NDAORALCAPSULE, EXTENDED RELEASE
Approved
Sep 2015
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
3/8 — Basic
DURLAZA (aspirin) by Bayer is [acetylsalicylic acid (asa)] inhibits prostaglandin synthesis resulting in inhibition of platelet aggregation for their lifespan of about 7-10 days. First approved in 2015.
Drug data last refreshed 11h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DURLAZA is an extended-release oral aspirin (acetylsalicylic acid) approved by the FDA in 2015 for cardiovascular indications. It works by irreversibly inhibiting COX-1 and preventing platelet aggregation through suppression of thromboxane A2 synthesis, with antiplatelet effects lasting 7-10 days. The formulation delivers sustained aspirin levels to reduce thrombotic events in at-risk populations.
Peak
Product is at peak commercial maturity with stable market presence; brand teams are focused on market maintenance and managed competition rather than growth initiatives.
Mechanism of Action
[acetylsalicylic acid (ASA)] inhibits prostaglandin synthesis resulting in inhibition of platelet aggregation for their lifespan of about 7-10 days. The acetyl group of aspirin binds with a serine residue of cyclooxygenase-1 (COX-1) , resulting in irreversible inactivation of the enzyme. Inhibition…
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
STudy of Aspirin Removal in Patients Supported by the Fully Magnetically Levitated CH-VAD Pump
Started Jun 2026
370 enrolled
LVAD (Left Ventricular Assist Device) ThrombosisLVADLVAD (Left Ventricular Assist Device)+9 more
A Study to Learn About How Safe BAY3389934 is and How it Affects Blood Clotting When Given Alone or With Aspirin in Healthy Participants
Started May 2026
16 enrolled
Drug-drug Interaction
to Evaluate the Safety and the Pharmacokinetic and Pharmacodynamic Interactions Between JP-1366 and Clopidogrel, Aspirin, Atorvastatin and Apixaban
Started Nov 2025
96 enrolled
Drug Drug Interaction (DDI)
Aspirin or Rivaroxaban Thromboprophylaxis for Patients With Multiple Myeloma
Started Sep 2025
530 enrolled
Multiple MyelomaVenous Thromboembolism
INdobufen Versus asPirin in Endovascular Unruptured Intracranial Aneurysms Treatment (INPUT)
Started Aug 2025
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.