NDAORALTABLETPriority Review
Approved
Apr 1967
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
18
Data completeness
3/8 — Basic
Priority Review
HALDOL (haloperidol) by Johnson & Johnson is clinical pharmacology the precise mechanism of action has not been clearly established. First approved in 1967.
Drug data last refreshed 14h ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
HALDOL (haloperidol) is a first-generation antipsychotic approved in 1967 that blocks dopamine receptors in the central nervous system. It is indicated for schizophrenia, bipolar disorder, schizoaffective disorder, psychosis, acute agitation, delirium, nausea, migraine headaches, and drug-induced akathisia. The precise mechanism of action has not been clearly established, though dopamine antagonism is believed central to its efficacy.
LOE Approaching
As a legacy product approaching loss of exclusivity, HALDOL teams are typically smaller and focused on defending market share against newer atypical antipsychotics with superior tolerability profiles.
Mechanism of Action
CLINICAL PHARMACOLOGY The precise mechanism of action has not been clearly established.
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (18)
IM Olanzapine Versus Haloperidol or Midazolam
Started Dec 2014
167 enrolled
Acute Agitation, Behavioural Emergency
Haldol/Diphenhydramine Versus Metoclopramide/Diphenhydramine for Treatment of Acute Headache in the ED: A RCT
Started Jun 2013
0Migraine HeadachesNauseaRestlessness
Pragmatic RCT Comparing Aripiprazole, Olanzapine and Haloperidol in the Treatment of Schizophrenia
Started Jul 2007
300 enrolled
Schizophrenia
Randomized Evaluation of the Effectiveness of Clozapine and Aripiprazole Versus Clozapine and Haloperidol in the Treatment of Schizophrenia
Started Sep 2006
106 enrolled
Schizophrenia
A Comparison Study of the Efficacy of Quetiapine and Haloperidol in Agitated Adults in Emergency Room
Started May 2006
72 enrolled
Agitation
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.