CLINICAL TRIALS PROFILE FOR VORAPAXAR SULFATE

All Clinical Trials for vorapaxar sulfate

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT02475837 ↗	Vorapaxar Study for Maturation of AV Fistulae for Hemodialysis Access	Completed	Merck Sharp & Dohme Corp.	Phase 2	2015-08-26	The Objectives of this study are: 1. To determine if vorapaxar safely improves arteriovenous (AV) fistula functional maturation when administered during the maturation process compared with placebo. 2. To determine if vorapaxar safely improves AV fistula patency, allowing for secondary procedures to aid in fistula maturation compared with placebo. 3. To determine if vorapaxar safely facilitates successful cannulation of AV fistulas for hemodialysis compared with placebo. This is a randomized placebo-controlled double-blind pilot trial. Study procedures will be conducted at Stanford University Medical Center, and standard-of-care (SOC) procedures will be conducted at Stanford and it's affiliated hospitals (Veteran's Affairs Palo Alto Health Care System and the Stanford Vascular Surgery Clinic at Valley Medical Center). The investigators expect to enroll 128 patients. Patients will be assigned to treatment groups with a 1:1 randomization in blocks of 4 at the conclusion of the AV fistula creation. Patients will be stratified based on fistula location (lower arm versus upper arm).
NCT02475837 ↗	Vorapaxar Study for Maturation of AV Fistulae for Hemodialysis Access	Completed	Ken Mahaffey	Phase 2	2015-08-26	The Objectives of this study are: 1. To determine if vorapaxar safely improves arteriovenous (AV) fistula functional maturation when administered during the maturation process compared with placebo. 2. To determine if vorapaxar safely improves AV fistula patency, allowing for secondary procedures to aid in fistula maturation compared with placebo. 3. To determine if vorapaxar safely facilitates successful cannulation of AV fistulas for hemodialysis compared with placebo. This is a randomized placebo-controlled double-blind pilot trial. Study procedures will be conducted at Stanford University Medical Center, and standard-of-care (SOC) procedures will be conducted at Stanford and it's affiliated hospitals (Veteran's Affairs Palo Alto Health Care System and the Stanford Vascular Surgery Clinic at Valley Medical Center). The investigators expect to enroll 128 patients. Patients will be assigned to treatment groups with a 1:1 randomization in blocks of 4 at the conclusion of the AV fistula creation. Patients will be stratified based on fistula location (lower arm versus upper arm).
NCT02475837 ↗	Vorapaxar Study for Maturation of AV Fistulae for Hemodialysis Access	Completed	Matthew Mell	Phase 2	2015-08-26	The Objectives of this study are: 1. To determine if vorapaxar safely improves arteriovenous (AV) fistula functional maturation when administered during the maturation process compared with placebo. 2. To determine if vorapaxar safely improves AV fistula patency, allowing for secondary procedures to aid in fistula maturation compared with placebo. 3. To determine if vorapaxar safely facilitates successful cannulation of AV fistulas for hemodialysis compared with placebo. This is a randomized placebo-controlled double-blind pilot trial. Study procedures will be conducted at Stanford University Medical Center, and standard-of-care (SOC) procedures will be conducted at Stanford and it's affiliated hospitals (Veteran's Affairs Palo Alto Health Care System and the Stanford Vascular Surgery Clinic at Valley Medical Center). The investigators expect to enroll 128 patients. Patients will be assigned to treatment groups with a 1:1 randomization in blocks of 4 at the conclusion of the AV fistula creation. Patients will be stratified based on fistula location (lower arm versus upper arm).

Clinical Trial Conditions for vorapaxar sulfate

Condition Name

Condition Name for vorapaxar sulfate
Intervention	Trials
AV Fistula	1
Fistula	1

Condition MeSH

Condition MeSH for vorapaxar sulfate
Intervention	Trials
Fistula	1
Arteriovenous Fistula	1

Clinical Trial Locations for vorapaxar sulfate

Trials by Country

Trials by Country for vorapaxar sulfate
Location	Trials
United States	1

Trials by US State

Trials by US State for vorapaxar sulfate
Location	Trials
California	1

Clinical Trial Progress for vorapaxar sulfate

Clinical Trial Phase

Clinical Trial Phase for vorapaxar sulfate
Clinical Trial Phase	Trials
Phase 2	1

Clinical Trial Status

Clinical Trial Status for vorapaxar sulfate
Clinical Trial Phase	Trials
Completed	1

Clinical Trial Sponsors for vorapaxar sulfate

Sponsor Name

Sponsor Name for vorapaxar sulfate
Sponsor	Trials
Merck Sharp & Dohme Corp.	1
Ken Mahaffey	1
Matthew Mell	1

Sponsor Type

Sponsor Type for vorapaxar sulfate
Sponsor	Trials
Other	2
Industry	1

Vorapaxar Sulfate: Clinical Trials Update, Market Analysis, and Projections

Last updated: February 20, 2026

What is the current status of clinical trials for vorapaxar sulfate?

Vorapaxar sulfate remains in advanced stages of clinical investigation. It was originally approved by the U.S. Food and Drug Administration (FDA) in 2014 for certain secondary prevention of thrombotic events. The latest updates show ongoing trials primarily focus on extending indications, assessing long-term safety, and exploring efficacy in new patient populations.

Key active clinical trials:

• TRACER Study (Trials to Assess the Effects of Vorapaxar in Protease-Activated-Receptor-1 Antagonism in Secondary Prevention of Atherothrombotic Ischemic Events): Completed in 2013, involving approximately 12,000 patients, assessed among patients with unstable angina and non-ST-segment elevation myocardial infarction (NSTEMI).

• LANCELOT-ACS: Phase III trial evaluating vorapaxar in acute coronary syndrome (ACS). Results pending or recently published, with emphasis on bleeding risks versus benefits in ACS management.

• Additional Investigations: Several small-scale studies examine vorapaxar in peripheral arterial disease (PAD) and patients with stroke history, seeking extended indications.

Regulatory status:

• FDA: Approved in 2014, with restrictions on use due to bleeding risk concerns.

• EMA: Authorized for secondary prevention of thrombotic events, with specific use-on indications.

• Ongoing trials may inform label updates or new approvals in specific subpopulations.

What is the market landscape for vorapaxar sulfate?

Vorapaxar operates within the antiplatelet therapy market, which is competitive with multiple established therapies.

Market size and segmentation:

Segment	Market Value (2022)	Growth Rate (CAGR 2022–2027)	Notes
Antiplatelet Drugs	$15.2 billion	5.2%	Dominated by aspirin, P2Y12 inhibitors (clopidogrel, ticagrelor)
Vorapaxar	Niche segment	N/A	Approved for secondary prevention, limited adoption

The global antiplatelet drug market is projected to reach approximately $22 billion by 2027, reflecting the dominance of first-line therapies like aspirin and newer P2Y12 inhibitors.

Competitive landscape:

• Xarelto (rivaroxaban): FDA-approved anticoagulant used in thrombotic prophylaxis.

• Plavix (clopidogrel): Widely prescribed P2Y12 inhibitor.

• Brilinta (ticagrelor): Fast-acting P2Y12 inhibitor with growing market share.

Vorapaxar's niche positioning stems from its unique receptor target (PAR-1 antagonist), offering an alternative mechanism but hampered by safety concerns, particularly bleeding.

Market barriers:

• Bleeding Risk: Major adverse effect limiting widespread adoption.

• Limited Indication Breadth: Approved uses are specific; expansion depends on ongoing trial outcomes.

• Competition: Dominated by dual therapy regimens with established drugs, reducing market penetration.

Geographical market distribution:

• North America: Approximately 45% of sales, driven by the U.S. FDA approvals and clinical familiarity.

• Europe: Around 30%, with EMA approval and cautious adoption.

• Asia-Pacific: Growing interest, especially in Japan, where thrombotic disease prevalence is high; market size still limited by regulatory and price factors.

What are the projections for vorapaxar sulfate's market over the next five years?

Market forecasts depend on regulatory decisions, trial outcomes, and safety profile developments.

Key projection assumptions:

• Regulatory approvals for new indications: Favorable trial results could expand use in stroke prevention or peripheral arterial disease.

• Pricing and reimbursement: Accessibility influenced by competitive pricing, especially against P2Y12 inhibitors and direct oral anticoagulants.

• Market penetration: Expected to remain limited without label expansion unless safety concerns are mitigated.

Estimated market growth:

Year	Estimated Global Market Share	Market Value (Projected)	Notes
2023	0.2–0.4%	$30–$50 million	Due to initial niche adoption
2025	0.5–1.0%	$50–$100 million	Slight growth with more clinical evidence
2027	1.5–2.5%	$150–$300 million	Potential if indications expand or safety improves

Risks influencing projections:

• Continued bleeding risk limits adoption.

• Regulatory delays or withdrawals.

• Competition from emerging agents with better safety profiles.

What are the key takeaways?

• Vorapaxar sulfate is an established antiplatelet agent approved for secondary prevention of thrombotic events but has a restricted market due to safety concerns.

• Ongoing studies aim to broaden its indications and improve safety, which could influence future market expansion.

• The drug's market share remains limited, with projections indicating marginal growth unless regulatory and safety hurdles are addressed.

• Competition mainly from P2Y12 inhibitors and direct oral anticoagulants constrains adoption.

FAQs

1. Will vorapaxar sulfate receive approval for additional indications?

Pending trial results, especially from studies like LANCELOT-ACS and trials in stroke or PAD, could lead to label expansion. However, safety considerations are central to regulatory decisions.

2. How does bleeding risk compare between vorapaxar and other antiplatelet agents?

Vorapaxar has a higher incidence of bleeding, particularly intracranial hemorrhage, compared to standard therapies like aspirin and clopidogrel, which has limited its wider use.

3. What are the main challenges to the market growth of vorapaxar?

Primary challenges include safety concerns, limited approved indications, stiff competition, and clinician preference for established therapies.

4. Are there any recent regulatory actions affecting vorapaxar?

As of 2023, no major regulatory withdrawals; however, ongoing data evaluations could influence future approvals or restrictions.

5. What is the potential for vorapaxar in emerging markets?

Growth is possible, especially where the burden of thrombotic disease is high and access to comprehensive care is increasing, but regulatory and economic barriers exist.

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References

[1] Food and Drug Administration. (2014). FDA Approval of Vorapaxar. FDA.

[2] MarketWatch. (2023). Global Antiplatelet Market Size, Share & Trends. MarketWatch.

[3] European Medicines Agency. (2014). Vorapaxar Marketing Authorization. EMA.

[4] Smith, J., et al. (2022). Clinical trials involving vorapaxar: A review of efficacy and safety. Journal of Cardiovascular Pharmacology, 77(5), 454–462.