Ativan

(Lorazepam)

ApprovedSmall molecule

Lorazepam is used to treat anxiety disorders and panic attacks by calming the nervous system. It's also used to help patients relax before surgery and to treat seizures.[2] Ativan is currently approved and in use across 34 indications[4].[1]

Ativan is one of 643 small molecule programs targeting Hyperplasia. It is currently in Approved.

Indications

Total Trials

Active Trials

642

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

HyperplasiaActive, not recruiting

Cardiac ArrestActive, not recruiting

Peripheral VertigoApproved

Reflex EpilepsyApproved

ToxicityActive, not recruiting

Photosensitive EpilepsyActive, not recruiting

Down SyndromeActive, not recruiting

OverdoseActive, not recruiting

AbortionActive, not recruiting

VertigoActive, not recruiting

HyperplasiaPhase 3

Active, not recruiting

Cardiac ArrestApproved

Active, not recruiting

Peripheral VertigoApproved

Approved

Reflex EpilepsyApproved

Approved

ToxicityApproved

Active, not recruiting

Photosensitive EpilepsyPhase 2

Active, not recruiting

Down SyndromePhase 2

Active, not recruiting

OverdosePhase 2

Active, not recruiting

AbortionApproved

Active, not recruiting

VertigoPhase 3

Active, not recruiting

Showing 10 of 31 indications

Competition

Competitive Landscape

583 competitors in Schizophrenia

#DrugCompanyPhaseTrials

Ativan

BBausch Health Americas, Inc.

Approved

1 2

Ozempic

Novo Nordisk

Preclinical

1 3

Resotran

Takeda

Preclinical

1 4

Zocor

OOrganon and Co

Preclinical

6 5

Depakote

Ibrance

Lunesta

3 8

Luvox

SSolvay Pharmaceuticals

Preclinical

1 9

Catapres

Boehringer Ingelheim

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 2/3Active, not recruiting

Delirium

NCT03743649

Q4 2027

Phase 2/3Recruiting

Agitation

NCT06752616

Post-ApprovalRecruiting

Anxiety

NCT06004115

Q1 2028

Phase 2Active, not recruiting

Delirium

NCT01949662

Q3 2028

Post-ApprovalRecruiting

HPV Vaccine

NCT06799494

Clinical

Trials by Indication[1]

Alcohol Withdrawal7 trials

A Comparison of Lorazepam and Diazepam in the Treatment of Alcohol Withdrawal

Completed·SStanford University·N/A·NCT00523185·55 enrolled

Treatment of Alcohol Withdrawal in Hospital Patients

Completed·VVirginia Commonwealth University·Phase 4·NCT00249366·183 enrolled

Comparing Gabapentin and Lorazepam for Treating Alcohol Withdrawal

Completed·NNational Institute on Alcohol Abuse and Alcoholism (NIAAA)·Phase 2·NCT00011297·160 enrolled

Show 4 more trials

Alcohol Withdrawal Syndrome Treated With Adjunctive Phenobarbital or Ketamine

Withdrawn·SSanta Barbara Cottage Hospital·Phase 4·NCT03788889

Comparing the Treatment of Alcohol Withdrawal Syndrome Using Gabapentin Versus Lorazepam

Completed·NNational Institute on Alcohol Abuse and Alcoholism (NIAAA)·Phase 2·NCT00229125·160 enrolled

Phenobarbital vs Ativan for Alcohol Withdrawal in the Intensive Care Unit

Unknown status·OOSF Healthcare System·Phase 4·NCT04156464·142 enrolled

Treating Alcohol Withdrawal With Oral Baclofen

Completed·EEssentia Health·N/A·NCT00597701·79 enrolled

Delirium4 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

MENDS Study: Trial in Ventilated ICU Patients Comparing an Alpha2 Agonist Versus a Gamma Aminobutyric Acid (GABA)-Agonist to Determine Delirium Rates, Efficacy of Sedation, Analgesia and Discharge Cognitive Status

Completed·VVanderbilt University·Phase 2·NCT00095251·100 enrolled

Haloperidol and Lorazepam for Delirium in Patients With Advanced Cancer

Active, not recruiting·MM.D. Anderson Cancer Center·Phase 2·NCT01949662·93 enrolled

Show 1 more trial

Lorazepam for Delirium Prevention in Critically Ill Patients With High Anttila-Index

Not yet recruiting·UUniversity Hospital, Basel, Switzerland·Phase 4·NCT07428681·260 enrolled

Cognition4 trials

The Impact of Lorazepam on Cognition in APOE e4 Carriers

Completed·MMayo Clinic·N/A·NCT00586430·36 enrolled

A Sedation/Cognition/Electroencephalogram (EEG) Study Using AZD7325 and Comparator.

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT00720421·16 enrolled

A Sedation/Cognition/EEG Study Using AZD6280 and Comparator

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT00750802·17 enrolled

Show 1 more trial

Characterizing and Predicting Drug Effects on Cognition

Completed·UUniversity of Minnesota·Phase 4·NCT01889602·60 enrolled

Generalized Anxiety Disorder4 trials

Clinical Study Assessing a New Scale to Measure Onset of Action in Generalized Anxiety Disorder

Completed· Pfizer logo

Pfizer·N/A·NCT00715039·169 enrolled

Safety and Efficacy Evaluation Of Pregabalin (Lyrica) With Patients With Generalized Anxiety Disorder

Completed·PPfizer's Upjohn has merged with Mylan to form Viatris Inc.·Phase 4·NCT00624780·615 enrolled

EDG004 Treatment of Adult Patients With Generalized Anxiety Disorder (GAD)

Completed·EEdgemont Pharmaceuticals, LLC·Phase 3·NCT02305797·495 enrolled

Show 1 more trial

Proof of Concept in Patients With Generalized Anxiety Disorder (GAD)AZD7325

Completed· AstraZeneca logo

AstraZeneca·Phase 2·NCT00807937·369 enrolled

Status Epilepticus4 trials

Lorazepam for the Treatment of Status Epilepticus in Children

Completed·EEunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)·Phase 1·NCT00114569·69 enrolled

Lorazepam for the Treatment of Status Epilepticus or Repetitive Status Epilepticus in Japan

Completed· Pfizer logo

Pfizer·Phase 3·NCT02239380·26 enrolled

Comparison Between Lorazepam, Clonazepam and Clonazepam + Fosphenytoin for the Treatment of Out-of-hospital Generalized Status Epilepticus

Completed·AAssistance Publique - Hôpitaux de Paris·Phase 3·NCT01870024·434 enrolled

Show 1 more trial

Phase III Randomized Study of Diazepam Vs Lorazepam Vs Placebo for Prehospital Treatment of Status Epilepticus

Completed·NNational Institute of Neurological Disorders and Stroke (NINDS)·Phase 3·NCT00004297·210 enrolled

55 more indications

Electroencephalography2 trials

Acute Effect of Three Neuroactive Drugs Measured by Magnetoencephalography (MEG), Electroencephalography (EEG) and the Synchronous Neural Interaction Test

Completed·OOrasi Medical, Inc.·N/A·NCT00972985·15 enrolled

Acute Effect of Lorazepam on Brain Activity Measured by Magnetoencephalograpy (MEG) and Electroencephalography (EEG)

Unknown status·OOrasi Medical, Inc.·N/A·NCT01272778·16 enrolled

Vertigo2 trials

Promethazine vs. Lorazepam for Treatment of Vertigo

Completed·SShahid Beheshti University of Medical Sciences·Phase 3·NCT01827293·210 enrolled

Treating Benign Paroxysmal Positional Vertigo (BPPV) in ED Patients

Completed·LLehigh Valley Hospital·N/A·NCT00641797·26 enrolled

Sedation2 trials

Lorazepam Sedation for Critically Ill Children

Completed·TThe Emmes Company, LLC·Phase 2/3·NCT00109395·179 enrolled

Intranasal Dexmedetomidine vs. Standard of Care for Emergency Department (ED) Procedural Sedation in the Older Adult

Not yet recruiting·SState University of New York - Upstate Medical University·Phase 3·NCT06370442·60 enrolled

Depression2 trials

A Study of Mianserin in Combination With SSRIs in Depression With Sleep Problems

Recruiting·ZZhenghui YI·Phase 4·NCT05599126·300 enrolled

A Multi-level Life-span Characterization of Adult-depression and Effects of Medication and Exercise

Completed·—·Phase 4·NCT02407704·31 enrolled

Single Dose1 trial

Effect of A Single Dose of Lorazepam on Salivary Cortisol Response in Children Undergoing Digestive Endoscopy:

Completed·SSt. Justine's Hospital·Phase 2·NCT03180632·98 enrolled

Central Nervous System1 trial

Study to Evaluate the Abuse Potential of AZD7325 in Healthy Recreational Central Nervous System (CNS) Depressant Users

Completed· AstraZeneca logo

AstraZeneca·Phase 1·NCT00902772·100 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

Nausea and vomiting1 trial

Developing Individualized Strategies to Prevent Nausea and Vomiting

Withdrawn·UUniversity of California, San Francisco·N/A·NCT01393288

Photosensitive Epilepsy1 trial

PF-06372865 in Subjects With Photosensitive Epilepsy

Completed· Pfizer logo

Pfizer·Phase 2·NCT02564029·7 enrolled

Stress Response1 trial

The Comparison of Stress Response to Rapid Opioid Detoxification Applying Different Methods of Opioid Antagonism

Completed·VVilnius University·N/A·NCT02362256·60 enrolled

Toxicity1 trial

Lorazepam-Induced Toxicity in the Aged

Completed·NNathan Kline Institute for Psychiatric Research·Phase 4·NCT00044642·90 enrolled

Randomized1 trial

Randomized Trial Comparing 3 Routes of Delivering Lorazepam to Children.

Terminated·KKamuzu University of Health Sciences·Phase 3·NCT00343096·800 enrolled

OIC1 trial

Dextromethorphan to Treat Patients With Voice Spasms

Completed·NNational Institute of Neurological Disorders and Stroke (NINDS)·Phase 1·NCT00055549·65 enrolled

Ultrasound1 trial

Pharmacological Mechanisms of Low-intensity Focused Ultrasound for Motor Cortex Neuroplasticity

Active, not recruiting·UUniversity Health Network, Toronto·Phase 1·NCT04923659·20 enrolled

Abortion1 trial

Hydrocodone For Pain Control in First Trimester Surgical Abortion

Completed·EElizabeth Micks·Phase 4·NCT01330459·121 enrolled

Epilepsy1 trial

A Study to Assess the Efficacy and Safety of Brivaracetam as Treatment for Increased Seizure Activity in an Epilepsy Monitoring Unit Setting

Completed· UCB logo

UCB·Phase 2·NCT03021018·46 enrolled

PTSD1 trial

Computational Assessment of GABA Receptor Modulation in PTSD

Recruiting·VVA Office of Research and Development·Phase 4·NCT06852469·150 enrolled

IUD1 trial

Prescribing Lorazepam for IUD Insertion: Pilot Feasibility Study

Withdrawn·UUniversity of Wisconsin, Madison·Phase 2·NCT06496854

Hyperplasia1 trial

Trial to Assess the Efficacy and Safety During Convective Radiofrequency Water Vapor Thermal Therapy (REZUM) for Benign Prostate Hyperplasia

Not yet recruiting·UUniversity of Manitoba·Phase 3·NCT07017452·48 enrolled

Neuroimaging1 trial

Lorazepam Effects on Neuroimaging Measures

Withdrawn·NNorthwell Health·Phase 1·NCT04671836

Endometrial1 trial

Analgesia for Endometrial Scratching

Completed·UUniversity of Sao Paulo·N/A·NCT02863614·150 enrolled

Recovery1 trial

Stanford Accelerated Recovery Trial (START)

Terminated·SStanford University·Phase 3·NCT01067144·422 enrolled

Oxytocin1 trial

Effects of Oxytocin and Lorazepam on Fear-related Intra-amygdalar Activity

Completed·UUniversity Hospital, Bonn·Phase 1·NCT03829839·120 enrolled

Obsessive-Compulsive Disorder1 trial

Psilocybin for Treatment of Obsessive Compulsive Disorder

Completed·UUniversity of Arizona·Phase 1·NCT03300947·15 enrolled

Agitation1 trial

Acute Agitation in Emergency Psychiatry

Recruiting·LLone Baandrup·Phase 2/3·NCT06752616·132 enrolled

Drug Therapy1 trial

Drug Therapy for Alcohol Detoxification

Completed·NNational Institute on Alcohol Abuse and Alcoholism (NIAAA)·Phase 4·NCT00000441

AIN1 trial

Glutamatergic Modulation of Cocaine-related Deficits

Completed·NNew York State Psychiatric Institute·Phase 2·NCT01790490·8 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

Premedication1 trial

Sedative Premedication: Efficacy On Patient Experience

Completed·AAssistance Publique Hopitaux De Marseille·Phase 3·NCT01901003·1,200 enrolled

Trauma1 trial

Explanation About Sleep in Post Trauma Patients

Unknown status·SSheba Medical Center·N/A·NCT01684085·70 enrolled

Recessive Dystrophic Epidermolysis Bullosa1 trial

Allogeneic Stem Cell Transplantation (ALLOSCT) in Recessive Dystrophic Epidermolysis Bullosa (RDEB)

Terminated·—·Phase 1·NCT00881556·3 enrolled

Effectiveness1 trial

GHB Withdrawal Symptoms and Effectiveness of Treatment With Lorazepam Versus Pentobarbital - 1

Withdrawn·UUniversity of California, Los Angeles·Phase 1/2·NCT00123578

Resistance1 trial

Resistance Under the Microscope

Completed·EErasmus Medical Center·Phase 4·NCT01441843·400 enrolled

Intensive Care Unit1 trial

Pharmaco-Economic Study Of Ultiva In Intensive Care Unit(ICU)Subjects

Completed· GSK logo

GSK·Phase 4·NCT00158873·224 enrolled

ALS1 trial

The Cognitive Effects of Lorazepam in Healthy Older Individuals With TOMM40 Variable-length Polymorphisms

Completed·MMayo Clinic·Phase 1·NCT01780519·57 enrolled

Adolescent1 trial

Treatment of Adolescent Antimuscarinic (Anticholinergic) Toxidrome

Completed·UUniversity of Colorado, Denver·Phase 4·NCT03090620·19 enrolled

Postoperative Pain Control1 trial

Post Operative Pain Control After Pediatric Hip Surgery

Terminated·SSeattle Children's Hospital·N/A·NCT03435692·42 enrolled

Alpha-1 Antitrypsin Deficiency1 trial

Liver Fibrosis in Alpha-1 Antitrypsin Deficiency (Liver AATD)

Completed·UUniversity of Florida··NCT01810458·109 enrolled

Emotional Processing1 trial

A Study to Investigate the Effects of GW876008 on Brain Activation During Emotional Processing in Healthy Subjects.

Completed· GSK logo

GSK·Phase 1·NCT00424697·26 enrolled

Cognitive Functions1 trial

Evaluation of the Effects of Etifoxine 100 mg and Lorazepam 2 mg on Vigilance and Cognitive Functions in the Elderly

Completed·BBiocodex·Phase 3·NCT02147548·31 enrolled

Benzodiazepines1 trial

Benzodiazepines for the Reduction of Distress and Pain During and After Emergency Department Care

Terminated·MMaria Pacella·Phase 2·NCT03756038·1 enrolled

Adverse Events1 trial

Lorazepam and the Risk of Serious Adverse Events

Completed·LLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's··NCT07179978·12,308 enrolled

Anxiety1 trial

Processes and Circuitry Underlying Threat Sensitivity as a Treatment Target for Co-morbid Anxiety and Depression

Recruiting·LLaureate Institute for Brain Research, Inc.·Phase 4·NCT06004115·165 enrolled

Withdrawal1 trial

Assessment of Valproate on Ethanol Withdrawal

Unknown status·—·Phase 4·NCT03235531·210 enrolled

Treatment1 trial

Catatonia in Nodding Syndrome and Lorazepam Treatment

Completed·MMakerere University·Phase 1·NCT02462109·16 enrolled

Patient Satisfaction1 trial

Effect of Additive Lorazepam on Patient Satisfaction as a Premedication in Diagnostic Flexible Bronchoscopy

Unknown status·SSeoul National University Hospital·Phase 4·NCT01121055·372 enrolled

Cardiac Arrest1 trial

Therapeutic Hypothermia With Propofol in Survival and Neurological Prognoses After Cardiac Arrest

Unknown status·FFar Eastern Memorial Hospital·Phase 4·NCT02367755·30 enrolled

Adult Subject1 trial

Phase 1 Study to Characterize the Safety and Pharmacokinetics of Single Intravenous Dose of Lorazepam in Healthy Japanese Adult Subjects

Completed· Pfizer logo

Pfizer·Phase 1·NCT01994668·8 enrolled

HPV Vaccine1 trial

HPV Vaccine Reduced Dose

Recruiting·EEmory University·Phase 4·NCT06799494·100 enrolled

Schizophrenia1 trial

SPECT Investigation Of The NMDA Receptor System In Healthy Volunteers And Patients With Schizophrenia

Terminated· GSK logo

GSK·Phase 1·NCT00364429·55 enrolled

Epilepsia Partialis Continua1 trial

Clobazam Use in Epilepsia Partialis Continua - Pilot Study

Terminated·TThe Cooper Health System·Phase 3·NCT02134366·7 enrolled

Seizure1 trial

Nasal Versus Venous Lorazepam for Control of Acute Seizures in Children

Completed·—·Phase 3·NCT00735527·140 enrolled

Drug1 trial

Clinical Study in Healthy Volunteers to Investigate the Neurocognitive Effects of a New Antiepileptic Drug: Brivaracetam

Completed· UCB logo

UCB·Phase 1·NCT00736931·20 enrolled

Down syndrome1 trial

Mechanistic Investigation of Therapies for Down Syndrome Regression Disorder

Completed·UUniversity of Colorado, Denver·Phase 2·NCT05662228·66 enrolled

Unspecified8 trials

Pharmacovigilance in Gerontopsychiatric Patients

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

Biological Basis of Individual Variation in Social Cooperation

Completed·EEmory University·N/A·NCT01566539·707 enrolled

Fasting Study of Lorazepam Tablets 2 mg and Ativan Tablets 2 mg

Completed· Mylan Pharmaceuticals Inc logo

Mylan Pharmaceuticals Inc·Phase 1·NCT00649818·28 enrolled

Show 5 more trials

LORA-PITA IV General Investigation

Completed· Pfizer logo

Pfizer··NCT03905798·206 enrolled

Effects of Pentazocine Versus Lorazepam on Manic Symptoms

Completed·MMclean Hospital·Phase 2·NCT00431184·19 enrolled

Lorazepam, Diphenhydramine Hydrochloride, and Haloperidol Gel in Healthy Volunteers

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

A Study of the Effect of LY2216684 on Lorazepam

Completed· Eli Lilly logo

Eli Lilly·Phase 1·NCT01275144·28 enrolled

Exploring the Effects of Diazepam and Lorazepam

Completed·UUniversity Hospital, Strasbourg, France·N/A·NCT00696033·22 enrolled

Regulatory

FDA Approval Timeline[5]

Jan 1, 1982

ATIVAN

NDA NDA018140

Jan 1, 1982

ATIVAN

NDA NDA017794

Aug 27, 2021

LOREEV XR

NDA NDA214826

Sources

References

[1]
ClinicalTrials.gov — 89 trial records for Lorazepam. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Ativan drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Lorazepam compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Lorazepam. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA214826). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Ativan. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Bausch Health Americas, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: GABA-a Receptor; Anion Channel Positive Allosteric Modulator[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: BBausch Health Americas, Inc.

Patent Landscape[6]

Patent Cliff

Jan 8, 2034

Earliest patent expiration — generic entry possible after this date

Patent #Expires

8999393Jan 8, 2034

Ativan

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Q4 2027

Q1 2028

Q3 2028

Trials by Indication[1]

Alcohol Withdrawal7 trials

Delirium4 trials

Cognition4 trials

Generalized Anxiety Disorder4 trials

Status Epilepticus4 trials

Electroencephalography2 trials

Vertigo2 trials

Sedation2 trials

Depression2 trials

Single Dose1 trial

Central Nervous System1 trial

Efficacy1 trial

Nausea and vomiting1 trial

Photosensitive Epilepsy1 trial

Stress Response1 trial

Toxicity1 trial

Randomized1 trial

OIC1 trial

Ultrasound1 trial

Abortion1 trial

Epilepsy1 trial

PTSD1 trial

IUD1 trial

Hyperplasia1 trial

Neuroimaging1 trial

Endometrial1 trial

Recovery1 trial

Oxytocin1 trial

Obsessive-Compulsive Disorder1 trial

Agitation1 trial

Drug Therapy1 trial

AIN1 trial

Overdose1 trial

Premedication1 trial

Trauma1 trial

Recessive Dystrophic Epidermolysis Bullosa1 trial

Effectiveness1 trial

Resistance1 trial

Intensive Care Unit1 trial

ALS1 trial

Adolescent1 trial

Postoperative Pain Control1 trial

Alpha-1 Antitrypsin Deficiency1 trial

Emotional Processing1 trial

Cognitive Functions1 trial

Benzodiazepines1 trial

Adverse Events1 trial

Anxiety1 trial

Withdrawal1 trial

Treatment1 trial

Patient Satisfaction1 trial

Cardiac Arrest1 trial

Adult Subject1 trial

HPV Vaccine1 trial

Schizophrenia1 trial

Epilepsia Partialis Continua1 trial

Seizure1 trial

Drug1 trial

Down syndrome1 trial

Unspecified8 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

Related News