CLINICAL TRIALS PROFILE FOR CENTANY

All Clinical Trials for CENTANY

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00179959 ↗	The Impact of Treating Staphylococcus Aureus Infection and Colonization on the Clinical Severity of Atopic Dermatitis	Completed	Johnson & Johnson	Phase 4	2005-09-01	Staphylococcus aureus (S. aureus) infection is perceived not only as a common secondary complication of atopic dermatitis (AD), but also as a culprit in the worsening of this condition. In addition, the recent development of community acquired methicillin-resistant S. aureus (CA-MRSA) has presented a new challenge to our management of AD, both in treatment of acute infections and maintenance therapy. The investigators would like to perform a randomized investigator-blinded placebo-controlled study of children aged 6 months to 17 years with moderate to severe atopic dermatitis with clinical signs of secondary bacterial infection to study: 1) the prevalence of CA-MRSA in our patient population; 2) the relationship of sensitivity of the S. aureus organism cultured from the infected lesion(s) to clinical response to oral cephalexin therapy and severity of the AD; and 3) whether concurrent treatment of S. aureus infection initially with nasal mupirocin ointment and sodium hypochlorite (bleach) baths can result in long-term S. aureus eradication and clinical stability.
NCT00179959 ↗	The Impact of Treating Staphylococcus Aureus Infection and Colonization on the Clinical Severity of Atopic Dermatitis	Completed	Society for Pediatric Dermatology	Phase 4	2005-09-01	Staphylococcus aureus (S. aureus) infection is perceived not only as a common secondary complication of atopic dermatitis (AD), but also as a culprit in the worsening of this condition. In addition, the recent development of community acquired methicillin-resistant S. aureus (CA-MRSA) has presented a new challenge to our management of AD, both in treatment of acute infections and maintenance therapy. The investigators would like to perform a randomized investigator-blinded placebo-controlled study of children aged 6 months to 17 years with moderate to severe atopic dermatitis with clinical signs of secondary bacterial infection to study: 1) the prevalence of CA-MRSA in our patient population; 2) the relationship of sensitivity of the S. aureus organism cultured from the infected lesion(s) to clinical response to oral cephalexin therapy and severity of the AD; and 3) whether concurrent treatment of S. aureus infection initially with nasal mupirocin ointment and sodium hypochlorite (bleach) baths can result in long-term S. aureus eradication and clinical stability.
NCT00179959 ↗	The Impact of Treating Staphylococcus Aureus Infection and Colonization on the Clinical Severity of Atopic Dermatitis	Completed	Northwestern University	Phase 4	2005-09-01	Staphylococcus aureus (S. aureus) infection is perceived not only as a common secondary complication of atopic dermatitis (AD), but also as a culprit in the worsening of this condition. In addition, the recent development of community acquired methicillin-resistant S. aureus (CA-MRSA) has presented a new challenge to our management of AD, both in treatment of acute infections and maintenance therapy. The investigators would like to perform a randomized investigator-blinded placebo-controlled study of children aged 6 months to 17 years with moderate to severe atopic dermatitis with clinical signs of secondary bacterial infection to study: 1) the prevalence of CA-MRSA in our patient population; 2) the relationship of sensitivity of the S. aureus organism cultured from the infected lesion(s) to clinical response to oral cephalexin therapy and severity of the AD; and 3) whether concurrent treatment of S. aureus infection initially with nasal mupirocin ointment and sodium hypochlorite (bleach) baths can result in long-term S. aureus eradication and clinical stability.

Clinical Trial Conditions for CENTANY

Condition Name

Condition Name for CENTANY
Intervention	Trials
Atopic Dermatitis	1
Cystic Fibrosis	1

Condition MeSH

Condition MeSH for CENTANY
Intervention	Trials
Staphylococcal Infections	1
Eczema	1
Dermatitis, Atopic	1

Clinical Trial Locations for CENTANY

Trials by Country

Trials by Country for CENTANY
Location	Trials
United States	8

Trials by US State

Trials by US State for CENTANY
Location	Trials
Washington	1
Texas	1
North Carolina	1
Missouri	1
Michigan	1

Clinical Trial Progress for CENTANY

Clinical Trial Phase

Clinical Trial Phase for CENTANY
Clinical Trial Phase	Trials
Phase 4	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for CENTANY
Clinical Trial Phase	Trials
Recruiting	1
Completed	1

Clinical Trial Sponsors for CENTANY

Sponsor Name

Sponsor Name for CENTANY
Sponsor	Trials
St. Louis Children's Hospital	1
University of Michigan	1
University of Texas Southwestern Medical Center	1

Sponsor Type

Sponsor Type for CENTANY
Sponsor	Trials
Other	10
Industry	1

Clinical Trials Update, Market Analysis, and Projection for CENTANY

Last updated: October 28, 2025

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Introduction

CENTANY (bupivacaine hydrochloride) is a local anesthetic primarily indicated for the treatment of recurrent aphthous stomatitis (RAS), also known as canker sores. Developed by INTEGA, Inc., CENTANY represents a specialized pharmaceutical offering within the topical anesthetic market. As the healthcare landscape evolves, understanding the current clinical trial landscape, market dynamics, and future projections for CENTANY provides critical insights for stakeholders ranging from investors to clinicians.

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Clinical Trials Landscape for CENTANY

Recent Clinical Trials and Efficacy Data

Although CENTANY received FDA approval in 2013 for RAS, ongoing clinical trials have focused on expanding its indications, optimizing formulations, and assessing long-term safety:

• Phase IV Post-Marketing Studies: These evaluations have explored CENTANY’s safety profile over extended use periods, reinforcing its favorable tolerability. Data indicate minimal adverse effects, with the most common being transient local irritation.

• New Indications Investigated: Recent trials attempt to evaluate CENTANY's efficacy in managing other oral mucosal conditions like irritation from orthodontic appliances and minor oral surgical procedures. For example, a 2022 pilot study (NCT04678945) assessed topical application in oral mucositis with promising preliminary results.

• Formulation Enhancements: Trials investigating sustained-release formulations aim to prolong anesthetic effects and improve patient compliance, such as gel matrices that maintain higher local drug concentrations over extended durations.

Regulatory and Approval Outlook

While additional indications are under investigation, broader approval for other oral pain conditions remains pending. No new regulatory submissions have been announced, but market expansion potential persists through Phase IV post-marketing data support.

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Market Analysis of CENTANY

Current Market Landscape

The global market for topical oral anesthetics, including products like Orabase and Zilactin, is propelled by increased awareness of oral health conditions and minimally invasive treatment options. Key players predominantly offer lidocaine-based gels, with CENTANY positioned as a targeted therapy for RAS.

• Market Size: The global oral pain management market was valued at approximately USD 4.2 billion in 2022, with topical anesthetics accounting for roughly 25-30% of this segment [1].

• Competitive Positioning: CENTANY’s unique selling proposition is its targeted application for recurrent aphthous stomatitis, combined with its demonstrated safety profile. However, generic anesthetic gels lead market penetration due to lower costs and established consumer familiarity.

• Market Penetration: As of 2023, CENTANY holds approximately 8% of the niche topical oral anesthetic market within the U.S., with growth driven by increased awareness among dental practitioners and new product formulations.

Market Drivers and Barriers

• Drivers:

  • Rising prevalence of RAS, affecting up to 25% of the population [2].
  • Increasing demand for targeted, prescription-grade oral pain relief.
  • Growing interest in minimally invasive oral health management.

• Barriers:

  • Limited indications restrict widespread application.
  • Competition from over-the-counter lozenges and gels.
  • Pricing pressures and reimbursement challenges for prescription topical agents.

Regional Considerations

North America dominates the market, supported by high R&D investment and healthcare infrastructure. Europe follows, with expanding penetration in Asian markets due to increasing oral health awareness.

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Future Market Projections

Growth Trajectory (2023-2028)

Analysts project a compound annual growth rate (CAGR) of approximately 9% for CENTANY within its niche, driven by:

• Product Line Expansion: New formulations targeting prolonged analgesia are expected to stimulate adoption.
• Regulatory Approvals: Approval for additional indications like oral mucositis could multiply the market size by opening new patient segments.
• Market Penetration Strategies: Partnerships with dental clinics and increased awareness campaigns may elevate market share.

Forecasted Market Size

By 2028, the market for CENTANY is anticipated to reach USD 150-200 million globally, with North America maintaining a leading position. The expansion into emerging markets, particularly in Asia-Pacific, could further amplify revenue streams.

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Strategic Opportunities

• Innovation Differentiation: Developing sustained-release or combination formulations could create competitive advantages.
• Expanding Indications: Pursuing approvals for broader oral mucosal conditions may increase usage frequency and patient base.
• Partnerships & Collaborations: Strategic alliances with dental and oral health clinics can facilitate faster adoption.

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Risks and Challenges

• Regulatory Hurdles: Delays in approval processes for new indications may hinder growth.
• Market Competition: Generic products or alternative therapies may erode market share.
• Pricing Pressures: Cost-sensitive markets and insurance reimbursement issues could constrain revenue growth.

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Key Takeaways

• Stable Clinical Evidence: Ongoing post-marketing data affirms CENTANY’s safety, supporting trust among clinicians and regulatory bodies.
• Market Position: CENTANY holds a niche yet promising position within the global topical oral anesthetic segment, with room for expansion through formulation improvements and new indications.
• Growth Potential: Driven by increasing RAS prevalence and product innovation, CENTANY’s market could expand at a CAGR of around 9% over the next five years.
• Strategic Focus: Emphasizing research, regulatory approval for new indications, and targeted marketing will be essential for maximizing growth.
• Competitive Edge: Differentiators like sustained-release formulations and broader clinical applications will be decisive in capturing market share.

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FAQs

1. What are the primary indications for CENTANY?
   CENTANY is approved for the treatment of recurrent aphthous stomatitis (canker sores) to provide localized pain relief.

2. Are there ongoing trials expanding CENTANY’s uses?
   Yes, recent studies are evaluating its efficacy in managing other oral mucosal conditions, including oral mucositis and irritation from dental procedures.

3. How does CENTANY compare to other topical anesthetics?
   CENTANY offers targeted, prescription-grade analgesia with a proven safety profile, whereas over-the-counter options often contain lower concentrations of anesthesia and lack targeted formulations.

4. What is the projected growth for CENTANY over the next five years?
   The market is expected to grow at a CAGR of approximately 9%, driven by formulation improvements and new indications.

5. What are the main challenges facing CENTANY’s market expansion?
   Challenges include limited indications, fierce competition from generic brands, and pricing or reimbursement concerns across different regions.

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References

1. MarketsandMarkets. Oral Pain Management Market by Product, Application, and Region — Global Forecast to 2028. 2022.
2. Scully C, et al. Recurrent aphthous stomatitis: current concepts and management. Journal of Oral Pathology & Medicine, 2020.

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In Conclusion, CENTANY stands poised to deepen its footprint within the oral analgesic market through ongoing clinical validation, innovative formulation strategies, and broader indication approvals. The combination of rising patient demand, coupled with strategic R&D investments, will likely position CENTANY for sustained growth in the coming years.