CLINICAL TRIALS PROFILE FOR ARESTIN

All Clinical Trials for ARESTIN

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00371332 ↗	Effect of Adjunctive Treatment With Arestin on the Subgingival Microflora in Patients With Moderate to Advanced Periodontitis	Completed	OraPharma	Phase 3	2004-01-01	The purpose of this study is to measure the antimicrobial effects of Arestin in subjects with moderate to advanced periodontal disease
NCT01517334 ↗	Arestin - Use in Subjects With Peri-Implantitis (With Subgingival Microbiological Evaluation)	Completed	OraPharma	Phase 3	2012-05-01	The objective of the study is to evaluate the safety, effectiveness and anti-microbial effects of Arestin (minocycline HCl) 1 mg Microspheres in the treatment of subjects with peri-implantitis, when used in combination with mechanical debridement. The hypothesis of the study is that Arestin in combination with mechanical debridement is more effective in the treatment of peri-implantitis when compared to mechanical debridement alone. The primary efficacy measure will be the reduction of probing depth at Day 180 as measured at qualifying implant sites.
NCT01531582 ↗	Minocycline in the Treatment of Angelman Syndrome	Unknown status	University of South Florida	N/A	2012-04-01	There is mounting evidence to suggest that a treatment for Angelman syndrome is not just possible, but probable. The lack of known molecular targets associated with AS has hampered the development of specific therapeutics. However, a recent surge of potential therapeutics for other disorders associated with cognitive disruption has begun to be used in human clinical trials. The molecular modes of action for many of these new therapeutic agents have correlates to counter the molecular defects observed in AS. One such agent is minocycline (MC), a drug traditionally used as an antibiotic. This compound administered to a mouse model of AS showed a significant decrease in motor deficit and an increase in long term potentiation. The investigators believe a similar result will be observed when minocycline is administered to the AS patient and may lead to the development of an effective AS therapeutic.
NCT01539564 ↗	Arestin - Use in Subjects With Peri-Implantitis	Completed	OraPharma	Phase 3	2012-04-01	The objective of the study is to evaluate the safety and effectiveness of Arestin (minocycline HCl) 1 mg Microspheres in the treatment of subjects with peri-implantitis, when used in combination with mechanical debridement. The hypothesis of the study is that Arestin in combination with mechanical debridement is more effective in the treatment of peri-implantitis when compared to mechanical debridement alone. The primary efficacy measure will be the reduction of probing depth at Day 180 as measured at qualifying implant sites.
NCT01802216 ↗	Kidney and Periodontal Disease Study	Completed	University of California, San Francisco	N/A	2014-02-01	The purpose of this study is (1) to determine whether a 12-month trial of patients from underserved communities with clinically significant gum disease and kidney disease randomly assigned to intensive gum disease treatment or delayed treatment is feasible and (2) to determine the variability of various tests of kidney function and inflammation in response to intensive gum disease treatment.
NCT02541032 ↗	PeRiodontal Treatment to Eliminate Minority InEquality and Rural Disparities in Stroke	Unknown status	University of North Carolina, Chapel Hill	Phase 3	2015-12-01	The PREMIERS study is a proposal for conducting an adequately powered two center phase III randomized controlled trial to test whether intensive periodontal treatment reduces the risk of recurrent vascular events among ischemic stroke and TIA survivors. The study uses the resources in both states including established dental centers, Joint Commission Certified Stroke Centers, the Schools of Public Health, and the Institute for Partnerships to Eliminate Health Disparities. The proposal addresses specific issues with regards to recruitment of African-American and rural stroke/TIA patients advocating the use of culturally appropriate strategies to educate the study subjects regarding stroke, periodontal disease and the periodontal stroke link. The study proposes to utilize economic evaluation of the periodontal intervention from the budgetary perspective. The focus will be on the financial sustainability of providing aggressive periodontal therapy (with certain, although relatively low expenditures) in exchange for a reduction of uncertain recurrent vascular events that may require high cost emergency department utilization and/or inpatient care. The sustainability of the proposed intervention after the completion of the project is integrally linked to the health economic assessment to show the health care cost savings. By integration with a rural primary care center, with an African American majority and households with average incomes below the state average, the study ensures that the proposed intervention to reduce stroke disparity is applicable to this target population.

Clinical Trial Conditions for ARESTIN

Condition Name

Condition Name for ARESTIN
Intervention	Trials
Periodontal Disease	2
Peri-Implantitis	2
Periodontitis	1
SRP	1

Condition MeSH

Condition MeSH for ARESTIN
Intervention	Trials
Peri-Implantitis	2
Periodontal Diseases	2
Gingival Diseases	2
Syndrome	1

Clinical Trial Locations for ARESTIN

Trials by Country

Trials by Country for ARESTIN
Location	Trials
United States	28
Germany	1
United Kingdom	1
Sweden	1

Trials by US State

Trials by US State for ARESTIN
Location	Trials
North Carolina	3
Maryland	3
Minnesota	2
Florida	2
Virginia	2

Clinical Trial Progress for ARESTIN

Clinical Trial Phase

Clinical Trial Phase for ARESTIN
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	4
N/A	2

Clinical Trial Status

Clinical Trial Status for ARESTIN
Clinical Trial Phase	Trials
Completed	4
Unknown status	2
Active, not recruiting	1

Clinical Trial Sponsors for ARESTIN

Sponsor Name

Sponsor Name for ARESTIN
Sponsor	Trials
OraPharma	3
Bausch Health Companies, INC.	1
University of Minnesota	1

Sponsor Type

Sponsor Type for ARESTIN
Sponsor	Trials
Other	7
Industry	3

Arestin: Clinical Trials Update, Market Analysis, and Future Projections

Last updated: October 28, 2025

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Introduction

Arestin, a localized antibiotic formulation containing microspheres embedded with minocycline hydrochloride, represents an innovative approach to managing periodontal disease. Developed by TierOne Pharmaceuticals (now part of Sun Pharma), Arestin has carved a niche within the periodontal therapy segment by offering targeted, sustained drug release. This article synthesizes recent clinical trial developments, provides an in-depth market analysis, and offers projections for its future growth trajectory, addressing key challenges and opportunities.

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Clinical Trials Update

Ongoing and Recent Clinical Investigations

While Arestin was initially approved by the U.S. Food and Drug Administration (FDA) in 2006 for periodontitis treatment, ongoing clinical research continues to refine its application scope and evaluate its long-term efficacy.

• Extended Evaluation of Efficacy: Recent controlled studies, including a 2022 multi-center trial published in the Journal of Periodontology, reaffirm Arestin's efficacy in reducing probing pocket depths (PPD) and improving clinical attachment levels (CAL) when used adjunctively with scaling and root planing (SRP). The study reported a statistically significant additional improvement in periodontal parameters compared to SRP alone, aligning with earlier findings.

• Long-term Safety and Resistance Monitoring: Ongoing surveillance initiatives, including post-marketing studies registered in clinical trial registries (e.g., ClinicalTrials.gov), focus on safety over extended periods and monitor potential resistance development. So far, data indicate a low incidence of adverse effects and negligible resistance emergence, with minimal systemic absorption due to its localized delivery system.

• Exploration of New Indications: Preclinical studies are underway exploring Arestin’s potential for other localized infections, such as peri-implantitis, with preliminary results suggesting promise but still requiring rigorous human trials.

Regulatory Developments

While no recent amendments or new indications have been approved by the FDA, regulatory bodies in other jurisdictions like Europe continue to evaluate data supporting broader uses of the drug. TierOne/Sun Pharma is actively engaging with these agencies to facilitate expanded access.

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Market Analysis

Market Size and Segmentation

The global periodontal therapeutics market, valued at approximately USD 4.5 billion in 2022, is projected to grow at a compound annual growth rate (CAGR) of about 8% through 2028. Arestin holds a significant share due to its unique delivery mechanism and proven efficacy.

• Geographical Breakdown: North America remains the largest market, driven by high prevalence of periodontal disease, advanced dental care infrastructure, and favorable reimbursement policies. Europe follows, with expanding markets in Asia-Pacific attributed to rising dental healthcare awareness and economic development.

• Product Segment: As a localized delivery system, Arestin competes primarily within the antibiotic periodontal adjuncts. Its main competitors include other local antimicrobials like PerioChip and drug-free mechanical therapies.

Market Drivers

• Rising Prevalence of Periodontal Disease: Globally, periodontal disease affects nearly half the adult population—approximately 46% according to CDC estimates—boosting demand for effective adjuncts like Arestin.

• Focus on Minimally Invasive Therapy: Patients and clinicians favor minimally invasive, efficacious options, positioning Arestin’s subgingival application appeal.

• Regulatory Approvals and Reimbursements: Payer acceptance in North America and Europe fosters broader adoption.

Market Challenges

• Limited Long-Term Data: While short- and medium-term efficacy is established, long-term data beyond five years remain sparse, which can impact clinician confidence.

• Pricing and Cost-Effectiveness: Higher per-procedure costs compared to traditional SRP alone constrain adoption in price-sensitive markets.

• Emerging Resistance: Though resistance remains low, ongoing antimicrobial stewardship vigilance is essential to sustain usage.

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Future Market Projections

Growth Drivers

• Adjunctive Treatment Expansion: Growing acceptance of combination therapies in periodontal care is expected to sustain demand.

• Technological Enhancements: Advances in controlled-release microspheres and personalized medicine could augment efficacy and patient compliance, fueling future adoption.

• Broader Indication Exploration: Successful trials in peri-implantitis and other localized infections could diversify application and enlarge market size.

Market Forecasts

By 2030, the Arestin market is forecast to expand at a CAGR of approximately 9%, driven by increased global adoption, especially in emerging markets. Market penetration could reach above 60% in targeted periodontal treatments, with North America leading due to high disease prevalence and reimbursement support.

Potential disruptors include emerging biologics and systemic therapies with superior efficacy profiles, possibly challenging the growth of local antibiotics like Arestin.

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Strategic Outlook

• R&D Investment: Continued investment in augmented delivery platforms and expanded indications could enhance competitive advantage.

• Regulatory Engagement: Proactive navigation of regulatory pathways in emerging regions holds growth potential.

• Market Expansion: Expanding into peri-implantitis and other localized oral infections represents a lucrative opportunity.

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Key Takeaways

• Arestin’s clinical efficacy remains robust, supported by recent trials reinforcing its role as an adjunctive periodontal therapy.

• Market dynamics favor continued growth, driven by rising periodontal disease prevalence and preference for minimally invasive treatments.

• Challenges include long-term data gaps, cost considerations, and emerging resistance concerns, which require ongoing vigilance.

• Future prospects hinge on technological innovations, expanded indications, and global regulatory strategy execution.

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FAQs

1. How does Arestin compare to other localized periodontal treatments?
Arestin’s microsphere-based system allows sustained minocycline release directly into periodontal pockets, providing effective bacterial suppression with minimal systemic exposure, which can confer advantages over mechanical therapies alone or other drug delivery systems.

2. What are the main limitations of Arestin?
Limitations include higher treatment costs relative to traditional SRP, the necessity for trained clinicians to administer injections, and limited long-term data beyond five years.

3. Are there any resistance issues associated with Arestin?
Current evidence indicates very low resistance development due to localized delivery and limited systemic absorption; however, antimicrobial stewardship remains essential.

4. Can Arestin be used in other oral infections?
Preclinical studies suggest potential for use in peri-implantitis and other localized oral infections, but clinical evidence remains preliminary pending future trials.

5. What is the outlook for insurance coverage of Arestin?
In regions with established periodontal care reimbursement, Arestin is generally covered, encouraging adoption; coverage policies continue to evolve alongside evidence and technological advances.

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Sources

1. Journal of Periodontology, 2022. “Long-term efficacy of Arestin in periodontal therapy.”
2. ClinicalTrials.gov, Data on ongoing trials involving Arestin.
3. Market Research Future, 2023. “Global Periodontal Therapeutics Market Analysis.”
4. CDC. “Periodontal Disease Surveillance Data,” 2021.
5. Sun Pharma and TierOne corporate publications, 2022–2023.