Lurasidone
| Evidence Level: L4 | Predicted Indications: 10 |
Table of Contents
Lurasidone: From Bipolar Disorder and Schizophrenia to Manic Bipolar Affective Disorder
One-Sentence Summary
Lurasidone is an atypical antipsychotic originally used to treat bipolar disorder (bipolar depression) and schizophrenia. The TxGNN model predicts it may be effective for manic bipolar affective disorder, but only 1 clinical trial (withdrawn, with no participants enrolled) and 20 publications, mostly general reviews and guidelines, are currently linked to this direction.
Quick Overview
| Item | Content |
|---|---|
| Original Indication | Bipolar disorder, schizophrenia (the Singapore licence records contain no indication text) |
| Predicted New Indication | Manic bipolar affective disorder |
| TxGNN Prediction Score | 99.98% |
| Evidence Level | L4 |
| Singapore Market Status | ✓ Marketed |
| Number of Registrations | 3 |
| 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 known pharmacology, lurasidone is an atypical antipsychotic that blocks dopamine D2 and serotonin 5-HT2A receptors and also acts on 5-HT7 and 5-HT1A receptors. Atypical antipsychotics with this profile are commonly used to treat manic symptoms, so an antimanic effect is plausible.
The predicted indication overlaps heavily with the original use. Lurasidone is already used for bipolar disorder, so this is an extension within the same disease family, not a true repurposing signal. The existing literature is mostly about bipolar depression, not acute mania, so the evidence for mania is indirect.
Clinical Trial Evidence
| Trial Number | Phase | Status | Enrollment | Key Findings |
|---|---|---|---|---|
| NCT01932541 | Phase 4 | Withdrawn | 0 | 8-week open-label study of lurasidone for mania in children and adolescents aged 6-17 with bipolar I, II and spectrum disorders. No participants were enrolled, so there are no efficacy or safety results. |
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 39557452 | 2024 | Systematic review and dose-response meta-analysis | BMJ Mental Health | Lurasidone dose-response for efficacy, acceptability and metabolic/endocrine profile in bipolar depression (not mania) |
| 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 | Compared five FDA-approved atypical antipsychotics, including lurasidone, for bipolar depression across 16 RCTs (7,234 patients) |
| 33177610 | 2021 | Systematic review / network meta-analysis of RCTs | Molecular Psychiatry | Compared mood stabilizers and antipsychotics for maintenance-phase bipolar disorder |
| 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 |
| 37815563 | 2023 | Review | JAMA | Overview of the 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 |
| 39243127 | 2024 | Review | Med Sci Monit | Narrative review of new antipsychotics and mood stabilizers for bipolar disorder and schizophrenia |
| 31298818 | 2019 | Case report | Prim Care Companion CNS Disord | Report of lurasidone-induced mania, a safety signal relevant to this indication |
Singapore Market Information
| Authorization Number | Product Name | Dosage Form | Approved Indication |
|---|---|---|---|
| SIN15088P | LATUDA TABLET 40MG | Tablet, coated | Not recorded in the licence data |
| SIN16346P | LATUDA TABLET 20MG | Tablet, film coated | Not recorded in the licence data |
| SIN15089P | LATUDA TABLET 80MG | Tablet, coated | Not recorded in the licence data |
Safety Considerations
- Contraindication-related conditions (from knowledge graph associations, not label text): orthostatic hypotension and related autonomic disorders (multiple system atrophy, postural orthostatic tachycardia syndrome); liver failure and liver disease; impaired renal function; epilepsy; diabetes mellitus, hyperglycaemia and diabetic ketoacidosis; hyperlipidaemia; neutropenia, leukopenia and agranulocytosis; stroke, cerebrovascular disorders and transient ischaemic attack; neuroleptic malignant syndrome; tardive dyskinesia and other dyskinesias; hyperprolactinaemia and prolactin-producing pituitary tumours; gallbladder disease.
- Drug Interactions: 100 interactions were found in total. The first 20 listed include the following major interactions: bupropion, aprepitant, morphine and clarithromycin. Moderate interactions include antidiabetic agents (acarbose, albiglutide, alogliptin, metformin, pioglitazone, canagliflozin, chlorpropamide), anticholinergics (atropine, hyoscyamine, glycopyrronium), epinephrine, dexamethasone, cimetidine and lorcaserin.
Package insert warnings and contraindications were not available, so please refer to the package insert for full safety information.
Conclusion and Next Steps
Decision: Hold
Rationale: The only trial directly addressing mania was withdrawn with no participants, and the literature is mainly general bipolar reviews and guidelines, or lurasidone studies on bipolar depression. Because lurasidone's current use already covers bipolar disorder, this prediction is an extension within the same disease family and offers little new repurposing value. The prediction therefore remains a research question (L4).
To proceed, the following is needed:
- Randomised controlled trial data for lurasidone in acute manic or mixed episodes
- Package insert warnings and contraindications from HSA
- Detailed mechanism of action data (MOA)
- Review of the Singapore licensed indication wording, since the licence records contain no indication text
- A safety plan covering metabolic risk, extrapyramidal symptoms and the major drug interactions
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.