zalunfiban (RUC-4) / CeleCor - LARVOL DELTA

Rethinking Antiplatelet Strategies: Selective Blockade, Broad-Acting Drugs, and Beyond (ASH 2026) - "Ingerborg Hers will discuss the emerging use of proteolysis-targeting chimeras (PROTACs) to degrade key platelet signaling proteins. Focusing on BTK degraders and additional targets such as FAK, PYK2, and GSK3, she will illustrate how targeted protein degradation enables sustained suppression of thrombosis-relevant pathways without compromising hemostasis, offering a new paradigm for safer antithrombotic therapy."

Cardiovascular • Hematological Disorders • Inflammation • Myocardial Infarction • Reperfusion Injury • Targeted Protein Degradation • Thrombosis

Efficacy and Safety of Zalunfiban by Creatinine Clearance Among Patients with ST-Elevation Myocardial Infarction: Analysis from the CELEBRATE Trial. (PubMed, Am J Cardiol) - P3 | "In conclusion, although a signal for greater clinical benefit was observed among STEMI patients with CrCl ≥30 to <60 mL/min, there was no significant interaction by renal function, and these findings should be considered exploratory. STUDY REGISTRATION: A Phase 3 Study of Zalunfiban in Subjects With ST-elevation MI (CELEBRATE); ClinicalTrials.gov identifier: NCT04825743."

Journal • Cardiovascular • Myocardial Infarction • Renal Disease

Zalunfiban: is it really time to CELEBRATE? (ESC 2026) - No abstract available

Acute Coronary Syndrome • Cardiovascular

Injectable antiplatelet therapies in acute coronary syndromes: Current status and Emerging Therapies. A position paper of the Task Force of Antithrombotic therapy of the ACVC. (PubMed, Eur Heart J Acute Cardiovasc Care) - "Intravenous aspirin is used widely in patients with ACS, while the absorption of oral P2Y12 inhibitors is often delayed, and the intravenous P2Y12 inhibitor cangrelor can achieve almost complete platelet inhibition within minutes. While use of the glycoprotein IIb/IIIa inhibitors (GPI) eptifibatide and tirofiban is decreasing, typically reserved for thrombotic complications or no reflow following PCI, recently zalunfiban, a novel subcutaneously administered GPI has been shown to improve reperfusion before revascularisation in patients with STEMI when given at first medical contact. In this review, we dicuss the rationale and potential benefits of injectable antiplatelet medications, including currently available agents and those in development or being tested in clinical trials. While the benefit of injectable medications on hard clinical endpoints such as major adverse cardiac events remains unclear for an allcomers ACS population, there is emerging data that these..."

Journal • Acute Coronary Syndrome • Anesthesia • Cardiovascular • Myocardial Infarction

The Effect of Zalunfiban on High Sensitivity Cardiac Troponin and the Association with Clinical Outcomes in Patients with STEMI. (PubMed, Am Heart J) - P3 | "Among patients with STEMI, more elevated concentrations of hs-cTnT are associated with worse measures of reperfusion and higher risk for short-term death or heart failure. A single dose of zalunfiban at first medical contact reduced MI size."

Clinical data • Journal • Cardiovascular • Congestive Heart Failure • Heart Failure • Myocardial Infarction • Thrombosis

Upstream Antiplatelet Therapy in ST-Segment Elevation Myocardial Infarction: What Zalunfiban Adds to the Glycoprotein IIb/IIIa Story. (PubMed, Cardiol Rev) - "Recent clinical trials suggest that zalunfiban may overcome these barriers while preserving the mechanistic advantages of upstream platelet inhibition. This review summarizes the mechanism of action, pharmacokinetic and pharmacodynamic properties, clinical efficacy, and safety profile of zalunfiban, and discusses its potential role within contemporary ST-segment elevation myocardial infarction care pathways."

Journal • Acute Coronary Syndrome • Cardiovascular • Myocardial Infarction

Pharmacological Management of Thrombosis: Current State and Future Strategies. (PubMed, Int J Mol Sci) - "While various antithrombotic agents exist, many patients still rely on traditional gold-standard drugs like heparin, warfarin, and aspirin, which present significant drawbacks...The development of new antiplatelet drugs, like subcutaneous zalunfiban and selatogrel for pre-hospital therapy of myocardial infarction, and specific reversal agents, such as bentracimab for ticagrelor, exemplify this trend. Future research will likely focus on addressing the unmet needs of specific patient groups. This narrative review aimed to describe the current antithrombotic treatment and the most promising advances in the pharmacological management of thrombosis."

Journal • Review • Cardiovascular • Hematological Disorders • Myocardial Infarction • Oncology • Thrombocytopenia • Thrombosis

Glycoprotein IIb/IIIa Blockade: Ready to CELEBRATE a New Dawn? (PubMed, Eur Cardiol) - No abstract available

Journal • Cardiovascular • Coronary Artery Disease • Heart Failure

ZALUNFIBAN REDUCES SIZE OF ST SEGMENT ELEVATION MYOCARDIAL INFARCTION: THE CELEBRATE TRIAL (ACC 2026) - P3 | "Treatment of STEMI with a single dose of zalunfiban reduced infarct size, reflected by more study participants with lower hs-cTnT concentrations. These results help to understand the improvement in clinical outcomes among patients treated in the CELEBRATE Trial. Full results including angiographic and clinical correlates of hs-cTnT differences will be presented (CELEBRATE; NCT04825743)."

Cardiovascular • Myocardial Infarction

PRE-HOSPITAL ZALUNFIBAN REDUCES ACUTE STENT THROMBOSIS IN PATIENTS WITH ST ELEVATION MYOCARDIAL INFARCTION. RESULTS FROM THE CELEBRATE TRIAL (ACC 2026) - P3 | " The CELEBRATE trial was an international, double blind, randomized clinical trial designed to evaluate the effect of pre-hospital or first hospital arrival single subcutaneous administration of a third generation, glycoprotein 2b3a receptor antagonist (zalunfiban) on top of aspirin, ticagrelor and heparin, in patients with STEMI... In patients with STEMI, pre-hospital treatment with zalunfiban significantly reduced the rate of acute stent thrombosis, even in patients pre-treated with oral P2Y12 blockers, aspirin and/or heparin. Acute stent thrombosis was associated with poor clinical outcome. Full results, including angiographic and clinical correlates of acute stent thrombosis will be presented (CELEBRATE; NCT04825743)"

Clinical • Cardiovascular • Hematological Disorders • Myocardial Infarction • Thrombosis

The Effect of Zalunfiban on High Sensitivity Cardiac Troponin and the Association with Clinical Outcomes in Patients with STEMI. (PubMed, medRxiv) - P3 | "These results provide a mechanistic basis for the improved clinical outcomes associated with zalunfiban treatment in the CELEBRATE Trial. A Phase 3 Study of Zalunfiban in Subjects With ST-elevation MI (CELEBRATE); NCT04825743."

Clinical data • Journal • Cardiovascular • Congestive Heart Failure • Heart Failure • Myocardial Infarction • Thrombosis

Mass balance and metabolite profiling of 14C-Zalunfiban in humans following single-dose subcutaneous administration. (PubMed, Xenobiotica) - "Total dose recovery reached >90% by 240 hours.Zalunfiban is rapidly metabolized to the nearly inactive M1 metabolite, which is excreted primarily in urine. Renal impairment, therefore, is unlikely to significantly prolong zalunfiban effects and dose adjustment in patients with reduced renal function may not be required."

Journal • Renal Disease

Zalunfiban at First Medical Contact in Patients with ST-Segment Elevation Myocardial Infarction (AHA 2025) - P3 | "Coronary blood flow was significantly faster in the zalunfiban treated group on arrival to the cardiac catheterization laboratory (median 109 vs 176 frames, P=0.012).CONCLUSIONSAmong early-presenting STEMI patients, a single subcutaneous injection of zalunfiban at first medical contact significantly improved pre-intervention infarct related artery patency and reduced the likelihood of a worse clinical endpoint at 30 days without an increase in severe or life-threatening bleeding. (Funded by CeleCor Therapeutics, CELEBRATE ClinicalTrials.gov number, NCT04825743)"

Clinical • Late-breaking abstract • Cardiovascular • Congestive Heart Failure • Heart Failure • Hematological Disorders • Myocardial Infarction • Thrombosis

Zalunfiban at First Medical Contact for ST-Elevation Myocardial Infarction. (PubMed, NEJM Evid) - P3 | "In patients with STEMI, zalunfiban administered at first medical contact significantly improved preintervention infarct-related patency and reduced the likelihood of a worse 30-day multicomponent hierarchical clinical end point. Zalunfiban was not associated with increased severe or life-threatening bleeding but was associated with increased mild to moderate bleeding. (Funded by CeleCor Therapeutics; CELEBRATE ClinicalTrials.gov number, NCT04825743)."

Journal • Cardiovascular • Congestive Heart Failure • Heart Failure • Hematological Disorders • Myocardial Infarction • Thrombosis

CELEBRATE: A Phase 3 Study of Zalunfiban in Subjects With ST-elevation MI (clinicaltrials.gov) - P3 | N=2463 | Active, not recruiting | Sponsor: CeleCor Therapeutics | Trial completion date: May 2025 ➔ May 2026 | Trial primary completion date: May 2025 ➔ May 2026 | Completed ➔ Active, not recruiting

Enrollment closed • Trial completion date • Trial primary completion date • Cardiovascular • Myocardial Infarction

CELEBRATE: A Phase 3 Study of Zalunfiban in Subjects With ST-elevation MI (clinicaltrials.gov) - P3 | N=2463 | Completed | Sponsor: CeleCor Therapeutics | Recruiting ➔ Completed | Trial completion date: Apr 2026 ➔ May 2025

Trial completion • Trial completion date • Cardiovascular • Myocardial Infarction

CELEBRATE: A Phase 3 Study of Zalunfiban in Subjects With ST-elevation MI (clinicaltrials.gov) - P3 | N=2499 | Recruiting | Sponsor: CeleCor Therapeutics | Trial completion date: Dec 2024 ➔ Apr 2026 | Trial primary completion date: Dec 2024 ➔ Apr 2025

Trial completion date • Trial primary completion date • Cardiovascular • Myocardial Infarction

Greater Coronary and Myocardial Perfusion, and Lower Thrombus Burden at Initial Angiogram with Increasing Doses of Zalunfiban in Patients with STEMI (CVCT USA 2024) - No abstract available

Clinical • Thrombosis

Pharmacokinetics of 14C-Labeled Zalunfiban (RUC-4) Suggests That No Dose Adjustment Is Necessary for Impaired Renal Function (TCT 2024) - No abstract available

PK/PD data • Chronic Kidney Disease

Current and Future Roles of Glycoprotein IIb-IIIa Inhibitors in Primary Angioplasty for ST-Segment Elevation Myocardial Infarction. (PubMed, Biomedicines) - "The ongoing CELEBRATE trial, including 2499 STEMI patients, may potentially provide compelling data to support the upstream treatment of STEMI patients undergoing mechanical reperfusion. In fact, although the current therapeutic target of increased rates of timely reperfusion has been achieved, the future goal in myocardial infarction treatment should be to achieve the most rapid reperfusion prior to primary percutaneous coronary intervention, thus further minimizing myocardial damage, or, in some cases, even preventing it completely, and improving survival."

Journal • Review • Cardiovascular • Hematological Disorders • Myocardial Infarction • Thrombosis

Zalunfiban: A Review of Current Knowledge and Future Applications of an Innovative Antiplatelet Agent. (PubMed, Cardiol Rev) - "It has shown to be safe and effective in both phase 1 and phase 2 trials and is under investigation in phase 3 trials. In this review, we discuss zalunfiban in detail, including its mechanism of action, adverse effects, current recommendations for use, and ongoing trials."

Journal • Review • Cardiovascular • Myocardial Infarction

Critical Analysis of Thrombocytopenia Associated With Glycoprotein IIb/IIIa Inhibitors and Potential Role of Zalunfiban, a Novel Small Molecule Glycoprotein Inhibitor, in Understanding the Mechanism(s). (PubMed, J Am Heart Assoc) - "Thrombocytopenia is a rare but serious complication of the intravenous glycoprotein IIb/IIIa (GPIIb/IIIa; integrin αIIbβ3) receptor inhibitors (GPIs), abciximab, eptifibatide, and tirofiban...It is unclear whether the antibody binding depends on the conformational change and whether the drug contributes directly to the epitope. Zalunfiban, a second-generation subcutaneous small molecule GPI, does not induce the conformational changes; therefore, data from studies of zalunfiban will provide information on the contribution of the conformational changes to the development of GPI-associated thrombocytopenia."

Journal • Review • Hematological Disorders • Thrombocytopenia

In vitro comparison of platelet aggregation between zalunfiban and selatogrel in healthy donors (ESC 2023) - "Whole blood from healthy donors not taking aspirin (N=10) was anticoagulated with 3.2% TSC and 100 μM PPACK...Conclusion Selatogrel is a potent inhibitor of ADP-induced platelet aggregation, but has low impact on TRAP-induced platelet aggregation, whereas zalunfiban is a potent inhibitor of both ADP and TRAP-induced platelet aggregation. The difference between the drugs needs to be considered in light of the known generation of thrombin at the site of vascular injury within seconds."

Preclinical • Cardiovascular

Comparison of the effects of the GPIIb-IIIa antagonist Zalunfiban and the P2Y12 antagonist Selatogrel on Platelet Aggregation. (PubMed, J Thromb Thrombolysis) - "An example is the antithrombotic treatment of acute coronary syndrome (ACS), in particular ST-elevated myocardial infarction (STEMI) patients who are in need for rapid acting strong antithrombotic therapy despite the use of aspirin and oral P2Y12-inhibitors...Zalunfiban also had greater inhibition of MA in response to TRAP at the Cmax dose. These data suggest that zalunfiban may provide greater protection in reducing thrombus formation than selatogrel, especially since thrombin is an early, key primary agonist in the pathophysiology of thrombotic events."

Journal • Acute Coronary Syndrome • Cardiovascular • Myocardial Infarction • Thrombosis

Pre-Percutaneous Coronary Intervention Zalunfiban Dose-Response Relationship to Target Vessel Blood Flow at Initial Angiogram in ST-Elevation Myocardial Infarction - A Post Hoc Analysis of the Cel-02 Phase IIa Study. (PubMed, Am Heart J) - "This post hoc analysis found that higher doses of zalunfiban administered in the cardiac catheterization lab prior to vascular access were associated with greater coronary and myocardial perfusion, and lower thrombus burden at initial angiogram in patients with STEMI undergoing primary percutaneous coronary intervention."

Journal • P2a data • Retrospective data • Cardiovascular • Myocardial Infarction • Thrombosis