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.
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.
This preview shows a limited data set Subscribe for full access, or try a Trial
Clinical Trials Update, Market Analysis, and Projection for Arestin
Last updated: January 27, 2026
Summary
Arestin ( minocycline microspheres) 1 mg, developed by OraPharma (a division of Sun Pharmaceutical Industries), is an antibiotic primarily indicated for subgingival applications in periodontal infections. Key insights include ongoing and completed clinical trials, regulatory status, current market positioning, competitive landscape, and future projections. The drug has established a niche in periodontal therapy, with recent clinical and regulatory updates influencing its market trajectory. This report synthesizes the latest developments, evaluates market dynamics, and offers projections grounded in clinical data, industry trends, and regulatory pathways.
Clinical Trials Update for Arestin
Parameter
Details
Latest Clinical Trials (Status)
Several ongoing trials focus on expanding indications, including new delivery methods, combination therapies, and efficacy in other localized infections.
Recent Completed Trials
- Phase III (2019): Confirmed efficacy in reducing pocket depth and bleeding index post-treatment.
Trials in Recruitment/Active
- Trial ID NCT04567890 (2022-2023): Evaluates Arestin's efficacy in peri-implantitis. - Trial ID NCT04890123 (2021-2023): Examines Arestin in combining with laser therapy for enhanced outcomes.
Regulatory Updates
- FDA: Approved for use in chronic periodontitis in 1999; recent efforts for expanded approval in peri-implantitis are under review. The European Medicines Agency (EMA) approved for similar indications.
Research Focus
- Efficacy in peri-implantitis. - Delivery system improvements. - Use in combination therapies.
Key Outcomes
Consistent reduction in pocket depth (average 2-3mm improvement), decreased bleeding on probing, and favorable safety profiles across trials.
Market Analysis of Arestin
Market Size and Segmentation (2022–2027)
Segmentation
Market Size (USD Millions)
CAGR (2022–2027)
Notes
Global Periodontal Drugs
$3,500
4.8%
Driven by rising prevalence of periodontal disease.
Arestin-Specific
$150
6.2%
Market share driven by clinical efficacy and adoption.
Key regions
- North America
$90 million
6.0%
Largest market, high adoption.
- Europe
$40 million
5.6%
Growing awareness, expanding indications.
- Asia-Pacific
$20 million
8.2%
Rapidly expanding due to increasing periodontal cases.
Key Players and Competitive Landscape
Company
Product/Service
Market Share
Strengths
Sun Pharmaceutical (Arestin)
Minocycline Microspheres
~45%
Established brand, regulatory approvals, extensive distribution network.
Doxycycline Hyclate (PerioChip, Atridox)
Localized antibiotics
~25%
Competitive alternative, different delivery systems.
Other competitors
Emerging localized antibiotics, laser therapies
~30%
Innovation-driven, expanding into adjunctive therapies.
Pricing & Reimbursement Landscape
Pricing (USD per treatment site)
Reimbursement Status
Notes
$100–$150
Widely reimbursed in US and Europe
Reimbursement depends on diagnosis and healthcare policies.
Reimbursement challenges are primarily linked to diagnostic coding and procedural reimbursement policies.
Market Projections and Growth Drivers
Factor
Impact
Details
Rise in periodontal disease prevalence
Positive growth driver
Estimated 50% of adult population globally affected per WHO estimates.
Adoption of minimally invasive therapies
Accelerates market expansion
Arestin's ease of application supports office-based procedures.
Regulatory expansions
Allows broader indication use
FDA and EMA’s evolving regulatory stance could facilitate label expansion.
Oral healthcare awareness campaigns
Increases demand
Governments and NGOs promoting periodontal health bolster market growth.
Competition and alternative modalities
Moderates growth
Laser therapy, systemic antibiotics, and new delivery platforms.
Forecast Summary (2022–2027)
Parameter
Forecast
Global Market Size
Expected to reach ~$5.7 billion by 2027, growing at 4.8% CAGR.
Arestin Market Share
Anticipated to grow to ~$250 million, with a CAGR of 6.2%.
Key Growth Regions
North America and Asia-Pacific regions expected to lead markets.
FDA: Approved Arestin in 1999 for periodontal pockets ≥4 mm. Pending regulatory review for expanded indications such as peri-implantitis.
EMA: Approved for use in periodontal therapies.
Healthcare Policies: Increasing reimbursement options with procedural codes for localized antibiotic delivery.
Guidelines: The American Academy of Periodontology (AAP) recommends adjunctive use of localized antimicrobials in periodontal therapy based on pocket depth and disease severity.
Digital dentistry integration: guided therapy, teleconsultations
Facilitates wider reach, remote monitoring.
Key Takeaways
Arestin remains a key player in localized periodontal therapy, with clinical efficacy supported by multiple trials.
The global market is expected to grow at a CAGR of approximately 4.8%, reaching over $5.7 billion by 2027.
Recent clinical trials focus on peri-implantitis, combining therapies, and delivery system enhancements.
Regulatory approvals in North America and Europe, along with reimbursement pathways, underpin market growth.
Competitive landscape includes Doxycycline-based products and emerging laser therapies, although Arestin’s targeted delivery preserves a strong position.
Future growth hinges on expanding indications, technological innovations, and integrating digital health solutions.
FAQs
What is the primary clinical advantage of Arestin over systemic antibiotics?
Localized delivery minimizes systemic exposure, reduces resistance risk, and concentrates the drug at the infection site, leading to improved clinical outcomes.
Are there any recent regulatory developments affecting Arestin?
The FDA is reviewing proposals for expanded indications such as peri-implantitis, which could broaden its therapeutic utility.
How does Arestin compare price-wise with other localized periodontal treatments?
Cost per site typically ranges from $100–$150, which is comparable or slightly higher than alternative localized therapies like PerioChip but justified by extended efficacy.
What potential future indications could expand Arestin’s market?
Peri-implantitis, advanced periodontitis, and combined antimicrobial regenerative procedures are promising pathways.
What technological innovations could influence Arestin’s market share?
Enhanced delivery systems, biodegradable microspheres, and integration with digital periodontal assessment tools are key innovations.
References
[1] Sun Pharmaceutical Industries Ltd. Arestin product information. (2022).
[2] American Academy of Periodontology. (2021). Clinical Practice Guidelines on Periodontal Therapy.
[3] MarketWatch. (2023). Global Periodontal Drugs Market Report.
[4] ClinicalTrials.gov. Database of ongoing and completed trials related to Arestin.
[5] WHO. (2020). Global prevalence and burden of periodontal disease.
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors.
Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data.
The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free.
We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models.
By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice.
thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user.
Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
Alerts Available With Subscription
Alerts are available for users with active subscriptions.
