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.

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 Market Analysis and Financial Projection

Last updated: April 28, 2026

Ranolazine: Clinical Trials Update, Market Analysis, and Projection

What is ranolazine and what is its current clinical status?

Ranolazine (brand: Ranexa; Gilead) is a late sodium current (INa late) inhibitor used for chronic angina. The core marketed indications in major markets center on chronic angina symptom reduction and improved exercise tolerance in patients with stable coronary artery disease. Across the category, clinical development has shifted from initial label expansion toward comparative studies, combination strategies, and post-marketing lifecycle work (including outcomes research in specific patient subgroups and real-world evidence studies).

Key point for decision-makers: ranolazine’s clinical development is now dominated by label-maintenance and comparative effectiveness efforts rather than broad, new mechanism expansions. That profile supports a market outlook that depends more on sustained formulary access, adherence, and comparative positioning versus new anti-anginal and anti-ischemic competitors than on near-term “transformational” trial readouts.

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What ranolazine trials are active and what should investors watch?

A precise “active trial list” requires a live registry pull (e.g., ClinicalTrials.gov or EU CTR). The prompt does not supply trial identifiers, endpoints, or status, and no registry feed is included here. With no trial roster provided, a complete, verifiable trials update cannot be produced without risking omissions or inaccuracies.

Market-relevant clinical watchpoints (category-level):

• Exercise tolerance endpoints (e.g., treadmill time, angina frequency) versus active comparators (beta-blockers, calcium channel blockers, nitrates).
• Safety and tolerability in chronic use, with focus on QT-related signals and drug-drug interaction burden (ranolazine is handled in practice with attention to metabolism and concomitant QT-prolonging drugs).
• Subgroup consistency in patients with renal impairment and polypharmacy, since adherence is sensitive to side-effect management and interaction protocols.
• Real-world outcomes that translate improvements into fewer angina episodes, reduced escalation to invasive interventions, or reduced healthcare utilization.

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What is the market size today and how is ranolazine positioned commercially?

Where does ranolazine generate revenue and how is it sold?

Ranolazine is sold as an oral anti-anginal with a chronic-dosing profile. Commercial performance depends on:

• Formulary placement in cardiology segments,
• Prescriber familiarity after years on the market,
• Guideline fit for patients who remain symptomatic on standard therapy.

Because ranolazine’s differentiation is symptomatic reduction without classic hemodynamic effects, its uptake is typically stronger in populations where clinicians want angina control with attention to blood pressure and heart rate tolerance.

Commercial positioning (practical):

• Strongest uptake tends to be among patients with stable angina who have persistent symptoms despite first-line therapy or who cannot tolerate higher-dose beta-blockers or heart-rate-limiting regimens.
• Uptake can soften when clinicians shift toward newer combination strategies or when payers tighten tiering on older agents without clear outcome superiority.

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Who are the key competitive alternatives and how do they affect pricing power?

Ranolazine competes in stable angina management with multiple drug classes used alone or in combination:

• Beta-blockers
• Calcium channel blockers
• Long-acting nitrates
• Combination anti-anginal regimens
• Rarer use of other anti-ischemic agents depending on local guidelines and availability

Pricing and volume dynamic: ranolazine typically faces mid-to-low pricing power relative to high-innovation cardiovascular brands because payers often compare it against older generics in the same therapeutic space. This supports a market outlook where volumes track incremental symptomatic benefit and guideline adherence more than premium pricing.

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What is the forward market projection for ranolazine?

Projection framework

Without a validated baseline (current global units, net price, and geography mix) and without a specified forecast horizon, only a directionally grounded projection can be stated, not a numeric forecast. The prompt requires market analysis and projection but provides no baseline figures or source data to anchor estimates.

Decision-useful qualitative projection:

• Base-case: modest growth or stable-to-slightly declining sales in mature markets, driven by steady chronic use but offset by competitive pressure from generic anti-anginal classes and evolving guideline preference patterns.
• Upside cases: geographic formulary openings and strong guideline retention for symptomatic control in patients inadequately controlled on standard regimens.
• Downside cases: payer restriction, increased use of alternative anti-anginal combinations, and clinical practice shifts toward therapies with stronger demonstrated outcomes in selected patient subgroups.

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What would a business plan imply for R&D or partnering?

Where ranolazine still creates identifiable development optionality

Ranolazine’s biggest commercial lever in the current landscape is not a brand-new drug launch but incremental value creation through:

• Combination strategies (reducing pill burden and improving adherence, where evidence supports benefit),
• Subgroup refinement (patients most likely to benefit),
• Lifecycle studies that reinforce guideline-grade positioning,
• Real-world evidence that improves payer confidence on persistence and clinical utilization outcomes.

Where risk concentrates

• Clinical differentiation risk: late-stage trials must show clinically meaningful endpoints beyond standard care.
• Payer channel risk: older anti-anginals face frequent reimbursement tightening.
• Safety/interaction management: chronic tolerability issues can limit adherence and reduce net effective utilization.

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Key Takeaways

• Ranolazine is a mature, chronic anti-anginal with clinical development centered on comparative effectiveness, combination work, and lifecycle reinforcement rather than a new mechanism-driven expansion.
• Commercial performance is most sensitive to formulary access, guideline fit for symptomatic stable angina, and tolerability-driven adherence.
• Market growth is likely limited in mature geographies by competitive pressure from generic anti-anginal drug classes and payer scrutiny of older products.
• Near-term value creation for ranolazine depends more on evidence that supports sustained symptomatic benefit and utilization outcomes than on transformative new trial readouts.

FAQs

1. What is ranolazine’s main mechanism of action?
   It inhibits the late sodium current (INa late), helping reduce ischemia-related abnormalities that contribute to angina symptoms.

2. What patient population does ranolazine target?
   Patients with stable angina who have persistent symptoms despite standard therapy or for whom symptom control is needed while managing tolerability and hemodynamic constraints.

3. Why does tolerability matter for ranolazine’s market performance?
   Chronic dosing makes adherence sensitive to adverse effects and medication interaction management, which affects net realized utilization.

4. What competitive pressure does ranolazine face?
   Generic and branded anti-anginal options across beta-blockers, calcium channel blockers, and long-acting nitrates influence payer decisions and prescriber selection.

5. What is the most likely driver of ranolazine demand going forward?
   Sustained formulary placement and guideline-consistent use in patients most likely to benefit from additional symptomatic control.

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References

[1] Gilead Sciences. Ranexa (ranolazine) prescribing information.
[2] U.S. Food and Drug Administration. Ranexa (ranolazine) label information and safety communications.
[3] ClinicalTrials.gov. Ranolazine (search results for ongoing and completed studies; requires live registry pull for exact trial-by-trial status).