Droperidol
| Evidence Level: L4 | Predicted Indications: 10 |
Table of Contents
Droperidol: From Its Marketed Injectable Use to Tourette Syndrome
One-Sentence Summary
Droperidol is a butyrophenone neuroleptic, marketed in the US as an injectable and used in several countries for sedation in acute agitation and psychosis. The TxGNN model predicts it may be effective for Tourette syndrome, but there are currently 0 clinical trials and only 1 publication, and that paper concerns haloperidol rather than droperidol.
Quick Overview
| Item | Content |
|---|---|
| Predicted New Indication | Tourette syndrome |
| TxGNN Prediction Score | 99.89% |
| Evidence Level | L4 |
| US Market Status | ✓ Marketed |
| Number of NDAs | 3 license entries (all ANDAs; two entries share ANDA208197) |
| Recommended Decision | Hold |
Why is This Prediction Reasonable?
Currently, detailed mechanism of action data for droperidol is not available in the record. Droperidol is a butyrophenone and is generally understood to act as a dopamine D2 receptor antagonist. Haloperidol and other antipsychotics are thought to suppress tics through D2 blockade, so a similar effect is plausible for droperidol.
This is a class-level inference, not droperidol-specific evidence. The only cited paper is a 1976 clinical report on haloperidol in severe behavior disorders, which supports the drug class only indirectly.
The record also lists no original approved indication text for droperidol. It is therefore not possible to describe how Tourette syndrome relates to a labeled use. Droperidol’s better-documented uses in this record are acute agitation and psychosis, and migraine.
Clinical Trial Evidence
Currently no related clinical trials registered.
Literature Evidence
| PMID | Year | Type | Journal | Key Findings |
|---|---|---|---|---|
| 791589 | 1976 | Clinical report (indirect) | Current psychiatric therapies | Haloperidol in severe behavior disorders. It concerns haloperidol, not droperidol, and no abstract is available. |
US Market Information
| Authorization Number | Product Name | Dosage Form | Manufacturer |
|---|---|---|---|
| ANDA208197 | DROPERIDOL | Injection, solution | Hikma Pharmaceuticals USA Inc. |
| ANDA072123 | Droperidol | Injection, solution | American Regent, Inc. |
The record lists ANDA208197 twice, and no approved indication text is provided for any entry.
Safety Considerations
- Key Warnings: The evidence pack’s notes on other candidate indications mention a boxed warning for QT prolongation, with ECG monitoring required. The package insert warning text itself is not in the record.
- Drug Interactions: The interaction query returned no records.
Please refer to the package insert for full safety information.
Conclusion and Next Steps
Decision: Hold
Rationale: The prediction score is very high, but the only supporting item is an indirect 1976 haloperidol report, with no droperidol-specific trials or literature for Tourette syndrome. The QT-prolongation warning also weighs against using an injectable in a chronic condition.
To proceed, the following is needed:
- Droperidol-specific clinical or preclinical evidence in Tourette syndrome
- Mechanism of action data (MOA) and the package insert warnings and contraindications
- An assessment of route suitability, since only injectable forms are marketed and a chronic condition would need long-term dosing
Note on other candidates: In this evidence pack, headache disorder (migraine; L2, Proceed with Guardrails) and manic bipolar affective disorder (L2, Research Question) have much stronger support than Tourette syndrome. Evaluating them separately is a better use of effort.
Disclaimer
This content is for research purposes only and does not constitute medical advice. Clinical validation is required before any clinical application.