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Drug

Lorazepam

Approved · FDA
Emerging researchLate-stage development
Also known as Ativan, Loreev, o-Chlorooxazepam, o-Chloroxazepam+1 more

Ativan, Loreev, o-Chlorooxazepam, o-Chloroxazepam, Loracepam.

RxNorm6470UNIIO26FZP769L
1
Research papers
12
Active clinical trials
3
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Multimodal Analgesia Effect on Post Surgical Patient

Clinical trial2026-06-24Primary completion · ClinicalTrials.gov

Individualized Computational Assessment of the Effects of GABA Receptor Modulation in Posttraumatic Stress Disorder

Clinical trial2026-06-16Results expected Q2 2029 · ClinicalTrials.gov

Strategies for Persistent Agitated Delirium in Palliative Care

Clinical trial2026-06-15Results expected Q4 2028 · ClinicalTrials.gov

Label change: LORAZEPAM (ANDA200542)

Regulatory2026-05-15FDA

Synaptic Mechanisms of Continuous Theta Burst Stimulation in Depression

Clinical trial2026-05-13Results expected Q4 2030 · ClinicalTrials.gov

Mechanistic Investigation of Therapies for Down Syndrome Regression Disorder

Clinical trial2026-02-27Results expected Q4 2026 · ClinicalTrials.gov

Preventive Administration of Lorazepam in Critically Ill Patients With High Anttila-Index to Reduce the Incidence of Intensive Care Delirium: a Single-centre, Randomized, Controlled Clinical Trial - the Basel LOC2DEL-Trial

Clinical trial2026-02-27Results expected Q1 2028 · ClinicalTrials.gov

A Preliminary Double-Blind Randomized Controlled Trial of Haloperidol and Lorazepam for Delirium in Patients With Advanced Cancer Admitted to a Palliative Care Unit

Clinical trial2026-02-13Results posted · ClinicalTrials.gov

Prescribing Lorazepam for IUD Insertion: Pilot Feasibility Study

Clinical trial2026-01-01Withdrawn · ClinicalTrials.gov

Approval: LORAZEPAM (ANDA200542)

Regulatory2017-04-28FDA

Drug Safety Update: Lorazepam: reduction of recommended maximum daily dose

Regulatory2014-12-11MHRA

Lorazepam does not improve the quality of recovery in day-case surgery patients: a randomised placebo-controlled clinical trial.

Research2013-12-01European journal of anaesthesiology

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Lorazepam
Aliases & brands
AtivanLoreevo-Chlorooxazepamo-ChloroxazepamLoracepam
RxNorm CUI
6470
UNII
O26FZP769L
Regulatory jurisdictions
fdamhra

Regulatory timeline

3 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2017-04-28
Latest approval
2017-04-28
Authorities
FDA · MHRA
Total events
3
fdaU.S. Food and Drug Administration· 2 events
2026-05-15Label change
Label change: LORAZEPAM (ANDA200542)
Evidence ↗
2017-04-28Approval
Approval: LORAZEPAM (ANDA200542)
Evidence ↗
mhraMedicines and Healthcare products Regulatory Agency· 1 event
2014-12-11Safety communicationSafety
Drug Safety Update: Lorazepam: reduction of recommended maximum daily dose
Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).

Clinical trials

88 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
88
registered trials across all phases
LATEST COMPLETION 2023
12
Active studies
7
Recruiting
53
Late-stage (III+)
54
Completed
22
Discontinued
PHASE DISTRIBUTIONn = 88
Early Phase 14Phase 116Phase 1 / 21Phase 214Phase 2 / 33Phase 313Phase 422Phase N / A15

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Individualized Computational Assessment of the Effects of GABA Receptor Modulation in Posttraumatic Stress Disorder

RecruitingPH IVVA Office of Research and Developmentn=1502029

Preventive Administration of Lorazepam in Critically Ill Patients With High Anttila-Index to Reduce the Incidence of Intensive Care Delirium: a Single-centre, Randomized, Controlled Clinical Trial - the Basel LOC2DEL-Trial

Not yet recruitingPH IVUniversity Hospital, Basel, Switzerlandn=2602029

Comparing the Antibody and B Cell Responses Induced by 1- or 2-dose 9-valent HPV (9vHPV) Vaccination in Healthy Adults

RecruitingPH IVEmory Universityn=1002028

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

RecruitingPH IVLaureate Institute for Brain Research, Inc.n=1652027

Multimodal Analgesia Effect on Post Surgical Patient

Active, not recruitingPH IVUniversity of California, Davisn=602026

Recent completions

Trials that read out recently, adding to the completed evidence base.

Psilocybin for Treatment of Obsessive Compulsive Disorder

CompletedPH IUniversity of Arizonan=152023

A Phase I Study of Indenoisoquinoline LMP744 in Adults With Relapsed Solid Tumors and Lymphomas

CompletedPH INational Cancer Institute (NCI)n=362023

A Randomized Trial Comparing Physostigmine vs Lorazepam for Treatment of Adolescent Antimuscarinic (Anticholinergic) Toxidrome

CompletedPH IVUniversity of Colorado, Denvern=192020

Effect of A Single Dose of Lorazepam on Salivary Cortisol Response in Children Undergoing Digestive Endoscopy: a Randomized Double Blinded Study

CompletedPH IISt. Justine's Hospitaln=982018

A Multicenter, Open-Label, Randomized, Parallel-Group, Active-Controlled Study to Assess the Efficacy and Safety of Brivaracetam Administered Intravenously as Treatment for Increased Seizure Activity in an Epilepsy Monitoring Unit Setting

CompletedPH IIUCB Biopharma S.P.R.L.n=462018

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

CompletedPH IIIAssistance Publique - Hôpitaux de Parisn=4342018

Research activity

1 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Journals, researchers & institutions
Top journals
  • European journal of anaesthesiology1
Leading researchers
  • Duivenvoorden HJ1
  • Grüne F1
  • Klimek M1
  • Mijderwijk H1
  • Stolker RJ1
  • van Beek S1
Leading institutions
free-text, unnormalised
  • Erasmus University Medical Centre1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.