CLINICAL TRIALS PROFILE FOR CLONIDINE HYDROCHLORIDE

505(b)(2) Clinical Trials for clonidine hydrochloride

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	NCT07092566 ↗	R.E.C.K vs Exparel in Robotic Nephrectomy	NOT_YET_RECRUITING	Atrium Health Levine Cancer Institute	PHASE3	2025-11-01	The purpose of the study is to evaluate the efficacy of R.E.C.K (ropivacaine epinephrine clonidine ketorolac) vs Exparel during robotic partial and radical nephrectomy in a single institution, prospective, randomized trial. The study will evaluate post operative Numerical Rating Score (NRS) pain scores, post operative pain medication intake (opioids and over-the-counter pain medicines) and length of stay across the two patient cohorts. The findings will help to inform whether the increased cost of Exparel when compared to R.E.C.K is justified.
OTC	NCT07092566 ↗	R.E.C.K vs Exparel in Robotic Nephrectomy	NOT_YET_RECRUITING	Wake Forest University Health Sciences	PHASE3	2025-11-01	The purpose of the study is to evaluate the efficacy of R.E.C.K (ropivacaine epinephrine clonidine ketorolac) vs Exparel during robotic partial and radical nephrectomy in a single institution, prospective, randomized trial. The study will evaluate post operative Numerical Rating Score (NRS) pain scores, post operative pain medication intake (opioids and over-the-counter pain medicines) and length of stay across the two patient cohorts. The findings will help to inform whether the increased cost of Exparel when compared to R.E.C.K is justified.

All Clinical Trials for clonidine hydrochloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000279 ↗	Novel Medications for Opiate Detoxification - 4	Completed	National Institute on Drug Abuse (NIDA)	Phase 2	1994-09-01	The purpose of this study is to evaluate novel medications for opiate detoxification.
NCT00000279 ↗	Novel Medications for Opiate Detoxification - 4	Completed	VA Connecticut Healthcare System	Phase 2	1994-09-01	The purpose of this study is to evaluate novel medications for opiate detoxification.
NCT00000279 ↗	Novel Medications for Opiate Detoxification - 4	Completed	Yale University	Phase 2	1994-09-01	The purpose of this study is to evaluate novel medications for opiate detoxification.
NCT00000800 ↗	Methadone Effects on Zidovudine (ZDV, AZT) Disposition	Completed	Glaxo Wellcome	Phase 1	1969-12-31	To determine whether methadone maintenance alters the pharmacokinetics of zidovudine (AZT). To determine whether any such effect of methadone on disposition of AZT is time dependent and whether a metabolic interaction between AZT and methadone exists. Injection drug users represent an increasing proportion of HIV-infected persons. Since daily methadone maintenance is the major chemical treatment for injection drug abuse, it is important to determine the impact of methadone on AZT absorption, distribution, and elimination.
NCT00000800 ↗	Methadone Effects on Zidovudine (ZDV, AZT) Disposition	Completed	National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1	1969-12-31	To determine whether methadone maintenance alters the pharmacokinetics of zidovudine (AZT). To determine whether any such effect of methadone on disposition of AZT is time dependent and whether a metabolic interaction between AZT and methadone exists. Injection drug users represent an increasing proportion of HIV-infected persons. Since daily methadone maintenance is the major chemical treatment for injection drug abuse, it is important to determine the impact of methadone on AZT absorption, distribution, and elimination.
NCT00003771 ↗	Hormone Replacement Therapy and the Risk of Breast Cancer Recurrence in Women With Previous Early Stage Breast Cancer	Completed	European Organisation for Research and Treatment of Cancer - EORTC	Phase 3	1997-09-01	RATIONALE: Hormone replacement therapy is effective for relieving symptoms of menopause. It is not yet known if hormone replacement therapy increases the risk of breast cancer recurrence in women previously treated for early stage breast cancer. PURPOSE: Randomized phase III trial to determine the risk of breast cancer recurrence in women with previous early stage breast cancer who are receiving hormone replacement therapy for menopause symptoms.
NCT00003771 ↗	Hormone Replacement Therapy and the Risk of Breast Cancer Recurrence in Women With Previous Early Stage Breast Cancer	Completed	International Breast Cancer Study Group	Phase 3	1997-09-01	RATIONALE: Hormone replacement therapy is effective for relieving symptoms of menopause. It is not yet known if hormone replacement therapy increases the risk of breast cancer recurrence in women previously treated for early stage breast cancer. PURPOSE: Randomized phase III trial to determine the risk of breast cancer recurrence in women with previous early stage breast cancer who are receiving hormone replacement therapy for menopause symptoms.

Clinical Trial Conditions for clonidine hydrochloride

Condition Name

Condition Name for clonidine hydrochloride
Intervention	Trials
Postoperative Pain	21
Hypertension	15
Pain, Postoperative	15
Pain	14

Condition MeSH

Condition MeSH for clonidine hydrochloride
Intervention	Trials
Pain, Postoperative	48
Opioid-Related Disorders	17
Delirium	17
Hypertension	15

Clinical Trial Locations for clonidine hydrochloride

Trials by Country

Trials by Country for clonidine hydrochloride
Location	Trials
United States	268
Egypt	61
France	19
Brazil	17
Canada	16

Trials by US State

Trials by US State for clonidine hydrochloride
Location	Trials
New York	24
Maryland	19
California	17
North Carolina	17
Texas	16

Clinical Trial Progress for clonidine hydrochloride

Clinical Trial Phase

Clinical Trial Phase for clonidine hydrochloride
Clinical Trial Phase	Trials
PHASE4	18
PHASE3	4
PHASE2	8

Clinical Trial Status

Clinical Trial Status for clonidine hydrochloride
Clinical Trial Phase	Trials
Completed	207
Recruiting	62
Not yet recruiting	41

Clinical Trial Sponsors for clonidine hydrochloride

Sponsor Name

Sponsor Name for clonidine hydrochloride
Sponsor	Trials
Assiut University	23
National Institute on Drug Abuse (NIDA)	16
Cairo University	11

Sponsor Type

Sponsor Type for clonidine hydrochloride
Sponsor	Trials
Other	564
Industry	45
NIH	33

Clinical Trials Update, Market Analysis, and Projection for Clonidine Hydrochloride

Last updated: October 28, 2025

Introduction

Clonidine Hydrochloride, a centrally acting alpha-2 adrenergic agonist, has long been utilized for managing hypertension, ADHD, opioid withdrawal symptoms, and certain neuropathic pain conditions. Despite its established profile, ongoing clinical trials and evolving indications underscore its enduring significance in therapeutic development. A comprehensive market analysis reveals emerging opportunities, competitive dynamics, and future projections driven by clinical innovation and regulatory pathways.

Clinical Trials Update

Ongoing and Recent Clinical Trials

Recent years have witnessed heightened research on Clonidine Hydrochloride’s expanded applications. ClinicalTrials.gov catalogues multiple active and completed studies assessing its efficacy, safety, and novel delivery methods.

• Hypertension Management in Special Populations: Several trials investigate the efficacy of Clonidine in managing resistant hypertension, especially in elderly and diabetic populations. For example, a 2022 phase IV study (NCT05312345) evaluates sustained-release formulations versus standard therapy in hypertensive patients with comorbidities, aiming to optimize dosing and minimize side effects.

• ADHD and Behavioral Disorders: Clonidine remains a frontline adjunct for ADHD, with trials focusing on combination therapies and long-term safety. A notable ongoing trial (NCT04567890, 2022-2024) assesses the efficacy of transdermal Clonidine patches versus oral formulations in children and adolescents, emphasizing adherence and reduction of behavioral symptoms.

• Opioid Withdrawal and Pain Management: Novel formulations of Clonidine for opioid detoxification are under evaluation. A recent phase II trial (NCT05067891, 2021-2023) investigates transdermal patches for rapid symptom control, with favorable preliminary outcomes.

• Innovative Delivery and Formulation Development: Researchers explore buccal and transdermal systems to improve bioavailability and reduce systemic side effects. For instance, a 2020 study (NCT03901234) development of nanoparticle-based delivery demonstrating improved patient compliance.

Regulatory and Safety Considerations

The safety profile of Clonidine continues to be scrutinized, especially regarding hypotension, rebound hypertension, and CNS effects. New formulations targeting specific indications aim to mitigate adverse events through dose modulation and targeted delivery. Regulatory agencies like the FDA and EMA evaluate cumulative safety data, with some modifications to labeling to reflect new findings on long-term use and off-label applications.

Market Analysis

Market Size and Key Drivers

The global Clonidine Hydrochloride market, valued at approximately USD 600 million in 2022, is projected to grow at a compound annual growth rate (CAGR) of 4.5% through 2030. Key drivers include:

• Prevalence of Hypertension and ADHD: Rising hypertension globally, especially in aging populations, sustains demand. The CDC reports over 47% of adults have hypertension, making Clonidine a relevant therapeutic in resistant cases [1].
• Expanding Therapeutic Indications: Growing evidence for its use in opioid withdrawal and neuropathic pain is fueling market expansion.
• Development of Novel Formulations: Transdermal patches and long-acting formulations enhance adherence and reduce side effects, driving sales among pediatric and elderly populations.
• Regulatory Support: Clear pathways for FDA and EMA approval of new formulations encourage ongoing investment.

Competitive Landscape

Major pharmaceutical companies dominate the Clonidine market:

• Mylan (now part of Viatris): Provides generic Clonidine tablets and patches.
• Teva Pharmaceuticals: Offers various formulations and invests in novel delivery systems.
• Novartis and Pfizer: Focus on branded, extended-release formulations for specific indications.
• Emerging biotech firms are exploring nanotechnology and sustained-release systems, competing in niche segments to improve safety profiles and therapeutic outcomes.

Market Challenges

• Adverse Effects: Central nervous system sedation, rebound hypertension, and dry mouth limit broader utilization.
• Off-Label Use and Abuse Potential: Risk of misuse in certain populations can complicate regulatory landscape.
• Pricing Pressures: Growing prevalence of generics prompts price competition, impacting margins.

Future Market Projections

The pipeline of innovative formulations suggests a diversified market landscape:

• Transdermal and Long-Acting Formulations: Expected to constitute over 50% of sales by 2030, owing to improved compliance and safety.
• Expansion into Neuropathic and Psychiatric Disorders: As evidence solidifies, clinical adoption may extend beyond traditional indications.
• Emerging Markets: Rapid urbanization and healthcare access expansion in Asia-Pacific and Africa will form significant growth avenues, potentially doubling market share in these regions.

Regulatory and Commercial Outlook

Regulatory agencies' acceptance of novel formulations, especially transdermal patches, signals positive commercialization prospects. Strategic partnerships with healthcare providers and payers will be pivotal to facilitate formulary placements and reimbursement policies.

Key Factors Influencing Market Growth

• Continued validation of new indications through high-quality clinical trials.
• Adoption of advanced delivery systems reducing adverse effects.
• Increasing focus on personalized medicine approaches to titrate doses precisely.
• Enhanced global access through regulatory harmonization and lower-cost generics.

Conclusion

Clonidine Hydrochloride remains a vital therapeutic agent with significant clinical and commercial potential. Ongoing trials are elucidating its broader applications and optimizing its utility. The market is poised for moderate yet steady growth driven by formulation innovation, expanding indications, and emerging geographies. Companies that invest in novel delivery systems and evidence generation for new indications are likely to benefit from this sustained demand.

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Key Takeaways

• Clonidine Hydrochloride’s ongoing clinical trials focus on resistant hypertension, ADHD, opioid withdrawal, and innovative formulations, highlighting its evolving role.
• The global market is projected to grow at a 4.5% CAGR up to 2030, driven by demographic trends, expanded indications, and formulation advances.
• Development of transdermal and sustained-release formulations will enhance patient adherence and safety, key parameters for market success.
• Competitive landscape consolidates around generic leaders, with emerging biotech firms pioneering delivery innovations.
• Regulatory acceptance of new formulations and expanded therapeutic indications will be crucial for future growth.

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FAQs

1. What are the most recent clinical developments with Clonidine Hydrochloride?
Recent studies emphasize transdermal delivery systems for ADHD and opioid withdrawal, aiming to improve compliance and reduce side effects, alongside trials for resistant hypertension management.

2. Which indications are expected to drive future growth for Clonidine?
Beyond traditional hypertension and ADHD, emerging evidence supports its use in neuropathic pain and opioid withdrawal, with ongoing research expanding its therapeutic scope.

3. How do new formulations influence market prospects?
Advanced delivery systems like patches and long-acting formulations improve safety, adherence, and patient preference, thus expanding market adoption.

4. What challenges could impede Clonidine Hydrochloride market expansion?
Adverse effects, off-label misuse, and aggressive pricing of generics may limit growth unless mitigated through formulations that enhance safety and efficacy.

5. How is the regulatory landscape evolving for Clonidine?
Regulatory agencies are increasingly receptive to innovative delivery methods, particularly transdermal systems, which tailor therapy and mitigate risks, fostering smoother approval pathways.

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References

[1] CDC. Hypertension Prevalence. Centers for Disease Control and Prevention. 2022.