Cangrelor

Cangrelor is a direct P2Y 12 platelet receptor inhibitor that blocks ADP-induced platelet activation and aggregation. Cangrelor binds selectively and reversibly to the P2Y 12 receptor to prevent further signaling and platelet activation.

• KENGREAL is indicated as an adjunct to percutaneous coronary intervention (PCI) to reduce the risk of periprocedural myocardial infarction (MI), repeat coronary revascularization, and stent thrombosis (ST) in patients who have not been treated with a P2Y 12 platelet inhibitor and are not being given a glycoprotein IIb/IIIa inhibitor [see Clinical Studies ( 14.1 )]. KENGREAL is a P2Y 12 platelet inhibitor indicated as an adjunct to percutaneous coronary intervention (PCI) for reducing the risk of periprocedural myocardial infarction (MI), repeat coronary revascularization, and stent thrombosis (ST) in patients in who have not been treated with a P2Y 12 platelet inhibitor and are not being given a glycoprotein IIb/IIIa inhibitor.ICD-10: I21.9

• Significant active bleeding ( 4.1 ) Hypersensitivity to KENGREAL or any component of the product ( 4.2 ) 4.1 Significant Active Bleeding KENGREAL is contraindicated in patients with significant active bleeding [see Warnings and Precautions ( 5.1 ) and Adverse Reactions ( 6.1 )] . 4.2 Hypersensitivity KENGREAL is contraindicated in patients with known hypersensitivity (e.g., anaphylaxis) to KENGREAL or any component of the product [see Adverse Reactions ( 6.1 )] .contraindicated

KENGREAL is intended for administration via a dedicated IV line, only after reconstitution and dilution. ( 2.3 ) Administer 30 mcg/kg intravenous (IV) bolus prior to PCI followed immediately by a 4 mcg/kg/min IV infusion for at least 2 hours or duration of procedure, whichever is longer. ( 2.1 ) To maintain platelet inhibition after discontinuation of KENGREAL infusion, administer an oral P2Y 12 platelet inhibitor. ( 2.2 ) 2.1 Recommended Dosing The recommended dosage of KENGREAL is a 30 mcg/kg IV bolus followed immediately by a 4 mcg/kg/min IV infusion. Initiate the bolus infusion prior to PCI. The maintenance infusion should ordinarily be continued for at least 2 hours or for the duration of PCI, whichever is longer. 2.2 Transitioning Patients to Oral P2Y 12 Therapy To maintain platelet inhibition after discontinuation of KENGREAL infusion, administer an oral P2Y 12 platelet inhibitor, as described below: Ticagrelor: 180 mg at any time during KENGREAL infusion or immediately after discontinuation [see Clinical Pharmacology ( 12.2 )] . Prasugrel: 60 mg immediately after discontinuation of KENGREAL [see Drug Interactions ( 7.1 ) and Clinical Pharmacology ( 12.2 )] . Clopidogrel: 600 mg immediately after discontinuation of KENGREAL [see Drug Interactions ( 7.1 ) and Clinical Pharmacology ( 12.2 )] . 2.3 Preparation and Administration KENGREAL is intended for IV administration, after reconstitution and dilution. Preparation Reconstitute the vial prior to dilution in a bag. For each 50 mg/vial, reconstitute by adding 5 mL of Sterile Water for Injection.

Bleeding: Like other drugs that inhibit platelet P2Y 12 function, KENGREAL can increase the risk of bleeding ( 5.1 ) 5.1 Bleeding Drugs that inhibit platelet P2Y 12 function, including KENGREAL, increase the risk of bleeding. In CHAMPION PHOENIX bleeding events of all severities were more common with KENGREAL than with clopidogrel [see Adverse Reactions ( 6.1 )] . Bleeding complications with KENGREAL were consistent across a variety of clinically important subgroups (see Figure 1). Once KENGREAL is discontinued, there is no antiplatelet effect after an hour [see Clinical Pharmacology ( 12.3 )] .

The following adverse reactions are also discussed elsewhere in the labeling: Bleeding [see Warnings and Precautions ( 5.1 )] The most common adverse reaction is bleeding. ( 5.1 , 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Chiesi USA, Inc. at 1-888-661-9260 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reactions rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of KENGREAL has been evaluated in 13,301 subjects in controlled trials, in whom, 5,529 were in the CHAMPION PHOENIX trial. Bleeding There was a greater incidence of bleeding with KENGREAL than with clopidogrel. No baseline demographic factor altered the relative risk of bleeding with KENGREAL (see Table 1 and Figure 1).

8.1 Pregnancy Risk Summary There are no available data on cangrelor use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Untreated myocardial infarction can be fatal to the pregnant women and fetus ( see Clinical Considerations ). In animal reproduction studies, continuous infusion of cangrelor in pregnant rats and rabbits throughout organogenesis at dose approximately 2-times the maximum recommended human dose (MRHD) did not result in fetal malformations ( see Data ). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Myocardial infarction is a medical emergency in pregnancy which can be fatal to the pregnant woman and fetus if left untreated. Life-sustaining therapy for the pregnant woman should not be withheld due to potential concerns regarding the effects of cangrelor on the fetus. Labor or delivery Cangrelor use during labor and delivery may increase the risk for maternal bleeding and hemorrhage.

Metabolism

KENGREAL administered intravenously has linear pharmacokinetics in both healthy volunteers and patients. KENGREAL is rapidly distributed and metabolized, reaching C max within 2 minutes after administration of an intravenous bolus followed by infusion.

There is no specific treatment to reverse the antiplatelet effect of KENGREAL but the effect is gone within one hour after the drug is discontinued. In clinical trials, 36 patients received an overdose of KENGREAL, ranging from 36 to 300 mcg/kg (bolus dose) or 4.8 to 13.7 mcg/kg/min (infusion dose). The maximum overdose received was 10 times the PCI bolus dose or 3.5 times the PCI infusion dose in 4 patients. No clinical sequela were noted as a result of overdose following completion of KENGREAL therapy.

• Jun 22, 2015NDANDA204958Chiesi
• Aug 11, 2025ANDAANDA213551Gland

1. 1Off Label Use15840%
2. 2Vascular Stent Thrombosis328.1%
3. 3Drug Ineffective297.3%
4. 4Haemorrhage266.6%
5. 5Death225.6%
6. 6No Adverse Event205.1%
7. 7Cardiac Arrest184.5%
8. 8Inappropriate Schedule Of Product Administration184.5%
9. 9Cardiogenic Shock153.8%
10. 10Gastrointestinal Haemorrhage143.5%
11. 11Labelled Drug-drug Interaction Medication Error123.0%
12. 12Dyspnoea112.8%
13. 13Intentional Product Use Issue112.8%
14. 14Haemorrhage Intracranial102.5%
15. 15Cardiac Failure92.3%

The 10 most recently updated of 44 ClinicalTrials.gov registrations naming Cangrelor as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• The Bridging Antiplatelet Therapy With Cangrelor 2 Study
  Recruiting · Phase 4 · Interventional · 50 enrolled · University of Florida
  NCT07225842updated 2026-05-05
• Minimally Invasive Coronary Artery Bypass Supported by Cangrelor
  Recruiting · Observational · 30 enrolled · Cardiocentro Ticino
  NCT07514962updated 2026-04-14
• Evaluation of Myocardial Reperfusion After Primary PCI in Patients With High Platelet Reactivity Treated by Cangrelor or Not
  Completed · Phase 4 · Interventional · 128 enrolled · University Hospital, Caen
  NCT04927949updated 2026-04-02
• REperfusion With P2Y12 Inhibitors in Addition to mEchanical thRombectomy for perFUsion Imaging Selected Acute Stroke patiEnts
  Recruiting · Phase 3 · Interventional · 368 enrolled · Fondation Ophtalmologique Adolphe de Rothschild
  NCT04667078updated 2026-03-02
• ARCANGELO (itAlian pRospective Study on CANGrELOr)
  Completed · Observational · 1,005 enrolled · Chiesi Farmaceutici S.p.A.
  NCT04471870updated 2026-02-20
• Parenteral Antiplatelet Agents in Real-world Spanish PCI Patients
  Active not recruiting · Observational · 717 enrolled · Fundación EPIC
  NCT05193019updated 2026-02-10
• Proximal Internal Carotid Artery Acute Stroke Secondary to Tandem or Local Occlusion Thrombectomy Trial
  Recruiting · Phase 3 · Interventional · 404 enrolled · Mercy Health Ohio
  NCT05611242updated 2025-12-17
• Pharmacodynamic Effects of Cangrelor in ACS or CCS Patients Undergoing PCI (POMPEII Registry)
  Completed · Observational · 150 enrolled · Federico II University
  NCT04790032updated 2025-08-07
• Cangrelor in Acute Myocardial Infarction: Effectiveness and Outcomes Registry
  Active not recruiting · Observational · 5,050 enrolled · Chiesi USA, Inc.
  NCT04076813updated 2025-06-13
• The Effect of IV Cangrelor and Oral Ticagrelor Study
  Completed · Phase 4 · Interventional · 100 enrolled · The Royal Wolverhampton Hospitals NHS Trust
  NCT02733341updated 2025-05-02

Frequently asked questions

How does Cangrelor work?

Cangrelor is a direct P2Y 12 platelet receptor inhibitor that blocks ADP-induced platelet activation and aggregation. Cangrelor binds selectively and reversibly to the P2Y 12 receptor to prevent further signaling and platelet activation.

What is Cangrelor used for?

According to FDA labeling, Cangrelor carries indications including: KENGREAL is indicated as an adjunct to percutaneous coronary intervention (PCI) to reduce the risk of periprocedural myocardial infarction (MI), repeat coronary revascularization, and stent thrombosis (ST) in patients who have not been treated with a P2Y 12 platelet inhibitor and are not being given a glycoprotein IIb/IIIa inhibitor [see Clinical Studies ( 14.1 )]. KENGREAL is a P2Y 12 platelet inhibitor indicated as an adjunct to percutaneous coronary intervention (PCI) for reducing the risk of periprocedural myocardial infarction (MI), repeat coronary revascularization, and stent thrombosis (ST) in patients in who have not been treated with a P2Y 12 platelet inhibitor and are not being given a glycoprotein IIb/IIIa inhibitor.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Cangrelor?

Cangrelor is classified as Platelet aggregation inhibitors excl. heparin, P2Y12 Platelet Inhibitor, P2Y12 Receptor Antagonists, Decreased Platelet Aggregation.

What are the brand names for Cangrelor?

Cangrelor is marketed under brand names including Kengreal.

What are the contraindications for Cangrelor?

Cangrelor labeling lists contraindications including: Significant active bleeding ( 4.1 ) Hypersensitivity to KENGREAL or any component of the product ( 4.2 ) 4.1 Significant Active Bleeding KENGREAL is contraindicated in patients with significant active bleeding [see Warnings and Precautions ( 5.1 ) and Adverse Reactions ( 6.1 )] . 4.2 Hypersensitivity KENGREAL is contraindicated in patients with known hypersensitivity (e.g., anaphylaxis) to KENGREAL or any component of the product [see Adverse Reactions ( 6.1 )] .. Always consult the full prescribing information and a clinician.