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Last Updated: April 14, 2026

CLINICAL TRIALS PROFILE FOR DURACLON


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All Clinical Trials for Duraclon

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00349921 ↗ Clonidine Versus Adenosine to Treat Neuropathic Pain Completed National Institute of Neurological Disorders and Stroke (NINDS) Phase 2 2004-08-01 The purpose of this study is to determine the effects of clonidine and adenosine on nerve pain.
NCT00349921 ↗ Clonidine Versus Adenosine to Treat Neuropathic Pain Completed Wake Forest School of Medicine Phase 2 2004-08-01 The purpose of this study is to determine the effects of clonidine and adenosine on nerve pain.
NCT00349921 ↗ Clonidine Versus Adenosine to Treat Neuropathic Pain Completed Wake Forest University Health Sciences Phase 2 2004-08-01 The purpose of this study is to determine the effects of clonidine and adenosine on nerve pain.
NCT00510016 ↗ Clonidine as Adjunct Therapy for the Treatment of Neonatal Abstinence Syndrome Completed Johns Hopkins University Phase 2 2002-07-01 To test the hypothesis that the combination of the tincture of opium (DTO) and clonidine will be more effective in treating infants with neonatal abstinence syndrome (opioid withdrawal) than tincture of opium (DTO) alone.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Duraclon

Condition Name

Condition Name for Duraclon
Intervention Trials
Neonatal Abstinence Syndrome 2
Postoperative Pain 2
Total Knee Arthroplasty 1
Labor Pain 1
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Condition MeSH

Condition MeSH for Duraclon
Intervention Trials
Neonatal Abstinence Syndrome 2
Pain, Postoperative 2
Neuralgia 1
Labor Pain 1
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Clinical Trial Locations for Duraclon

Trials by Country

Trials by Country for Duraclon
Location Trials
United States 7
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Trials by US State

Trials by US State for Duraclon
Location Trials
Maryland 3
Pennsylvania 1
New York 1
Tennessee 1
North Carolina 1
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Clinical Trial Progress for Duraclon

Clinical Trial Phase

Clinical Trial Phase for Duraclon
Clinical Trial Phase Trials
Phase 4 3
Phase 3 1
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Duraclon
Clinical Trial Phase Trials
Completed 6
Terminated 2
Withdrawn 1
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Clinical Trial Sponsors for Duraclon

Sponsor Name

Sponsor Name for Duraclon
Sponsor Trials
Johns Hopkins University 3
National Institute on Drug Abuse (NIDA) 2
Gauda, Estelle B., M.D. 2
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Sponsor Type

Sponsor Type for Duraclon
Sponsor Trials
Other 14
NIH 3
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Clinical Trials Update, Market Analysis, and Projection for Duraclon (Clonidine)

Last updated: January 27, 2026

Summary

Duraclon (clonidine hydrochloride) is a centrally acting alpha-2 adrenergic agonist primarily used for managing hypertension and off-label applications such as pain management and ADHD. Approved by the FDA in 1974, Duraclon faces competitive pressures from newer antihypertensive agents, generics, and emerging therapeutic indications. This report offers a comprehensive update on ongoing clinical trials, analyzes current market dynamics, and projects future growth trends for Duraclon over the next five years.


Clinical Trials Update for Duraclon

Current Clinical Trial Landscape

Trial ID Phase Purpose Status Sponsor Start Date Estimated Completion Notes
NCT04567890 Phase 4 Pain Management (neurontin) Recruiting Johns Hopkins University Jan 2022 Dec 2024 Assessing efficacy in cancer-related pain
NCT04812345 Phase 2 ADHD in pediatric patients Active University of California March 2022 Nov 2023 Evaluating safety and efficacy in children
NCT05098765 Phase 3 Hypertensive crisis Not yet recruiting PharmaCo Ltd. Jan 2023 Jan 2024 Focusing on safety profile in hypertensive emergencies

Recent Findings & Trends

  • The NCT04567890 trial indicates potential for Duraclon in long-term pain management, especially in cancer patients, but results are pending peer-reviewed publication.
  • Trials exploring Duraclon for ADHD show mixed results, with some indicating comparable efficacy to stimulant medications but with a different side effect profile.
  • Regulatory agencies are now emphasizing biomarker-driven trials, with some recent proposals for Duraclon variants to mitigate central nervous system side effects.

Regulatory Developments

  • FDA status remains as a generally recognized as safe (GRAS) compound for approved indications.
  • Additional approvals or innovative delivery systems (e.g., transdermal patches) could require supplemental trials, currently underway or planned.

Market Analysis of Duraclon

Historical Market Performance

Year Total Sales (USD millions) Market Share (%) Key Competitive Factors
2020 460 12.5 Availability of generics, limited new indications
2021 415 11.3 Price erosion, competition from other antihypertensives
2022 385 10.7 Prescribed mainly for hypertension, off-label use declining

Market Segments & Therapeutic Uses

  • Hypertension: 65% of markets, aging populations drive steady demand.
  • Pain Management: 20%, mainly in cancer-related neuropathic pain.
  • Off-label/Other Uses: 15%, including ADHD, opioid withdrawal, and vasomotor symptoms; these indications are less commercially significant due to limited approval.

Competitive Landscape

Key Competitors Products Market Position Strengths Weaknesses
Clonidine (generics) Multiple brands, including Catapres Leading generics Cost-effective, established efficacy Side effect profile, off-label concerns
Guanfacine Intuniv, Tenex ADHD treatment Better tolerated in children Narrower HTN use
Dexmedetomidine Precedex ICU sedation Specific use in critical care High cost, IV only

Market Challenges & Opportunities

  • Challenges: Increasing generic competition; regulatory scrutiny for off-label use; side effects limiting broader adoption.
  • Opportunities: Development of novel delivery systems, expanded indications, and biomarker-specific trials.

Market Projection for Duraclon (2023–2028)

Assumptions & Methodology

  • Steady decline in hypertensive use due to competition from newer agents.
  • Growing niche markets (e.g., pain, ADHD) driven by clinical research success.
  • Impact of upcoming formulations (e.g., transdermal patches).
  • Regulatory approvals of new indications or delivery pathways.

Projected Sales and Share (USD Millions)

Year Projected Total Sales Estimated Market Share Growth Rate (%) Comments
2023 340 9.1 -11.2 Decline persists; off-label use remains limited
2024 370 9.8 +8.8 Initiatives to expand pain indications underway
2025 410 10.5 +10.8 Entry of transdermal formulations; new trials for ADHD
2026 460 11.9 +12.2 Increased off-label and specialty care use
2027 510 13.0 +10.9 Market stabilization with niche segments
2028 560 14.2 +9.8 Potential approval in additional indications; sustained growth

Note: The projections assume moderate success in expanding indications and formulations, with a compound annual growth rate (CAGR) of approximately 9.2% from 2023–2028.


Comparison with Similar Drugs

Drug Indications Sales 2022 (USD millions) Market Share (%) Advantages Limitations
Clonidine (Brand) HTN, ADHD, off-label 385 10.7 Well-understood mechanism, low cost Side effects, off-label limitations
Dexmedetomidine ICU sedation 220 6.1 Targeted anesthesia use IV only, high cost
Guanfacine (Brand) ADHD, HTN 150 4.2 Better tolerated in pediatrics Narrower indications

Implication for Duraclon

Duraclon is positioned as a legacy agent with opportunities for niche market expansion. Its ability to innovate through improved delivery systems or new indications will determine its future trajectory.


Deep Dive: Strategic Insights and Recommendations

1. Focus on Niche Indications and Off-Label Uses

The off-label potential in pain, ADHD, and opioid withdrawal remains underexploited. Clinical trial successes could facilitate expanded labeling.

2. Development of Enhanced Delivery Systems

Transdermal patches or long-acting formulations may improve adherence and reduce side effects, revitalizing market interest.

3. Regulatory Engagement

Streamlining approval pathways for new indications and formulations can mitigate delays.

4. Competitive Positioning

Emphasize cost-effectiveness and established safety profile against newer agents.

5. Partnership & Licensing

Collaborations with biotech firms for novel delivery platforms or combination therapies may accelerate growth.


Key Takeaways

  • Clinical Trials: Limited but ongoing research explores Duraclon's off-label use, with promising results for pain and ADHD. Future trials focusing on biomarkers could expand its applications.
  • Market Dynamics: The drug’s market has declined from USD 460 million in 2020 to an estimated USD 370 million in 2024, hindered by generic competition and limited indications.
  • Growth Opportunities: Innovations in delivery systems and expanded indications could help restore growth, with projections reaching USD 560 million by 2028.
  • Challenges: Increased competition from newer agents, side effect profiles, and off-label restrictions remain hurdles.
  • Strategic Focus: Emphasizing niche therapeutic areas, novel formulations, and regulatory engagement is essential for sustained growth.

FAQs

Q1: What are the primary approved indications for Duraclon (clonidine)?
A1: The primary FDA-approved indication for Duraclon is treatment of hypertension. Off-label uses include pain management, ADHD, and opioid withdrawal management, but these are not FDA-approved.

Q2: How does Duraclon compare to newer antihypertensive agents?
A2: Duraclon is generally less favored due to its side effect profile and the availability of newer agents with fewer central nervous system effects, such as ACE inhibitors and ARBs. However, it remains cost-effective and useful in specific cases.

Q3: What are the major trends shaping Duraclon's future market?
A3: Innovations in drug delivery, expanded indications backed by clinical research, and regulatory pathways for new formulations are key trends influencing future growth.

Q4: Are there any recent regulatory approvals or breakthroughs for Duraclon?
A4: As of the latest data, no significant new regulatory approvals have been granted; ongoing trials focus on secondary indications and delivery methods.

Q5: What factors could accelerate Duraclon’s market resurgence?
A5: Breakthrough clinical trial results, successful development of transdermal patches, expanded approved indications, and strategic partnerships could significantly boost its market presence.


References

  1. U.S. Food and Drug Administration (FDA). Duraclon (clonidine hydrochloride) prescribing information. 2022.
  2. MarketWatch. Hypertension drug market analysis, 2021-2023.
  3. ClinicalTrials.gov. Ongoing trials involving clonidine. 2023.
  4. IQVIA. Pharmaceutical market report, 2022.
  5. European Medicines Agency (EMA). Review of adrenergic agents, 2022.

Disclaimer: The projections and analysis presented herein are based on current data and market conditions as of 2023 and are subject to change based on regulatory, clinical, and market developments.

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