Summary
Lorazepam has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Anxiety Disorders would be drug repurposing rather than first-in-human development. This does not mean it is approved for Anxiety Disorders. ClinicalTrials.gov lists 8 registered trials linking Lorazepam to Anxiety Disorders: 7 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT00624780). The largest enrolment is 1200 participants (NCT01901003). Registration activity spans 2007 to 2021. The literature layer holds 11 publications for this pair: 1 Cochrane review, 4 meta-analyses, 1 randomised controlled trial publication and 5 clinical trial publications. Publication years run from 2007 to 2026. Because at least one synthesis-level source exists (systematic review, meta-analysis or Cochrane review), this pair has been assessed beyond single studies, although the synthesis may concern a different indication.
The RepurpOS disease-intelligence file for Anxiety ranks 535 candidate therapeutics from Open Targets, ChEMBL, DGIdb and PubMed; only a minority carry direct clinical evidence, and this page covers one of those. Spontaneous remission context recorded for the condition: GAD: spontaneous remission in ~25-30% at 1 year without treatment; social anxiety: 36% remission at 12 years untreated; panic disorder: 50-65% spontaneous partial remission but relapse common; 40-60% remain symptomatic at 5 years.
Evidence table
| Evidence tier | A · Strong |
|---|---|
| Evidence score | 76.5 (trials 26.5, literature 30.0, tier 15, approved bonus 5.0) |
| Registered trials | 8 total: 0 recruiting, 0 active / not yet recruiting, 7 completed, 1 other |
| Linked publications | 11 (5 clinical trial publications, 4 meta-analyses, 1 Cochrane review, 1 randomised controlled trial publication) |
| Agent type | Drug (Small molecule) |
| Development stage (any indication) | Approved |
| Mechanism / class | Not recorded |
| Data sources | Open Targets, ChEMBL |
How the evidence score is calculated
- Each registered trial scores by status (recruiting / active / enrolling 3, completed 2.5, not yet recruiting 2, unknown 1, terminated / withdrawn / suspended 0.5) plus a phase bonus (phase 3-4 +2, phase 2 +1, phase 1 +0.5). The trial component is capped at 30.
- Each literature item scores by design (Cochrane review 5, meta-analysis 4, systematic review 3, RCT 3, clinical trial publication 2, curated reference 1.5, other PubMed record 1). The literature component is capped at 30.
- The existing evidence tier adds 15 (A / Strong), 10 (B / Moderate), 5 (C / Preliminary) or 0 (D / Anecdotal).
- Agents approved for any indication (max clinical phase 4) add 5, because an approved agent has an established safety profile that lowers the barrier to repurposing trials.
- The score ranks what has been studied, not what works. It does not read effect sizes or directions of effect.
Registered clinical trials
| NCT ID | Title | Status | Phase | Enrolment |
|---|---|---|---|---|
| NCT01441843 | Resistance Under the Microscope 2010 | completed | Phase 4 | 400 |
| NCT00624780 | Safety and Efficacy Evaluation Of Pregabalin (Lyrica) With Patients With Generalized Anxiety Disorder 2009 | completed | Phase 4 | 615 |
| NCT02305797 | EDG004 Treatment of Adult Patients With Generalized Anxiety Disorder (GAD) 2015 | completed | Phase 3 | 495 |
| NCT01901003 | Sedative Premedication: Efficacy On Patient Experience 2012 | completed | Phase 3 | 1,200 |
| NCT00513565 | A Study To Investigate Effects Of GSK561679 On Brain Activation During Emotional Processing In Healthy Volunteers 2007 | completed | Phase 1 | 22 |
| NCT02312739 | Nitrous Oxide for Pain Management During In-office Transcervical Sterilization 2014 | completed | Not applicable | 72 |
| NCT00613067 | ERP N1 as a Treatment Predictor of Generalized Anxiety Disorder 2007 | completed | Not applicable | 35 |
| NCT05102331 | Lavender Oil Aromatherapy for The Treatment of Acute Anxiety During Bone Marrow Biopsy Procedures 2021 | withdrawn | Not applicable | — |
Published literature
- Clinical trial publication A randomized clinical trial of repeated doses of psilocybin for the treatment of obsessive-compulsive disorderMoreno FA, Allen KE, Wiegand CB et al. · Journal of psychopharmacology (Oxford, England) · 2026 · PMID 41825921
- Meta-analysis Pharmacologic predictors of benzodiazepine response trajectory in anxiety disorders: a Bayesian hierarchical modeling meta-analysisStimpfl JN, Mills JA, Strawn JR · CNS spectrums · 2023 · PMID 34593077
- Meta-analysis Efficacy and safety of lavender essential oil (Silexan) capsules among patients suffering from anxiety disorders: A network meta-analysisYap WS, Dolzhenko AV, Jalal Z et al. · Scientific reports · 2019 · PMID 31792285
- Clinical trial publication Coadministration of disulfiram and lorazepam in the treatment of alcohol dependence and co-occurring anxiety disorder: an open-label pilot studyBogenschutz MP, Bhatt S, Bohan J et al. · The American journal of drug and alcohol abuse · 2016 · PMID 27184605
- Clinical trial publication Pregabalin long-term treatment and assessment of discontinuation in patients with generalized anxiety disorderKasper S, Iglesias-García C, Schweizer E et al. · The international journal of neuropsychopharmacology · 2014 · PMID 24351233
- Clinical trial publication Evaluation of the effects of venlafaxine and pregabalin on the carbon dioxide inhalation models of Generalised Anxiety Disorder and panicDiaper A, Osman-Hicks V, Rich AS et al. · Journal of psychopharmacology (Oxford, England) · 2013 · PMID 22516666
- Randomized controlled trial Lack of efficacy of L-759274, a novel neurokinin 1 (substance P) receptor antagonist, for the treatment of generalized anxiety disorderMichelson D, Hargreaves R, Alexander R et al. · The international journal of neuropsychopharmacology · 2013 · PMID 22433185
- Clinical trial publication Therapeutic effectiveness of Galphimia glauca vs. lorazepam in generalized anxiety disorder. A controlled 15-week clinical trialHerrera-Arellano A, Jiménez-Ferrer JE, Zamilpa A et al. · Planta medica · 2012 · PMID 22828921
- Cochrane review Efficacy of drug treatments for generalised anxiety disorder: systematic review and meta-analysisBaldwin D, Woods R, Lawson R et al. · BMJ (Clinical research ed.) · 2011 · PMID 21398351
- Meta-analysis An effect-size analysis of pharmacologic treatments for generalized anxiety disorderHidalgo RB, Tupler LA, Davidson JR · Journal of psychopharmacology (Oxford, England) · 2007 · PMID 17984162
- Meta-analysis Benzodiazepines in generalized anxiety disorder: heterogeneity of outcomes based on a systematic review and meta-analysis of clinical trialsMartin JL, Sainz-Pardo M, Furukawa TA et al. · Journal of psychopharmacology (Oxford, England) · 2007 · PMID 17881433
Mechanism and notes
No mechanism of action is recorded for this pair in the source databases.
OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL. The tier describes how well the drug-disease link is documented, not how well the drug works.
Frequently asked questions
Is Lorazepam approved for Anxiety Disorders?
Lorazepam has reached the approved stage (maximum clinical phase 4) for at least one indication, so its use in Anxiety Disorders would be drug repurposing rather than first-in-human development. This does not mean it is approved for Anxiety Disorders. Approval status for the specific indication should always be confirmed with the relevant regulator and prescribing information.
Is Lorazepam in clinical trials for Anxiety Disorders?
ClinicalTrials.gov lists 8 registered trials linking Lorazepam to Anxiety Disorders: 7 have completed; 1 is terminated, withdrawn, suspended or of unknown status. The most advanced is Phase 4 (NCT00624780). The largest enrolment is 1200 participants (NCT01901003). Registration activity spans 2007 to 2021.
What does the evidence show for Lorazepam in Anxiety Disorders?
Lorazepam has both completed registered trials and synthesis-level publications linked to Anxiety Disorders. That is the strongest profile in this database, but the summaries here do not extract effect sizes, so read the linked reviews for direction and magnitude of benefit. OSMF's existing evidence tier for this pair is A (Strong), derived from the strength of the disease association recorded in Open Targets and ChEMBL. The tier describes how well the drug-disease link is documented, not how well the drug works.
Cite this page
Data: ClinicalTrials.gov, PubMed, Open Targets, ChEMBL, DGIdb and the OSMF therapeutic agent database. Last updated 2026-07-05. Page built 2026-10-07.