Haldol

(Haloperidol)

ApprovedSmall molecule

Haloperidol is used to treat severe mental health conditions like schizophrenia and psychosis, helping to reduce hallucinations and delusions. It's also sometimes used to control severe behavioral problems and to stop hiccups or nausea.[2] Haldol is currently approved and in use across 28 indications[4].[1]

Haldol is one of 543 small molecule programs targeting Gastroparesis. It is currently in Approved.

Indications

104

Total Trials

Active Trials

542

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[4][1]

Indication

GastroparesisActive, not recruiting

Nicotine DependenceApproved

Bipolar I DisorderActive, not recruiting

Mental or Behavioural DisorderActive, not recruiting

Mood DisorderApproved

StrokeActive, not recruiting

TicsActive, not recruiting

OverdoseActive, not recruiting

Huntington DiseaseApproved

Schizoaffective DisorderActive, not recruiting

GastroparesisApproved

Active, not recruiting

Nicotine DependenceApproved

Approved

Bipolar I DisorderPhase 3

Active, not recruiting

Mental or Behavioural DisorderApproved

Active, not recruiting

Mood DisorderApproved

Approved

StrokePreclinical

Active, not recruiting

TicsApproved

Active, not recruiting

OverdosePhase 2

Active, not recruiting

Huntington DiseaseApproved

Approved

Schizoaffective DisorderApproved

Active, not recruiting

Showing 10 of 24 indications

Competition

Competitive Landscape

583 competitors in Schizophrenia

#DrugCompanyPhaseTrials

Haldol

DDePuy Orthopaedics

Approved

18 2

Celexa

AbbVie

Preclinical

4 3

Inapsine

Alnylam Pharmaceuticals

Preclinical

1 4

Zocor

OOrganon and Co

Preclinical

6 5

Depakote

Ibrance

Comtan

Orion Corporation, Orion Pharma

Preclinical

1 8

Luvox

SSolvay Pharmaceuticals

Preclinical

1 9

Vivarin

HHikma Pharmaceuticals LLC

Preclinical

1 10

Compazine

GGlaxo Dba Glaxosmithkline

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 3Recruiting

Olanzapine

NCT07246187

Phase 2/3Active, not recruiting

Delirium

NCT03743649

Q1 2027

Phase 2/3Recruiting

Delirium

NCT05431595

Q2 2027

Post-ApprovalRecruiting

Back Pain

NCT06395428

Phase 2/3Active, not recruiting

Delirium

NCT03021486

Q3 2028

Phase 2Not yet recruiting

Effectiveness

NCT06218524

Clinical

Trials by Indication[1]

Delirium22 trials

Haloperidol and Lorazepam in Controlling Symptoms of Persistent Agitated Delirium in Patients With Advanced Cancer Undergoing Palliative Care

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2/3·NCT03743649·110 enrolled

Pilot Study of Haloperidol to Treat Critical Illness Delirium

Completed·UUniversity of Colorado, Denver·Phase 2·NCT00429676·20 enrolled

Methylphenidate, Rivastigmine or Haloperidol in Hypoactive Delirium in Intensive Care Patients

Terminated·UUMC Utrecht·Phase 3·NCT00599287·80 enrolled

Show 19 more trials

ORIC-I: Optimizing Recovery From Intensive Care: Mechanical Ventilation and Delirium

Terminated·UUniversity of Pittsburgh·Phase 3·NCT00300391·40 enrolled

Dexmedetomidine for the Treatment of Delirium After Heart Surgery

Terminated·TThorax-Kärlkliniken·Phase 3·NCT01140529·3 enrolled

Treatment of Hypoactive Delirium and Outcome Measures

Unknown status·IInstituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran·Phase 3·NCT02345902·60 enrolled

Baden Prevention and Reduction of Incidence of Postoperative Delirium Trial

Completed·UUniversity Hospital, Basel, Switzerland·Phase 4·NCT02433041·200 enrolled

Haloperidol With or Without Chlorpromazine in Treating Delirium in Patients With Advanced, Metastatic, or Recurrent Cancer

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2/3·NCT03021486·70 enrolled

PROfylactic Haloperidol in Patients Defined as High Risk for DElirium With Delirium Risk mOdel

Unknown status·ZZuyderland Medisch Centrum·Phase 4·NCT03199950·1,366 enrolled

Pharmacological Management of Delirium

Completed·IIndiana University·N/A·NCT00842608·551 enrolled

A Double-blind, Randomized, Controlled Trial of Quetiapine Versus Haloperidol for the Treatment of Delirium

Terminated·—·Phase 3·NCT00954603·52 enrolled

The MIND Study: Modifying the INcidence of Delirium

Completed·VVanderbilt University·Phase 2·NCT00096863·102 enrolled

Managing Agitated Delirium With Neuroleptics and Anti-Epileptics as a Neuroleptic Sparing Strategy

Recruiting·MM.D. Anderson Cancer Center·Phase 2/3·NCT05431595·42 enrolled

Haloperidol for Delirium in Adult Critically Ill Patients

Terminated·EErasmus Medical Center·Phase 3·NCT03628391·142 enrolled

Haloperidol Prophylaxis in Cardiac Surgery for Patients at Risk for Delirium

Completed·MMcMaster University·Phase 3·NCT01862302·25 enrolled

Haloperidol vs Olanzapine for the Management of ICU Delirium

Terminated·RRichard Hall·N/A·NCT00833300·200 enrolled

Trial Comparing Haloperidol, Quetiapine and Placebo in the Pharmacological Treatment of Delirium

Completed·—·Phase 3·NCT01811459·107 enrolled

Quetiapine Versus Haloperidol in the Management of Hyperactive Delirium

Completed·—·Phase 3·NCT05690698·100 enrolled

Valproic Acid for Treatment of Hyperactive or Mixed Delirium in ICU

Terminated·SStanford University·Phase 4·NCT02343575·3 enrolled

Combination of Haloperidol and Magnesium for Delirium Prevention in Critically Ill Elderly

Completed·—·Phase 2/3·NCT06168773·135 enrolled

Comparing Haloperidol and Olanzapine in Treating Terminal Delirium

Unknown status·HHCA Hospice Care·Phase 2·NCT04750395·80 enrolled

Agents Intervening Against Delirium in Intensive Care Unit

Unknown status·ZZealand University Hospital·Phase 4·NCT03392376·1,000 enrolled

Schizophrenia18 trials

Family Intervention in Recent Onset Schizophrenia Treatment (FIRST)

Completed· Johnson & Johnson logo

Johnson & Johnson··NCT02600741·296 enrolled

Pragmatic RCT Comparing Aripiprazole, Olanzapine and Haloperidol in the Treatment of Schizophrenia

Completed· Mario Negri Institute for Pharmacological Research logo

Mario Negri Institute for Pharmacological Research·Phase 4·NCT01052389·300 enrolled

Comparison of Intramuscular Olanzapine and Intramuscular Haloperidol in Patients With Schizophrenia

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT00485901·50 enrolled

Show 15 more trials

Study of add-on Ramelteon Therapy on Sleep and Circadian Rhythm Disruption in Patients With Schizophrenia

Completed·—·Phase 4·NCT03075657·120 enrolled

A Study to Compare Disease Progression and Modification Following Treatment With Paliperidone Palmitate Long-Acting Injection or Oral Antipsychotics in Participant's With Recent-onset Schizophrenia or Schizophreniform

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT02431702·337 enrolled

Multicenter, Open-Label, Randomised, Haloperidol-controlled Study to Evaluate Seroquel as Mono-Therapy in the Treatment of Agitated Symptoms in the Patients With Acute Episode of Schizophrenia

Completed·PPeking University·N/A·NCT00631722·80 enrolled

Clozapine Versus Haloperidol for Treating the First Episode of Schizophrenia

Terminated·HHarvard Medical School (HMS and HSDM)·Phase 4·NCT00169091·32 enrolled

A 4-week, Randomized, Rater-blinded, Parallel Study to Evaluate Quetiapine in Improving Sleep Quality of Schizophrenia

Completed·GGuang Dong Provincial Mental Health Institute·N/A·NCT00642369·60 enrolled

Metabolic Profile and Anthropometric Changes in Schizophrenia

Completed·—·N/A·NCT00534183·2,006 enrolled

To Determine if Olanzapine is More Cost Effective Than Haloperidol for the Treatment of Schizophrenia

Completed·UUS Department of Veterans Affairs·Phase 4·NCT00007774·600 enrolled

Antipsychotic Effects of Sorghum Bicolor (JOBELYN) in the Treatment of Schizophrenia

Unknown status·—·Phase 1/2·NCT02240173·100 enrolled

Pilot Study to Evaluate the Efficacy and Safety of Quetiapine Fumarate Instant-Release (Seroquel IR) in Controlling Agitation and Aggressive Symptoms in the Acute Treatment of Patients With Schizophrenia

Unknown status·SSichuan University·Phase 4·NCT00838032·70 enrolled

Clinical Effectiveness of Newer Antipsychotics in Comparison With Conventional Antipsychotics in Schizophrenia

Completed·—·Phase 4·NCT01164059·149 enrolled

5HT3 Antagonism and Auditory Gating in Schizophrenia

Completed·UUS Department of Veterans Affairs·N/A·NCT00018850

Efficacy and Safety of Risperidone Oral Solution Combination Clonazepam Versus Haloperidol Intramuscular (IM) Injection for Treatment of Acute Psychotic Agitation in Schizophrenia

Completed·—·Phase 4·NCT00859872·198 enrolled

Lurasidone Effects on Tissue Glutamate in Schizophrenia

Completed·UUniversity of Texas Southwestern Medical Center·Phase 4·NCT02199743·35 enrolled

A Study To Evaluate The Efficacy And Safety Of Intramuscular Levosulpiride In Patients With Agitation Of Schizophrenia

Completed·SShanghai Mental Health Center·Phase 2/3·NCT00866645·240 enrolled

A Comparison of Study Drug With Placebo and Haloperidol in Patients With Schizophrenia

Completed· Sumitomo Pharma America, Inc. logo

Sumitomo Pharma America, Inc.·Phase 2·NCT00044044·356 enrolled

Agitation10 trials

Rapid Agitation Control With Ketamine in the Emergency Department

Completed·DDavid Barbic·Phase 2·NCT03375671·81 enrolled

Haloperidol vs. Valproate in Agitation

Completed·SShahid Beheshti University of Medical Sciences·Phase 3·NCT01750541·56 enrolled

A Study of Olanzapine in Patients With Acute Agitation

Unknown status· Qilu Pharmaceutical Co., Ltd. logo

Qilu Pharmaceutical Co., Ltd.·Phase 3·NCT05803642·318 enrolled

Show 7 more trials

Pre-hospital Agitation and Sedation Trial: A Randomized Controlled Trial of Haloperidol Versus Midazolam for the Sedation of the Agitated Patient

Completed·CCatholic Health East·N/A·NCT01501123·10 enrolled

Agitation in Alzheimer's Disease

Completed·NNational Institute on Aging (NIA)·Phase 3·NCT00000179

Ketamine Versus Haloperidol for Severe Agitation Outside the Hospital

Withdrawn·HHennepin Healthcare Research Institute·Phase 4·NCT02103881

Reducing Ketamine-Induced Agitation, by Midazolam or Haloperidol Premedication After Adult Procedural Sedation

Completed·TTehran University of Medical Sciences·Phase 4·NCT02909465·185 enrolled

A Comparison of Dexmedetomidine and Haloperidol in Patients With Intensive Care Unit (ICU)-Associated Agitation and Delirium

Completed·AAustin Health·Phase 2·NCT00505804·20 enrolled

A Randomized, Open-Label, Multi-Center Study To Evaluate The Efficacy And Safety Of Intramuscular Ziprasidone In Patients With Agitation

Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 3·NCT00723606·376 enrolled

Olanzapine, Haloperidol, Ziprasidone, Midazolam for Acute Undifferentiated Agitation

Completed·HHennepin Healthcare Research Institute··NCT03211897·737 enrolled

Treatment4 trials

Treatment Strategies in CHS

Completed·UUniversity of Calgary·Phase 4·NCT04176055·4 enrolled

Study of Preladenant for the Treatment of Neuroleptic Induced Akathisia (Study P05145)

Terminated· Merck & Co. logo

Merck & Co.·Phase 2·NCT00693472·46 enrolled

A Study in the Treatment of Acute Mania

Terminated· Eli Lilly logo

Eli Lilly·Phase 4·NCT00767715·11 enrolled

Show 1 more trial

Efficacy Study of Switching Stabilized Schizophrenic Patients From Conventional to Atypical Antipsychotic Treatment

Completed· Eli Lilly logo

Eli Lilly·Phase 4·NCT00191555·360 enrolled

Antipsychotics3 trials

Typical Versus Atypical Antipsychotics; Occupation of Striatal Receptors and the Appearance of Extrapyramidal Symptomatology, in Healthy Volunteers

Unknown status·HHospital Clinic of Barcelona·Phase 1·NCT01259973·24 enrolled

Evaluation of the Necessity of Long-term Pharmacological Treatment With Antipsychotics in Schizophrenic Patients

Completed·TTechnical University of Munich·Phase 4·NCT02307396·21 enrolled

Do Antipsychotics Block Insulin Action in the Brain: is it a Class Effect?

Not yet recruiting·CCentre for Addiction and Mental Health·Phase 4·NCT07109245·35 enrolled

33 more indications

Nausea and vomiting3 trials

Real-time Decision Support for Postoperative Nausea and Vomiting (PONV) Prophylaxis

Completed·VVanderbilt University·N/A·NCT02625181·27,034 enrolled

Comparison of Haloperidol and Ondansetron in Reducing Postoperative Nausea and Vomiting in RA-SAB Patients

Completed·RRully Riyandika·N/A·NCT07087925·40 enrolled

Haloperidol for the Treatment of Nausea and Vomiting in the ED

Completed·—·Phase 4·NCT04764344·60 enrolled

Headache3 trials

Haldol/Diphenhydramine Versus Metoclopramide/Diphenhydramine for Treatment of Acute Headache in the ED: A RCT

Withdrawn·UUnited States Naval Medical Center, Portsmouth·Phase 4·NCT02098499

IV Haloperidol for the Treatment of Headache in the ED

Completed·—·Phase 4·NCT02747511·118 enrolled

Efficacy of Haloperidol vs. Metoclopramide for Treatment of Acute Headaches and Migraines in the Emergency Department

Terminated·OOhioHealth·Phase 4·NCT02972502·66 enrolled

Aggression2 trials

Clozapine IM and Aggression in Schizophrenic Patients

Withdrawn·—·Phase 3·NCT00189995

Clozapine and Olanzapine Treatment of Aggression

Completed·NNathan Kline Institute for Psychiatric Research·N/A·NCT01123408·110 enrolled

Chronic2 trials

Metabolic Effects of Subchronic Dopamine D2 Receptor Blockade by Antipsychotic Drugs in Healthy Humans

Completed·LLeiden University Medical Center·N/A·NCT00625170·11 enrolled

Metabolic Effects of Subchronic Dopamine D2 Receptor Blockade by Haloperidol in Healthy Humans

Completed·LLeiden University Medical Center·N/A·NCT00625014·8 enrolled

Efficacy and Safety2 trials

Long-Term Efficacy and Safety of Asenapine Using Haloperidol as a Positive Control (41513)(COMPLETED)(P05785)

Completed·OOrganon and Co·Phase 3·NCT00156065·187 enrolled

Efficacy and Safety of Asenapine With Placebo and Haloperidol (41023)(P05926)(COMPLETED)

Completed·OOrganon and Co·Phase 3·NCT00156104·460 enrolled

Olanzapine2 trials

IM Olanzapine Versus Haloperidol or Midazolam

Terminated·TThe University of Hong Kong·Phase 4·NCT02380118·167 enrolled

Comparing Haloperidol to Olanzapine in the Treatment of Suspected Cannabinoid Hyperemesis in the Emergency Department

Recruiting·—·Phase 3·NCT07246187·114 enrolled

Post-Operative Delirium2 trials

Preventing Post-Operative Delirium in Patients Undergoing a Pneumonectomy, Esophagectomy or Thoracotomy

Completed·IIndiana University·Phase 4·NCT02213900·135 enrolled

Post-operative Haloperidol Versus Placebo for Prevention of Post-operative Delirium After Acute Hip Surgery

Completed·—·Phase 3·NCT00250237·220 enrolled

Aripiprazole2 trials

Effects of Aripiprazole and Haloperidol on Mesolimbic System Functioning

Completed·OOslo University Hospital·Phase 4·NCT01161277·54 enrolled

Study of Aripiprazole in Patients With Acute Bipolar Mania

Completed· Otsuka logo

Otsuka·Phase 3·NCT00097266·615 enrolled

Efficacy1 trial

A Comparison Study of the Efficacy of Quetiapine and Haloperidol in Agitated Adults in Emergency Room

Completed·UUniversity of Southern California·Phase 4·NCT00457366·72 enrolled

Brain Injury1 trial

Comparison of Haloperidol and Dexmedetomidine for Delirium and Agitation in ICU Patients With Traumatic Brain Injury

Not yet recruiting·—·N/A·NCT06993194·40 enrolled

Absorption1 trial

Evidence of Haloperidol Absorption After Topical Administration

Withdrawn·—·Phase 1·NCT01684969

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 4·NCT00253110·396 enrolled

Ondansetron1 trial

Haloperidol, Droperidol, Ondansetron in Cannabis Hyperemesis

Terminated·CCorewell Health South·Phase 3·NCT05065567·32 enrolled

Emergency Department Patient1 trial

Haloperidol Prophylaxis in Older Emergency Department Patients

Completed·AAmsterdam UMC, location VUmc·Phase 4·NCT01530308·242 enrolled

Depression1 trial

Ziprasidone vs. Sertraline/Haloperidol in Psychotic Depression

Completed·—·Phase 2/3·NCT00340379·72 enrolled

Back pain1 trial

Haloperidol for Pain Control in Patients With Acute Musculoskeletal Back Pain in the Emergency Department

Recruiting·—·Phase 4·NCT06395428·75 enrolled

Stroke1 trial

A Study to Assess Stroke Risk Among Users of Typical Versus Atypical Antipsychotics Stratified by Broad Age Group

Completed· Johnson & Johnson logo

Johnson & Johnson··NCT04002700·1,234,412 enrolled

Dexamethasone1 trial

Comparative Efficacy of Dexamethasone - Ondansetron Versus Dexamethasone - Haloperidol in Reducing PONV

Completed·UUniversitas Padjadjaran·Phase 2·NCT06428084·38 enrolled

Overdose1 trial

Meth-OD: A Study of IXT-m200 in Patients With Toxicity From Methamphetamine Overdose

Terminated·IInterveXion Therapeutics, LLC·Phase 2·NCT04715230·20 enrolled

Function1 trial

The Modifying the Impact of ICU-Associated Neurological Dysfunction-USA (MIND-USA) Study

Completed·VVanderbilt University Medical Center·Phase 3·NCT01211522·566 enrolled

Drug Interactions1 trial

Drug Interactions With Risk of QT-prolongation in a General Hospital

Completed·KKU Leuven··NCT02043912·222 enrolled

Bipolar Disorder1 trial

Longitudinal Comparative Effectiveness of Bipolar Disorder Therapies

Terminated·UUniversity of New Mexico··NCT02893371·1,037,352 enrolled

Cognitive Function1 trial

Evaluation of Negative Symptoms and Cognitive Function After Administration of Antipsychotics in Healthy Volunteer

Completed·—··NCT01185418·80 enrolled

Cognition1 trial

Early Recognition and Optimal Treatment of Delirium in Patients With Advanced Cancer

Completed·AAmsterdam UMC, location VUmc·N/A·NCT01539733·101 enrolled

AIN1 trial

Modulation of Regional Brain Activation in Schizophrenic Patients by Pharmacological Therapy

Terminated·UUniversity of Jena·Phase 4·NCT00419653·19 enrolled

Bipolar I Disorder1 trial

Trial of Olanzapine in Patients With Manic or Mixed Episode of Bipolar I Disorder

Completed· Eli Lilly logo

Eli Lilly·Phase 3·NCT00129220·224 enrolled

Nausea1 trial

Haloperidol and Dexamethasone Towards Postoperative Nausea and Pain in Adult After Laparoscopy

Completed·IIndonesia University·Phase 4·NCT05246631·80 enrolled

Effectiveness1 trial

The Effectiveness of HP and TMZ Synergism on Adult Recurrence GBM

Not yet recruiting·SSouthern Medical University, China·Phase 2·NCT06218524·200 enrolled

ALD1 trial

To Demonstrate the Relative Bioequivalency of Generic Haloperidol Tablets Versus Haldol in Normal Volunteers

Completed· Novartis logo

Novartis·Phase 1·NCT00946491·30 enrolled

Unspecified5 trials

D1 and D2 Dopamine Receptors in Gambling and Amphetamine Reinforcement

Completed·CCentre for Addiction and Mental Health·Phase 2·NCT02203786·60 enrolled

Lorazepam, Diphenhydramine Hydrochloride, and Haloperidol Gel in Healthy Volunteers

Completed·VVirginia Commonwealth University·N/A·NCT01204255·11 enrolled

Pharmacovigilance in Gerontopsychiatric Patients

Terminated·HHannover Medical School·Phase 3·NCT02374567·407 enrolled

Show 2 more trials

Pharmacological Modulation of Belief Salience

Completed·KKing's College London·Phase 1·NCT03754062·30 enrolled

Learning and Decision-making

Completed·MMaastricht University·N/A·NCT06014606·150 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 1, 1982

HALDOL

NDA NDA015922

Jan 1, 1982

HALDOL

NDA NDA015923

Jan 1, 1982

HALDOL

NDA NDA015921

Jan 1, 1982

HALDOL SOLUTAB

NDA NDA017079

Sources

References

[1]
ClinicalTrials.gov — 104 trial records for Haloperidol. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Haldol drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Haloperidol compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Haloperidol. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA015922). U.S. Food & Drug Administration.
[6]
SEC EDGAR — DePuy Orthopaedics company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Serotonin 2a (5-Ht2a) Receptor Antagonist; D2-Like Dopamine Receptor Inverse Agonist[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: DDePuy Orthopaedics

Haldol

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q1 2027

Q2 2027

Q3 2028

Trials by Indication[1]

Delirium22 trials

Schizophrenia18 trials

Agitation10 trials

Treatment4 trials

Antipsychotics3 trials

Nausea and vomiting3 trials

Headache3 trials

Aggression2 trials

Chronic2 trials

Efficacy and Safety2 trials

Olanzapine2 trials

Post-Operative Delirium2 trials

Aripiprazole2 trials

Efficacy1 trial

Brain Injury1 trial

Absorption1 trial

Gastroparesis1 trial

TIPS1 trial

Sedation1 trial

Schizoaffective Disorder1 trial

Ondansetron1 trial

Emergency Department Patient1 trial

Depression1 trial

Back pain1 trial

Stroke1 trial

Dexamethasone1 trial

Overdose1 trial

Function1 trial

Drug Interactions1 trial

Bipolar Disorder1 trial

Cognitive Function1 trial

Cognition1 trial

AIN1 trial

Bipolar I Disorder1 trial

Nausea1 trial

Effectiveness1 trial

ALD1 trial

Unspecified5 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

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