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Data updated: May 26, 2026

DURLAZA (aspirin)

Pain Approved 2015-09-04
Jump to: Indications Approvals Trials Competitors Safety Patents
1
Indication
--
Phase 3 Trials
10
Years on Market

Details

Status
Discontinued
First Approved
2015-09-04
Routes
ORAL
Dosage Forms
CAPSULE, EXTENDED RELEASE

Companies

HESP
Active Ingredient: ASPIRIN

DURLAZA Approval History

2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
3 FDA actions from 2015 to 2015
Sep 2015 SUPPL
Label · Labeling
FDA Letter Label
Sep 2015 SUPPL
Label · Labeling
FDA Letter Label
Sep 2015 ORIGINAL
New Form · Type 3 - New Dosage Form
FDA Letter Label

What DURLAZA Treats

1 FDA approvals

Originally approved for its first indication in 2015 .

  • Other (1)
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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

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Active Pipeline

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Ongoing clinical trials by development phase

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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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.

DURLAZA FDA Label Details

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Data Sources

FDA Approval: NDA200671 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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