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Drug

Prasugrel

Approved · EMA
Emerging researchLate-stage development

Also known as Effient, Prasugrel Hydrochloride.

RxNorm613391ChEMBLCHEMBL1201772UNII34K66TBT99
2
Research papers
8
Active clinical trials
3
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Cessation of Migraine Headaches With Patent Foramen Ovale-Directed Therapy (COMFORT - PFO): An Investigator-Initiated Study

Clinical trial2026-06-05Results expected Q4 2027 · ClinicalTrials.gov

Hunting for the Long-Term EffeCts of P2Y12 Inhibitor monotHerapy and Coagulation Monitoring After PCI: an Open-label, Randomized Study.

Clinical trial2026-05-13Results expected Q2 2028 · ClinicalTrials.gov

Comparison of Dual Antiplatelet Therapy De-escalation by Dose Reduction Versus Switching in Patients Undergoing PCI: A Prospective, Randomized Pharmacodynamic Study - The Switching Antiplatelet-8 (SWAP-8) Study

Clinical trial2026-05-12Results expected Q4 2026 · ClinicalTrials.gov

Strategies for Antiplatelet Management Following Acute Coronary Syndrome

Clinical trial2026-04-02Results expected Q3 2029 · ClinicalTrials.gov

Prasugrel Monotherapy Reduced Dose in Acute and Chronic Coronary Syndrome Patients After Percutaneous Coronary Intervention

Clinical trial2026-04-01Primary completion · ClinicalTrials.gov

Switching From Dual Antiplatelet Therapy to Monotherapy With Potent P2Y12 Inhibitors: Pharmadodynamic Comparison Between Prasugrel and Ticagrelor Monotherapy. The Switching Antiplatelet -7 (SWAP-7) Study

Clinical trial2026-02-05Results expected Q3 2026 · ClinicalTrials.gov

Switching From Clopidogrel to Low-dose Prasugrel in Patients at Dual-risk Following Percutaneous Coronary Intervention (TAILOR-BLEED-2)

Clinical trial2025-11-04Results expected Q3 2027 · ClinicalTrials.gov

Drug Safety Update: Prasugrel (Efient): increased risk of bleeding

Regulatory2014-12-11MHRA

Drug Safety Update: Prasugrel (Efient▼): rare but serious hypersensitivity reactions

Regulatory2014-12-11MHRA

Pretreatment with prasugrel in non-ST-segment elevation acute coronary syndromes.

Research2013-09-01The New England journal of medicine

Pharmacodynamic effects of prasugrel dosing regimens in patients on maintenance prasugrel therapy: results of a prospective randomized study.

Research2012-05-01Journal of the American College of Cardiology

Approval: Efient (EMA)

Regulatory2009-02-24EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Prasugrel
Aliases & brands
EffientPrasugrel Hydrochloride
RxNorm CUI
613391
ChEMBL ID
CHEMBL1201772
UNII
34K66TBT99
Regulatory jurisdictions
emamhra

Regulatory timeline

3 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2009-02-24
Latest approval
2009-02-24
Authorities
EMA · MHRA
Total events
3
emaEuropean Medicines Agency· 1 event
2009-02-24Approval
Approval: Efient (EMA)
Indication: Efient, co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in patients with acute coronary syndrome (i.e. unstable angina,… Show full indication

Efient, co-administered with acetylsalicylic acid (ASA), is indicated for the prevention of atherothrombotic events in patients with acute coronary syndrome (i.e. unstable angina, non-ST-segment-elevation myocardial infarction [UA / NSTEMI] or ST-segment-elevation myocardial infarction [STEMI]) undergoing primary or delayed percutaneous coronary intervention (PCI).

Evidence ↗
mhraMedicines and Healthcare products Regulatory Agency· 2 events
2014-12-11Safety communicationSafety
Drug Safety Update: Prasugrel (Efient): increased risk of bleeding
Evidence ↗
2014-12-11Safety communicationSafety
Drug Safety Update: Prasugrel (Efient▼): rare but serious hypersensitivity reactions
Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).

Clinical trials

123 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
123
registered trials across all phases
LATEST COMPLETION 2024
8
Active studies
7
Recruiting
97
Late-stage (III+)
91
Completed
24
Discontinued
PHASE DISTRIBUTIONn = 123
Phase 111Phase 215Phase 2 / 31Phase 329Phase 460Phase N / A7

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Strategies for Antiplatelet Management Following Acute Coronary Syndrome

Not yet recruitingPH IVKey trialInstituto de Investigación Sanitaria de la Fundación Jiménez Díazn=8,1002030

Switching From Clopidogrel to Low-dose Prasugrel in Patients at Dual-risk Following Percutaneous Coronary Intervention (TAILOR-BLEED-2)

RecruitingPH IVUniversity of Floridan=402027

Prasugrel Monotherapy Reduced Dose in Acute and Chronic Coronary Syndrome Patients After Percutaneous Coronary Intervention

RecruitingPH IVJ.P.S Henriquesn=3002027

Comparison of Dual Antiplatelet Therapy De-escalation by Dose Reduction Versus Switching in Patients Undergoing PCI: A Prospective, Randomized Pharmacodynamic Study - The Switching Antiplatelet-8 (SWAP-8) Study

RecruitingPH IVUniversity of Floridan=782027

Switching From Dual Antiplatelet Therapy to Monotherapy With Potent P2Y12 Inhibitors: Pharmadodynamic Comparison Between Prasugrel and Ticagrelor Monotherapy. The Switching Antiplatelet -7 (SWAP-7) Study

RecruitingPH IVUniversity of Floridan=482026

Recent completions

Trials that read out recently, adding to the completed evidence base.

Harmonizing Optimal Strategy for Treatment of Coronary Artery Diseases Trial - Comparison of REDUCTION of PrasugrEl Dose & POLYmer TECHnology in ACS Patients (HOST REDUCE POLYTECH RCT Trial) Comparison of the Efficacy and Safety of Biostable Polymer DES (Promus PremierTM, Xience Alpine®, and Resolute Onyx®) With Biodegradable Polymer DES (Biomatrix®, Biomatrix Flex®, Nobori®, Ultimaster®,Synergy®, and Orsiro®)and Conventional Dose Prasugrel Therapy With Reduced Dose Prasugrel Therapy in Acute Coronary Syndrome Patients Treated With Percutaneous Coronary Intervention

CompletedPH IVKey trialSeoul National University Hospitaln=3,4292024

Pharmacodynamic and Pharmacokinetic Profiles on Switching From Cangrelor to Prasugrel in Patients With Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention: The Switching Antiplatelet -6 (SWAP-6) Study

CompletedPH IVUniversity of Floridan=3592023

Clopidogrel Monotherapy in High Bleeding Risk Patients Undergoing Percutaneous Coronary Interventions: A Safety Assessment, Pilot Study to Reduce Post-Discharge Bleeding

CompletedPH IVMayo Clinicn=982023

Optical Coherence Tomography-Guided PCI With Single-Antiplatelet Therapy

CompletedPH IIAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)n=752023

Switching From Standard of Care Dual Antiplatelet Treatment (DAPT) Regimens With Aspirin Plus a P2Y12 Inhibitor to Dual Pathway Inhibition (DPI) With Low-dose Rivaroxaban in Adjunct to Aspirin in Patients With Coronary Artery Disease: The Switching Anti-Platelet and Anti-Coagulant Therapy (SWAP-AC) Study

CompletedPH IVUniversity of Floridan=902022

Platelet Aggregation and Adenosine Levels Among Patients With Stable Chronic Coronary Artery Disease Taking Ticagrelor or Prasugrel

CompletedPH IVUniversity of Sao Paulon=872021

Research activity

2 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20122013
Major research themes2
Coronary Angiography1Premedication1
Journals, researchers & institutions
Top journals
  • Journal of the American College of Cardiology1
  • The New England journal of medicine1
Leading researchers
  • Angioli P1
  • Angiolillo DJ1
  • Bass TA1
  • Bolognese L1
  • Box LC1
  • Cayla G1
  • Charlton RK1
  • Costigan TM1
Leading institutions
free-text, unnormalised
  • Institut de Cardiologie1
  • University of Florida College of Medicine1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.