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

Last Updated: February 11, 2025

CLINICAL TRIALS PROFILE FOR CEVIMELINE


✉ Email this page to a colleague

« Back to Dashboard


All Clinical Trials for Cevimeline

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00017511 ↗ Cevimeline in Treating Patients With Dry Mouth Caused by Radiation Therapy for Head and Neck Cancer Completed Daiichi Sankyo Inc. Phase 3 2001-06-01 RATIONALE: Cevimeline may be effective in treating dry mouth that is caused by radiation therapy for head and neck cancer. It is not yet known if cevimeline is more effective than no therapy in treating dry mouth caused by radiation therapy. PURPOSE: Randomized phase III trial to determine the effectiveness of cevimeline in treating patients who have dryness of the mouth caused by radiation therapy for head and neck cancer.
NCT00017511 ↗ Cevimeline in Treating Patients With Dry Mouth Caused by Radiation Therapy for Head and Neck Cancer Completed Daiichi Sankyo, Inc. Phase 3 2001-06-01 RATIONALE: Cevimeline may be effective in treating dry mouth that is caused by radiation therapy for head and neck cancer. It is not yet known if cevimeline is more effective than no therapy in treating dry mouth caused by radiation therapy. PURPOSE: Randomized phase III trial to determine the effectiveness of cevimeline in treating patients who have dryness of the mouth caused by radiation therapy for head and neck cancer.
NCT00466388 ↗ Study of the Effectiveness of Cevimeline on Oral Health in Patients With Radiation Induced Xerostomia Completed Duke University Phase 4 2007-05-01 The purpose of this study is to determine the effectiveness of cevimeline (versus placebo) on the oral health of patients who have dry mouth which was caused by radiation therapy that was given for treatment of head and/or neck cancer.
NCT00466388 ↗ Study of the Effectiveness of Cevimeline on Oral Health in Patients With Radiation Induced Xerostomia Completed American Academy of Otolaryngology-Head and Neck Surgery Foundation Phase 4 2007-05-01 The purpose of this study is to determine the effectiveness of cevimeline (versus placebo) on the oral health of patients who have dry mouth which was caused by radiation therapy that was given for treatment of head and/or neck cancer.
NCT01690052 ↗ Efficacy of Cevimeline Versus Pilocarpine in the Secretion of Saliva Completed University of Kentucky N/A 2009-01-01 The main objectives were: 1) To determine the efficacy of both cevimeline and pilocarpine in the secretion of saliva in patients with xerostomia, and 2) To compare the side-effects between the treatment for xerostomia with cevimeline and with pilocarpine.
NCT01903109 ↗ Crossover Bioequivalence Study of Cevimeline 30 mg Capsules Under Fed Conditions Completed Roxane Laboratories Early Phase 1 2009-02-01 The objective of this study was to prove the bioequivalence of Roxane Laboratories' Cevimeline 30 mg under fed conditions
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Cevimeline

Condition Name

Condition Name for Cevimeline
Intervention Trials
Dry Mouth 3
Head and Neck Cancer 1
Oral Complications 1
Overactive Bladder Syndrome 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 Cevimeline
Intervention Trials
Xerostomia 4
Syndrome 1
Sjogren's Syndrome 1
Radiation Injuries 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for Cevimeline

Trials by Country

Trials by Country for Cevimeline
Location Trials
United States 43
Taiwan 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 Cevimeline
Location Trials
Kentucky 3
Kansas 2
Illinois 2
Colorado 2
Nevada 2
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for Cevimeline

Clinical Trial Phase

Clinical Trial Phase for Cevimeline
Clinical Trial Phase Trials
Phase 4 2
Phase 3 1
N/A 1
[disabled in preview] 2
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for Cevimeline
Clinical Trial Phase Trials
Completed 5
Recruiting 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for Cevimeline

Sponsor Name

Sponsor Name for Cevimeline
Sponsor Trials
Roxane Laboratories 2
American Academy of Otolaryngology-Head and Neck Surgery Foundation 1
University of Kentucky 1
[disabled in preview] 3
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for Cevimeline
Sponsor Trials
Industry 4
Other 4
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Cevimeline: Clinical Trials, Market Analysis, and Projections

Introduction to Cevimeline

Cevimeline, a cholinergic agent with muscarinic agonist activity, is primarily used to treat the symptoms of dry mouth (xerostomia) associated with Sjögren's syndrome. This drug targets the M1 and M3 receptors prevalent in exocrine glands, making it an effective treatment for patients suffering from this autoimmune disorder.

Clinical Trials Overview

Several clinical trials have been conducted to evaluate the safety and efficacy of cevimeline in treating xerostomia in patients with Sjögren's syndrome.

  • Study Design and Participants: A double-blind, randomized, placebo-controlled trial involved 75 patients with Sjögren syndrome and associated salivary gland dysfunction. Participants were randomized to receive either 30 mg or 60 mg of cevimeline three times daily or a placebo for six weeks[1][4].
  • Outcomes: Patients in both cevimeline groups showed significant improvements in dry mouth symptoms, salivary flow, and the use of artificial saliva compared to the placebo group. The 30 mg dose was particularly well-tolerated and provided substantial relief from xerostomia symptoms[1][4].
  • Adverse Events: While both dosages provided symptomatic improvement, the 60 mg dose was associated with an increase in adverse events, particularly gastrointestinal tract disorders. Nausea was one of the most frequent adverse events leading to patient withdrawal[1][4].

Market Analysis

The market for cevimeline is growing, driven by several key factors.

Market Size and Forecast

  • The cevimeline market was valued at $22.9 billion in 2023 and is projected to reach $68.4 billion by 2030, growing at a CAGR of 4.2% from 2024 to 2030[2].

Growth Drivers

  • Research and Development: Continuous R&D in autoimmune disorders is expected to yield novel therapeutic choices, including drugs like cevimeline[2].
  • Healthcare Infrastructure: Improvements in global healthcare infrastructure, especially in emerging nations, will enhance access to medical services, diagnosis, and prescription drugs[2].
  • Patient-Centric Approaches: The trend towards patient-centric healthcare, where regimens are customized to meet individual patient needs, may increase the demand for drugs like cevimeline[2].
  • Government Initiatives: Government activities aimed at increasing healthcare access, raising public awareness of autoimmune illnesses, and promoting related research will positively impact the market[2].

Challenges and Limitations

  • Limited Indications: Cevimeline is primarily intended for treating dry mouth associated with Sjögren’s syndrome, which limits its potential patient population and market growth[2].
  • Side Effects and Safety Concerns: The drug may be associated with side effects and unpleasant reactions, which could impact its adoption and usage, especially in patients with specific medical conditions[2].
  • Competitive Landscape: Cevimeline may face competition from other drugs or therapies for Sjögren’s syndrome or dry mouth, potentially reducing its market share[2].
  • Generic Competition: The availability of generic cevimeline could lead to price competition, lowering the market value of the branded version[2].
  • Regulatory Challenges: Changes in regulatory regulations or difficulties in securing regulatory clearances for new indications could hamper market growth[2].
  • High Treatment Costs: Significant out-of-pocket payments or lack of insurance coverage may make cevimeline a financial hardship for some patients[2].

Global Market Segmentation

The global cevimeline market is segmented based on several criteria:

Distribution Channel

  • Hospital Pharmacies: Focus on distribution through hospital pharmacies where patients commonly receive prescriptions from healthcare providers.
  • Retail Pharmacies: Market where cevimeline might be purchased without a prescription[2].

Patient Demographic

  • The market is also segmented based on patient demographics, which can help in targeting specific patient groups more effectively.

Formulation Type

  • Different formulations of cevimeline can cater to various patient needs and preferences.

Geography

  • The market is segmented geographically, with key regions including North America, Europe, Asia Pacific, South America, and the Middle East and Africa[2].

Future Projections and Trends

Technological Advancements

  • Rapid technological evolution, including advancements in drug delivery systems and personalized medicine, is expected to positively impact the market growth of cevimeline[3].

Increasing Prevalence of Chronic Diseases

  • The rising prevalence of chronic diseases, including autoimmune disorders like Sjögren’s syndrome, will drive the demand for effective treatments like cevimeline[3].

Globalization of Clinical Trials

  • The globalization of clinical trials will facilitate the development and approval of new drugs, including cevimeline, in various regions[3].

Key Takeaways

  • Cevimeline has shown significant efficacy in treating xerostomia in patients with Sjögren's syndrome through clinical trials.
  • The market for cevimeline is projected to grow substantially, driven by R&D, healthcare infrastructure improvements, and patient-centric approaches.
  • However, the market faces challenges such as limited indications, side effects, and regulatory hurdles.
  • Segmentation based on distribution channels, patient demographics, formulation types, and geography will be crucial for market strategy.

FAQs

What is Cevimeline used for?

Cevimeline is primarily used to treat the symptoms of dry mouth (xerostomia) associated with Sjögren's syndrome.

How effective is Cevimeline in clinical trials?

Clinical trials have shown that cevimeline significantly improves dry mouth symptoms, salivary flow, and the use of artificial saliva in patients with Sjögren's syndrome[1][4].

What are the common side effects of Cevimeline?

Common side effects include nausea, gastrointestinal tract disorders, and other muscarinic agonist-related adverse events[1][4].

What is the projected market size of Cevimeline by 2030?

The cevimeline market is projected to reach $68.4 billion by 2030, growing at a CAGR of 4.2% from 2024 to 2030[2].

What are the key drivers of the Cevimeline market growth?

Key drivers include continuous R&D in autoimmune disorders, improvements in healthcare infrastructure, patient-centric approaches, and government initiatives[2].

Cited Sources

  1. JAMA Internal Medicine: "Cevimeline for the Treatment of Xerostomia in Patients With Sjögren Syndrome"[1]
  2. Verified Market Research: "Cevimeline Market Size, Share, Opportunities, Scope & Forecast"[2]
  3. Grand View Research: "Clinical Trials Market Size, Share And Growth Report, 2030"[3]
  4. PubMed: "Cevimeline for the treatment of xerostomia in patients with Sjögren syndrome"[4]
  5. QY Research: "Global Reagent Grade Cevimeline Hydrochloride Market Insights, Forecast to 2030"[5]

More… ↓

⤷  Try for Free

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. 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.