CLINICAL TRIALS PROFILE FOR LORAZEPAM

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. ...

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.
NCT00004297 ↗	Phase III Randomized Study of Diazepam Vs Lorazepam Vs Placebo for Prehospital Treatment of Status Epilepticus	Completed	National Institute of Neurological Disorders and Stroke (NINDS)	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.
NCT00011297 ↗	Comparing Gabapentin and Lorazepam for Treating Alcohol Withdrawal	Completed	National Institute on Alcohol Abuse and Alcoholism (NIAAA)	Phase 2	1969-12-31	This study will evaluate a safe and useful medication for outpatient detoxification that is as effective as benzodiazepines in the short-term, and more effective in the protracted withdrawal period. Gabapentin (Neurontin) will be compared to a standard benzodiazepine, lorazepam (Ativan), for its effectiveness in treating alcohol withdrawal.

Clinical Trial Conditions for LORAZEPAM

Condition Name

Condition Name for LORAZEPAM
Intervention	Trials
Schizophrenia	15
Bipolar Disorder	12
Status Epilepticus	11
Healthy	10

Condition MeSH

Condition MeSH for LORAZEPAM
Intervention	Trials
Disease	21
Anxiety Disorders	19
Schizophrenia	18
Depression	17

Clinical Trial Locations for LORAZEPAM

Trials by Country

Trials by Country for LORAZEPAM
Location	Trials
United States	231
Japan	17
Netherlands	15
Canada	12
Germany	10

Trials by US State

Trials by US State for LORAZEPAM
Location	Trials
California	22
New York	20
Texas	15
Ohio	15
Pennsylvania	15

Clinical Trial Progress for LORAZEPAM

Clinical Trial Phase

Clinical Trial Phase for LORAZEPAM
Clinical Trial Phase	Trials
PHASE4	2
PHASE3	3
PHASE2	3

Clinical Trial Status

Clinical Trial Status for LORAZEPAM
Clinical Trial Phase	Trials
Completed	126
Terminated	24
Recruiting	19

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

Sponsor Type

Sponsor Type for LORAZEPAM
Sponsor	Trials
Other	255
Industry	65
NIH	36

Last updated: July 24, 2026

Lorazepam clinical trials update, market size, and forecast: pipeline status, exclusivity risks, and commercial outlook

Executive summary: Lorazepam remains a mature, off-patent benzodiazepine with extensive generic penetration in the US. The clinical-trials landscape is dominated by legacy pharmacology and formulation work rather than new registration-enabling studies. Market growth is largely tied to persistent demand for anxiety, insomnia, and procedural sedation, with headwinds from long-term safety scrutiny and substitution to non-benzodiazepine options. Near-term commercial upside is constrained by generic competition, while value migration continues toward branded and product-differentiated presentations in select markets (notably liquid/IV and certain branded products where still protected by specific formulations, labeling, or exclusivity).

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What is the latest clinical trials status for lorazepam (completed, recruiting, and ongoing studies)?

Bottom line: There is no evidence that lorazepam has an active, late-stage (Phase 3) registration program that would materially change its regulatory status in the US or major comparator markets. The observable clinical footprint trends toward:

• formulation and bioavailability comparisons
• route-of-administration work (oral vs. sublingual/oral concentrate vs. IV)
• peri-procedural sedation protocols
• withdrawal and tolerability studies in substance-use and geriatric settings
• regimen comparisons against other CNS depressants or standard-of-care pathways

Which trial types dominate lorazepam studies?

Typical categories:

• Pharmacokinetics/bioequivalence (PK/BE): generic entrants and product lifecycle maintenance
• Acute care and procedural sedation: lorazepam schedules and combination protocols
• Symptom-control and endpoints: agitation, anxiety scores, sleep latency, rescue medication use
• Safety and discontinuation: tapering schedules and adverse event characterization

How to interpret “activity” in lorazepam’s trial registry signals

For a mature generic drug, “ongoing” trial signals often reflect:

• BE studies required for ANDA approvals
• IRB-driven hospital studies focused on dosing practices rather than drug-label expansion
• small investigator-initiated trials that do not alter label exclusivity

Implication for investors/licensing: pipeline utility is mostly limited to product differentiation and lifecycle extensions, not new market creation.

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Are there any Phase 3 or NDA-relevant lorazepam trials that could change approval or label?

Featured snippet answer: There is no identifiable pattern of Phase 3/NDA-enabling lorazepam trials that would create new US exclusivity or drive a label expansion comparable to a novel CNS agent.

What would count as “NDA-relevant” for lorazepam?

The only plausible pathways to meaningful regulatory and commercial change would be:

• a new route (if not already broadly accepted) with a distinct clinical endpoint package
• a new indication with a large randomized evidence set
• an improved dosage form that meaningfully changes safety or efficacy and is supported by robust trial design

Observed reality: the dominant research is not structured for those outcomes.

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What is the market size and competitive landscape for lorazepam in the US and major EU markets?

Executive snapshot: Lorazepam is a high-volume, low-unit-value generic drug. Pricing power is limited by widespread generic substitution, multi-source supply, and payor formularies that treat benzodiazepines as interchangeable on a class basis.

Competitive structure

• US: multiple ANDA manufacturers with 1 mg, 2 mg, and liquid/solution presentations across common dosing strengths; competition intensifies around supply stability and customer contracting
• EU: national equivalents with generic saturation; brand presence varies by country and historical settlement patterns

Where demand persists

Lorazepam demand clusters around:

• acute anxiety and agitation
• insomnia management in specific clinical contexts
• procedural sedation and premedication
• hospital-based use (ED, inpatient psychiatry, peri-procedural settings)

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How strong is lorazepam’s exclusivity and patent estate, and what does that mean for generic entry risk?

Bottom line: Lorazepam’s core drug substance is off-patent, so the principal IP protections in practice are product- and process-level: formulation patents (where any remain), Orange Book-listed device/label exclusivity for specific products, and manufacturing/process IP for certain presentations.

What exclusivity typically exists for a mature benzodiazepine

• Orphan or pediatric exclusivity: unlikely for lorazepam given long history and broad use
• 505(b)(2) or 3rd-party exclusivity tied to a specific branded product formulation/label: possible in niche presentations, but does not typically block ANDAs on drug substance
• Patent thickets for specific forms: liquid concentrate, IV formulations, or stability-related compositions

Paragraph IV and ANDA strategy implications

For a generic entrant considering market share:

• the drug substance pathway is usually straightforward
• market access depends on securing manufacturing supply, negotiating distribution, and surviving any product-specific Orange Book listings tied to target SKUs

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What is the Orange Book status of lorazepam products, and which listings matter to biosimilar-like concerns?

Featured snippet answer: Lorazepam is not a biologic; “biosimilar risk” is not applicable. Orange Book considerations focus on small-molecule patents and exclusivities tied to specific lorazepam drug products (tablets, solution, concentrate, and certain IV presentations).

Which Orange Book listing categories typically drive litigation

• formulation/composition-of-matter for a specific drug product
• method-of-use patents limited to labeled indications
• manufacturing/process patents

Commercial impact: most disputes, when they occur, are SKU-specific and do not translate into long blockades on the drug class.

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How does lorazepam compare with competing benzodiazepines (alprazolam, clonazepam, diazepam) on clinical use and market outlook?

Executive comparison: Lorazepam’s differentiation is clinical practicality: reliable onset for anxiety/agitation and extensive hospital workflow adoption. Alprazolam and clonazepam compete more heavily in outpatient anxiety and panic pathways, while diazepam competes for specific procedural and seizure contexts.

Where lorazepam tends to hold share

• acute care protocols favor predictable dosing and titration
• hospital formularies treat lorazepam as a standard “rescue” option for agitation/anxiety

Where competitors can take share

• outpatient reliance on alternatives with different pharmacokinetic profiles
• payor-driven substitution within benzodiazepines
• substitution toward non-benzodiazepine anxiolytics/sedatives over time

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What regulatory headwinds affect lorazepam demand (boxed warnings, REMS, opioid co-use, and labeling changes)?

Market effect: The biggest regulatory headwind is risk management around CNS depressants. While lorazepam is not REMS-listed in the same way as some other products, the broad class-level warnings and prescriber scrutiny can affect:

• long-term prescribing volumes
• dose escalation and renewal behavior
• hospital prescribing approvals for chronic use

Commercial translation

• near-term: demand stability due to acute-care use and established protocols
• medium-term: gradual pressure from safer-at-scale alternatives and tighter prescribing patterns

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What are the key market demand drivers for lorazepam over the next 3 to 7 years?

Drivers that continue to support baseline demand

• persistent incidence of anxiety disorders and agitation episodes
• acute care reliance and substitution within benzodiazepine class
• continued availability of multiple generic formulations that keeps access high

Offsetting factors

• tighter clinical guidance limiting long-term benzodiazepine use
• substitution toward SSRIs/SNRIs, buspirone, and non-benzodiazepine sleep agents
• payer utilization management and prescriber audits in some systems

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Lorazepam revenue projection: what growth rate is realistic under generic saturation?

Projection framework (drug-class reality):

• Unit volume: stable-to-slow growth or flat-to-low single digits, influenced by patient mix and acute admissions
• Net pricing: downward pressure from generic competition, tendering, and supply normalization
• Revenue: typically tracks with population and prescribing changes, net of price declines

Actionable investor takeaway: for lorazepam, returns are driven more by contracting, supply chain resilience, and SKU mix than by clinical pipeline breakthroughs.

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What commercialization strategy works best for new-to-market lorazepam products (tablets vs. liquid vs. IV)?

Best fit strategy by product type

• Liquid/oral concentrate: tends to address pediatric/elderly and administration compliance needs, supporting differentiated contracts even in a generic landscape
• IV formulations: supports hospital procurement, protocol standardization, and peri-procedural use
• Tablets: compete on price and supply, with differentiation mainly through packaging, stability, and bioavailability compliance

Manufacturing/IP barriers that matter

• bioequivalence and stability requirements
• sourcing of controlled intermediates
• scale economics and regulatory inspection readiness
• short-term supply disruptions that can create temporary pricing rebounds

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What patent litigation affects lorazepam market access and generic launch timing?

Bottom line: Litigation risk is usually not “systemic” to the drug class. It is product-SKU and listing-specific, usually affecting the timing of market entry for particular presentations rather than blocking the entire molecule.

Where litigation most often concentrates

• IV or solution formulations with stability or concentration-specific patents
• method-of-use tied to labeled indications for acute settings
• process patents protecting manufacturing yield/impurity profiles for specific strengths or dosage forms

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Key Takeaways

• Clinical pipeline: lorazepam’s clinical activity is dominated by formulation, PK/BE, and pragmatic acute-care studies rather than NDA/Phase 3 programs that would change its regulatory posture.
• Market dynamics: lorazepam is a mature, generic-saturated product. Competitive pressure constrains pricing and limits growth to volume and contract-driven SKU mix.
• Risk factors: regulatory scrutiny on CNS depressant safety shapes prescribing patterns, mainly affecting long-term use rather than acute hospital reliance.
• Commercial outlook: realistic near-to-medium term performance depends on supply, contracting, and differentiation in liquid/IV presentations rather than breakthrough efficacy.

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FAQs

1) What are the most common lorazepam clinical trial endpoints used in ongoing studies?
PK/BE endpoints (Cmax, Tmax, AUC), clinical anxiety/agitation scales, sleep latency, and rescue-medication frequency.

2) Does lorazepam have REMS requirements that impact prescribing and pharmacy distribution?
Lorazepam’s distribution and prescribing are shaped more by class risk warnings and payer utilization management than by a dedicated REMS program in the way seen for select higher-risk products.

3) Which lorazepam formulations are most likely to be differentiated for market access in generic competitions?
Liquid/oral concentrate and IV/solution presentations, where usability and stability can support SKU-specific differentiation.

4) How do generic price tenders typically affect lorazepam revenue for manufacturers?
They compress net pricing and shift value to winning contracts, supply reliability, and strength/formulation mix.

5) Are non-benzodiazepines replacing lorazepam in anxiety and insomnia treatment pathways?
They can reduce long-term benzodiazepine utilization, but lorazepam retains acute-care roles where rapid symptom control and protocol familiarity drive continued use.

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References

No external sources were cited in the provided content.