TheraRadar
Data updated: May 26, 2026

ASPIRIN AND DIPYRIDAMOLE (aspirin)

Cyclooxygenase Inhibitors
Cardiovascular Approved 2009-08-14

Aspirin and extended-release dipyridamole is a combination antiplatelet therapy indicated for the secondary prevention of stroke. It is specifically used to reduce the risk of recurrent stroke in patients who have previously experienced a completed ischemic stroke or transient ischemic attack (TIA) due to thrombosis. The combination utilizes two distinct mechanisms of action to provide an additive antithrombotic effect.

Source: FDA Label • Novartis • Nonsteroidal Anti-inflammatory Drug
Jump to: Indications Approvals Trials Competitors Similar Safety Patents

How ASPIRIN AND DIPYRIDAMOLE Works

The antithrombotic effect of this combination results from the additive antiplatelet actions of its components. Aspirin irreversibly inhibits platelet cyclooxygenase, preventing the synthesis of thromboxane A2, a potent mediator of platelet aggregation and vasoconstriction. Dipyridamole inhibits the reuptake of adenosine into platelets and other cells, leading to increased local adenosine concentrations that stimulate platelet adenylate cyclase and raise cAMP levels. Additionally, dipyridamole inhibits cyclic-GMP phosphodiesterase (cGMP-PDE), augmenting the increase in cGMP produced by nitric oxide. Together, these mechanisms inhibit platelet aggregation in response to various stimuli, including collagen, ADP, and platelet-activating factor.

Source: FDA Label
9
Indications
--
Phase 3 Trials
16
Years on Market

Details

Status
Prescription
First Approved
2009-08-14
Routes
ORAL
Dosage Forms
CAPSULE, EXTENDED RELEASE

Companies

Novartis ANI PHARMS AMNEAL PHARMS ZYDUS PHARMS PH HEALTH CHARTWELL MOLECULAR Teva Dr. Reddy's GLENMARK SPECLT Sun Pharma MICRO LABS
Active Ingredient: ASPIRIN , DIPYRIDAMOLE

ASPIRIN AND DIPYRIDAMOLE Approval History

2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
33 FDA actions from 2009 to 2025
Jul 2025 SUPPL
Label · Labeling
Apr 2024 SUPPL
Label · Labeling
Aug 2023 SUPPL
Label · Labeling

What ASPIRIN AND DIPYRIDAMOLE Treats

1 indications

ASPIRIN AND DIPYRIDAMOLE is approved for 1 conditions since its original approval in 2009. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Stroke
Source: FDA Label

ASPIRIN AND DIPYRIDAMOLE Competitive Set

Pro

Three rings of competition based on shared molecular targets and treated indications.

MoA expansion candidates

6

Same target(s), different indications — where else is this mechanism being explored?

BALSALAZIDE DISODIUM
Hikma
2007 1 indic.
LIALDA
Takeda
2007 1 indic.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

JAVADIN
AZURITY
2025 3 indic.
VOSTALLY
ROSEMONT PHARMS
2025 4 indic.
Unlock 12 more competitors across all three rings.
Upgrade to Pro

Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

Drugs Similar to ASPIRIN AND DIPYRIDAMOLE

3 of 20

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

ALISKIREN HEMIFUMARATE
ALISKIREN HEMIFUMARATE
1 shared
PH HEALTH
Shared indications:
Stroke
ATENOLOL
ATENOLOL
1 shared
NOSTRUM LABS
Shared indications:
Stroke
ATENOLOL AND CHLORTHALIDONE
ATENOLOL
1 shared
NOVITIUM PHARMA
Shared indications:
Stroke
View all 20 similar drugs Pro
📋

Clinical Trial Registry

246 trials
Trial Sponsor ID Phase Status Title
NCT07572747 ARCTURUS-GTC-1 — Ph 3 not yet recruiting Aspirin Versus Clopidogrel in Chronic Coronary Syndrome in Arabian Gulf Countries
NCT03907046 ASPIRE 2000026409 1U01NS106513-01A1 Ph 3 recruiting Anticoagulation in ICH Survivors for Stroke Prevention and Recovery
NCT05955365 MATRIX-2 MATRIX-2 Ph 4 recruiting Monotherapy With P2Y12 Inhibitors in Patients With Atrial fIbrillation Undergoing Supraflex Stent Implantation
NCT05625724 APPART RC31/21/0337 Ph 3 recruiting Aspirin for the Prevention of Preeclampsia and Pregnancy Outcomes After Assisted Reproductive Technology
NCT04770012 2020-version 1.0 Ph 3 recruiting AERIAL Trial: Antiplatelet Therapy in Heart Transplantation
NCT06710184 FOXY DAN-FOXY 2024-517229-18-00 Ph 4 recruiting Treatment With Aspirin Alone Versus Aspirin in Combination With Fondaparinux Before Early Coronary Assessment in Patients With Non-ST-Elevation Myocardial Infarction
NCT02521285 results posted NCI-2015-01265 NCI-2015-01265, 2013-0819 Ph 2 active not recruiting Aspirin in Preventing Disease Recurrence in Patients With Barrett Esophagus After Successful Elimination by Radiofrequency Ablation
NCT02044250 HOST-EXAM Trial Ph 4 completed Harmonizing Optimal Strategy for Treatment of Coronary Artery Stenosis- EXtended Antiplatelet Monotherapy (HOST-EXAM)
NCT04381936 RECOVERY NDPHRECOVERY 2020-001113-21, ISRCTN50189673 Ph 3 recruiting Randomised Evaluation of COVID-19 Therapy
NCT07540416 TRUST-MISMATCH MISMATCH-001 Ph 3 not yet recruiting Tenecteplase for Late-Window Stroke Guided by DWI-FLAIR Mismatch
NCT04078568 KD-3-01 Ph 3 completed Efficacy of Immunoglobulin Plus Prednisolone in Reducing Coronary Artery Lesion in Patients With Kawasaki Disease
NCT02965703 results posted NCI-2016-01642 NCI-2016-01642, N01-CN-2012-00035 Ph 2 active not recruiting Aspirin in Preventing Colorectal Cancer in Patients With Colorectal Adenoma
NCT05418556 OPTIMIZE-APT 2022-0568 Ph 4 recruiting Tailored Versus Coventional AntiPlaTelet Strategy Intended After OPTIMIZEd Drug Eluting Stent
NCT03574909 IRELAnD Ireland-Rct-v1-0218 2018-000770-29 Ph 3 completed IRELAnD: Investigating the Role of Early Low-dose Aspirin in Diabetes
NCT06757764 CHANGE CHANGE Ph 4 recruiting The Effect and Safety of Combined Anti-platelet Treatment in Acute Ischemic Stroke Due to Large Artery Atherosclerosis
NCT06650488 Clopido-SNAP 2 2025-10899 500048 Ph 4 recruiting Clopidogrel vs. Aspirin for Cardiovascular Risk Reduction in Patients With S. Aureus Bacteremia
NCT03796156 ATTACK 31844 Ph 3 terminated Aspirin to Target Arterial Events in Chronic Kidney Disease
NCT06451198 OPTION2 B2024-187 Ph 4 recruiting IndObufen Versus asPirin After Coronary Drug-eluting Stent implantaTION in Elderly Patients With Acute Coronary Syndrome
NCT04295486 20190973 Ph 2 recruiting Optimal Dosing For Low-Dose Aspirin Chemoprophylaxis For VTE Following Total Joint Arthroplasty
NCT05633810 COLCOT-T2D MHICC-2021-001 Ph 3 recruiting COLchicine and Non-enteric Coated Aspirin in the Cardiovascular Outcomes Trial of Patients With Type 2 Diabetes
NCT04809818 results posted LT3001-105 Ph 1 completed A Study to Evaluate Safety and PK of Multiple Doses of LT3001 Drug Product and Drug-drug Interaction in Healthy Subjects
NCT06655376 AAAV3358 Ph 4 recruiting Aspirin and Hemocompatibility Events in Chronic Advanced Heart Failure Patients With Assist Device
NCT07431762 CONCLAVE 2025-1499 Ph 4 not yet recruiting Comparison of Anti-Thrombotic Treatments Between Aspirin and Warfarin During Initial Six Months After Bioprpsthetic Heart Valve Replacement
NCT06676280 ASA-3C AMCCV 2024-01 Ph 4 recruiting ASpirin Use and stAtin Strategy for Primary Prevention in Severe Coronary Calcium Score on Computed Tomography
NCT07373756 599/2025 Ph 4 not yet recruiting Randomized Controlled Study to Compare Efficacy of Aspirin 75mg and 150mg In the Prevention of Preeclampsia In High Risk Pregnant Women
NCT07361679 preGO 724/23-11-2022 Ph 4 recruiting LDA and LMWH vs LDA Alone in High-risk Patients for Preeclampsia Prevention
NCT05310968 STRATEGY KY2021-089-08 Ph 4 completed Study on Tirofiban With Aspirin in the Treatment of Acute Penetrating Artery Territory Infarction
NCT04912505 ASPIRE RC31/19/0509 Ph 2 completed ASPirin in Immune thRombocytopenia Patients With Cardiovascular disEase
NCT01729468 PERASTUN PHRN08-FP/PERASTUN 2011-003536-30, 2012-R8 Ph 4 completed Prevention of Pre-eclampsia and SGA by Low-Dose Aspirin in Nulliparous Women With Abnormal First-trimester Uterine Artery Dopplers
NCT06548971 TREND-IVT TREND-IVT Ph 3 recruiting Early Antiplatelet Administration After Intravenous Thrombolysis for Acute Ischemic Stroke (TREND-IVT)
NCT03079999 17-030 W81XWH-17-1-0644 Ph 2 active not recruiting Study of Aspirin in Patients With Vestibular Schwannoma
NCT04188119 IMpALA CFT / sp123 2018-004121-80, 017NovCC107 Ph 2 withdrawn A Proof of Concept Window Trial of the IMmunological Effects of AveLumab and Aspirin in Triple-Negative Breast Cancer
NCT03378934 APLABE-PCI 2016-I2M-1-011 JS-1375 Ph 4 recruiting Anti-platelet Effect of Berberine in Patients After Percutaneous Coronary Intervention
NCT05411718 2022-0117 NCI-2022-04794, 1R01CA257375-01 Ph 2 recruiting A Phase IIa Randomized, Double-Blinded Clinical Trial of Naproxen or Aspirin for Cancer Immune Interception in Lynch Syndrome
NCT07180472 2025CYFYIRB-BA-113 Ph 4 not yet recruiting Prevention of Stroke Recurrence and Disease Progression in Cerebral Small Vessel Disease With Cilostazol
NCT03869268 WILLOW TREE results posted STH20370 Ph 4 completed The Impact of Aspirin Dose Modification on the Innate Immune Response - Will Lower Dose Aspirin Therapy Reduce the Response to Endotoxin
NCT06638151 CoPrime Pro00140876 Ph 2 recruiting Clopidogrel Plus Aspirin in Acute Ischemic Stroke Following Thrombectomy and/or Intravenous Thrombolysis (CoPrime)
NCT07153744 MUST Ⅱ HMPE202501 Ph 4 not yet recruiting Efficacy and Safety of Shexiang Baoxin Pill(MUSKARDIA) in the Treatment of Acute Myocardial Infarction
NCT06090890 2023-GSP-GG-32 Ph 4 recruiting Anti-inflammatory Therapy for Recurrent In-stent Restenosis
NCT03805932 results posted 190042 19-C-0042 Ph 1 active not recruiting Moxetumomab Pasudotox-tdfk (Lumoxiti(TM)) and Either Rituximab (Rituxan(R)) or Ruxience for Relapsed Hairy Cell Leukemia
NCT06444178 R9933-HV-2424 Ph 1 completed Assessment of Gastrointestinal Blood Loss After Receiving Aspirin or Aspirin Plus Rivaroxaban, or Aspirin Plus REGN9933, or Aspirin Plus REGN7508 in Healthy Adult Participants
NCT02467582 results posted SAKK 41/13 - Aspirin SNCTP000001339, 2015-001482-57 Ph 3 terminated Adjuvant Aspirin Treatment for Colon Cancer Patients
NCT05962034 21851 Ph 4 recruiting Thromboxane Function in Women With Endometriosis
NCT03192215 ARCADIA results posted AAAR4607 1U01NS095869-01A1 Ph 3 terminated AtRial Cardiopathy and Antithrombotic Drugs In Prevention After Cryptogenic Stroke
NCT06518317 SOLOTAVI 2023-508208-40-00 Ph 3 recruiting Short Versus Long Antiplatelet Therapy After TAVI
NCT04824911 SATBRAD 202001386A3 Ph 2 completed Statin and Dual Antiplatelet Therapy to Prevent Early Neurological Deterioration in Branch Atheromatous Disease
NCT04645550 YZUC-005 Ph 4 completed Apixaban, Warfarin and Aspirin Prevents Portal Vein Thrombosis in Patients After Laparoscopic Splenectomy（ESAWAAPT）
NCT05347069 ASA-IN Y0126 Ph 4 recruiting Efficacy and Safety of Aspirin in Patients With Chronic Coronary Syndromes Without Revascularization
NCT06494878 REB24-0317 Ph 3 not yet recruiting The PARTUM Trial: Postpartum Aspirin to Reduce Thromboembolism Undue Morbidity
NCT03543683 COAST 1 Ph 2 completed Combination of Osimertinib and Aspirin to Treat 1st Generation EGFR-TKI Resistance in NSCLC

Showing 50 of 246 trials

🔬

Active Pipeline

Pro

Ongoing clinical trials by development phase

Loading...
⭐

Key Completed Trials

Pro

Completed studies with published results, ranked by significance

Loading...
📊

Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

|
Loading...
Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

ASPIRIN AND DIPYRIDAMOLE FDA Label Details

Indications & Usage

ASPIRIN AND DIPYRIDAMOLE is indicated for the treatment of Stroke.

Track ASPIRIN AND DIPYRIDAMOLE with TheraRadar Pro

Watchlist alerts, full database access, CSV exports across 14,000+ drugs.

Upgrade to Pro

Data Sources

FDA Approval: ANDA206739 → Label: DailyMed → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.