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Antiplatelet Monotherapy
Antiplatelet Monotherapy is a Antiplatelet agent Small molecule drug developed by Hospital Israelita Albert Einstein. It is currently in Phase 3 development for Secondary prevention of cardiovascular events, Acute coronary syndrome, Stroke prevention. Also known as: Monotherapy.
Antiplatelet monotherapy inhibits platelet aggregation to reduce thrombotic events.
Antiplatelet monotherapy inhibits platelet aggregation to reduce thrombotic events. Used for Secondary prevention of cardiovascular events, Acute coronary syndrome, Stroke prevention.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Cardiovascular Phase 3 risk
-2.0pp
Modern cardiovascular outcome trials are large + long; many fail to beat aggressive standard-of-care.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Antiplatelet Monotherapy |
|---|---|
| Also known as | Monotherapy |
| Sponsor | Hospital Israelita Albert Einstein |
| Drug class | Antiplatelet agent |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | Phase 3 |
Mechanism of action
Antiplatelet agents work by interfering with platelet activation and clumping through various mechanisms such as cyclooxygenase inhibition, ADP receptor antagonism, or phosphodiesterase inhibition. This prevents thrombus formation and reduces the risk of cardiovascular events including myocardial infarction and stroke. The specific mechanism depends on the particular antiplatelet agent being used in the monotherapy regimen.
Approved indications
- Secondary prevention of cardiovascular events
- Acute coronary syndrome
- Stroke prevention
Common side effects
- Bleeding
- Gastrointestinal hemorrhage
- Dyspepsia
- Bruising
Key clinical trials
- The 10-Year Extended Follow-up of the DACAB Trial
- Aspirin-free Strategy With Ticagrelor in Patients With a Myocardial Infarction Treated Medically Alone (PHASE3)
- STrategies for Antithrombotic tReatment Following Transcatheter Edge-to-Edge Repair in Patients Without an Indication for Oral Anticoagulant (PHASE4)
- Tailoring Bleeding Reduction Approaches in Patients Undergoing PCI (PHASE4)
- Prasugrel Monotherapy Reduced Dose in Acute and Chronic Coronary Syndrome Patients After Percutaneous Coronary Intervention (PROMOTE) (PHASE4)
- EdoxabaN foR IntraCranial Hemorrhage Survivors With Atrial Fibrillation (ENRICH-AF) (PHASE4)
- Optimal Antiplatelet and Lipid Therapy in ACS With DES: OPACT Trial (NA)
- The Switching Antiplatelet-9 (SWAP-9) Study (PHASE4)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Antiplatelet Monotherapy CI brief — competitive landscape report
- Antiplatelet Monotherapy updates RSS · CI watch RSS
- Hospital Israelita Albert Einstein portfolio CI
Frequently asked questions about Antiplatelet Monotherapy
What is Antiplatelet Monotherapy?
How does Antiplatelet Monotherapy work?
What is Antiplatelet Monotherapy used for?
Who makes Antiplatelet Monotherapy?
Is Antiplatelet Monotherapy also known as anything else?
What drug class is Antiplatelet Monotherapy in?
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Related
- Drug class: All Antiplatelet agent drugs
- Manufacturer: Hospital Israelita Albert Einstein — full pipeline
- Therapeutic area: All drugs in Cardiovascular
- Indication: Drugs for Secondary prevention of cardiovascular events
- Indication: Drugs for Acute coronary syndrome
- Indication: Drugs for Stroke prevention
- Also known as: Monotherapy
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing