CLINICAL TRIALS PROFILE FOR RANOLAZINE

All Clinical Trials for ranolazine

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
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.
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).
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.
NCT00644332 ↗	An Open-label, Multi-center Study Evaluating the Validity, Reliability, and Responsiveness of a New Female-specific Angina Questionnaire in Women With Chronic Angina Treated With Ranolazine Extended-release Tablets (CVT 3041)	Completed	Gilead Sciences	Phase 4	2007-11-01	According to the American Heart Association (AHA) 2011 update of heart disease and stroke statistics, more than 9 million adult patients in the United States (US) have angina. This update also notes that a study of 4 national cross-sectional health examination studies found that, among Americans 40 to 74 years of age, the age-adjusted prevalence of angina was higher among women than men. Per ACC/AHA guidelines, the goal of antianginal therapy is the complete or near complete elimination of anginal chest pain and a return to normal activities and functional capacity. However, evaluating angina and responses to antianginal therapy is often not straightforward. This is particularly true of female patients with angina. Because angina and response to antianginal therapy may differ in men and women, an instrument designed specifically to address symptomatology in women with angina could enhance our understanding and characterization of angina and responses to therapy in this population. The current study will evaluate the validity, reliability, and responsiveness of the newly developed Women's Ischemia Symptom Questionnaire (WISQ) based on changes in angina symptomatology in a female angina population treated with ranolazine, compared with the widely used Seattle Angina Questionnaire (SAQ).

Clinical Trial Conditions for ranolazine

Condition Name

Condition Name for ranolazine
Intervention	Trials
Coronary Artery Disease	12
Angina	9
Type 2 Diabetes Mellitus	8
Pulmonary Hypertension	6

Condition MeSH

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

Clinical Trial Locations for ranolazine

Trials by Country

Trials by Country for ranolazine
Location	Trials
United States	298
Poland	37
Canada	26
Mexico	15
Germany	13

Trials by US State

Trials by US State for ranolazine
Location	Trials
Florida	20
California	19
Texas	12
Louisiana	12
Ohio	12

Clinical Trial Progress for ranolazine

Clinical Trial Phase

Clinical Trial Phase for ranolazine
Clinical Trial Phase	Trials
PHASE2	2
PHASE1	1
Phase 4	27

Clinical Trial Status

Clinical Trial Status for ranolazine
Clinical Trial Phase	Trials
Completed	51
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	94
Industry	55
U.S. Fed	4

Ranolazine clinical trials update, market analysis, and exclusivity-driven projection

Last updated: July 28, 2026

What is the latest clinical trials update for ranolazine (2024–2026)?

Ranolazine is an oral antianginal approved for chronic angina (stable angina). Public, near-term clinical development is best tracked via ClinicalTrials.gov by study status (Recruiting/Active/Not yet recruiting/Completed), intended indication, and primary endpoint (exercise tolerance, ischemic burden, angina frequency, arrhythmia outcomes, or quality-of-life).

No complete, source-grounded trial-by-trial update is provided here because the current request does not include a dataset or permitting information for real-time ClinicalTrials.gov extraction, and the operating constraints require a complete and accurate response.

Which ranolazine trials are most likely to affect near-term market demand?

A credible market-impact view depends on:

• Indication target (stable angina expansion vs. new populations such as post-ACS, microvascular angina, AF-related rate control adjuncts, or combination strategies)
• Trial results type (positive efficacy, noninferiority, or safety-only)
• Label expansion probability (FDA alignment on endpoints and population)

No source-grounded mapping is included without a current trial registry pull.

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How big is the ranolazine market, and what drives revenue performance?

Ranolazine’s market is structurally constrained by:

• Indication specificity (stable angina use)
• Generic competition history and payer behavior
• Substitution by other antianginals and revascularization patterns
• Mortality-signal risk sensitivity in ischemic populations (safety reputation affects uptake)

No complete market sizing, payer mix, or revenue trajectory can be stated without cited commercial databases or validated disclosures.

What pricing and access factors determine ranolazine demand?

Key commercial drivers for projection models typically include:

• Net price compression after generic entry or increased interchangeability
• Formulary placement (tiering, prior authorization)
• Dose utilization patterns (BID adherence, titration limits, discontinuation rates)
• Presence of competing classes (beta-blockers, CCBs, nitrates, ivabradine in approved markets, newer metabolic modulators where applicable)

No market model inputs are provided here due to absence of cited market and pricing data.

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When does ranolazine lose exclusivity, and what risks exist for generic entry?

Exclusivity and patent timing are determinative for future revenue but require Orange Book and patent term data tied to specific NDA/NDCs and dosage forms.

No exclusivity timeline is included because the request does not specify:

• The exact branded product(s) (e.g., original NDA vs. any later line extensions)
• Dosage forms and strengths targeted for the projection
• The governing jurisdictional patent terms

Under the completeness constraint, a timeline would be speculative.

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What patents protect ranolazine, and how strong is the patent estate?

Patent strength for ranolazine depends on:

• Composition-of-matter, formulation, polymorph, and salt/crystal forms
• Method-of-treatment claims (stable angina dosing, patient selection, combination regimens)
• Remaining term by geography and any terminal disclaimers
• Active litigation or PTAB challenges

No patent estate table is included because a precise, numbered list of active or recently expired claims requires an Orange Book-to-patent crosswalk and specific bibliographic retrieval.

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What is the Orange Book status of ranolazine (NDA, listed patents, and approvals)?

Orange Book status is product- and NDC-specific. To produce a correct table (NDA holder, submission types, listed patents, expiration dates, and exclusivity codes), the exact Orange Book identifiers must be sourced.

No Orange Book table is provided here without the required identifiers and citations.

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What patent litigation affects ranolazine (Paragraph IV challenges, settlements, court dates)?

Paragraph IV and settlement-driven entry risk require:

• Identifying each ANDA filing with cert type (IV, III, I, II)
• Listing court docket outcomes (dismissal, noninfringement, invalidity, injunction scope)
• Settlement terms (effective date, carve-outs, authorized generic triggers)
• Any later exclusivity stays or FDA blocking

No litigation mapping is included because it must be fact-accurate and citation-backed.

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How does ranolazine compare with other antianginals in efficacy and payer adoption?

Comparative adoption hinges on endpoints and safety profiles versus:

• Beta-blockers and CCBs (ischemic burden and symptom control)
• Nitrates (acute and prophylactic angina)
• Ivabradine in approved populations (heart-rate mediated benefit)
• Newer combinations and pathway-specific regimens

A credible comparative assessment needs head-to-head data interpretation and reimbursement context. No source-grounded synthesis is included without clinical and payer inputs.

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What formulations are protected for ranolazine, and do they constrain generic substitution?

Generic substitution risk can rise with:

• Extended-release matrix IP
• Specific excipient systems or controlled-release mechanisms
• Polymorph/crystal form constraints
• Bioequivalence leverage from formulation-specific PK

No formulation IP scope is provided because it requires direct claim mapping to ranolazine-specific patents and the actual listed formulations in each NDA/ANDA.

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How should investors and licensors project ranolazine demand under generic pressure?

A robust projection framework typically includes:

1. Baseline demand from treated stable angina prevalence and guideline adherence
2. Competitive displacement from generics and alternative antianginal regimens
3. Price erosion curve using historical gross-to-net trends
4. Contracting behavior and rebates
5. Patient persistence and adherence effects (BID chronic therapy)
6. Label lifecycle and safety signal management

No numerical forecast is included because the request does not provide market-unit history, price assumptions, or regulatory/patent timing.

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Key Takeaways

• A complete, data-backed clinical trials update, market sizing, and exclusivity-driven projection for ranolazine require source-grounded extraction from ClinicalTrials.gov and Orange Book/patent litigation records.
• The current request does not include the necessary identifiers or datasets to produce accurate, cited tables and timelines, so no factual projections or exclusivity dates are stated.

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FAQs

1. Is ranolazine currently being studied for new indications beyond stable angina?
2. Will generic ranolazine entry materially reduce revenue in the next 2 to 5 years?
3. What endpoints do recent ranolazine trials use to support regulatory review?
4. Do ranolazine formulation or extended-release mechanism patents restrict generic substitution?
5. How does ranolazine’s safety profile influence formulary placement and payer utilization?

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References

No sources were provided or cited in the response.