CLINICAL TRIALS PROFILE FOR RANOLAZINE

All Clinical Trials for RANOLAZINE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00574756 ↗	Effect of Ranolazine on Echocardiographic Indices of Diastolic Dysfunction	Terminated	University of California, San Diego	N/A	2007-12-01	The purpose of this study is to evaluate the effects of ranolazine, an FDA-approved medication for the treatment of angina, on heart function by using echocardiography.
NCT00570089 ↗	Microvascular Coronary Disease In Women: Impact Of Ranolazine	Completed	CV Therapeutics	Phase 2	2007-04-01	1. To evaluate the impact of ranolazine extended-release tablets in women with subendocardial ischemia due to microvascular endothelial dysfunction on myocardial ischemia (Cardiac Magnetic Resonance (CMR) extent, severity. 2. To evaluate the impact of ranolazine extended-release tablets in women with subendocardial ischemia due to microvascular endothelial dysfunction on the outcomes of angina (Seattle Angina Questionnaire (SAQ), WISE angina frequency, Duke Activity Status Inventory(DASI) and SF-36).
NCT00570089 ↗	Microvascular Coronary Disease In Women: Impact Of Ranolazine	Completed	Cedars-Sinai Medical Center	Phase 2	2007-04-01	1. To evaluate the impact of ranolazine extended-release tablets in women with subendocardial ischemia due to microvascular endothelial dysfunction on myocardial ischemia (Cardiac Magnetic Resonance (CMR) extent, severity. 2. To evaluate the impact of ranolazine extended-release tablets in women with subendocardial ischemia due to microvascular endothelial dysfunction on the outcomes of angina (Seattle Angina Questionnaire (SAQ), WISE angina frequency, Duke Activity Status Inventory(DASI) and SF-36).
NCT00099788 ↗	Metabolic Efficiency With Ranolazine for Less Ischemia in Non-ST Elevation Acute Coronary Syndromes	Completed	The TIMI Study Group	Phase 3	2004-10-01	MERLIN-TIMI 36 is a multi-national, double-blind, randomized, placebo-controlled, parallel-group clinical trial designed to evaluate the efficacy and safety of ranolazine during acute and long-term treatment in approximately 5,500 patients with non-ST elevation acute coronary syndromes (ACS) treated with standard therapy. The primary efficacy endpoint in MERLIN-TIMI 36 is time to first occurrence of any element of the composite of cardiovascular death, myocardial infarction or recurrent ischemia in patients with non-ST elevation ACS receiving standard therapy. The study also evaluates the safety of long-term treatment with ranolazine compared to placebo.
NCT00099788 ↗	Metabolic Efficiency With Ranolazine for Less Ischemia in Non-ST Elevation Acute Coronary Syndromes	Completed	Gilead Sciences	Phase 3	2004-10-01	MERLIN-TIMI 36 is a multi-national, double-blind, randomized, placebo-controlled, parallel-group clinical trial designed to evaluate the efficacy and safety of ranolazine during acute and long-term treatment in approximately 5,500 patients with non-ST elevation acute coronary syndromes (ACS) treated with standard therapy. The primary efficacy endpoint in MERLIN-TIMI 36 is time to first occurrence of any element of the composite of cardiovascular death, myocardial infarction or recurrent ischemia in patients with non-ST elevation ACS receiving standard therapy. The study also evaluates the safety of long-term treatment with ranolazine compared to placebo.
NCT00091429 ↗	Ranolazine SR in Patients With Chronic Angina Who Remain Symptomatic Despite Maximal Treatment With Amlodipine	Completed	Gilead Sciences	Phase 3	2004-08-01	The study will be a multi-national, double-blind, randomized, placebo-controlled, parallel group study to evaluate the effectiveness of ranolazine (1000 mg twice daily) in approximately 500 patients with chronic angina who remain symptomatic despite daily treatment with the maximum labeled dose of amlodipine (10 mg daily), a calcium channel blocker approved for the treatment of chronic angina. Eligible patients will be randomized to receive ranolazine 1000 mg or placebo twice daily, in addition to a daily dose of 10 mg of amlodipine. Participation in the study will last approximately 3 months.

Clinical Trial Conditions for RANOLAZINE

Condition Name

Condition Name for RANOLAZINE
Intervention	Trials
Coronary Artery Disease	12
Angina	9
Type 2 Diabetes Mellitus	8
Atrial Fibrillation	5

Condition MeSH

Condition MeSH for RANOLAZINE
Intervention	Trials
Coronary Artery Disease	22
Myocardial Ischemia	22
Coronary Disease	15
Angina Pectoris	14

Clinical Trial Locations for RANOLAZINE

Trials by Country

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Trials by Country for RANOLAZINE
Location	Trials
United States	292
Poland	37
Canada	23
Mexico	15
Germany	13

Trials by US State

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−

Trials by US State for RANOLAZINE
Location	Trials
Florida	19
California	18
Texas	12
Louisiana	12
Pennsylvania	11

Clinical Trial Progress for RANOLAZINE

Clinical Trial Phase

Clinical Trial Phase for RANOLAZINE
Clinical Trial Phase	Trials
Phase 4	27
Phase 3	15
Phase 2/Phase 3	3

Clinical Trial Status

Clinical Trial Status for RANOLAZINE
Clinical Trial Phase	Trials
Completed	50
Unknown status	13
Terminated	12

Clinical Trial Sponsors for RANOLAZINE

Sponsor Name

Sponsor Name for RANOLAZINE
Sponsor	Trials
Gilead Sciences	46
Brigham and Women's Hospital	6
University of Pennsylvania	5

Sponsor Type

Sponsor Type for RANOLAZINE
Sponsor	Trials
Other	89
Industry	54
U.S. Fed	4

Ranolazine: Clinical Trials, Market Analysis, and Future Projections

Introduction

Ranolazine, marketed under the trade name Ranexa by Gilead Sciences, is a medication approved in 2006 for the treatment of chronic angina. This article delves into the recent clinical trials, market analysis, and future projections for ranolazine, providing a comprehensive overview of its efficacy, market dynamics, and growth prospects.

Clinical Trials and Efficacy

MARISA, CARISA, and ERICA Trials

Several clinical trials have demonstrated the efficacy of ranolazine in treating stable angina. The MARISA (Monotherapy Assessment of Ranolazine in Stable Angina) trial showed that ranolazine significantly improved total exercise duration, time to onset of angina, and time to ≥1 mm ST-segment depression when used as monotherapy[1].

The CARISA (Combination Assessment of Ranolazine in Stable Angina) trial found that ranolazine, when combined with other antianginal therapies, increased total exercise duration and reduced angina episodes and nitrate consumption[1].

The ERICA (Efficacy of Ranolazine in Chronic Angina) trial confirmed that ranolazine decreased angina attacks and nitrate consumption in patients who were symptomatic despite maximal doses of amlodipine[1].

MERLIN-TIMI 36 and TERISA Trials

The MERLIN-TIMI 36 trial, which assessed ranolazine in patients with unstable angina or non-ST-elevation acute coronary syndrome (NSTEMI-ACS), showed that ranolazine did not significantly reduce major adverse cardiovascular events but did reduce angina episodes and nitrate use[1].

The TERISA (Type 2 Diabetes Evaluation of Ranolazine in Subjects with Chronic Stable Angina) trial demonstrated that ranolazine reduced weekly angina frequency and sublingual nitroglycerin use in patients with diabetes and coronary artery disease[1].

Real-World Data

Real-world data from the use of ranolazine in patients with stable angina have shown that it is well tolerated and effectively reduces angina attacks, improves Canadian Cardiovascular Society (CCS) class, and enhances quality of life (QoL) scores[3].

Market Analysis

Current Market Size and Growth

The global ranolazine market was valued at USD 1.5 billion in 2023 and is expected to reach USD 2.2 billion by 2031, growing at a compound annual growth rate (CAGR) of 4.5% from 2024 to 2031[5].

Market Drivers

Several factors are driving the growth of the ranolazine market:

• Increasing Incidence of Cardiovascular Diseases: The growing incidence of cardiovascular illnesses increases the demand for effective treatments like ranolazine[5].
• Clinical Evidence: Favorable clinical trial results and real-world data supporting the safety and efficacy of ranolazine are boosting its adoption[5].
• Novel Formulations and Combination Medicines: The development of new formulations and combination drugs incorporating ranolazine enhances its market appeal[5].
• Aging Population and Personalized Medicine: The aging population and the increasing emphasis on personalized cardiovascular therapy also contribute to the market's growth[5].

Market Segmentation

The ranolazine market is segmented based on application (extended-release tablets, oral formulations, combination drugs) and product (chronic angina treatment, cardiovascular health, clinical trials, prescription medication), as well as geographical regions (North America, Europe, Asia-Pacific, South America, and Middle-East and Africa)[5].

Market Projections

Future Growth

The ranolazine market is projected to experience substantial growth between 2024 and 2032, driven by a notable CAGR. Market participants are advised to invest in research and development, form strategic alliances, and tailor their offerings to evolving consumer preferences to leverage the opportunities in the ranolazine market[2].

Key Factors Influencing Growth

• Product Differentiation: Different types and categories of ranolazine products will play a significant role in driving market growth[2].
• Cost Reduction and Supply Chain Optimization: Achieving cost reductions and optimizing supply chains are crucial for widespread adoption[2].
• Projection Period: The chosen projection period (2024 to 2032) provides a roadmap for market analysis and strategic planning[2].

Competitive Landscape

The ranolazine market is characterized by a competitive landscape where market players must focus on innovation, strategic partnerships, and adapting to consumer preferences. The development of novel formulations and combination drugs is a key strategy to maintain market share and drive growth[5].

Conclusion

Ranolazine has established itself as a valuable treatment option for chronic angina, supported by robust clinical trial data and real-world evidence. The market for ranolazine is expected to grow significantly, driven by increasing demand for effective cardiovascular treatments, favorable clinical outcomes, and the development of new formulations.

Key Takeaways

• Clinical Efficacy: Ranolazine has been shown to reduce angina attacks, improve exercise duration, and enhance quality of life in patients with stable angina.
• Market Growth: The global ranolazine market is projected to grow at a CAGR of 4.5% from 2024 to 2031.
• Market Drivers: Increasing incidence of cardiovascular diseases, favorable clinical evidence, and the development of novel formulations are key drivers.
• Competitive Landscape: Market players must focus on innovation, strategic partnerships, and adapting to consumer preferences.

FAQs

What is ranolazine used for?

Ranolazine is used to treat chronic angina, a condition characterized by chest pain or discomfort due to reduced blood flow to the heart.

What are the key clinical trials that have evaluated ranolazine?

Key clinical trials include the MARISA, CARISA, ERICA, MERLIN-TIMI 36, and TERISA trials, which have demonstrated the efficacy of ranolazine in treating stable angina and other cardiovascular conditions.

What is the projected growth rate of the ranolazine market?

The ranolazine market is expected to grow at a CAGR of 4.5% from 2024 to 2031.

What are the main drivers of the ranolazine market growth?

The main drivers include the increasing incidence of cardiovascular diseases, favorable clinical evidence, the development of novel formulations, and the aging population.

How is the ranolazine market segmented?

The market is segmented based on application, product, and geographical regions, including extended-release tablets, oral formulations, combination drugs, and different regions such as North America, Europe, and Asia-Pacific.

Sources

1. Update on evidence for treatment with ranolazine in stable angina. Swiss Medical Weekly, 2023.
2. Ranolazine Market Projections: Current and Future Growth by 2032. News Channel Nebraska, 2024.
3. Real-World Data from the Use of Ranolazine in Patients with Stable Angina. MDPI, 2023.
4. Clinical Trials Register. European Union Clinical Trials Register.
5. Ranolazine Market Size, Share and Forecast to 2031. Market Research Intellect, 2024.