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

Last Updated: March 17, 2025

CLINICAL TRIALS PROFILE FOR CHOLINE FENOFIBRATE


✉ Email this page to a colleague

« Back to Dashboard


All Clinical Trials for choline fenofibrate

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT00673881 ↗ ABT-335 (Choline Fenofibrate) Reverse Cholesterol Transport (RCT) Study Completed Radiant Research Phase 1/Phase 2 2008-03-01 The objectives of the study are: 1. To evaluate the effect of ABT-335 (choline fenofibrate) on several parameters of RCT (reverse cholesterol transport) in men and post-menopausal women diagnosed with dyslipidemia (i.e., low high-density lipoprotein [HDL] cholesterol levels and elevated triglyceride [TG] concentrations). 2. To evaluate longitudinal changes in several parameters of RCT in subjects with low HDL. 3. To obtain pilot data for power calculations for subsequent comparative study.
NCT00616772 ↗ Safety and Efficacy Study Using ABT-335 (Investigational Drug) in Combination With Atorvastatin, to Study the Effects on Thickening of the Blood Vessel Wall in Patients With Abnormal Lipid (Fat) Levels in the Blood Completed AbbVie (prior sponsor, Abbott) Phase 3 2008-02-01 The primary purpose of this study is to test the effect and safety of once daily ABT-335 on the thickness of the lining of the carotid artery (a blood vessel to the brain) in patients with abnormal blood lipids who have optimal levels of low density lipoprotein cholesterol ("bad cholesterol") after taking atorvastatin.
NCT00639158 ↗ Safety and Efficacy Study Comparing ABT-335 Coadministered With Atorvastatin and Ezetimibe to Atorvastatin Coadministered With Ezetimibe in Subjects With Multiple Abnormal Lipid (Fat) Levels in the Blood Completed Abbott Phase 3 2008-02-01 The primary purpose of this study is to compare the safety and efficacy of ABT-335 (investigational drug) coadministered with atorvastatin and ezetimibe to atorvastatin coadministered with ezetimibe in subjects with abnormal lipid (fat) levels in the blood.
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 3 of 3 entries

Clinical Trial Conditions for choline fenofibrate

Condition Name

5220-0.500.511.522.533.544.555.5DyslipidemiaCoronary Heart DiseaseDyslipidemias[disabled in preview]
Condition Name for choline fenofibrate
Intervention Trials
Dyslipidemia 5
Coronary Heart Disease 2
Dyslipidemias 2
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

722001234567DyslipidemiasMyocardial IschemiaHeart Diseases[disabled in preview]
Condition MeSH for choline fenofibrate
Intervention Trials
Dyslipidemias 7
Myocardial Ischemia 2
Heart Diseases 2
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for choline fenofibrate

Trials by Country

+
Trials by Country for choline fenofibrate
Location Trials
United States 50
United Kingdom 1
Denmark 1
Italy 1
Spain 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 choline fenofibrate
Location Trials
Illinois 3
Georgia 2
Florida 2
Colorado 2
California 2
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for choline fenofibrate

Clinical Trial Phase

42.9%28.6%28.6%000.511.522.53Phase 4Phase 3Phase 2[disabled in preview]
Clinical Trial Phase for choline fenofibrate
Clinical Trial Phase Trials
Phase 4 3
Phase 3 2
Phase 2 2
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

71.4%14.3%14.3%0-0.500.511.522.533.544.555.5CompletedNot yet recruitingTerminated[disabled in preview]
Clinical Trial Status for choline fenofibrate
Clinical Trial Phase Trials
Completed 5
Not yet recruiting 1
Terminated 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for choline fenofibrate

Sponsor Name

trials000111112222AbbottDaewon Pharmaceutical Co., Ltd.Radiant Research[disabled in preview]
Sponsor Name for choline fenofibrate
Sponsor Trials
Abbott 2
Daewon Pharmaceutical Co., Ltd. 2
Radiant Research 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

72.7%27.3%0012345678IndustryOther[disabled in preview]
Sponsor Type for choline fenofibrate
Sponsor Trials
Industry 8
Other 3
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Choline Fenofibrate: Clinical Trials, Market Analysis, and Projections

Introduction to Choline Fenofibrate

Choline fenofibrate, a choline salt of fenofibric acid, is a lipid-modifying agent designed to treat various forms of dyslipidemia. It is more hydrophilic than traditional fenofibrate, which can enhance its bioavailability and efficacy.

Clinical Trials Update

Efficacy and Safety in Mixed Dyslipidemia

A significant clinical trial conducted in India compared the efficacy and safety of choline fenofibrate with micronized fenofibrate in patients with mixed dyslipidemia. This randomized, open-label, multicenter study involved 226 patients, with 116 receiving choline fenofibrate (135 mg delayed release tablets) and 110 receiving micronized fenofibrate (160 mg tablets) once daily for 12 weeks. The primary endpoint was the percentage change in serum triglyceride (TG) levels. The results showed a significant reduction in TG levels in both groups (34.24% for choline fenofibrate and 38.13% for micronized fenofibrate), although the difference between the groups was not statistically significant. Both treatments were safe and well-tolerated, with a significant increase in high-density lipoprotein cholesterol (HDL-C) in both groups[1].

Carotid Atherosclerosis in Type 2 Diabetes

Another ongoing clinical trial is assessing the effect of choline fenofibrate compared to policosanol in Korean patients with type 2 diabetes and asymptomatic atherosclerosis. This randomized controlled study aims to evaluate the impact of choline fenofibrate on the progression of carotid intima-media thickness and carotid artery plaque using 3D carotid ultrasound. The study includes patients with mixed dyslipidemia and carotid artery plaque, and it excludes those with severe renal dysfunction, uncontrolled hypertension, and other specific conditions[4].

Market Analysis

Current Market Size and Growth

The Choline Fenofibrate API market has been experiencing rapid growth, driven by the increasing demand for lipid-modifying agents to treat hyperlipidemia and related cardiovascular diseases. The global market is projected to grow at a compound annual growth rate (CAGR) of 14.5% from 2022 to 2028, with an expected market size surpassing USD 300 million by 2028[5].

Market Segmentation

The market is segmented by type (Choline Fenofibrate API) and application (Pharmaceutical Industry), as well as by geographical regions including North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. Key regions such as North America and Europe are contributing substantially to the market due to their advanced healthcare infrastructure and significant investments in research and development[2][5].

Key Players and Competitive Dynamics

The Choline Fenofibrate API market is dominated by several key players, including MuseChem, Achemtek, Clearsynth, and Tecoland. These companies are focusing on strategic initiatives such as expansions, product innovations, and collaborations to strengthen their market presence. The competitive dynamics are driven by the need for advanced lipid-regulating therapies and the growing awareness of lipid disorders[5].

Market Projections

Future Growth and Opportunities

The Choline Fenofibrate API market is poised for significant growth due to several factors:

  • Increasing Prevalence of Dyslipidemia: The rising prevalence of dyslipidemia and related cardiovascular diseases is driving the demand for effective lipid-modifying agents.
  • Advancements in Formulation and Delivery: Innovations in formulation and delivery methods are enhancing the efficacy of choline fenofibrate, making it a preferred choice for healthcare professionals.
  • Regulatory Approvals: Regulatory approvals for generics and new formulations are increasing the accessibility of choline fenofibrate, contributing to market growth.
  • Strategic Collaborations: Key players are engaging in strategic collaborations and partnerships to expand their product offerings and market presence[2][5].

Regional Outlook

The market is expected to see substantial growth in regions with advanced healthcare infrastructure, such as North America and Europe. Asia-Pacific is also emerging as a significant market due to the growing pharmaceutical industry and increasing awareness of lifestyle-related diseases[5].

Key Takeaways

  • Clinical Efficacy: Choline fenofibrate has shown significant efficacy in reducing triglyceride levels and increasing HDL-C, comparable to micronized fenofibrate.
  • Market Growth: The Choline Fenofibrate API market is projected to grow at a CAGR of 14.5% from 2022 to 2028.
  • Key Players: Companies like MuseChem, Achemtek, Clearsynth, and Tecoland are driving the market through strategic initiatives.
  • Regional Focus: North America, Europe, and Asia-Pacific are key regions contributing to the market growth.

FAQs

What is the primary use of choline fenofibrate?

Choline fenofibrate is primarily used to treat mixed dyslipidemia, reducing triglyceride levels and increasing high-density lipoprotein cholesterol (HDL-C).

How does choline fenofibrate compare to micronized fenofibrate?

Choline fenofibrate has been shown to be as safe and effective as micronized fenofibrate in reducing triglyceride levels and increasing HDL-C, based on a clinical trial in Indian patients[1].

What is the projected growth rate of the Choline Fenofibrate API market?

The Choline Fenofibrate API market is expected to grow at a CAGR of 14.5% from 2022 to 2028[5].

Which regions are driving the growth of the Choline Fenofibrate API market?

North America, Europe, and Asia-Pacific are the key regions driving the growth of the Choline Fenofibrate API market due to their advanced healthcare infrastructure and growing demand for lipid-modifying agents[5].

Who are the key players in the Choline Fenofibrate API market?

Key players include MuseChem, Achemtek, Clearsynth, and Tecoland, which are focusing on strategic initiatives to expand their market presence[5].

Sources

  1. Patel P, Barkate H. Comparison of efficacy and safety of choline fenofibrate (fenofibric acid) to micronized fenofibrate in patients of mixed dyslipidemia: A randomized, open-label, multicenter clinical trial in Indian population. Indian J Endocrinol Metab. 2016 Jan-Feb;20(1):67-71. doi: 10.4103/2230-8210.172243.
  2. Market Research Intellect. Choline Fenofibrate API Sales Market Size, Scope And Forecast 2023-2031.
  3. Acasti Pharma Inc. NASDAQ & TSX-V: ACST Company Overview November/December 2017.
  4. CenterWatch. Choline Fenofibrate and Carotid Atherosclerosis in Patients With Type 2 Diabetes and Combined Dyslipidemia.
  5. Markets CAGR. Choline Fenofibrate API Market, Global Outlook and Forecast 2022-2028 Market Research Report.

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.