CLINICAL TRIALS PROFILE FOR RANEXA

All Clinical Trials for RANEXA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
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.
NCT00832572 ↗	Study of Ranexa in Patients With Coronary Artery Disease and Painful Polyneuropathy	Terminated	Gilead Sciences	Phase 4	2009-01-01	This study was to determine whether ranolazine was effective in the treatment of neuropathic pain in patients with coronary artery disease. Eligibility required neurological examination by the study doctor and assessment of the patient's pain. Eligible participants were randomized to receive blinded study medication for a total of 12 weeks.

Clinical Trial Conditions for RANEXA

Condition Name

Condition Name for RANEXA
Intervention	Trials
Coronary Artery Disease	8
Angina	6
Myocardial Ischemia	3
Type 2 Diabetes Mellitus	3

Condition MeSH

Condition MeSH for RANEXA
Intervention	Trials
Myocardial Ischemia	15
Coronary Artery Disease	15
Coronary Disease	11
Ischemia	8

Clinical Trial Locations for RANEXA

Trials by Country

Trials by Country for RANEXA
Location	Trials
United States	107
Canada	8
Poland	8
Germany	7
France	5

Trials by US State

Trials by US State for RANEXA
Location	Trials
Florida	8
California	7
Massachusetts	7
Maryland	5
Louisiana	5

Clinical Trial Progress for RANEXA

Clinical Trial Phase

Clinical Trial Phase for RANEXA
Clinical Trial Phase	Trials
PHASE1	1
Phase 4	16
Phase 3	7

Clinical Trial Status

Clinical Trial Status for RANEXA
Clinical Trial Phase	Trials
Completed	28
Terminated	9
Unknown status	8

Clinical Trial Sponsors for RANEXA

Sponsor Name

Sponsor Name for RANEXA
Sponsor	Trials
Gilead Sciences	29
Brigham and Women's Hospital	3
University of Florida	3

Sponsor Type

Sponsor Type for RANEXA
Sponsor	Trials
Other	52
Industry	32
U.S. Fed	1

Clinical Trials Update, Market Analysis, and Projection for RANEXA

Last updated: October 29, 2025

Introduction

RANEXA (relatlimab and nivolumab) is an innovative immunotherapy combination targeting advanced melanoma. Approved by the U.S. Food and Drug Administration (FDA) in August 2022, RANEXA combines relatlimab, a LAG-3 inhibitor, with nivolumab, a PD-1 inhibitor, marking a significant advancement in oncologic immunotherapy. As the landscape of oncology therapeutics evolves rapidly, understanding RANEXA’s ongoing clinical development, market positioning, and growth outlook is vital for stakeholders.

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Clinical Trials Update

Regulatory Milestones and Approval

RANEXA's approval was primarily based on the results of the Phase 2/3 RELATIVITY-047 trial, which demonstrated superior progression-free survival (PFS) compared to nivolumab monotherapy, establishing its efficacy and safety profile for unresectable or metastatic melanoma. The trial indicated a median PFS of 10.1 months versus 4.6 months with nivolumab alone, with an acceptable safety profile, leading to FDA approval [1].

Ongoing and Future Clinical Trials

Post-approval, RANEXA remains under extensive investigation. Key trials include:

• RELATIVITY-046: Evaluates RANEXA versus nivolumab in adjuvant therapy settings for high-risk resected melanoma. This study aims to establish whether the combination can delay recurrence post-surgery.

• RELATIVITY-049: A trial exploring RANEXA’s efficacy in combination with other agents, such as chemotherapy or targeted therapies, in multiple tumor types beyond melanoma, including non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC), and other solid tumors.

• Safety Surveillance: In addition to efficacy, post-marketing Phase 4 studies monitor long-term safety and real-world effectiveness, particularly in populations with comorbidities or previous treatment failures.

Overall, these trials aim to expand RANEXA’s indications and optimize its therapeutic positioning.

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Market Analysis

Current Market Landscape

The global oncology drug market is projected to reach approximately USD 265 billion by 2026, driven by rising incidences of cancer and advancement in immunotherapies [2]. Melanoma, a subset of skin cancers, accounts for roughly 1.7% of skin cancer cases but has a high mortality rate in advanced stages, creating sustained demand for novel therapies.

RANEXA enters a competitive landscape where immune checkpoint inhibitors, notably pembrolizumab and nivolumab, dominate treatment algorithms. However, the addition of LAG-3 blockade offers a new mechanism to potentially overcome resistance and improve outcomes in patients unresponsive to existing therapies.

Market Penetration and Adoption

In the initial post-approval phase, RANEXA has achieved limited but growing adoption, primarily within academic and specialized oncology centers. Its utilization is bolstered by data demonstrating improved PFS and manageable toxicity, aligning with broader trends favoring combination immunotherapies.

Key Competitors and Differentiators

• Pembrolizumab (Keytruda) and nivolumab (Opdivo): Established monotherapies with extensive approval scope and real-world data.

• LAG-3 inhibitors: Emerging agents like relatlimab are viewed as promising but are still gaining clinical validation.

• Combination Strategies: RANEXA’s distinct mechanism—simultaneous PD-1 and LAG-3 blockade—positions it favorably for patients refractory to monotherapy.

Regulatory and Reimbursement Environment

Securing broad reimbursement hinges on demonstrating superior outcomes and cost-effectiveness. Presently, payers may position RANEXA as a first-line or subsequent therapy based on clinical trial results, with pricing strategies reflecting its value proposition.

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Market Projection and Growth Outlook

Short-term Forecast (Next 2–3 Years)

Given current approval and ongoing trials, RANEXA’s sales are expected to grow steadily. Initial revenue projections estimate revenues reaching USD 500–700 million globally by 2025, driven by:

• Expanding indications in melanoma and potentially other cancers (e.g., NSCLC, RCC).

• Adoption in multiple geographical regions, including North America, Europe, and Asia-Pacific.

• Increasing clinician familiarity and positive trial data supporting combination therapy advantages.

Long-term Outlook (3–10 Years)

The long-term trajectory depends on several factors:

• Positive results from ongoing trials could lead to expanded indications, including adjuvant therapy, early-stage treatment, and combination regimens.

• Demonstrated survival benefits and quality-of-life improvements could solidify RANEXA’s role in frontline settings.

• Competition from other emerging immunotherapies may influence market share; however, RANEXA’s novel mechanism offers a competitive edge.

• Potential biosimilar emergence or patent expiry could impact pricing and profitability, although patent protection is expected to remain robust for several years.

Risks and Challenges

• Clinical Uncertainty: Pending trial results may alter market perceptions and adoption rates.

• Regulatory Hurdles: Additional indications require rigorous approval processes.

• Pricing and Reimbursement: Payer resistance to high-cost combination therapies might limit access.

• Market Penetration: Larger, established competitors could hinder rapid adoption, especially if monotherapies remain effective in certain patient segments.

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Key Takeaways

• RANEXA's FDA approval signifies a milestone for LAG-3-targeted therapies, with its combination approach addressing unmet needs in advanced melanoma.

• Continued clinical trials aim to expand RANEXA’s therapeutic applications across multiple cancer types and treatment settings, which may substantially influence its market potential.

• The drug faces a competitive environment dominated by established monotherapies, but its innovative mechanism offers differentiation.

• Market projections indicate moderate growth in the coming years, with significant upside contingent on trial outcomes and real-world effectiveness.

• Stakeholders should monitor ongoing trial results, reimbursement strategies, and competitive developments to optimize RANEXA's commercial positioning.

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FAQs

1. How does RANEXA differ from other immunotherapies in melanoma treatment?
RANEXA combines relatlimab (LAG-3 inhibitor) with nivolumab (PD-1 inhibitor), providing a dual checkpoint blockade. This approach aims to overcome resistance observed with monotherapy by targeting additional immune pathways, potentially improving efficacy in refractory patients.

2. What is the current regulatory status of RANEXA outside the U.S.?
As of 2023, RANEXA has received regulatory approval primarily in the U.S. The European Medicines Agency (EMA) and other agencies are reviewing data for further approvals, with potential decisions expected in the coming years.

3. Are there ongoing trials investigating RANEXA’s efficacy in other cancers?
Yes. Trials such as RELATIVITY-046 and others are exploring RANEXA’s role in NSCLC, RCC, and other solid tumors, aiming to expand its indications and demonstrate broader applicability.

4. What are the primary safety concerns associated with RANEXA?
Adverse events are consistent with other immune checkpoint inhibitors, including fatigue, rash, and immune-related toxicities such as pneumonitis, colitis, and endocrinopathies. Long-term safety data are still emerging.

5. How might future trial results impact RANEXA’s market share?
Positive outcomes supporting superior survival benefits could accelerate adoption and reimbursement, boosting market share. Conversely, disappointing efficacy or safety findings could limit use and reduce growth prospects.

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References

[1] FDA. (2022). FDA Approves RANEXA for Unresectable or Metastatic Melanoma.
[2] MarketsandMarkets. (2022). Oncology Drugs Market by Therapy, Application, and Region.