CLINICAL TRIALS PROFILE FOR ACAMPROSATE CALCIUM

All Clinical Trials for ACAMPROSATE CALCIUM

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00571103 ↗	Acamprosate in the Treatment of Pathological Gambling	Completed	Forest Laboratories	Phase 4	2007-10-01	The purpose of this study is to see whether acamprosate (Campral) will curb the desire to gamble in people with pathological gambling disorder.
NCT00571103 ↗	Acamprosate in the Treatment of Pathological Gambling	Completed	University of Nebraska	Phase 4	2007-10-01	The purpose of this study is to see whether acamprosate (Campral) will curb the desire to gamble in people with pathological gambling disorder.
NCT00571103 ↗	Acamprosate in the Treatment of Pathological Gambling	Completed	University of Iowa	Phase 4	2007-10-01	The purpose of this study is to see whether acamprosate (Campral) will curb the desire to gamble in people with pathological gambling disorder.
NCT00591565 ↗	An 8 Week Open-Label Study to Evaluate the Efficacy and Safety of Acamprosate Calcium (Campral) as Augmentation Therapy in Patients With Anxiety Symptoms Who Are Only Partial Responders to SSRI or SNRI Antidepressants	Completed	Forest Laboratories	N/A	2006-06-01	This study is designed to evaluate anxious patients who are only partially responsive to typical SSRI or SNRI anti-anxiety medication therapy. Patients who are less than 50% anxiety-alleviated on their SSRI medication will be asked to join the study and be placed on Acamprosate as well. This type of add-on therapy is common in outpatient psychiatric care. This is a rater-blinded, patient open-label, non-placebo prospective study, where all subjects will receive Acamprosate for 8 weeks. This study would be the first to date in this treatment-resistant patient population, as the investigators will utilize the a comprehensive set of rating scales in order to best categorize patient responses in regards to anxiety, co-occurring depression, sleep disorders, alcohol use, and social functioning with this drug. This study may be pivotal to the initiation of future double-blind, placebo-controlled studies for this agent
NCT00591565 ↗	An 8 Week Open-Label Study to Evaluate the Efficacy and Safety of Acamprosate Calcium (Campral) as Augmentation Therapy in Patients With Anxiety Symptoms Who Are Only Partial Responders to SSRI or SNRI Antidepressants	Completed	State University of New York - Upstate Medical University	N/A	2006-06-01	This study is designed to evaluate anxious patients who are only partially responsive to typical SSRI or SNRI anti-anxiety medication therapy. Patients who are less than 50% anxiety-alleviated on their SSRI medication will be asked to join the study and be placed on Acamprosate as well. This type of add-on therapy is common in outpatient psychiatric care. This is a rater-blinded, patient open-label, non-placebo prospective study, where all subjects will receive Acamprosate for 8 weeks. This study would be the first to date in this treatment-resistant patient population, as the investigators will utilize the a comprehensive set of rating scales in order to best categorize patient responses in regards to anxiety, co-occurring depression, sleep disorders, alcohol use, and social functioning with this drug. This study may be pivotal to the initiation of future double-blind, placebo-controlled studies for this agent

Clinical Trial Conditions for ACAMPROSATE CALCIUM

Condition Name

Condition Name for ACAMPROSATE CALCIUM
Intervention	Trials
Alcohol Dependence	2
Alcohol Use Disorder	1
Alcoholism	1
Amyotrophic Lateral Sclerosis	1

Condition MeSH

Condition MeSH for ACAMPROSATE CALCIUM
Intervention	Trials
Alcoholism	4
Frontotemporal Dementia With Motor Neuron Disease	1
Amyotrophic Lateral Sclerosis	1
Anxiety Disorders	1

Clinical Trial Locations for ACAMPROSATE CALCIUM

Trials by Country

Trials by Country for ACAMPROSATE CALCIUM
Location	Trials
United States	7
India	1
Germany	1

Trials by US State

Trials by US State for ACAMPROSATE CALCIUM
Location	Trials
Maryland	2
New York	2
Illinois	1
California	1
New Mexico	1

Clinical Trial Progress for ACAMPROSATE CALCIUM

Clinical Trial Phase

Clinical Trial Phase for ACAMPROSATE CALCIUM
Clinical Trial Phase	Trials
PHASE4	1
PHASE1	1
Phase 4	3

Clinical Trial Status

Clinical Trial Status for ACAMPROSATE CALCIUM
Clinical Trial Phase	Trials
RECRUITING	3
Completed	2
Withdrawn	2

Clinical Trial Sponsors for ACAMPROSATE CALCIUM

Sponsor Name

Sponsor Name for ACAMPROSATE CALCIUM
Sponsor	Trials
Forest Laboratories	2
Synchroneuron Inc.	2
Technische Universität Dresden	1

Sponsor Type

Sponsor Type for ACAMPROSATE CALCIUM
Sponsor	Trials
Other	6
Industry	4
NIH	2

Last updated: April 27, 2026

Acamprosate Calcium: Clinical Trials Update, Market Analysis, and 5-Year Projection

What is acamprosate calcium and where is it used clinically?

Acamprosate calcium is an approved treatment for maintaining abstinence after alcohol dependence treatment. The drug is positioned for relapse prevention rather than acute detoxification. Commercial use centers on alcohol use disorder (AUD), typically after achieving abstinence.

What does the current clinical-trials landscape look like?

Acamprosate calcium is an established, off-patent therapy in major markets. The clinical-trial flow is dominated by academic or investigator-initiated studies, real-world effectiveness work, and combination or adherence-related research, rather than large, late-stage pivotal development.

Trial profile (high-level)

• Dominant focus: abstinence maintenance, relapse outcomes, and post-treatment follow-up
• Trial types: pragmatic studies, adherence and implementation studies, and outcome harmonization studies
• Phase mix: limited late-phase activity; incremental studies more common than registration-enabling programs

Evidence base shape

• The current trial pipeline is best understood as an “evidence maintenance” ecosystem, not a pipeline for a new regulatory product. That reality changes how investors underwrite incremental value: differentiation is expected to come from adherence models, care pathways, and patient selection rather than new molecular entities.

(No additional trial-level facts are provided here due to the absence of verifiable, up-to-date registry data in the input.)

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How big is the acamprosate calcium market and what is the demand base?

Market structure

The acamprosate calcium market is driven by:

• AUD prevalence and treatment uptake
• Post-detox abstinence programs and outpatient relapse-prevention care
• Guideline positioning for relapse prevention therapies
• Generic availability in most major markets

Competitive structure

• First-line relapse-prevention comparators typically include other AUD relapse-prevention and pharmacotherapy options (with selection influenced by contraindications, adherence, and patient profile).
• Generic acamprosate compresses price and shifts competition to supply reliability, distribution reach, and payer access.

Pricing and revenue model

For an off-patent product, revenue is mainly a function of:

• unit volume (scripts and adherence persistence)
• payer reimbursement levels
• generic pricing pressure
• country-level prescribing and formulary coverage

Key market assumption set for projection

A robust forecast for an older generic therapy generally tracks:

1. AUD treated population trend (influenced by screening and care model capacity)
2. Share-of-therapy (guideline alignment plus prescriber habits)
3. Generic erosion (price compression)
4. Adherence and persistence effects (real-world discontinuation drives effective utilization)

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What is the 5-year market projection for acamprosate calcium?

Projection approach

Given the product’s maturity and generic exposure, the most defensible forward model is:

• moderate growth in treated volume
• partial offset by continued generic price erosion
• net result typically shifts with country-specific reimbursement dynamics and care-program throughput

Base-case forecast (directional)

• Net market growth: low single-digit CAGR in value terms is the typical pattern for mature generic AUD relapse-prevention drugs
• Volume vs. value: volume can rise faster than revenue if average selling prices fall

(No numeric forecast is issued because the input does not include required baseline market size, current revenues, or verified registry trends.)

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What regulatory and lifecycle factors shape acamprosate calcium economics?

Patent and exclusivity reality

• Acamprosate calcium is mature and widely available as a generic.
• Lifecycle value concentrates in:
  • formulation and brand differentiation (where still present in certain territories)
  • distribution and payer contracting
  • evidence generation that supports guideline and reimbursement retention

Safety and adherence considerations

A key practical determinant of utilization is adherence. In clinical practice, adherence constraints can limit real-world effectiveness even when the evidence supports abstinence maintenance.

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Where are the main commercial risks and upside levers?

Commercial risks

• Ongoing price competition in generic segments
• Switching behavior to alternate AUD pharmacotherapies where payer coverage is favorable
• Low persistence typical of chronic behavioral-health pharmacotherapy without support structures

Upside levers

• Integration into care pathways (post-detox follow-up scheduling, case management)
• Payer programs tied to relapse prevention or quality metrics
• Improved adherence support linked to dispensing and follow-up

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Key Takeaways

• Acamprosate calcium is a mature AUD relapse-prevention therapy whose clinical trial activity is typically incremental and evidence-maintenance oriented.
• The market is structurally constrained by generic competition; revenue growth is driven primarily by treated volume, prescribing persistence, and payer formularies.
• For 5-year planning, the most reliable assumption is low single-digit value growth driven by utilization modestly exceeding price erosion, with volatility from country-level reimbursement and competitive switching.

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FAQs

1) Is there late-stage, registration-enabling clinical development for acamprosate calcium?

Clinical activity is generally incremental rather than late-stage pivotal, consistent with an established off-patent product.

2) What endpoints matter most in ongoing trials for acamprosate calcium?

Studies typically emphasize abstinence maintenance and relapse-related outcomes over follow-up horizons consistent with outpatient relapse prevention.

3) What drives sales for acamprosate calcium in a generic market?

Script volume, payer coverage, and persistence/adherence in real-world use are the dominant drivers.

4) What is the biggest factor limiting real-world effectiveness?

Adherence and persistence after treatment initiation, especially without structured follow-up support.

5) How should investors underwrite upside for a mature generic AUD drug?

Upside is more likely to come from care-pathway adoption, adherence models, and payer contracting than from new molecular or regulatory breakthroughs.

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References

1. APA. Alcohol dependence: treatment guidelines and pharmacotherapy positioning (general background).
2. FDA/EMA label references for acamprosate calcium (indication and use pattern).