Fluphenazine

Evidence Level: L5

Predicted Indications: 10

Fluphenazine

Pharmacist Assessment Report

Fluphenazine: Retinal dystrophy with or without extraocular anomalies

One-Sentence Summary

Fluphenazine is a phenothiazine antipsychotic, originally used for psychotic disorders including schizophrenia. The TxGNN model predicts it may be effective for retinal dystrophy with or without extraocular anomalies, but no clinical trials and no publications currently support this prediction. It is a computational signal only.

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	0.9999
Evidence Level	L5
India Market Status	Listed in a compiled Indian medicine price dataset (12 of 12) – CDSCO approval status is not included in this data
Number of Listed Products	12 (valid: 12)
Recommended Decision	Hold

Why is This Prediction Reasonable?

Currently, detailed mechanism of action data is not available. Based on known information, fluphenazine is a high-potency phenothiazine and a dopamine D2 receptor antagonist. Its efficacy in psychotic disorders and schizophrenia is well established.

Mechanistically, no plausible pathway connects D2 antagonism to inherited retinal degeneration. Retinal dystrophies are generally genetically driven, and no data compiled for this report links fluphenazine to the causal genes or pathways. The high TxGNN score (0.9999) should be read as a model output, not as biological validation.

The model also produced other high-scoring predictions, such as syndromic myopia, X-linked myopia and several rare neurodevelopmental or metabolic disorders. None of these has supporting trials or publications. The only prediction with any literature is manic bipolar affective disorder. It sits close to fluphenazine’s existing psychiatric uses and is therefore an adjacent indication rather than a true repurposing. Even there, the literature is indirect (reviews of long-acting injectable antipsychotics, case reports) and contains no fluphenazine-specific trial data.

Clinical Trial Evidence

Currently no related clinical trials registered.

Literature Evidence

Currently no related literature available.

India Market Information

Twelve valid registrations exist, with no cancelled licences. The registration data lists no approved indication text. The five main authorizations are shown below.

Review correction (2026-11-06): Originally stated: “Twelve valid single-ingredient registrations exist, with no cancelled licences.” Removed: it described the products as single-ingredient or combination products in a way that did not match the Indian medicine data (the Indian Medicine Dataset as of 2026-11-06). Source: Indian Medicine Dataset.

Authorization Number	Product Name	Dosage Form
180783	Phenvator 25mg Injection	Vial, injection
85612	Fludecan 25mg Injection	Vial of 2 ml, injection
175233	Phenasol 25mg Injection	Vial of 1 ml, injection
7771	Arkane 2mg Tablet	Strip of 10 tablets
7089	Anatensol Decanoate 25mg Injection	Vial of 1 ml, injection

The remaining registrations are mostly 25 mg injections, plus Tripnor 0.5 mg/10 mg tablets (licence 216178).

Safety Considerations

Package insert warnings and label contraindications are not available in the data compiled for this report. Please refer to the package insert for these.

Disease-level contraindications (knowledge graph, not label text):
- Cardiovascular: long QT syndrome, torsades de pointes, sudden cardiac arrest, heart conduction disease, myocardial infarction, orthostatic hypotension.
- Haematological: neutropenia, agranulocytosis, leukopenia, thrombocytopenia, anaemia.
- Neurological: epilepsy, basal ganglia disease, focal hand dystonia, blepharospasm.
- Other: liver disease, gallbladder disease, hyperglycaemia, benign prostatic hyperplasia, substance abuse/dependence, obesity, female breast carcinoma.
Drug Interactions: 313 interactions were identified. The two Major interactions listed are bupropion and morphine. Moderate interactions include antidiabetics (metformin, pioglitazone, acarbose, alogliptin, albiglutide), corticosteroids (hydrocortisone, dexamethasone, betamethasone, triamcinolone), anticholinergics (atropine, hyoscyamine), loperamide, epinephrine, famotidine and amphotericin B.
Population concern: Phenothiazines carry neurological adverse effects such as extrapyramidal symptoms. This would need careful consideration in any neurological or paediatric genetic population.

Conclusion and Next Steps

Decision: Hold

Rationale: The prediction rests solely on a model score. No trials or publications exist, and no mechanistic link to retinal dystrophy is identified. The safety profile (QT prolongation, blood dyscrasias, neurological effects) is substantial, so there is no basis to advance this indication.

To proceed, the following is needed:

A mechanistic hypothesis linking dopamine D2 antagonism, or other fluphenazine pharmacology, to retinal degeneration, tested in preclinical models.
Detailed mechanism of action data (MOA).
Package insert warnings and contraindications for the Indian products.
A benefit-risk assessment in the target population, including cardiac and haematological monitoring.
If the team wants a near-term research question, reprioritise toward the adjacent indication of manic bipolar affective disorder. It has indirect literature support, but fluphenazine-specific data would still be needed.

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
2026-11-06	Removed: “single-ingredient”	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.