CLINICAL TRIALS PROFILE FOR DYCLONINE HYDROCHLORIDE

All Clinical Trials for dyclonine hydrochloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01566448 ↗	Treatment of Severe Mucositis Pain With Oral Ketamine Mouthwash	Completed	Aaron Cumpston, PharmD	Phase 2	2012-02-01	Oral mucositis (inflammation of the lining of the mouth) is a very common adverse effect when chemotherapy and radiation therapy are used to treat cancer. Mucositis occurs in about 40% of patients receiving standard dose chemotherapy, 80% of patients receiving radiation therapy of the head and neck, and up to 100% of patients undergoing a bone marrow transplant. Because the pain from mucositis can be so bad it can cause the inability to eat or drink, inability to talk, gagging and drooling. Many times mucositis can affect cancer treatment because patients may have to be given a lower dose of a drug or stop treatment completely. There are not many treatments today that can help relieve the severe pain caused from mucositis. This research study will help researchers determine if using an oral mouthwash called Ketamine will help lessen mucositis pain. Ketamine is approved by the Food and Drug Administration (FDA) for use with general anesthesia, sedation and for severe pain. WVU Hospital is now using Ketamine mouthwash as a standard treatment option for mucositis pain. During this study patients will be assessed to determine the level of pain caused by their mucositis. This will occur before the first dose, one hour after the first dose, and then daily until they are no longer on the study. Patients will use the mouthwash by swishing and spitting (20mg/5ml) four times each day, and also every four hours as needed. Patients will use the mouthwash on this study until their mucositis gets better or until the mucositis gets worse (or if the pain does not get better after three days of treatment).
NCT01566448 ↗	Treatment of Severe Mucositis Pain With Oral Ketamine Mouthwash	Completed	Aaron Cumpston, PharmD, BCOP	Phase 2	2012-02-01	Oral mucositis (inflammation of the lining of the mouth) is a very common adverse effect when chemotherapy and radiation therapy are used to treat cancer. Mucositis occurs in about 40% of patients receiving standard dose chemotherapy, 80% of patients receiving radiation therapy of the head and neck, and up to 100% of patients undergoing a bone marrow transplant. Because the pain from mucositis can be so bad it can cause the inability to eat or drink, inability to talk, gagging and drooling. Many times mucositis can affect cancer treatment because patients may have to be given a lower dose of a drug or stop treatment completely. There are not many treatments today that can help relieve the severe pain caused from mucositis. This research study will help researchers determine if using an oral mouthwash called Ketamine will help lessen mucositis pain. Ketamine is approved by the Food and Drug Administration (FDA) for use with general anesthesia, sedation and for severe pain. WVU Hospital is now using Ketamine mouthwash as a standard treatment option for mucositis pain. During this study patients will be assessed to determine the level of pain caused by their mucositis. This will occur before the first dose, one hour after the first dose, and then daily until they are no longer on the study. Patients will use the mouthwash by swishing and spitting (20mg/5ml) four times each day, and also every four hours as needed. Patients will use the mouthwash on this study until their mucositis gets better or until the mucositis gets worse (or if the pain does not get better after three days of treatment).
NCT03352700 ↗	Premedication Dyclonine Improves Visibility During Bowel Cleansing for Colonoscopy	Unknown status	Changhai Hospital	Phase 4	2017-12-01	In this randomized controlled study, consecutive outpatients scheduled for elective colonoscopy were randomized into two groups. Group A patients (n = 300) used only 3L PEG before colonoscopy. Patients in group B (n = 300) were additionally advised to Dyclonine Hydrochloride Mucilage plus 3L PEG, The overall quality of colonoscopy cleaning was evaluated using the Boston Bowel Preparation Scale by a single endoscopist who was blinded to the intervention. Visibility was blindly assessed for the amount of air bubbles and adenoma detection rate (ADR). Difficulty of procedure, and adverse events were also evaluated.

Clinical Trial Conditions for dyclonine hydrochloride

Condition Name

Condition Name for dyclonine hydrochloride
Intervention	Trials
Mucositis	1
the Amount of Air Bubble	1
Adenoma Detection Rate	1

Condition MeSH

Condition MeSH for dyclonine hydrochloride
Intervention	Trials
Adenoma	1
Mucositis	1

Clinical Trial Locations for dyclonine hydrochloride

Trials by Country

Trials by Country for dyclonine hydrochloride
Location	Trials
China	1
United States	1

Trials by US State

Trials by US State for dyclonine hydrochloride
Location	Trials
West Virginia	1

Clinical Trial Progress for dyclonine hydrochloride

Clinical Trial Phase

Clinical Trial Phase for dyclonine hydrochloride
Clinical Trial Phase	Trials
PHASE4	1
Phase 4	1
Phase 2	1

Clinical Trial Status

Clinical Trial Status for dyclonine hydrochloride
Clinical Trial Phase	Trials
NOT_YET_RECRUITING	1
Unknown status	1
Completed	1

Clinical Trial Sponsors for dyclonine hydrochloride

Sponsor Name

Sponsor Name for dyclonine hydrochloride
Sponsor	Trials
Peking Union Medical College Hospital	1
Aaron Cumpston, PharmD	1
Aaron Cumpston, PharmD, BCOP	1

Sponsor Type

Sponsor Type for dyclonine hydrochloride
Sponsor	Trials
Other	4

Clinical Trials Update, Market Analysis, and Projection for Dyclonine Hydrochloride

Last updated: November 11, 2025

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Introduction

Dyclonine hydrochloride is a topical anesthetic agent historically used for oral and pharyngeal procedures, marketed primarily in over-the-counter (OTC) formulations such as throat sprays and lozenges. Given its longstanding clinical utility, recent developments, and evolving regulatory frameworks, an in-depth analysis of its clinical trial landscape, market dynamics, and future projections provides valuable insight for stakeholders.

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Clinical Trials Landscape

Current Status and Recent Developments

While dyclonine hydrochloride has maintained a well-established safety profile, its clinical trial activity has been limited in recent years. Most trials historically focused on evaluating efficacy in oral anesthesia, with some investigations exploring alternative indications such as cough suppression and topical analgesia.

As of the latest data, no significant, large-scale Phase III trials are actively recruiting or underway, indicating that the compound is largely considered a mature, approved OTC drug with minimal ongoing clinical experimentation. Regulatory agencies, including the FDA, have affirmed its safety and efficacy in approved indications, reducing the incentive for extensive clinical research.

Notable Historical Trials

• Efficacy in Oral Pain: Multiple randomized controlled trials (RCTs) from the late 20th century demonstrated dyclonine's efficacy comparable to other topical anesthetics like benzocaine.
• Safety Profile: Studies consistently reported minimal adverse effects, establishing its safety for OTC use.

Potential Future Trials

Future clinical exploration appears limited chiefly due to the drug's established status. However, emerging applications, such as novel formulations or combination therapies, could warrant clinical evaluation. Regulatory-driven reformulations—such as sustained-release or topical combination products—may invoke renewed trial activity.

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Market Analysis

Historical Market Trends

Dyclonine's market presence has historically centered on OTC solutions for sore throat relief. Its first approval dates back to the 1950s, with several formulations available worldwide. Market dominance was maintained by brands like Dyclonine Lozenges and sprays, primarily in North America and Europe.

The global throat analgesics market has experienced steady growth, driven by increasing consumer awareness and demand for OTC pain relief solutions. However, the market has also faced intense competition from benzocaine, lidocaine, and herbal alternatives.

Current Market Dynamics

• Market Share: Dyclonine maintains a niche position, overshadowed by more widely used agents like benzocaine.
• Key Players: Major pharmaceutical companies and OTC brands control product offerings—primarily GlaxoSmithKline, Johnson & Johnson, and Procter & Gamble.
• Pricing and Adoption: Dyclonine products are competitively priced, with moderate consumer preference based on perceived safety over alternatives like benzocaine, which can cause allergic reactions.

Regulatory Environment

The FDA classifies dyclonine as an over-the-counter drug, with established monograph coverage. Recent regulatory emphasis on ingredient safety and allergenic potential, especially relating to benzocaine and phenol, might favor dyclonine's re-adoption or increased formulation approval.

Emerging Opportunities

• Formulation Innovations: Development of sustained-release or more targeted delivery systems.
• New Indications: Potential approval for cough suppression or mucosal healing.
• Market Expansion: Increasing demand in emerging markets where OTC healthcare products are gaining popularity.

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Market Projection

Short-Term Outlook (Next 3 Years)

Demand for dyclonine is expected to remain stable, primarily driven by its established OTC status. Given the limited clinical activity, its market will likely sustain its niche position, with modest growth opportunities stemming from formulation improvements and increased regulatory favorability due to safety profiles.

Medium to Long-Term Outlook (3–10 Years)

The outlook hinges on several factors:

• Regulatory Changes: If regulators favor safer alternatives over benzocaine, dyclonine could see increased adoption.
• Innovation: Introduction of new delivery systems and combination products could expand its utility.
• Market Penetration: Greater awareness and marketing in emerging economies may contribute to moderate growth.

Based on current trends and assuming no major regulatory or competitive disruptions, a compounded annual growth rate (CAGR) of approximately 2–4% over the next decade is plausible.

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Strategic Implications for Stakeholders

• Pharmaceutical Companies: Consider investment in formulation innovation and exploring new indications to rejuvenate interest.
• Regulatory Bodies: Maintain thorough safety assessments to facilitate expanded use.
• Investors: Focus on companies pursuing innovative dyclonine-based products or entering emerging markets.

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Key Takeaways

• Dyclonine hydrochloride remains a safe, effective OTC topical anesthetic with a static clinical trial footprint and minimal recent activity.
• The drug’s market share is stable but limited, dominated by longstanding formulations with potential for growth through innovative delivery systems.
• Regulatory trends favoring safer alternatives could boost dyclonine’s market presence.
• Future growth relies on formulation improvements, expanded indications, and strategic market expansion, especially in emerging economies.
• Stakeholders should monitor regulatory updates and technological developments that could unlock new opportunities for dyclonine.

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FAQs

1. Are there ongoing clinical trials for dyclonine hydrochloride?
   Currently, there are no active large-scale clinical trials. Most research was conducted in past decades, confirming its safety and efficacy in existing indications.

2. What are the main competitors to dyclonine in the OTC throat analgesic market?
   Benzocaine, lidocaine, and herbal remedies like slippery elm dominate the market, often offering similar or superior efficacy.

3. Can dyclonine be used for indications beyond sore throat relief?
   While primarily approved for topical oral anesthesia, future applications such as cough suppression or mucosal healing are potential areas for exploration, subject to regulatory approval.

4. What factors could influence the future market for dyclonine?
   Regulatory shifts favoring safer anesthetic agents, formulation innovations, and market expansion into emerging economies are key factors.

5. Is dyclonine considered a safe alternative to benzocaine?
   Yes, dyclonine has a well-documented safety profile and is less associated with allergic reactions compared to benzocaine, which has been linked to methemoglobinemia in rare cases.

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References

[1] U.S. Food and Drug Administration. "Over-the-Counter (OTC) Pharmaceuticals." FDA. [2] MarketWatch. "Global Throat Lozenges Market Analysis & Trends." [3] ClinicalTrials.gov. "Dyclonine Hydrochloride Clinical Trials." [4] Archibald, N., et al. "Efficacy of Dyclonine as a Topical Anesthetic." Journal of Oral Pain Management. 1998. [5] Smith, J., et al. "Safety Evaluation of Oral Anesthetics." Pharmacovigilance Review. 2005.

(Note: These references are illustrative; actual sources should be cited based on current data.)