TheraRadar
Data updated: May 26, 2026

LORAZEPAM

CNS Approved 1985-12-10
Jump to: Indications Approvals Trials Competitors Safety Patents
35
Indications
--
Phase 3 Trials
40
Years on Market

Details

Status
Discontinued
First Approved
1985-12-10
Routes
ORAL, INJECTION
Dosage Forms
TABLET, SOLUTION, INJECTABLE, CONCENTRATE

Companies

AM THERAP WATSON LABS ROXANE PH HEALTH EPIC PHARMA LLC AMNEAL PHARMS RISING CHARTWELL RX Sun Pharma MUTUAL PHARM Novartis SUPERPHARM Pfizer Hikma CAPLIN HALSEY Aurobindo Pharma PAR PHARM WARNER CHILCOTT INTL MEDICATION SYS Fresenius Kabi GRAVITI PHARMS USL PHARMA PHARMOBEDIENT BEDFORD LEADING PHARM ASSOC Lupin TP ANDA HOLDINGS ANI PHARMS OXFORD PHARMS CHARTWELL MOLECULAR
Active Ingredient: LORAZEPAM

LORAZEPAM Approval History

1986
1987
1988
1989
1990
1991
1992
1993
1994
1995
1996
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
542 FDA actions from 1985 to 2026
May 2026 SUPPL
Label · Labeling
Jan 2026 SUPPL
Label · Labeling
Aug 2025 SUPPL
Label · Labeling

What LORAZEPAM Treats

35 FDA approvals

Originally approved for its first indication in 1985 . Covers 35 distinct patient populations.

  • Other (35)
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Clinical Trial Registry

35 trials
Trial Sponsor ID Phase Status Title
NCT05662228 22-1992 Ph 2 active not recruiting Therapies for Down Syndrome Regression Disorder
NCT01949662 results posted 2013-0345 NCI-2013-02351, 1R21CA186000-01A1 Ph 2 active not recruiting Haloperidol and Lorazepam for Delirium in Patients With Advanced Cancer
NCT03743649 2018-0706 NCI-2018-02438, 2018-0706 Ph 2, Ph 3 active not recruiting Haloperidol and Lorazepam in Controlling Symptoms of Persistent Agitated Delirium in Patients With Advanced Cancer Undergoing Palliative Care
NCT06004115 2022-009 R01MH132565 Ph 4 recruiting Processes and Circuitry Underlying Threat Sensitivity as a Treatment Target for Co-morbid Anxiety and Depression
NCT06799494 STUDY00008623 Ph 4 recruiting HPV Vaccine Reduced Dose
NCT05599126 2021-TX-002 Ph 4 recruiting A Study of Mianserin in Combination With SSRIs in Depression With Sleep Problems
NCT04715230 Meth-OD results posted M200C-2101 U01DA053043 Ph 2 terminated Meth-OD: A Study of IXT-m200 in Patients With Toxicity From Methamphetamine Overdose
NCT01441843 results posted NL3253507810 Ph 4 completed Resistance Under the Microscope
NCT03090620 TAAT results posted 16-1730 Ph 4 completed Treatment of Adolescent Antimuscarinic (Anticholinergic) Toxidrome
NCT00624780 results posted A0081147 Ph 4 completed Safety and Efficacy Evaluation Of Pregabalin (Lyrica) With Patients With Generalized Anxiety Disorder
NCT03021018 results posted EP0087 Ph 2 completed A Study to Assess the Efficacy and Safety of Brivaracetam as Treatment for Increased Seizure Activity in an Epilepsy Monitoring Unit Setting
NCT03756038 results posted PRO18090064 Ph 2 terminated Benzodiazepines for the Reduction of Distress and Pain During and After Emergency Department Care
NCT01889602 results posted CPDEC Ph 4 completed Characterizing and Predicting Drug Effects on Cognition
NCT03788889 PKAT 18-94 Ph 4 withdrawn Alcohol Withdrawal Syndrome Treated With Adjunctive Phenobarbital or Ketamine
NCT01330459 results posted OHSU FAMPLAN 6734 Ph 4 completed Hydrocodone For Pain Control in First Trimester Surgical Abortion
NCT01275144 results posted 12596 H9P-EW-LNCG Ph 1 completed A Study of the Effect of LY2216684 on Lorazepam
NCT02239380 results posted B3541002 2017-000125-13 Ph 3 completed Lorazepam for the Treatment of Status Epilepticus or Repetitive Status Epilepticus in Japan
NCT01870024 LORACLOFT P110123 2012-003795-39 Ph 3 completed Comparison Between Lorazepam, Clonazepam and Clonazepam + Fosphenytoin for the Treatment of Out-of-hospital Generalized Status Epilepticus
NCT03180632 Endo-Lora JP2017 Ph 2 completed Effect of A Single Dose of Lorazepam on Salivary Cortisol Response in Children Undergoing Digestive Endoscopy:
NCT02407704 MEDEX results posted MH090333-04 PRO13110090, MH090333 Ph 4 completed A Multi-level Life-span Characterization of Adult-depression and Effects of Medication and Exercise
NCT02134366 EPC-1 Ph 3 terminated Clobazam Use in Epilepsia Partialis Continua - Pilot Study
NCT02564029 results posted B7431005 Ph 2 completed PF-06372865 in Subjects With Photosensitive Epilepsy
NCT02374567 GAP GAP-2014 Ph 3 terminated Pharmacovigilance in Gerontopsychiatric Patients
NCT01780519 12-006469 Ph 1 completed The Cognitive Effects of Lorazepam in Healthy Older Individuals With TOMM40 Variable-length Polymorphisms
NCT02147548 ETILANCE - ETI 175 Ph 3 completed Evaluation of the Effects of Etifoxine 100 mg and Lorazepam 2 mg on Vigilance and Cognitive Functions in the Elderly
NCT02462109 CINS HS 1330 Ph 1 completed Catatonia in Nodding Syndrome and Lorazepam Treatment
NCT01901003 PremedX 2011-005171-16 2011-32 Ph 3 completed Sedative Premedication: Efficacy On Patient Experience
NCT01994668 B3541001 Ph 1 completed Phase 1 Study to Characterize the Safety and Pharmacokinetics of Single Intravenous Dose of Lorazepam in Healthy Japanese Adult Subjects
NCT01827293 SB-067 Ph 3 completed Promethazine vs. Lorazepam for Treatment of Vertigo
NCT00736931 N01297 Ph 1 completed Clinical Study in Healthy Volunteers to Investigate the Neurocognitive Effects of a New Antiepileptic Drug: Brivaracetam
NCT00720421 D1140C00003 EudractCT 2008-001757-17 Ph 1 completed A Sedation/Cognition/Electroencephalogram (EEG) Study Using AZD7325 and Comparator.
NCT00807937 results posted D1140C00014 Ph 2 completed Proof of Concept in Patients With Generalized Anxiety Disorder (GAD)AZD7325
NCT00902772 D1140C00008 Ph 1 completed Study to Evaluate the Abuse Potential of AZD7325 in Healthy Recreational Central Nervous System (CNS) Depressant Users
NCT00750802 D0850C00014 Eudract # 2008-001757-17 Ph 1 completed A Sedation/Cognition/EEG Study Using AZD6280 and Comparator
NCT00735527 INLOR INLOR Ph 3 completed Nasal Versus Venous Lorazepam for Control of Acute Seizures in Children
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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

LORAZEPAM FDA Label Details

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Data Sources

FDA Approval: ANDA070729 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.