for manic/mixed and depressed episodes in paediatric bipolar disorder |
| 38618207 | 2024 | Network meta-analysis | EClinicalMedicine | Metabolic effects of antipsychotics and mood stabilisers in bipolar disorder |
| 31298818 | 2019 | Case report | Prim Care Companion CNS Disord | Lurasidone-induced mania, a reminder that the drug can itself trigger manic switching |
Canada Market Information
| DIN | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| 02387778 | LATUDA | Not specified | Not specified |
| 02413361 | LATUDA | Not specified | Not specified |
| 02422050 | LATUDA | Not specified | Not specified |
| 02504529 | TARO-LURASIDONE | Not specified | Not specified |
| 02505894 | PMS-LURASIDONE | Not specified | Not specified |
The rest are generics (for example Sandoz, Jamp, Auro, NRA and Taro products).
Safety Considerations
Contraindication-related conditions (drawn from the knowledge graph, not from label text): the drug is linked to caution or contraindication in conditions including:
- Orthostatic hypotension and related autonomic disorders
- Liver failure, liver disease and impaired renal function
- Diabetes, hyperglycaemia, diabetic ketoacidosis, hyperlipidaemia
- Neutropenia, leukopenia, agranulocytosis
- Stroke, cerebrovascular disorders and transient ischaemic attack
- Epilepsy
- Neuroleptic malignant syndrome and tardive dyskinesia
- Hyperprolactinaemia
Drug Interactions: 100 interactions were found in total. Examples:
- Major: bupropion, aprepitant, morphine, clarithromycin
- Moderate: metformin, pioglitazone, canagliflozin, acarbose, epinephrine, atropine, dexamethasone, cimetidine
For official warnings and contraindications, please refer to the package insert.
Conclusion and Next Steps
Decision: Hold
Rationale: Evidence for acute mania is therefore insufficient to recommend advancing. The high TxGNN score reflects the existing bipolar disorder indication, not new evidence.
To proceed, the following is needed:
- Confirmation of the label indications for the Canadian products (currently blank in the compiled data)
- Package insert warnings and contraindications from Health Canada, which are required before safety screening
- Mechanism of action data from DrugBank
- Mania-specific efficacy evidence, such as randomised trials in acute manic or mixed episodes
- Review of the interaction profile (CYP3A4 inhibitors and inducers) and metabolic monitoring requirements
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.