CLINICAL TRIALS PROFILE FOR DIPYRIDAMOLE

505(b)(2) Clinical Trials for DIPYRIDAMOLE

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Formulation	NCT02273518 ↗	Study to Compare the Pharmacokinetics of Dipyridamole in Three Different Asasantin Extended Release (ER) Formulations in Healthy Male and Female Volunteers	Completed	Boehringer Ingelheim	Phase 1	2001-04-01	Comparative pharmacokinetics of dipyridamole in two new formulations of Asasantin ER compared to the present commercial formulation
New Formulation	NCT02273531 ↗	Bioequivalence of a New Asasantin Formulation Extended Release (ER) Compared to the Commercially Available Asasantin Formulation (Aggrenox®; Extended Release) in Healthy Male and Female Volunteers	Completed	Boehringer Ingelheim	Phase 1	2004-01-01	Study to establish the bioequivalence of a new formulation of Asasantin ER compared to the present commercially available Asasantin ER formulation (Aggrenox®)

All Clinical Trials for DIPYRIDAMOLE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000463 ↗	Post Coronary Artery Bypass Graft (CABG) Study	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1987-04-01	To determine the relative effectiveness of moderate versus more aggressive lipid lowering, and of low dose anticoagulation versus placebo, in delaying saphenous vein coronary bypass graft atherosclerosis and preventing occlusion of saphenous grafts of patients with saphenous vein coronary bypass grafts placed 1 to 11 years previously.
NCT00000496 ↗	Platelet Drug Trial in Coronary Disease Progression	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1979-12-01	To determine the effectiveness of the platelet inhibitor drugs dipyridamole and aspirin in reducing the angiographic progression of coronary artery disease over a five-year period and to test the predictive value of the platelet survival half-life in identifying patients with more rapid progression of coronary disease and development of its complications.
NCT00000510 ↗	Platelet-Inhibitor Drug Trial in Coronary Angioplasty	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 3	1983-09-01	To determine the effectiveness of dipyridamole and aspirin in prevention of restenosis of the dilated lesion in patients who had undergone percutaneous transluminal coronary angioplasty (PTCA). Secondary aims were to determine the effectiveness of platelet inhibitor therapy in reducing the incidence of coronary events and the severity and incidence of angina.
NCT00000527 ↗	Recurrent Carotid Stenosis	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 2	1986-08-01	To determine whether recurrent stenosis following carotid endarterectomy could be reduced by pre- and post-operative oral administration of platelet-inhibiting drugs.
NCT00000527 ↗	Recurrent Carotid Stenosis	Completed	Emory University	Phase 2	1986-08-01	To determine whether recurrent stenosis following carotid endarterectomy could be reduced by pre- and post-operative oral administration of platelet-inhibiting drugs.
NCT00002487 ↗	Methotrexate Plus Dipyridamole in Treating Patients With Advanced Ovarian Cancer	Unknown status	Ottawa Regional Cancer Centre	Phase 2	1991-07-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Dipyridamole may increase the effectiveness of methotrexate and kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining methotrexate and dipyridamole in treating patients with advanced ovarian cancer that is recurrent after or refractory to cisplatin-based chemotherapy.
NCT00003018 ↗	S9700 Combination Chemotherapy in Treating Patients With Stage II or Stage III Pancreatic Cancer	Completed	National Cancer Institute (NCI)	Phase 2	1997-09-01	RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. Chemotherapy following surgery may be an effective treatment for pancreatic cancer. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating patients with stage II or stage III pancreatic cancer that has not been surgically removed.

Clinical Trial Conditions for DIPYRIDAMOLE

Condition Name

Condition Name for DIPYRIDAMOLE
Intervention	Trials
Healthy	12
Stroke	5
Coronary Artery Disease	4
Myocardial Ischemia	4

Condition MeSH

Condition MeSH for DIPYRIDAMOLE
Intervention	Trials
Coronary Artery Disease	12
Myocardial Ischemia	12
Ischemia	9
Coronary Disease	9

Clinical Trial Locations for DIPYRIDAMOLE

Trials by Country

Trials by Country for DIPYRIDAMOLE
Location	Trials
United States	135
Canada	14
Netherlands	13
Italy	6
China	6

Trials by US State

Trials by US State for DIPYRIDAMOLE
Location	Trials
Ohio	6
Pennsylvania	6
Oklahoma	5
Michigan	5
California	5

Clinical Trial Progress for DIPYRIDAMOLE

Clinical Trial Phase

Clinical Trial Phase for DIPYRIDAMOLE
Clinical Trial Phase	Trials
PHASE2	2
Phase 4	21
Phase 3	10

Clinical Trial Status

Clinical Trial Status for DIPYRIDAMOLE
Clinical Trial Phase	Trials
Completed	54
Unknown status	10
Terminated	7

Clinical Trial Sponsors for DIPYRIDAMOLE

Sponsor Name

Sponsor Name for DIPYRIDAMOLE
Sponsor	Trials
Boehringer Ingelheim	19
Radboud University	10
National Heart, Lung, and Blood Institute (NHLBI)	4

Sponsor Type

Sponsor Type for DIPYRIDAMOLE
Sponsor	Trials
Other	87
Industry	33
NIH	7

DIPYRIDAMOLE Market Analysis and Financial Projection

Last updated: April 24, 2026

Dipyridamole: Clinical Trials Update, Market Analysis, and Projection

Dipyridamole is an established anti-platelet/anti-adenosine-uptake small molecule with a long regulatory footprint. Public late-stage development pipelines are sparse, and commercial performance is driven mainly by legacy, off-patent supply chains and geographic generics rather than brand-led growth. The addressable market is therefore less about “next approvals” and more about chronic demand for antiplatelet therapy in cardiovascular settings and procedural use where local standards support dipyridamole-containing regimens.

What does the clinical trial landscape show for dipyridamole?

Public clinical trial activity for dipyridamole is limited at the late stage. Available record streams center on older indications, adjuvant combinations, and academic mechanistic studies rather than broad Phase 3 programs.

Observed patterns in public registries

• Low frequency of new interventional entries compared with actively developed cardiovascular agents (P2Y12 inhibitors, anticoagulants, PCSK9).
• Older or non-core datasets dominate: trials tied to platelet function, cardiology adjunct protocols, or comparative pharmacology.
• Most activity is not clearly connected to a large, pivotal, Phase 3 development package that would credibly re-shift the global market.

Market implication

• With limited late-stage pipeline visibility, market upside does not depend on imminent new label expansions.
• Demand remains largely replacement and maintenance supply for clinicians already using dipyridamole-based antiplatelet strategies, plus niche procedural/adjunct roles.

How large is the dipyridamole market today, and what drives it?

Because dipyridamole is widely off-patent in most jurisdictions, market size is best treated as a volume-and-price mix problem. In practice, revenue depends on:

• National formulary coverage and inclusion in cardiology treatment protocols
• Generic price levels and tender dynamics in public systems
• Competition against alternative antiplatelet regimens (aspirin alone, clopidogrel, ticagrelor, prasugrel, cilostazol in certain vascular indications)
• Local brand persistence where legacy products retain distribution advantages

Commercial structure

• Generic-first: pricing pressure is the primary variable; marketing spend is not the main lever.
• Regimen-level switching: prescribers may shift patients to other antiplatelets based on guideline preference and reimbursement design.

Practical drivers by use-case

• Cardiovascular prevention and secondary prevention frameworks where dipyridamole combinations are acceptable.
• Adjunct anti-platelet strategies where older regimens remain standard-of-care in certain countries.
• Hospital procurement: tender-led volumes often favor the lowest-bid suppliers with consistent quality.

What is the forward market outlook (base case, bull case, bear case)?

Without clear late-stage breakthroughs, projections hinge on macro cardovascular demand, competitive substitution, and generic pricing.

Base case (most likely)

• Stable to low single-digit volume growth driven by aging demographics and stable secondary prevention populations.
• Flat to modestly declining net revenue per unit due to continued generic price pressure.
• Overall revenue trends follow volume minus price erosion.

Directionally expected outcome: marginal growth or slight revenue decline depending on region tender cycles.

Bull case

• Improved formulary retention in key geographies plus new local guideline emphasis for dipyridamole-containing regimens.
• Pricing stabilization in regions with fewer suppliers or where regulatory quality controls reduce low-cost entrants.
• A limited number of label-reinforcement or pharmacovigilance updates keep adoption steady.

Outcome: low-to-mid single-digit revenue growth sustained for several years.

Bear case

• Faster substitution to newer, guideline-preferred antiplatelet classes.
• Aggressive tender cycles push prices down.
• Documented supply disruptions among generic manufacturers tighten supply quality and reduce dispensing.

Outcome: low single-digit revenue contraction with intermittent volatility in volumes.

What competitive forces matter most for dipyridamole?

1. Therapy substitution risk
   • Competing antiplatelets and combination strategies have deeper trial and guideline alignment, especially for acute coronary syndromes and post-stent settings.
2. Generic supply dynamics
   • Market share is controlled by who can supply tenders consistently at lowest compliant price.
3. Clinical practice inertia
   • Where older regimens are entrenched, dipyridamole retains stable demand despite off-patent economics.
4. Regulatory and quality compliance
   • For generics, batch-to-batch controls and dissolution/bioequivalence performance determine tender eligibility.

How does dipyridamole usage typically map to product forms and dosing realities?

Commercial dipyridamole exposure is split between:

• Oral formulations used in chronic antiplatelet settings
• Alternative administration contexts in certain cardiology workflows depending on country labeling and guideline practice

For forecasting, this matters because:

• Oral steady-state demand is less sensitive to short-term clinical trends than acute procedural products.
• Tender and reimbursement schedules determine market continuity more than marketing.

What would investors and R&D teams do with this outlook?

• R&D stance: without a visible pivotal late-stage program, R&D should target either:
  • formulation value (bioavailability, stability, patient adherence), or
  • narrow combination/label maintenance work aligned to local guidelines.
• Commercial stance: growth is most achievable by:
  • securing tender relationships,
  • reducing cost-to-serve via manufacturing scale,
  • improving dossier quality for regulatory submissions in high-volume markets.

Key Takeaways

• Dipyridamole shows limited late-stage clinical momentum in public trial visibility; the market is legacy and generic-led.
• The near-term outlook depends on formulary retention, tender-driven pricing, and substitution risk versus newer antiplatelet classes.
• Revenue projections are most plausibly flat to low-growth in base case with price erosion balancing volume, while bull and bear cases depend on regional procurement and guideline adherence.

FAQs

Is dipyridamole expected to see a new wave of Phase 3 approvals globally?

Public record visibility indicates no clear, dominant Phase 3 program that would drive a rapid label expansion-led market shift.

What is the biggest determinant of dipyridamole revenue over the next 3 to 5 years?

Generic pricing and tender execution in key geographies, offset by steady volume demand from chronic antiplatelet use.

Which competitive agents most threaten dipyridamole substitution?

Modern antiplatelet regimens used in guideline-preferred pathways, including P2Y12 inhibitors and related combination strategies where adopted.

Where could dipyridamole retain stronger demand?

Markets where dipyridamole-containing regimens remain embedded in formulary and cardiology practice and where generic competition remains manageable.

What is the highest ROI strategy for new market entrants?

Manufacturing and dossier execution that wins tender-based volume while maintaining quality and bioequivalence consistency.

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References

[1] ClinicalTrials.gov. (n.d.). Dipyridamole trials (search results). https://clinicaltrials.gov/
[2] U.S. National Library of Medicine. (n.d.). Dipyridamole compound information. https://pubchem.ncbi.nlm.nih.gov/
[3] PubChem. (n.d.). Dipyridamole (CID, substance data). https://pubchem.ncbi.nlm.nih.gov/