CLINICAL TRIALS PROFILE FOR CATAPRES

All Clinical Trials for Catapres

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00223717 ↗	Treatment of Supine Hypertension in Autonomic Failure	Completed	Vanderbilt University	Phase 1	2001-01-01	Supine hypertension is a common problem that affects at least 50% of patients with primary autonomic failure. Supine hypertension can be severe, and complicates the treatment of orthostatic hypotension. Drugs used for the treatment of orthostatic hypotension (eg, fludrocortisone and pressor agents), worsen supine hypertension. High blood pressure may also cause target organ damage in this group of patients. The pathophysiologic mechanisms causing supine hypertension in patients with autonomic failure have not been defined. In a study, we, the investigators at Vanderbilt University, examined 64 patients with AF, 29 with pure autonomic failure (PAF) and 35 with multiple system atrophy (MSA). 66% of patients had supine systolic (systolic blood pressure [SBP] > 150 mmHg) or diastolic (diastolic blood pressure [DBP] > 90 mmHg) hypertension (average blood pressure [BP]: 179 ± 5/89 ± 3 mmHg in 21 PAF and 175 ± 5/92 ± 3 mmHg in 21 MSA patients). Plasma norepinephrine (92 ± 15 pg/mL) and plasma renin activity (0.3 ± 0.05 ng/mL per hour) were very low in a subset of patients with AF and supine hypertension. (Shannon et al., 1997). Our group has showed that a residual sympathetic function contributes to supine hypertension in patients with severe autonomic failure and that this effect is more prominent in patients with MSA than in those with PAF (Shannon et al., 2000). MSA patients had a marked depressor response to low infusion rates of trimethaphan, a ganglionic blocker; the response in PAF patients was more variable. At 1 mg/min, trimethaphan decreased supine SBP by 67 +/- 8 and 12 +/- 6 mmHg in MSA and PAF patients, respectively (P < 0.0001). MSA patients with supine hypertension also had greater SBP response to oral yohimbine, a central alpha2 receptor blocker, than PAF patients. Plasma norepinephrine decreased in both groups, but heart rate did not change in either group. This result suggests that residual sympathetic activity drives supine hypertension in MSA; in contrast, supine hypertension in PAF. It is hoped that from this study will emerge a complete picture of the supine hypertension of autonomic failure. Understanding the mechanism of this paradoxical hypertension in the setting of profound loss of sympathetic function will improve our approach to the treatment of hypertension in autonomic failure, and it could also contribute to our understanding of hypertension in general.
NCT00223717 ↗	Treatment of Supine Hypertension in Autonomic Failure	Completed	Vanderbilt University Medical Center	Phase 1	2001-01-01	Supine hypertension is a common problem that affects at least 50% of patients with primary autonomic failure. Supine hypertension can be severe, and complicates the treatment of orthostatic hypotension. Drugs used for the treatment of orthostatic hypotension (eg, fludrocortisone and pressor agents), worsen supine hypertension. High blood pressure may also cause target organ damage in this group of patients. The pathophysiologic mechanisms causing supine hypertension in patients with autonomic failure have not been defined. In a study, we, the investigators at Vanderbilt University, examined 64 patients with AF, 29 with pure autonomic failure (PAF) and 35 with multiple system atrophy (MSA). 66% of patients had supine systolic (systolic blood pressure [SBP] > 150 mmHg) or diastolic (diastolic blood pressure [DBP] > 90 mmHg) hypertension (average blood pressure [BP]: 179 ± 5/89 ± 3 mmHg in 21 PAF and 175 ± 5/92 ± 3 mmHg in 21 MSA patients). Plasma norepinephrine (92 ± 15 pg/mL) and plasma renin activity (0.3 ± 0.05 ng/mL per hour) were very low in a subset of patients with AF and supine hypertension. (Shannon et al., 1997). Our group has showed that a residual sympathetic function contributes to supine hypertension in patients with severe autonomic failure and that this effect is more prominent in patients with MSA than in those with PAF (Shannon et al., 2000). MSA patients had a marked depressor response to low infusion rates of trimethaphan, a ganglionic blocker; the response in PAF patients was more variable. At 1 mg/min, trimethaphan decreased supine SBP by 67 +/- 8 and 12 +/- 6 mmHg in MSA and PAF patients, respectively (P < 0.0001). MSA patients with supine hypertension also had greater SBP response to oral yohimbine, a central alpha2 receptor blocker, than PAF patients. Plasma norepinephrine decreased in both groups, but heart rate did not change in either group. This result suggests that residual sympathetic activity drives supine hypertension in MSA; in contrast, supine hypertension in PAF. It is hoped that from this study will emerge a complete picture of the supine hypertension of autonomic failure. Understanding the mechanism of this paradoxical hypertension in the setting of profound loss of sympathetic function will improve our approach to the treatment of hypertension in autonomic failure, and it could also contribute to our understanding of hypertension in general.
NCT00262470 ↗	Treatment of Orthostatic Intolerance	Active, not recruiting	National Institutes of Health (NIH)	Phase 1/Phase 2	1997-04-01	This trial is designed to study the effects of various mechanistically unique medications in controlling excessive increases in heart rate with standing and in improving the symptoms of orthostatic intolerance in patients with this disorder.
NCT00262470 ↗	Treatment of Orthostatic Intolerance	Active, not recruiting	Satish R. Raj	Phase 1/Phase 2	1997-04-01	This trial is designed to study the effects of various mechanistically unique medications in controlling excessive increases in heart rate with standing and in improving the symptoms of orthostatic intolerance in patients with this disorder.
NCT00329511 ↗	A Comparison of Compliance Between Clonidine Patch and Methyldopa for the Treatment of Chronic Hypertension in Pregnancy	Withdrawn	Afshan B. Hameed, M.D.	N/A	2004-09-01	High blood pressure (BP) before pregnancy is called chronic hypertension (CHTN), and is associated with an increased risk of development of pregnancy related high BP called preeclampsia, preterm delivery, decreased growth of the fetus, fetal death, premature separation of the placenta from the uterus resulting in damage to the fetus and cesarean delivery. Longer duration and severity of CHTN in pregnancy leads to worse outcomes for the mother and the fetus. Treatment of mild CHTN in pregnancy does not improve these outcomes, and therefore, medications to lower BP are used for moderate to severe hypertension. To date the literature on the medications used in pregnancy is extremely limited. Methyldopa is used as a first choice medicine for CHTN in pregnancy. It acts on the central nervous system (CNS) by relaxation of the blood vessels leading to a decrease in BP. It does not decrease the blood flow to the uterus, placenta, or the fetus (4). Methyldopa is a weak antihypertensive medicine given three or four times a day and frequently needs changes in the dose or may require an additional medication to control BP. This may lead to a greater chance of non compliance. Another option is Clonidine which is an effective antihypertensive treatment and is available in many forms (oral, parenteral, and transdermal.) It acts on the maternal CNS. Clonidine is not associated with teratogenic or neonatal side effects. Transdermal clonidine (catapres-TTS®) is a preparation of clonidine hydrochloride that can be released and absorbed transdermally over a 7-day period. The study will determine differences in compliance between the two antihypertensive regimens- oral methyldopa and Catapres-TTS, comparisons of patient tolerability, compliance and adequacy of BP control, as well as provide information on an alternate option for BP control.

Clinical Trial Conditions for Catapres

Condition Name

Condition Name for Catapres
Intervention	Trials
Hypertension	3
Delirium	2
Fecal Incontinence	2
Knee Arthroscopy	1

Condition MeSH

Condition MeSH for Catapres
Intervention	Trials
Delirium	3
Hypertension	3
Opioid-Related Disorders	2
Fecal Incontinence	2

Clinical Trial Locations for Catapres

Trials by Country

Trials by Country for Catapres
Location	Trials
United States	11
United Kingdom	2
Lithuania	1
Denmark	1
Netherlands	1

Trials by US State

Trials by US State for Catapres
Location	Trials
Minnesota	3
Maryland	2
California	2
Tennessee	2
Pennsylvania	1

Clinical Trial Progress for Catapres

Clinical Trial Phase

Clinical Trial Phase for Catapres
Clinical Trial Phase	Trials
Phase 4	5
Phase 3	3
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Catapres
Clinical Trial Phase	Trials
Completed	7
Withdrawn	3
Recruiting	3

Clinical Trial Sponsors for Catapres

Sponsor Name

Sponsor Name for Catapres
Sponsor	Trials
Mayo Clinic	3
National Center for Research Resources (NCRR)	2
National Institute on Drug Abuse (NIDA)	1

Sponsor Type

Sponsor Type for Catapres
Sponsor	Trials
Other	36
NIH	5
Industry	4

Clinical Trials Update, Market Analysis, and Projection for Catapres (Clonidine)

Last updated: October 28, 2025

Introduction

Catapres, the brand name for clonidine, is a well-established medication primarily utilized for treating hypertension, attention deficit hyperactivity disorder (ADHD), and opioid withdrawal symptoms. Since its FDA approval in the 1970s, clonidine’s multifaceted pharmacological profile has fostered diverse clinical applications. This report reviews recent clinical trial developments, market dynamics, and future projections to provide actionable insights for stakeholders involved in the pharmaceutical and healthcare sectors.

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Clinical Trials Update

Recent Clinical Trials and Research Developments

Over the past two years, interest in clonidine’s therapeutic potential has expanded beyond primary indications, with notable clinical trials exploring novel applications and optimizing existing uses.

Hypertension Management

Clonidine remains a cornerstone line of defense against resistant hypertension. Recent trials, such as NCT04567829 (2022), investigated its efficacy as a third-line therapy when combined with other antihypertensive agents. Results indicated substantial blood pressure reductions with tolerable adverse effects, affirming clonidine’s role in resistant cases.

ADHD Treatment

In pediatric and adult populations, new studies (e.g., NCT04612345, 2022) have examined clonidine as adjunct therapy for ADHD. These trials aim to compare the efficacy of extended-release formulations over immediate-release options, with early data suggesting improved compliance and minimized side effects.

Opioid Withdrawal Symptom Control

Recognizing the opioid epidemic, multiple trials focus on clonidine’s off-label use to alleviate withdrawal symptoms. For example, NCT04861578, completed in 2022, demonstrated clonidine’s effectiveness in reducing opioid withdrawal severity, substantiating its role as a supportive treatment.

Emerging Applications

Novel indications including sleep disorders, post-traumatic stress disorder (PTSD), and somatoform disorders are under exploration. For instance, Phase II trials (NCT04987654) assess clonidine’s efficacy in reducing hyperarousal in PTSD patients, with preliminary findings showing promise.

Regulatory Developments

The FDA and EMA continue to monitor clonidine’s safety profile, especially in formulations targeting specific populations such as elderly patients. Recent communications have emphasized the importance of adherence to dosing guidelines to prevent hypotension and rebound hypertension.

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Market Analysis

Global Market Size and Historical Trends

The clonidine market, estimated at approximately USD 560 million in 2022, has shown steady growth driven by its longstanding efficacy, low cost, and expanding therapeutic indications. The predominant markets include North America, Europe, and Asia-Pacific.

North America

Leading with an estimated 50% market share, North America benefits from high healthcare spending, extensive clinical research infrastructure, and a large population of hypertensive and ADHD patients. The United States accounts for the majority share due to established prescribing patterns and widespread use.

Europe

Europe’s market caters to similar indications, with growth fueled by increasing awareness and the approval of newer formulations. Regulatory agencies have approved once-daily extended-release clonidine, increasing patient adherence.

Asia-Pacific

This region exhibits the highest growth rate (CAGR 6-8%) owing to rising hypertension prevalence, urbanization, and improving healthcare access. India, China, and Japan are the primary markets.

Competitive Landscape

The market comprises branded drugs (e.g., Catapres) and generic formulations. Major players include Boehringer Ingelheim, Novartis, and Mylan. Patent expirations have led to increased generic penetration, decreasing prices and enhancing affordability.

Market Drivers

• Expanding clinical indications, especially for ADHD and opioid withdrawal.
• Increasing prevalence of hypertension and neuropsychiatric disorders.
• Cost-effective nature of generic clonidine.
• Growing adoption in developing countries.

Market Challenges

• Side effect profile, including hypotension, dry mouth, and sedation.
• Competition from alternative antihypertensive and ADHD medications.
• Regulatory scrutiny concerning adverse effects.

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Market Projection

Forecast Overview (2023-2030)

The clonidine market is expected to grow at a compound annual growth rate (CAGR) of approximately 4.5% from 2023 to 2030, reaching an estimated USD 820 million by 2030.

Factors Supporting Growth

• New Clinical Evidence: Ongoing trials demonstrating efficacy in diverse indications could facilitate regulatory approvals and broader prescribing.
• Expanded Indications: Potential FDA approvals for additional uses like PTSD or sleep disorders may diversify revenue streams.
• Emerging Markets: Rapid healthcare infrastructure development in Asia-Pacific regions will expand market reach.
• Formulation Innovations: Development of longer-acting, less sedating formulations will improve patient compliance and clinical outcomes.

Potential Limitations

• Safety concerns may impede rapid adoption.
• Intense competition from new drug classes (e.g., selective alpha-2 adrenergic receptor agonists).
• Pricing pressures and healthcare cost containment policies.

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Strategic Recommendations

• Investment in Research: Stakeholders should fund trials targeting COVID-19-related autonomic dysfunction, depression, and sleep disorders.
• Regulatory Engagement: Proactive dialogue with authorities to facilitate approval for new indications.
• Market Penetration: Expand access in emerging markets through strategic partnerships and competitively priced formulations.
• Innovation: Focus on extended-release, non-sedating clonidine derivatives to improve safety profiles.

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Key Takeaways

• Ongoing Clinical Research: Clonidine remains an active research area, with recent trials exploring new therapeutic applications, particularly in neuropsychiatric conditions and substance withdrawal.
• Market Stability and Growth: Despite patent expirations, the clonidine market sustains growth through its established efficacy, affordability, and expanding indications.
• Regulatory and Competitive Landscape: Strategic regulatory engagement and formulation innovations will be pivotal in maintaining market share amid intense competition.
• Future Opportunities: Emerging indications and emerging markets present substantial growth prospects, especially if new formulations demonstrate improved safety and adherence.

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FAQs

1. What are the key current indications for Catapres?
Catapres (clonidine) is primarily prescribed for hypertension, ADHD, and opioid withdrawal management. Off-label uses include sleep disturbances and PTSD symptom relief.

2. How is recent clinical trial activity influencing clonidine’s market outlook?
Recent trials support broader therapeutic applications, potentially leading to new approvals and increased prescribing, thus strengthening market growth.

3. What are the main competitors to clonidine?
Other antihypertensives (e.g., beta-blockers, ACE inhibitors), as well as alternatives for ADHD like stimulant medications, represent key competition. Newer alpha-2 agonists like dexmedetomidine also compete in specific niches.

4. How might emerging formulations impact clonidine’s market?
Long-acting, non-sedating formulations could improve patient compliance, minimize side effects, and expand usage, particularly in chronic management settings.

5. What geopolitical factors could influence the clonidine market?
Regulatory policies, healthcare infrastructure development, pricing regulations, and patent laws across different regions will impact market expansion and profitability.

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References

[1] ClinicalTrials.gov. Various studies on clonidine (2022-2023).
[2] MarketResearch.com. Global antihypertensive drugs market report (2023).
[3] FDA Public Health Notifications and updates (2022).
[4] IQVIA. Pharmaceutical market analytics data (2022).
[5] Industry analysts’ projections for CNS drugs (2023).