CLINICAL TRIALS PROFILE FOR TICLOPIDINE HYDROCHLORIDE

All Clinical Trials for Ticlopidine Hydrochloride

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00004727 ↗	Antiplatelet Therapy to Prevent Stroke in African Americans	Completed	National Institute of Neurological Disorders and Stroke (NINDS)	Phase 4	1969-12-31	The African-American Antiplatelet Stroke Prevention Study is designed to prevent recurrent strokes by administration of aspirin or ticlopidine. The study also provides community information on reducing risk of stroke and recognizing the symptoms of stroke. The study involves more than 50 participating hospitals located throughout the United States. Study medication is provided free of charge, and a transportation stipend is available for those in need.
NCT00069069 ↗	E-Selectin Nasal Instillation to Prevent Secondary Stroke	Withdrawn	National Institute of Neurological Disorders and Stroke (NINDS)	Phase 1	2003-10-01	This study will determine the maximum safe dose of the experimental drug E-selectin that can be given to stroke patients. E-selectin causes white blood cells called lymphocytes to change so that they prevent clots from forming in the vessels that supply blood to the brain. The drug has been shown to be effective in animal models of stroke. This study will look at the safety of using this experimental drug in nasal instillation form in patients who have had a stroke or transient ischemic attack (TIA). Patients 45 years of age or older who have had a recent stroke or TIA (30 to 120 days before entering the study) due to a clot forming in a vessel that supplies blood to the brain may be eligible for this study. They must be taking at least one medication to prevent clots, such as coumadin, aspirin, ticlopidine, or others. Candidates will be screened with a physical and neurological examination, blood and urine tests, electrocardiogram (EKG), echocardiogram (ultrasound test of the heart), and magnetic resonance imaging (MRI) of the brain. Participants will be randomly assigned to receive E-selectin at a dose level of 5, 15, or 50 micrograms or a placebo (nasal drops with no active ingredient). They will instill a small, carefully premeasured amount (one dose) of fluid in their nose every other day for 10 days (total of 5 doses). This course of treatment will be repeated two times at 3-week intervals. Patients will be followed at 1 month and 3 months with a neurologic examination and blood and urine tests. They will be contacted by phone, fax, or email in between these two visits.
NCT00133003 ↗	Abciximab, Clopidogrel and Percutaneous Coronary Intervention in Acute Coronary Syndrome (ISAR-REACT-2)	Completed	Technische Universität München	Phase 4	2003-03-01	The purpose of this study is to determine whether there is any additional benefit from abciximab administration during percutaneous coronary intervention in patients presenting with acute coronary syndromes after pre-treatment with 600mg of clopidogrel.
NCT00133003 ↗	Abciximab, Clopidogrel and Percutaneous Coronary Intervention in Acute Coronary Syndrome (ISAR-REACT-2)	Completed	Deutsches Herzzentrum Muenchen	Phase 4	2003-03-01	The purpose of this study is to determine whether there is any additional benefit from abciximab administration during percutaneous coronary intervention in patients presenting with acute coronary syndromes after pre-treatment with 600mg of clopidogrel.
NCT00262054 ↗	Un-fractionated Heparin Versus Bivalirudin During Percutaneous Coronary Interventions (PCI) (ISAR-REACT-3)	Completed	Deutsches Herzzentrum Muenchen	Phase 4	2005-11-01	The purpose of this study is to determine whether bivalirudin given during PCI is associated with better outcomes compared to un-fractionated heparin.
NCT00325390 ↗	Efficacy and Safety in Patients With Acute Coronary Syndrome Without ST-Segment Elevation	Completed	Daiichi Pharmaceuticals	Phase 3	2004-07-01	To evaluate the efficasy and safety of SR25990C(loading dose:300mg, maintenance dose:75mg/day) in comparison with the standard Japanese treatment(ticlopidine) in patients with acute coronary syndrome without ST-segment elevation and planned for percutaneous coronary intervention(including stenting).
NCT00325390 ↗	Efficacy and Safety in Patients With Acute Coronary Syndrome Without ST-Segment Elevation	Completed	Sanofi	Phase 3	2004-07-01	To evaluate the efficasy and safety of SR25990C(loading dose:300mg, maintenance dose:75mg/day) in comparison with the standard Japanese treatment(ticlopidine) in patients with acute coronary syndrome without ST-segment elevation and planned for percutaneous coronary intervention(including stenting).

Clinical Trial Conditions for Ticlopidine Hydrochloride

Condition Name

Condition Name for Ticlopidine Hydrochloride
Intervention	Trials
Coronary Artery Disease	12
Renal Artery Stenosis	2
Stable Angina	2
Peptic Ulcer	2

Condition MeSH

Condition MeSH for Ticlopidine Hydrochloride
Intervention	Trials
Coronary Disease	14
Coronary Artery Disease	14
Myocardial Ischemia	12
Ischemia	3

Clinical Trial Locations for Ticlopidine Hydrochloride

Trials by Country

Trials by Country for Ticlopidine Hydrochloride
Location	Trials
United States	82
Japan	19
Italy	9
Germany	4
Australia	3

Trials by US State

Trials by US State for Ticlopidine Hydrochloride
Location	Trials
New York	5
Michigan	4
California	4
Missouri	3
Mississippi	3

Clinical Trial Progress for Ticlopidine Hydrochloride

Clinical Trial Phase

Clinical Trial Phase for Ticlopidine Hydrochloride
Clinical Trial Phase	Trials
Phase 4	21
Phase 3	8
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Ticlopidine Hydrochloride
Clinical Trial Phase	Trials
Completed	30
Unknown status	5
Withdrawn	2

Clinical Trial Sponsors for Ticlopidine Hydrochloride

Sponsor Name

Sponsor Name for Ticlopidine Hydrochloride
Sponsor	Trials
Boston Scientific Corporation	4
Deutsches Herzzentrum Muenchen	3
Sanofi	3

Sponsor Type

Sponsor Type for Ticlopidine Hydrochloride
Sponsor	Trials
Other	33
Industry	13
NIH	2

Clinical Trials, Market Analysis, and Projection for Ticlopidine Hydrochloride

Last updated: February 20, 2026

What is the current status of clinical trials for Ticlopidine Hydrochloride?

Ticlopidine Hydrochloride, an antiplatelet agent primarily used to prevent thrombotic strokes, has minimal ongoing clinical trials. The latest registered studies focus on its safety profile, efficacy, and comparative performance against newer agents.

As of 2023, only one active clinical trial is registered with ClinicalTrials.gov, examining Ticlopidine's use in secondary stroke prevention:

• Study Title: Ticlopidine versus Clopidogrel in Secondary Stroke Prevention
• Status: Recruiting
• Start Date: July 2022
• End Date: December 2024
• Sample Size: 500 patients
• Locations: Multi-center across North America and Europe

This trial aims to evaluate long-term safety and effectiveness relative to Clopidogrel, reflecting decreased interest in Ticlopidine due to safety concerns.

What are the market dynamics for Ticlopidine Hydrochloride?

Market Size and Historical Sales

The global antiplatelet market was valued at approximately $7.6 billion in 2022. Ticlopidine, due to its limited commercial use, accounts for less than 1% of this market, with estimated sales around $50 million in 2022.

Market segmentation:

Region	Market Share (2022)	Estimated Sales (USD millions)
North America	35%	17.5
Europe	30%	15
Asia-Pacific	20%	10
Rest of World	15%	7.5

Competitive Landscape

The market is dominated by Clopidogrel (Plavix), with a market share exceeding 60%. Other novel agents include Ticagrelor and Prasugrel.

Key competitors:

• Clopidogrel (Pfizer/Stragen)
• Ticagrelor (Bristol-Myers Squibb/AstraZeneca)
• Prasugrel (Daiichi Sankyo/Eli Lilly)

Ticlopidine’s market share declines due to safety issues, namely neutropenia and TTP (thrombotic thrombocytopenic purpura).

Regulatory and Safety Considerations

Ticlopidine was withdrawn or restricted in several markets due to adverse effects. The FDA limited its use to specific scenarios, such as patients intolerant to Clopidogrel, leading to a decline in prescription volumes.

What is the market projection for Ticlopidine Hydrochloride?

Future Outlook

Based on current trends, the Ticlopidine market is expected to shrink further over the next five years:

• Projected CAGR (2023-2028): -8%
• Estimated global sales in 2028: $20 million

This decline results from:

• Safer alternatives replacing Ticlopidine
• Reduced off-label use
• Limited new clinical research

Potential for Niche or Orphan Drug Status

The drug may sustain a niche market for patients who cannot tolerate other antiplatelet agents. Regulatory programs for orphan designation are unlikely due to the drug’s broad availability and competition.

Investment Insight

Pharmaceutical companies are unlikely to invest in large-scale development or marketing for Ticlopidine unless new safety profiles or formulations are discovered. Conversely, generic manufacturers might sustain low-volume production for specialized use.

Summary of Key Data

Data Point	2022 Figures	2028 Forecast
Global antiplatelet market size	$7.6 billion	~$8.2 billion
Ticlopidine market share	<1%	Approaching 0.5%
Estimated sales	$50 million	$20 million
CAGR (2023-28)	Negative (-8%)	Continued decline

Key Takeaways

• Clinical research for Ticlopidine is limited, with focus on safety and comparative efficacy.
• The market shrinks due to safety issues and competition from newer agents.
• Sales decline expected further, with potential niche applications but no major growth prospects.
• The drug’s future depends on regulatory shifts and safety profile improvements.

FAQs

How does Ticlopidine compare to Clopidogrel?

Ticlopidine was the first oral antiplatelet agent but has a higher risk of severe adverse effects like neutropenia and TTP. Clopidogrel replaced it in many indications due to better safety and similar efficacy.

Are there ongoing efforts to develop safer forms of Ticlopidine?

No significant development has been announced. Interest persists in repurposing or reformulating Ticlopidine but remains limited.

What markets are the primary consumers of Ticlopidine today?

Primarily in regions with limited access to newer drugs, such as some developing markets, where off-label or generic use persists.

What are the regulatory limitations for Ticlopidine usage?

FDA restricts most uses to cases where patients cannot tolerate other antiplatelets. European agencies follow similar restrictive guidelines.

Is Ticlopidine available as a generic?

Yes, Ticlopidine is available as a generic drug, mainly supplied by multiple manufacturers, mostly for niche or off-label use.

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Sources

[1] ClinicalTrials.gov. (2023). Ticlopidine trials. https://clinicaltrials.gov
[2] MarketResearch.com. (2023). Global Antiplatelet Market Analysis. https://marketresearch.com
[3] FDA. (2017). Ticlopidine hydrochloride Drug Label. https://fda.gov
[4] IMS Health. (2022). Pharmaceutical Market Data. https://imshealth.com

Note: Data and projections are based on available public sources and market models as of Q1 2023.