Lurasidone

Evidence Level: L5

Predicted Indications: 9

Lurasidone

Pharmacist Assessment Report

Lurasidone: Retinal dystrophy with or without extraocular anomalies

One-Sentence Summary

Lurasidone is an atypical antipsychotic originally used to treat bipolar disorder and schizophrenia. This is not a truly novel indication, because lurasidone is already used in bipolar disorder (mainly bipolar depression).

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
India Market Status	Listed in a compiled Indian medicine price dataset (at least 20) – CDSCO approval status is not included in this data
Number of Listed Products	at least 20
Recommended Decision	Hold (treat as a research question)

Why is This Prediction Reasonable?

Currently, detailed mechanism of action data is not available in the data compiled for this report. Based on general knowledge of the drug class, lurasidone is an atypical antipsychotic. Its blocking of dopamine D2 and serotonin 5-HT2A receptors, together with activity at 5-HT7 and 5-HT1A receptors, plausibly supports an antimanic effect.

Lurasidone is already used in bipolar disorder, and mania is one phase of that condition. The prediction is therefore close to the drug’s existing use rather than a leap into a new disease area.

The evidence for acute mania is weaker than for bipolar depression. Most of the literature found concerns bipolar depression, and the only trial directly testing mania was withdrawn. The mechanistic link rests on general class pharmacology, not on a documented mechanism record.

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NCT01932541	Phase 4	Withdrawn	0	8-week open-label study of lurasidone (Latuda) for mania in children and adolescents aged 6-17 with bipolar I, II and spectrum disorders. No participants were enrolled, so there are no efficacy or safety data.

Literature Evidence

PMID	Year	Type	Journal	Key Findings
39557452	2024	Meta-analysis	BMJ Ment Health	Dose-response meta-analysis of lurasidone for bipolar depression, covering efficacy, acceptability and metabolic/endocrine profile
37595997	2023	Network meta-analysis	Lancet Psychiatry	Comparative efficacy and tolerability of drugs for acute bipolar depression in adults
38487836	2024	Network meta-analysis	Eur Psychiatry	Efficacy and tolerability of FDA-approved atypical antipsychotics, including lurasidone, in bipolar depression (16 RCTs, 7,234 patients)
33177610	2021	Network meta-analysis	Mol Psychiatry	Mood stabilizers and/or antipsychotics in the maintenance phase of bipolar disorder
29536616	2018	Guideline/Review	Bipolar Disord	CANMAT/ISBD 2018 guidelines for managing bipolar disorder
34599629	2021	Guideline/Review	Bipolar Disord	CANMAT/ISBD recommendations for bipolar disorder with mixed presentations
37815563	2023	Review	JAMA	Review of diagnosis and treatment of bipolar disorder
36472471	2022	Review	J Child Adolesc Psychopharmacol	Treatment algorithms for manic/mixed and depressed episodes in pediatric bipolar disorder
39243127	2024	Review	Med Sci Monit	Narrative review of newer antipsychotics and mood stabilizers, including lurasidone, in bipolar disorder and schizophrenia
24170243	2014	Commentary	Am J Psychiatry	Commentary on lurasidone and bipolar disorder

India Market Information

Lurasidone has 20 valid single-ingredient registrations, with no cancelled licences. All are oral tablets (strip of 10 tablets). The registration records carry no approved-indication text. The five listed below are examples.

Authorization Number	Product Name	Dosage Form	Approved Indication
131548	Luratrend 80mg Tablet (Abbott)	Tablet, strip of 10	Not stated in the registration record
124437	Lurafic 80mg Tablet (Lupin)	Tablet, strip of 10	Not stated in the registration record
128942	Lurakem 80mg Tablet (Alkem)	Tablet, strip of 10	Not stated in the registration record
217059	Tablura 40 Tablet (Cipla)	Tablet, strip of 10	Not stated in the registration record
121556	Lurasid 40 Tablet (Intas)	Tablet, strip of 10	Not stated in the registration record

Safety Considerations

The package insert warnings and contraindications could not be retrieved, so please refer to the package insert for label safety information.

Disease-level contraindication signals (from the knowledge graph, not label text): The graph links lurasidone to a broad set of conditions of concern, including:
- Cardiovascular and neurological: orthostatic hypotension, stroke and cerebrovascular disorders, transient ischemic attack, epilepsy, neuroleptic malignant syndrome, tardive dyskinesia
- Metabolic and endocrine: hyperglycemia, diabetes mellitus, diabetic ketoacidosis, hyperlipidemia, hyperprolactinemia
- Haematological, hepatic and renal: neutropenia, leukopenia, agranulocytosis, liver disease or failure, impaired renal function
Drug interactions: 179 interactions were recorded. Examples classed as Major are bupropion, aprepitant, morphine and clarithromycin. Moderate examples include several antidiabetic agents (acarbose, metformin, pioglitazone, alogliptin, canagliflozin, chlorpropamide, albiglutide), anticholinergics (atropine, hyoscyamine, glycopyrronium), epinephrine, dexamethasone, cimetidine and lorcaserin. Strong CYP3A4 inhibitors and inducers deserve particular attention when assessing this class of interaction.
Metabolic monitoring: Weight gain and glucose dysregulation with antipsychotics are discussed in the supporting literature, so metabolic monitoring is advisable.

Conclusion and Next Steps

Decision: Hold (treat as a research question)

Rationale: The TxGNN score is very high, but lurasidone is already used in bipolar disorder, so this prediction adds little that is new. Package-insert safety data are also missing.

Review correction (2026-10-31): Originally stated: “The TxGNN score is very high, but lurasidone is already used in bipolar disorder, so this prediction adds little that is new. Direct evidence for acute mania is thin: the only mania trial was withdrawn with no enrolment, and the supporting literature is mostly reviews, guidelines and meta-analyses on bipolar depression.” Removed: it said the product records were cancelled, discontinued, or not current, which did not match the Indian medicine data (the Indian Medicine Dataset as of 2026-10-31). Source: Indian Medicine Dataset.

To proceed, the following is needed:

Package-insert warnings and contraindications from the Indian regulatory sources, to enable safety screening
Mechanism of action data (for example from DrugBank)
Randomized controlled trial evidence specific to acute manic or mixed episodes (adult and paediatric)
Review of the approved indication wording on the Indian labels, to confirm whether acute mania falls inside or outside the current labelling
A metabolic, cardiovascular and drug-interaction monitoring plan

Note on other TxGNN predictions: The nine other predictions in the ranked list (for example retinal dystrophy, hydranencephaly, X-linked myopia, Charcot-Marie-Tooth disease type 1G) have no clinical trials or literature and no plausible mechanistic link. They are rated L5 and Hold, and are best regarded as network-proximity artefacts rather than real therapeutic signals.

Review Log

Below is the review log for this page: statements checked against official Indian medicine data (the Indian Medicine Dataset used by this site). Corrections are limited to basic factual statements; model predictions, evidence levels, and conclusions were not rewritten.

Review date	Item	Action	Source
2026-10-31	Removed: “Direct evidence for acute mania is thin: the only mania trial was withdrawn with no enrolment, and the supporting literature is mostly revie”	Corrected	Indian Medicine Dataset

Disclaimer

This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.