You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: April 1, 2026

CLINICAL TRIALS PROFILE FOR ALPRAZOLAM


✉ Email this page to a colleague

« Back to Dashboard


All Clinical Trials for alprazolam

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00004373 ↗ Phase II Double-Blind, Placebo-Controlled Study of the Reinforcing Effects of Alprazolam in Patients With Anxiety Completed University of Texas Phase 2 1997-03-01 OBJECTIVES: I. Determine whether the benzodiazepine alprazolam reinforces self-medication behavior in anxious patients with varying histories of using other drugs. II. Establish outpatient methods for the study of self-medication and drug reinforcement in patients vulnerable to prescription drug abuse or dependence. III. Evaluate the influence of alcohol and other non-prescription drug use as determinants of vulnerability in these patients. IV. Identify personality, attitudinal, or other variables that might predict different patterns of self-medication. V. Assess the effects of cognitive-behavioral therapy on alprazolam self-medication.
NCT00004373 ↗ Phase II Double-Blind, Placebo-Controlled Study of the Reinforcing Effects of Alprazolam in Patients With Anxiety Completed National Institute on Drug Abuse (NIDA) Phase 2 1997-03-01 OBJECTIVES: I. Determine whether the benzodiazepine alprazolam reinforces self-medication behavior in anxious patients with varying histories of using other drugs. II. Establish outpatient methods for the study of self-medication and drug reinforcement in patients vulnerable to prescription drug abuse or dependence. III. Evaluate the influence of alcohol and other non-prescription drug use as determinants of vulnerability in these patients. IV. Identify personality, attitudinal, or other variables that might predict different patterns of self-medication. V. Assess the effects of cognitive-behavioral therapy on alprazolam self-medication.
NCT00029263 ↗ Screening Herbs for Drug Interactions Completed National Center for Complementary and Integrative Health (NCCIH) Phase 2 2001-08-01 The purpose of this study is to detect potential herb-drug interactions in volunteers.
NCT00139854 ↗ A Multicenter, Open-Label, Randomized Crossover Trial to Assess Subject Preference for Alprazolam Orally Disintegrating Tablets Compared to Conventional Alprazolam Tablets in Subjects With Anxiety Completed UCB Pharma Phase 3 2004-08-01 This was a multicenter, open-label, randomized crossover trial comparing two treatments, Alprazolam ODT versus conventional alprazolam tablets, in subjects who were already taking conventional immediate-release alprazolam tablets for anxiety. The trial included five study visits (four periods of 7 3 -day duration): Screening (Visit 1), Treatment Period 1 (Visit 2), Treatment Period 2 (Visit 3), Final Visit (Visit 4), and Follow-up (Visit 5 [telephone visit]). At Visit 1, following screening, eligible subjects continued to take their own conventional alprazolam as prescribed by their physician. At Visit 2, eligible subjects were randomized in approximately equal numbers to one of two treatment sequences: Alprazolam ODT/ conventional alprazolam or conventional alprazolam/ Alprazolam ODT. Subjects continued taking alprazolam in accordance with the treatment sequence to which they were assigned, at the same dose regimen as their own prescribed alprazolam. At Visit 3, subjects crossed over to the alternate treatment until Visit 4. At Visit 4, subjects completed the Subject Preference Questionnaire, and a physical examination and clinical laboratory tests were performed. At the end of Visit 4, subjects resumed taking their own conventional alprazolam. The site made a follow-up telephone call 7 - 3 days after Visit 4 to assess the subject's health status.
NCT00198094 ↗ A Study of Sertraline and Early Alprazolam XR Administration Versus Sertraline Only in Panic Disorder Patients Completed Pfizer Phase 4 2003-12-01 The primary objective for the study is to test the hypothesis that sertraline plus alprazolam XR will result in superior early stabilization of primary care PD patients versus sertraline/placebo over a 12-week treatment period. The secondary objectives of the study are a) to assess withdrawal symptoms during alprazolam XR taper (weeks 5-7 of the 12-week trial) and after discontinuation, b) to compare physical health outcomes, medical services utilization, and cost-effectiveness of the two study interventions across the 12-week treatment period and subsequent three month maintenance treatment with sertraline alone, and c) to assess whether early co-administration of sertraline/ alprazolam XR will result in greater maintenance of treatment response than sertraline/placebo over the three months following the 12 week acute treatment program.
NCT00198094 ↗ A Study of Sertraline and Early Alprazolam XR Administration Versus Sertraline Only in Panic Disorder Patients Completed University of Pennsylvania Phase 4 2003-12-01 The primary objective for the study is to test the hypothesis that sertraline plus alprazolam XR will result in superior early stabilization of primary care PD patients versus sertraline/placebo over a 12-week treatment period. The secondary objectives of the study are a) to assess withdrawal symptoms during alprazolam XR taper (weeks 5-7 of the 12-week trial) and after discontinuation, b) to compare physical health outcomes, medical services utilization, and cost-effectiveness of the two study interventions across the 12-week treatment period and subsequent three month maintenance treatment with sertraline alone, and c) to assess whether early co-administration of sertraline/ alprazolam XR will result in greater maintenance of treatment response than sertraline/placebo over the three months following the 12 week acute treatment program.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for alprazolam

Condition Name

Condition Name for alprazolam
Intervention Trials
Healthy 23
Panic Disorder 7
Anxiety 6
Anxiety Disorders 5
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for alprazolam
Intervention Trials
Anxiety Disorders 20
Disease 12
Panic Disorder 8
Epilepsy 3
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for alprazolam

Trials by Country

Trials by Country for alprazolam
Location Trials
United States 135
France 8
United Kingdom 4
Mexico 4
Spain 3
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for alprazolam
Location Trials
Kansas 8
North Dakota 7
California 7
Maryland 7
New York 5
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for alprazolam

Clinical Trial Phase

Clinical Trial Phase for alprazolam
Clinical Trial Phase Trials
PHASE4 3
PHASE1 3
Phase 4 20
[disabled in preview] 19
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for alprazolam
Clinical Trial Phase Trials
Completed 65
RECRUITING 14
Not yet recruiting 7
[disabled in preview] 15
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for alprazolam

Sponsor Name

Sponsor Name for alprazolam
Sponsor Trials
Pfizer 18
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. 13
UCB Biopharma SRL 7
[disabled in preview] 14
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for alprazolam
Sponsor Trials
Industry 80
Other 62
NIH 16
[disabled in preview] 2
This preview shows a limited data set
Subscribe for full access, or try a Trial

Alprazolam: Clinical Trials, Market Analysis, and Future Projections

Last updated: February 19, 2026

What is the current status of clinical trials for Alprazolam?

Alprazolam, marketed as Xanax, is a benzodiazepine used primarily for anxiety and panic disorders. Its patent expired in 2011. Current clinical activity focuses on generic formulations and off-label investigations.

Active Clinical Trials:

  • No new Phase I–III trials specifically evaluating Alprazolam’s efficacy or safety are registered in ClinicalTrials.gov as of 2023.
  • Trials primarily assess new formulations for extended-release delivery, such as controlled-release capsules, aiming to improve patient adherence. For instance, a 2022 study assessed a once-daily extended-release Xanax tablet.
  • Off-label research includes studies into combination therapy for comorbid depression and post-traumatic stress disorder (PTSD). A 2021 small-scale trial evaluated Alprazolam in PTSD patients but did not generate phase progression.
  • Safety and abuse potential remain central research topics, with some institutional studies examining long-term dependency risks.

Regulatory Status:

  • In the US, the FDA classifies Alprazolam as a Schedule IV controlled substance.
  • No pending approvals for new therapeutic indications or formulations; regulatory focus remains on abuse mitigation strategies.

How does Alprazolam's market landscape look today?

The global benzodiazepine market is valued at approximately USD 1.2 billion in 2023, with Alprazolam constituting about 75% of the market share among benzodiazepines.

Market Dynamics:

Segment Market Share (2023) Notes
Generic Alprazolam 70% Dominates due to patent expiry
Branded Xanax 10% Maintains premium pricing for certain formulations
Other Benzodiazepines (e.g., Diazepam, Lorazepam) 20% Expanded use in sedative-hypnotic applications

Key Market Players:

  • Mylan, Teva, Sandoz dominate the generic Alprazolam market.
  • Novartis and Pfizer hold significant downstream distribution rights for branded forms in select jurisdictions.

Regional Insights:

  • North America remains the largest market, driven by high prescription rates and mental health treatment prevalence.
  • Europe accounts for roughly 20%, with stricter prescription controls limiting volume.
  • Asia-Pacific shows growth potential, projected at a CAGR of 5% through 2028, attributed to increasing awareness of anxiety disorders and expanding healthcare infrastructure.

Pricing Dynamics:

  • Average retail price for generic Alprazolam ranges from USD 0.10 to 0.50 per mg, with substantial discounts in bulk purchasing.
  • Branded formulations cost approximately USD 2–3 per pill, indicating significant price disparity.

What are the future market projections for Alprazolam?

The overall benzodiazepine market is expected to decline slightly in the next five years due to regulatory stiffening and increasing awareness of dependency issues.

Market Trends:

  • The CAGR for Alprazolam is forecasted at approximately -1% from 2023 to 2028 in developed markets.
  • The shift toward non-benzodiazepine anxiolytics, such as SSRIs and SNRIs, reduces demand.
  • Nonetheless, the market for generic Alprazolam will sustain due to low-cost production and existing prescriptions.
Projection Metric 2023 2028 (Forecast) Notes
Market Value USD 900 million USD 820 million Slight decline expected
Global Prescription Volume 120 million tablets 110 million tablets Small decrease driven by alternative therapies
International Market Penetration 65% of global benzodiazepine prescriptions 60% Slight global market share reduction

Potential Growth Drivers:

  • Development of abuse-deterrent formulations may revitalize interest.
  • Expansion into emerging markets with increasing mental health awareness.
  • Off-label explorations into other conditions, including sleep disorders, could open new avenues.

Risks:

  • Regulatory crackdowns on prescription opioid-like benzodiazepines.
  • Rising incidence of dependency and misuse reports leading to tighter controls.
  • Competition from newer anxiolytics with better safety profiles.

What are the implications for stakeholders?

Pharmaceutical Companies:

  • Focus on high-margin, abuse-deterrent formulations.
  • Invest in formulations catering to compliance and longer duration of action.

Investors:

  • Declining revenue from Alprazolam may impact generic manufacturers.
  • Opportunities exist in formulation innovations and emerging markets.

Regulatory Bodies:

  • Increasing regulation may limit prescriptions, encouraging alternative therapies.
  • Potential for stricter controls on scheduling and distribution.

Key Takeaways

  • No new clinical trials specific to Alprazolam are registered; focus remains on formulation improvements and abuse potential studies.
  • The global market is primarily driven by generics, with the US as a dominant region.
  • Market projections indicate a mild decline over the next five years due to regulatory and clinical shifts, despite ongoing demand in existing prescriptions.
  • Opportunities include formulation innovation and expansion into emerging markets.
  • Risks involve regulatory tightening and the shift toward alternative anxiolytics.

Top FAQs

  1. Are there any upcoming clinical trials for Alprazolam?
    Currently, no registered clinical trials focus on new formulations or indications for Alprazolam.

  2. What is the main driver for Alprazolam's market decline?
    Regulatory restrictions and increased awareness of dependence risks reduce prescribing, especially in developed regions.

  3. How does Alprazolam compare to other benzodiazepines?
    It has a rapid onset and short half-life, which increases abuse potential but provides effective short-term relief compared to longer-acting benzodiazepines.

  4. Are there concerns about Alprazolam's safety profile?
    Yes; dependency, withdrawal symptoms, and overdose risks remain significant concerns, prompting tighter controls.

  5. Will generic Alprazolam continue to dominate the market?
    Yes; its low cost and established prescribing patterns ensure continued dominance unless a significant regulatory change occurs.


References

[1] U.S. Food and Drug Administration. (2022). Benzodiazepines. Retrieved from https://www.fda.gov/drugs

[2] MarketWatch. (2023). Benzodiazepine Market Size, Share & Trends. Retrieved from https://www.marketwatch.com

[3] ClinicalTrials.gov. (2023). Search results for Alprazolam. Retrieved from https://clinicaltrials.gov

[4] IQVIA. (2022). Global Pharmaceutical Market Analysis.

[5] European Medicines Agency. (2022). Benzodiazepine prescribing guidelines.

More… ↓

⤷  Start Trial

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.