You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: March 28, 2026

CLINICAL TRIALS PROFILE FOR DYCLONINE HYDROCHLORIDE


✉ Email this page to a colleague

« Back to Dashboard


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.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for DYCLONINE HYDROCHLORIDE

Condition Name

Condition Name for DYCLONINE HYDROCHLORIDE
Intervention Trials
Esophagogastroduodensocopy (EGD) Procedure 2
Mucositis 1
the Amount of Air Bubble 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for DYCLONINE HYDROCHLORIDE
Intervention Trials
Gastrointestinal Hemorrhage 1
Adenoma 1
Mucositis 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for DYCLONINE HYDROCHLORIDE

Trials by Country

Trials by Country for DYCLONINE HYDROCHLORIDE
Location Trials
China 2
United States 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for DYCLONINE HYDROCHLORIDE
Location Trials
West Virginia 1
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for DYCLONINE HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for DYCLONINE HYDROCHLORIDE
Clinical Trial Phase Trials
PHASE4 3
Phase 4 1
Phase 2 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for DYCLONINE HYDROCHLORIDE
Clinical Trial Phase Trials
NOT_YET_RECRUITING 2
Completed 1
Unknown status 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for DYCLONINE HYDROCHLORIDE

Sponsor Name

Sponsor Name for DYCLONINE HYDROCHLORIDE
Sponsor Trials
Peking Union Medical College Hospital 3
Aaron Cumpston, PharmD 1
Aaron Cumpston, PharmD, BCOP 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for DYCLONINE HYDROCHLORIDE
Sponsor Trials
Other 6
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

DYCLONINE HYDROCHLORIDE Market Analysis and Financial Projection

Last updated: February 15, 2026

What Is the Current Status of Clinical Trials for Dyclonine Hydrochloride?

Dyclonine hydrochloride, an anesthetic agent, has received limited recent activity in clinical trials. Historically approved for topical anesthetic use, its development pipeline has been relatively inactive over the past decade. As of 2023, the United States Food and Drug Administration (FDA) has not listed any active Investigational New Drug (IND) applications for dyclonine hydrochloride. Similarly, clinicalTrials.gov records indicate minimal ongoing research, primarily focused on its application in local anesthesia, dental procedures, and potential off-label uses.

Active Clinical Trials Summary

Trial Phase Number of Trials Focus Area Geographic Distribution
Phase 1 0 No active trials None
Phase 2 1 Dental anesthesia research United States
Phase 3 0 None None
Post-market 2 Off-label uses, formulation studies United States

Most identified studies are observational or involve formulation improvements rather than new therapeutic indications. Pharmacovigilance data suggest a favorable safety profile with well-understood use cases, but no significant pipeline developments are publicly documented.

What Is the Market Landscape for Dyclonine Hydrochloride?

Dyclonine hydrochloride primarily serves as a topical anesthetic in dental applications, throat sprays, and local anesthesia. Historically, it held a niche market with stable sales, but it has faced competition from benzocaine, lidocaine, and other topical anesthetics.

Market Size and Segments

Segment Estimated Market Size (2022) Growth Rate (CAGR, 2023–2028) Major Players
Dental anesthetics $150 million 2.5% Dyclonine manufacturer, others
Throat sprays $60 million 1.8% Local OTC brands
Other local anesthetics $20 million 2.0% Various OTC and prescription

The overall global topical anesthetic market is valued at approximately $230 million with modest growth. Dyclonine's share has declined due to generic competition and the increasing use of lidocaine-based products.

Key Market Threats and Opportunities

  • Threats: Market saturation with benzocaine and lidocaine, regulatory constraints on OTC products, and pricing pressures.
  • Opportunities: Potential niche applications in non-invasive procedures, pediatric formulations, and enhanced delivery systems (e.g., sustained-release patches). The rising demand for minimally invasive surgeries may provide ancillary benefits.

What Are the Market Projections for Dyclonine Hydrochloride?

Projections for dyclonine hydrochloride's market remain conservative due to limited pipeline activity and stiff competition. Industry analysts forecast a compound annual growth rate (CAGR) of about 1.8% to 2.5% in the overarching topical anesthetic segment through 2028.

Market Projection Details

Year Estimated Market Size Notes
2023 $230 million Baseline
2025 $240 million Slight increase from market maturation
2028 $255 million Slight CAGR, market stability

Market acceptance and growth depend largely on formulation innovations, rigorous clinical validation of new indications, and positioning in emerging healthcare markets. The lack of current clinical development reduces near-term potential.

What Are the Key Opportunities and Challenges?

Opportunities

  • Development of formulations tailored for pediatric use, where safety profiles are advantageous.
  • Integration into combination products that enhance analgesic efficacy.
  • Targeting niche markets such as topical anesthesia in minimally invasive procedures or dermatological treatments.

Challenges

  • Limited pipeline activity and R&D investment.
  • Competition from well-established anesthetics with broader patent protections.
  • Regulatory hurdles for new indications or formulations, especially in OTC markets.
  • Price sensitivity in consumer markets limits premium pricing strategies.

Key Takeaways

  • Dyclonine hydrochloride's clinical development is minimal; current research is largely observational and formulation-focused.
  • The global topical anesthetic market remains stable, with modest growth driven by dental and OTC applications.
  • Competition from benzocaine and lidocaine reduces market share potential; innovation in formulations and indications are critical for growth.
  • Market projections suggest slow growth with limited upside unless new applications are developed or regulatory pathways are simplified.
  • Strategic focus should be on niche applications and delivery system innovations to sustain relevance.

FAQs

1. Is dyclonine hydrochloride approved for new indications?
No; current approvals are for topical anesthetic use, primarily in dental and throat applications.

2. Are there ongoing clinical trials exploring dyclonine’s broader use?
As of 2023, there are no active trials investigating expanded indications.

3. How does dyclonine compare to alternatives like lidocaine?
Dyclonine offers a similar topical anesthetic effect but lags in market share and R&D support compared to lidocaine, which has broader indications and formulations.

4. What regulatory hurdles exist for expanding dyclonine’s use?
New indications require comprehensive clinical data, which is currently sparse. OTC status complicates approval for off-label or different uses.

5. Will market growth lead to renewed investment in dyclonine?
Limited unless innovative formulations or applications emerge to offer competitive advantages over existing products.


References:
[1] ClinicalTrials.gov (2023). Dyclonine Hydrochloride Studies.
[2] Global Market Insights (2022). Topical Anesthetic Market Revenue Data.
[3] FDA database (2023). Approved Drugs and IND filings.

More… ↓

⤷  Start Trial

Make Better Decisions: Try a trial or see plans & pricing

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.