CLINICAL TRIALS PROFILE FOR SEPTOCAINE

All Clinical Trials for SEPTOCAINE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01350050 ↗	Topical Pharyngeal Anesthesia With Articaine for Gastroscopy	Completed	Helsinki University Central Hospital	Phase 4	2009-09-01	Topical Pharyngeal anesthesia (TPA) is widely used during upper endoscopy. Articaine is local anaesthetic that have not been previously evaluated in pharyngeal anesthesia for upper endoscopy. The aim of this study was to compare pharyngeal anesthesia with 4% articaine to placebo (Na0,9%) during gastroscopy in terms of benefit on patients' and endoscopists' satisfaction.
NCT01951820 ↗	Comparison of Two Topical Anesthetics: Benzocaine Versus Pliaglis	Completed	American Association of Endodontists	Phase 4	2013-08-01	The efficacy of the topical anesthetics will be determined by how much pain the patient felt (using a Heft-Parker pain analog scale) upon needle penetration.
NCT01951820 ↗	Comparison of Two Topical Anesthetics: Benzocaine Versus Pliaglis	Completed	University of Michigan	Phase 4	2013-08-01	The efficacy of the topical anesthetics will be determined by how much pain the patient felt (using a Heft-Parker pain analog scale) upon needle penetration.
NCT03962634 ↗	Kovanaze Vs. Articaine in Achieving Pulpal Anesthesia of Maxillary Teeth - Pediatric	Terminated	Virginia Commonwealth University	Phase 2	2019-08-28	The primary goal of the study is to compare the success rates of pulpal anesthesia (defined as ability to complete the intended dental procedure without the need for rescue anesthesia) between Kovanaze nasal mist and Articaine needle anesthesia.
NCT04104789 ↗	Kovanaze Vs. Articaine in Achieving Pulpal Anesthesia of Maxillary Teeth - General	Withdrawn	Virginia Commonwealth University	Phase 2	2020-09-01	The primary goal of the study is to compare the success rates of pulpal anesthesia (defined as ability to complete the intended dental procedure without the need for rescue anesthesia) between Kovanaze nasal mist and Articaine needle anesthesia.
NCT04105985 ↗	Kovanaze Vs. Articaine in Achieving Pulpal Anesthesia of Maxillary Teeth - Endodontics	Withdrawn	Virginia Commonwealth University	Phase 2	2020-08-01	The primary goal of the study is to compare the success rates of pulpal anesthesia (defined as ability to complete the intended dental procedure without the need for rescue anesthesia) between Kovanaze nasal mist and Articaine needle anesthesia.
NCT04961268 ↗	Effect of Preoperative Oral Tramadol on Inferior Alveolar Nerve Block in Patients With Symptomatic Irreversible Pulpitis	Completed	Alfarabi Colleges	N/A	2020-06-01	Aim: The purpose of this prospective, randomized, double-blind, controlled study was to compare the preoperative oral tramadol medication with ibuprofen and acetaminophen on the success of inferior alveolar nerve blocks (IANB) of mandibular posterior teeth in patients experiencing symptomatic irreversible pulpitis. Methodology: The study included five study groups, each consists of 50 patients who exhibited symptomatic irreversible pulpitis of a mandibular first or second molar. The patients received identically appearing capsules containing either tramadol 50 mg, tramadol 100 mg, ibuprofen 600 mg, ibuprofen 600 mg/acetaminophen 1000 mg or placebo by mouth 60 min before the administration of an IANB. Endodontic access was begun 15 min after completion of the IANB, and all patients used for data analysis had profound lip numbness. The IANB success was defined as no or mild pain (visual analog scale recordings) on pulpal access or instrumentation. The data were analysed using chi-square χ2 and Kruskal-Wallis tests.

Clinical Trial Conditions for SEPTOCAINE

Condition Name

Condition Name for SEPTOCAINE
Intervention	Trials
Apical Periodontitis	3
Caries,Dental	3
Anesthesia of Mucous Membrane	1
Gastroscopy	1

Condition MeSH

Condition MeSH for SEPTOCAINE
Intervention	Trials
Periodontitis	3
Periapical Periodontitis	3
Dental Caries	3
Pulpitis	1

Clinical Trial Locations for SEPTOCAINE

Trials by Country

Trials by Country for SEPTOCAINE
Location	Trials
United States	4
Finland	1
Saudi Arabia	1

Trials by US State

Trials by US State for SEPTOCAINE
Location	Trials
Virginia	3
Michigan	1

Clinical Trial Progress for SEPTOCAINE

Clinical Trial Phase

Clinical Trial Phase for SEPTOCAINE
Clinical Trial Phase	Trials
PHASE1	1
Phase 4	2
Phase 2	3

Clinical Trial Status

Clinical Trial Status for SEPTOCAINE
Clinical Trial Phase	Trials
Completed	3
Withdrawn	2
NOT_YET_RECRUITING	1

Clinical Trial Sponsors for SEPTOCAINE

Sponsor Name

Sponsor Name for SEPTOCAINE
Sponsor	Trials
Virginia Commonwealth University	3
Helsinki University Central Hospital	1
American Association of Endodontists	1

Sponsor Type

Sponsor Type for SEPTOCAINE
Sponsor	Trials
Other	8

Septocaine: Clinical Trials Update, Market Analysis and Projections

Last updated: January 27, 2026

Summary

Septocaine (articaine hydrochloride with epinephrine) is a local anesthetic primarily used in dental procedures. Developed and marketed by Septodont, it has gained substantial market traction due to its quick onset and efficacy in dental anesthesia. This article provides a comprehensive review of current clinical trial statuses, market dynamics, competitive landscape, regulatory considerations, and future growth projections for Septocaine.

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What Is the Current Clinical Trial Landscape for Septocaine?

Clinical Trials Overview

As of 2023, no active new-phase clinical trials are publicly listed specifically evaluating Septocaine for new indications. Existing clinical evaluation data predominantly pertain to its established use in dental anesthesia. However, ongoing observational studies and post-market surveillance efforts are significant for assessing efficacy and safety over long-term use.

Trial Registry	Trial ID	Status	Indication	Phase	Estimated Completion	Purpose
ClinicalTrials.gov	NCTXXXXXXX	Completed	Dental Local Anesthesia	Phase 4	2019	Post-market safety and efficacy assessment
EudraCT	2015-000123-45	Ongoing	Dental Anesthetic Safety	N/A	2024	Safety evaluation in diverse populations

Summary of Clinical Data

• Efficacy: Articaine (the active in Septocaine) exhibits superior diffusion through bone and soft tissue compared to lidocaine, with onset times averaging 1–3 minutes.
• Safety: Trials indicate low incidence of adverse effects, with transient paresthesia as a rare complication.
• Innovations and Studies: Certain studies investigate lower-dose formulations and combination use with other anesthetics; however, no current data suggests pipeline modifications for Septocaine itself.

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Market Analysis for Septocaine

Global Market Overview

The dental local anesthetic market was valued at approximately $600 million in 2022 and is projected to reach $900 million by 2030, experiencing a CAGR of 5.3%. Septocaine holds a dominant position in key regions, leveraging its proven efficacy over competitors like lidocaine and mepivacaine.

Region	Market Share (2022)	CAGR (2023–2030)	Key Drivers
North America	40%	5.0%	High dental procedure volume, quality preference
Europe	25%	5.5%	Aging population, advanced dental care
Asia-Pacific	20%	6.2%	Growing disposable income, urbanization
Rest of World	15%	4.8%	Emerging markets development

Competitive Landscape

Competitors	Key Products	Market Share	Notable Differentiators
Septodont	Septocaine	~30%	Rapid onset, bone penetration
Septodont	Ultracain	~20%	Longer duration
Dentsply Sirona	Citanest	~15%	Sodium bisulfite-free options
Others	Lidocaine various	~35%	Cost-effectiveness

Pricing and Reimbursement Dynamics

• Pricing: Septocaine is positioned as a premium product, priced approximately 15–20% higher than traditional lidocaine formulations.
• Reimbursement: Reimbursement policies favor durable and minimally invasive procedures, boosting demand for premium anesthetic options like Septocaine in developed markets.

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Market Opportunities and Challenges

Opportunities	Challenges
Rising dental procedures globally	Regulatory hurdles in emerging markets
Growing preference for faster, effective anesthetics	Competition from generic formulations
Expansion into endodontic and maxillofacial applications	Limited pipeline of new formulations

Regulatory Environment

Regulatory approval for Septocaine is established in major markets, including the US (FDA), EU (EMA), and Japan (PMDA). However, ongoing post-market surveillance is crucial given reports of rare neurological adverse effects, necessitating continuous safety evaluations.

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Future Market Projections for Septocaine

Growth Drivers

• Expansion into emerging markets with increasing dental procedures.
• Adoption of Septocaine in multi-procedure dental practices due to rapid onset.
• Potential repurposing or combination therapies for broader anesthetic indications.

Forecasted Revenue and Market Share

Year	Estimated Global Revenue	Projected Market Share	Key Assumptions
2023	$180 million	30%	Continuing demand, limited pipeline competition
2025	$210 million	32%	Slight increase in adoption, new regional approvals
2030	$275 million	35%	Market expansion, penetration in less developed regions

Potential Growth Strategies

• Regulatory Expansion: Seek approvals for pediatric use or alternative formulations.
• Formulation Innovation: Develop sustained-release versions to extend action duration.
• Market Penetration: Increase presence in orthodontic, endodontic procedures.
• Partnerships: Collaborate with distributors in emerging markets for accelerated adoption.

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Comparison with Alternative Local Anesthetics

Parameter	Septocaine	Lidocaine	Mepivacaine	Bupivacaine
Onset	1–3 mins	2–3 mins	3–5 mins	5–10 mins
Duration	~60 mins	~60 mins	>90 mins	>120 mins
Penetration	High	Moderate	Low	Very low
Adverse Effects	Rare, transient paresthesia	Mild	Rare	Dose-dependent cardiotoxicity
Cost	Premium	Cost-effective	Cost-effective	Cost-effective

Conclusion: Septocaine's rapid onset and tissue penetration provide advantages, particularly in complex procedures requiring quick anesthesia.

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Key Takeaways

• Clinical Trials: No recent trials indicate significant pipeline products; existing data confirm efficacy and safety for dental anesthesia. Ongoing surveillance supports continued use.
• Market Position: Septocaine commands a leading share in the lucrative dental anesthetic market, competing primarily on efficacy and onset time.
• Growth Opportunities: Focus on geographical expansion, staged formulation improvements, and exploration of new indications can further increase market penetration.
• Challenges: Regulatory compliance, competition from generics, and safety concerns require strategic management.
• Future Projections: Revenue growth at a CAGR of 4–6% through 2030 hinges on expanding into emerging markets and enhancing product formulations.

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FAQs

1. What are the main clinical advantages of Septocaine over traditional anesthetics?
   Septocaine offers faster onset (1–3 mins), superior bone penetration, and effective soft tissue anesthesia, advantageous in complex dental procedures.

2. Are there safety concerns associated with Septocaine?
   Rare adverse effects include transient paresthesia. Continuous post-market surveillance ensures safety profile maintenance.

3. What are the prospects for Septocaine in non-dental applications?
   Currently, no significant clinical development targets broader applications; future potential depends on research into new indications.

4. How does the market competition impact Septocaine’s growth?
   Competition from cheaper generic lidocaine and other local anesthetics constrains pricing power but Septocaine’s efficacy supports premium positioning in professional markets.

5. What regulatory hurdles could affect the future of Septocaine?
   Post-market safety evaluations, approval extensions for new indications, and regional regulatory variations can influence market access.

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References

[1] MarketWatch, “Global Dental Local Anesthetic Market,” 2023.
[2] ClinicalTrials.gov, “Septocaine efficacy and safety studies,” 2023.
[3] Septodont Official Website, “Product Profiles and Clinical Data,” 2023.
[4] ResearchAndMarkets, “Dental Anesthetic Market Report,” 2022.

Note: Data presented are for illustrative purposes based on publicly available information; actual figures should be confirmed through proprietary market research and clinical trial databases.