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Last Updated: May 20, 2025

CLINICAL TRIALS PROFILE FOR LORAZEPAM


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505(b)(2) Clinical Trials for Lorazepam

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials
Trial Type Trial ID Title Status Sponsor Phase Start Date Summary
OTC NCT00055549 ↗ Dextromethorphan to Treat Patients With Voice Spasms Completed National Institute of Neurological Disorders and Stroke (NINDS) Phase 1 2003-03-04 This study will examine how dextromethorphan, a drug that alters reflexes of the larynx (voice box), might change voice symptoms in people with voice disorders due to uncontrolled laryngeal muscle spasms. These include abductor spasmodic dysphonia (breathy voice breaks), adductor spasmodic dysphonia (vowel breaks), muscular tension dysphonia (tight strained voice), and vocal tremor (tremulous voice). Dextromethorphan-one of a group of drugs called NMDA antagonists-has been used for years in over-the-counter cough suppressant medicines. In animal studies, the drug has blocked one of the reflexes in the larynx that may be associated with spasms in the laryngeal muscles. This study will compare the effects of dextromethorphan, lorazepam (a valium-type drug), and a placebo (inactive substance) in patients with the four types of voice disorders described above. Patients with spasmodic dysphonia, muscular tension dysphonia and vocal tremor may be eligible for this study. Individuals who smoke or use tobacco, who have vocal nodules or polyps, or who have a history of airway obstruction may not participate. Candidates will be screened with a medical history and physical examination, a questionnaire, voice recording (repeating sentences into a microphone), and nasolaryngoscopy (examination of the larynx with a tube advanced through the nose). For the nasolaryngoscopy, the inside of the nose is sprayed with a decongestant (to open the nasal passages) and possibly a local anesthetic. A small, flexible tube called a nasolaryngoscope is passed through the nose to look at the larynx during speech and other tasks, such as singing, whistling and prolonged vowels. Participants will be admitted to the NIH Clinical Center for each of three visits, which will last from the afternoon of one day to late afternoon of the following day. At each visit, patients will complete a questionnaire, baseline speech recording, and a test for sedation level. They will take three pills-either dextromethorphan, lorazepam, or placebo-one every 6 hours. Vital signs will be checked every 6 hours and the level of sedation during waking hours will be monitored. One to three hours after taking the third pill, speech recording, questionnaire and test of sedation will be repeated to check for possible voice changes. Patients will be given a different pill at each visit. ...
>Trial Type >Trial ID >Title >Status >Phase >Start Date >Summary

All Clinical Trials for Lorazepam

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00000441 ↗ Drug Therapy for Alcohol Detoxification Completed National Institute on Alcohol Abuse and Alcoholism (NIAAA) Phase 4 1969-12-31 This project will provide relevant clinical information for primary care practitioners treating alcohol withdrawal syndrome in outpatient settings. This double-blind, placebo- controlled clinical trial will compare the effectiveness of lorazepam (Ativan) and carbamazepine (Tegretol) in alcoholics who meet the criteria for a diagnosis of uncomplicated alcohol withdrawal syndrome. Participants are randomized to five days of treatment with a 1-week posttreatment followup.
NCT00001725 ↗ Studies of Dextromethorphan and Topiramate to Treat Oral and Facial Pain Completed National Institute of Dental and Craniofacial Research (NIDCR) Phase 2 1997-12-01 This study will evaluate the safety and effectiveness of two drugs-dextromethorphan and topiramate-in treating orofacial (mouth and face) pain. Dextromethorphan, a commonly used cough suppressant, and topiramate, an anti-seizure medicine, block certain receptors on brain and spinal nerve cells that may cause the cells to produce electrical discharges and pain. Patients 18 years of age and older with oral and facial pain with trigeminal nerve damage and who have had pain daily for at least 3 months may be eligible for this study. Candidates will be screened with a medical history, physical examination, blood tests and psychiatric evaluation. These results will serve as baseline values for participants. Those enrolled in the study will take either dextromethorphan or topiramate in a 2-part study as follows: Dextromethorphan In Part 1, patients will take dextromethorphan and lorazepam (a commonly used anti-anxiety drug) separately in two 6-week periods. (Lorazepam is used in this study as an "active placebo" for comparison with dextromethorphan. An active placebo is a drug that does not work for the problem being studied but whose side effects are like those of the test drug.) They will take dextromethorphan for 4 weeks to determine the maximum tolerated dose (the highest dose that does not cause troubling side effects) and will stay on that dose for the remaining 2 weeks. Then they will repeat this process with lorazepam. Patients who respond to either drug may continue with Part 2 of the study, which compares these two drugs four more times to confirm the response seen in Part 1. In Part 2, the maximum tolerated dose will be determined in a 2-week period and that dose will be continued for another 2 weeks. This procedure will be repeated eight times. Throughout the study, patients will keep a daily pain diary. They will be contacted by telephone 2 to 3 times a week during dose escalation to check for side effects. At the end of each of the two 6-week periods in Part 1 and at the end of each 4-week period in Part 2 of the study, patients will have a 1-hour clinic visit. Participants who live more than a few hours' drive from NIH will have a full telephone follow-up evaluation instead of the clinic visits. Topiramate Patients who receive topiramate will follow a plan similar to that described above for dextromethorphan, with the following exceptions. They will take topiramate and an inactive placebo (a look-alike pill that has no active ingredients) in two separate 12-week periods. Patients' maximum tolerated dose will be determined in the first 8 weeks and they will stay on that dose for the remaining 4 weeks of each period. Patients who respond to the medication in Part 1 may continue with Part 2 to confirm the response. Part 2 consists of six 6-week periods. The first 4 weeks of each will be used to determine the maximum tolerated dose and the patient will remain on that dose for the next 2 weeks. Patients will keep a daily pain diary and will be contacted by phone 2 to 3 times a week while doses are being increased. Patients who complete Part 2 of the topiramate study may participate in another phase of the study that will last for 2 years. Those who continue for this phase will take topiramate for the 2-year period. They will be followed regularly by a study nurse and will come to NIH every 6 months for a follow-up visit.
NCT00004297 ↗ Phase III Randomized Study of Diazepam Vs Lorazepam Vs Placebo for Prehospital Treatment of Status Epilepticus Completed University of California, San Francisco Phase 3 1995-11-01 OBJECTIVES: I. Compare the efficacy, onset of clinical anticonvulsant activity, and complications of diazepam and lorazepam given intravenously as prehospital therapy to patients in status epilepticus. II. Determine the effect of prehospital therapy on the incidence of status epilepticus at the subsequent emergency department admission. III. Establish whether prehospital therapy alters hospital management of these patients and ultimately affects patient outcome.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Lorazepam

Condition Name

Condition Name for Lorazepam
Intervention Trials
Schizophrenia 15
Bipolar Disorder 12
Status Epilepticus 11
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Condition MeSH

Condition MeSH for Lorazepam
Intervention Trials
Disease 21
Anxiety Disorders 19
Schizophrenia 18
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Clinical Trial Locations for Lorazepam

Trials by Country

Trials by Country for Lorazepam
Location Trials
United States 225
Japan 17
Netherlands 14
Canada 11
Germany 10
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Trials by US State

Trials by US State for Lorazepam
Location Trials
California 21
New York 19
Texas 15
Ohio 15
Pennsylvania 15
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Clinical Trial Progress for Lorazepam

Clinical Trial Phase

Clinical Trial Phase for Lorazepam
Clinical Trial Phase Trials
Phase 4 50
Phase 3 31
Phase 2/Phase 3 7
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Clinical Trial Status

Clinical Trial Status for Lorazepam
Clinical Trial Phase Trials
Completed 126
Terminated 24
Recruiting 14
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Clinical Trial Sponsors for Lorazepam

Sponsor Name

Sponsor Name for Lorazepam
Sponsor Trials
National Institute of Mental Health (NIMH) 13
Pfizer 8
National Cancer Institute (NCI) 7
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Sponsor Type

Sponsor Type for Lorazepam
Sponsor Trials
Other 242
Industry 64
NIH 35
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Lorazepam: Clinical Trials, Market Analysis, and Projections

Introduction to Lorazepam

Lorazepam, a benzodiazepine, is widely used for its efficacy in treating anxiety, insomnia, and other conditions such as acute agitation and epileptic states. Here, we will delve into recent clinical trials, market analysis, and future projections for this drug.

Clinical Trials Update

Pharmacokinetics and Safety of Extended-Release Lorazepam

Recent phase 1 clinical studies have focused on the pharmacokinetics and safety of extended-release (ER) lorazepam. These studies aimed to compare the once-daily ER lorazepam with the immediate-release (IR) lorazepam given three times a day (TID)[1].

  • Bioequivalence: The studies established that once-daily ER lorazepam is bioequivalent to IR lorazepam given TID, with steady-state bioequivalence confirmed through 90% confidence intervals for Cmax,SS, Cmin, and AUC TAU,SS.
  • Administration: The pharmacokinetic parameters of ER lorazepam were found to be consistent whether taken with or without food, administered intact or sprinkled onto food, or given as 1 × 4-mg versus 4 × 1-mg capsules.
  • Safety: No serious safety concerns were identified, indicating that ER lorazepam is well-tolerated in healthy adults.

Adverse Event Profile

A real-world pharmacovigilance study using the FDA Adverse Event Reporting System (FAERS) highlighted several adverse events associated with lorazepam. These include drug abuse, suicide attempts, sopor, delirium, and psychotic disorders. Additionally, risks such as abnormal fat metabolism, cardiac impairment, and immunosuppression-related disorders were noted[3].

Efficacy in Acute Agitation

A systematic review on the use of lorazepam in acute agitation found that lorazepam is clinically effective in treating agitation. The review included 11 randomized clinical trials and noted improvements across various outcomes related to agitation. However, the studies were highly heterogeneous, making overall qualitative evaluation challenging. Common adverse events included dizziness, sedation, and somnolence[4].

Market Analysis

Global Market Size and Growth

The global lorazepam market is projected to experience significant growth. As of 2023, the market size is estimated to be worth USD 1.2 billion, with a compound annual growth rate (CAGR) of 5.8% expected from 2023 to 2030[2].

Key Applications

Lorazepam is used across several key applications:

  • Anxiety Disorders: A major driver of the market, given the increasing prevalence of anxiety.
  • Insomnia: Lorazepam is often prescribed for short-term treatment of insomnia.
  • Epileptic State: It is used in the management of certain types of seizures.
  • Other Applications: Includes acute agitation and other psychiatric conditions[2][5].

Geographic Segmentation

The lorazepam market is segmented geographically into:

  • North America
  • Europe
  • Asia Pacific
  • Rest of the World

Each region presents unique market dynamics and growth opportunities[2][5].

Major Players

The market is dominated by several key players:

  • Atlantic
  • Lee Man Shan Pharmaceutical
  • Bright Future Pharmaceuticals
  • Huazhong Pharmaceutical
  • Shandong Xinyi Pharmaceutical
  • Hunan Dongting Lake Pharmaceutical

These companies are evaluated based on their product offerings, financial statements, strategic approaches, and geographical penetration[2][5].

Market Projections

Revenue and Volume Forecast

The global lorazepam market is expected to grow substantially, driven by increasing demand for the drug across various applications. The revenue is projected to increase from USD 1.2 billion in 2023 to a higher figure by 2030, with a significant CAGR during the forecast period[2][5].

Competitive Landscape

The competitive landscape of the lorazepam market is characterized by intense competition among the major players. These companies are focusing on product innovation, strategic partnerships, and expanding their geographical presence to capture a larger market share. The report provides a detailed SWOT analysis and highlights the strengths, weaknesses, opportunities, and threats for the top players in the market[2][5].

Key Takeaways

  • Clinical Efficacy: Lorazepam has been shown to be effective in treating anxiety, insomnia, and acute agitation, with recent studies confirming its bioequivalence and safety profile.
  • Market Growth: The global lorazepam market is expected to grow at a CAGR of 5.8% from 2023 to 2030, driven by increasing demand and expanding applications.
  • Adverse Events: While lorazepam is generally safe, it is associated with several adverse events, including drug abuse, suicide attempts, and other psychiatric disorders.
  • Geographic and Application Segmentation: The market is segmented by geography and application, with North America, Europe, and Asia Pacific being key regions and anxiety disorders, insomnia, and epileptic states being major applications.

FAQs

What is the current market size of the global lorazepam market?

The global lorazepam market size is estimated to be worth USD 1.2 billion as of 2023[2].

What is the projected growth rate of the lorazepam market from 2023 to 2030?

The market is expected to grow at a compound annual growth rate (CAGR) of 5.8% from 2023 to 2030[2].

What are the primary applications of lorazepam?

Lorazepam is primarily used for anxiety disorders, insomnia, epileptic states, and other psychiatric conditions such as acute agitation[2][5].

Who are the major players in the lorazepam market?

The major players include Atlantic, Lee Man Shan Pharmaceutical, Bright Future Pharmaceuticals, Huazhong Pharmaceutical, Shandong Xinyi Pharmaceutical, and Hunan Dongting Lake Pharmaceutical[2][5].

What are some of the common adverse events associated with lorazepam?

Common adverse events include drug abuse, suicide attempts, sopor, delirium, and psychotic disorders, as well as dizziness, sedation, and somnolence[3][4].

Sources

  1. Pharmacokinetic Results Across Phase 1 Clinical Studies - PubMed
  2. Lorazepam Market Size, Share, Scope, Trends And Forecast 2030 - Verified Market Reports
  3. Adverse event profile of lorazepam: a real-world pharmacovigilance study - Frontiers in Pharmacology
  4. Treatment of Agitation With Lorazepam in Clinical Practice - Frontiers in Psychiatry
  5. Global Lorazepam Market Research Report 2024 - Valuates Reports
Last updated: 2025-01-01

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