A Phase 3 Study of Zalunfiban in Subjects With ST-elevation MI

Summary

This is a Phase 3 prospective, blinded, randomized, placebo controlled, international multicenter study. Subjects with STEMI will be enrolled in the ambulance if they meet all eligibility criteria. These subjects will be evaluated by (para)medics who transport the subjects to the participating hospitals in Europe and North America. Hospitals and ambulance services with experience in ambulance studies will be selected. Each subject will receive a single subcutaneous injection containing either Disaggpro(tm) zalunfiban Dose 1 (0.110 mg/kg) or Disaggpro(tm) zalunfiban Dose 2 (0.130 mg/kg) or placebo

Timeline

Start

2021-04-24

Primary completion

2026-05-13

Completion

2026-05-13

Outcome

Met primary endpoint

paper The primary efficacy end point was significantly improved by zalunfiban (adjusted odds ratio 0.79; 95% confidence interval, 0.65 to 0.98; P=0.028). PMID 41211981 ↗

release “The results of the pivotal CeleBrate study, which met both its primary efficacy and safety endpoints, were presented today” celecor.com ↗

Publications

• Januzzi JL, Gibson CM, Chi G, Coller BS, Granger CB, Montalescot G, Rikken SAOF, Verburg A, Berg JMT, van 't Hof AWJ; CELEBRATE Investigators. The effect of zalunfiban on high sensitivity cardiac troponin and the association with clinical outcomes in patients with STEMI. Am Heart J. 2026 Jun 16;301:107513. doi: 10.1016/j.ahj.2026.107513. Online ahead of print.
• Januzzi JL, Gibson CM, Chi G, Coller BS, Granger CB, Montalescot G, Rikken SAOF, Verberg A, Ten Berg JM, van 't Hof AWJ. The Effect of Zalunfiban on High Sensitivity Cardiac Troponin and the Association with Clinical Outcomes in Patients with STEMI. medRxiv [Preprint]. 2026 Feb 9:2026.02.03.26345522. doi: 10.64898/2026.02.03.26345522.
• Van't Hof AWJ, Gibson CM, Rikken SAOF, Januzzi JL, Granger CB, van Beurden A, Rasoul S, Ruiters L, Vainer J, Verburg A, Arslan F, Jukema JW, Durieux M, Polad J, van Vliet R, van den Branden BJL, Magro M, Remkes W, Beelen J, Hermanides R, Tolsma R, Gosselink M, Vinereanu D, Chioncel V, van de Hoef TP, Boomars R, Arkenbout KE, van Houwelingen GK, Hengstman G, van de Wetering H, Pisters R, Kala P, Merkely B, Ecollan P, Lapostolle F, Giugliano RP, Welsh RC, Levy M, Arias-Mendoza A, Baron N, Cociorva D, Wittes J, Unger EF, Coller BS, Ten Berg JM, Montalescot G. Zalunfiban at First Medical Contact for ST-Elevation Myocardial Infarction. NEJM Evid. 2026 Jan;5(1):EVIDoa2500268. doi: 10.1056/EVIDoa2500268. Epub 2025 Nov 10.
• Rikken SAOF, Selvarajah A, Hermanides RS, Coller BS, Gibson CM, Granger CB, Lapostolle F, Postma S, van de Wetering H, van Vliet RCW, Montalescot G, Ten Berg JM, van 't Hof AWJ; CELEBRATE investigators. Prehospital treatment with zalunfiban (RUC-4) in patients with ST- elevation myocardial infarction undergoing primary percutaneous coronary intervention: Rationale and design of the CELEBRATE trial. Am Heart J. 2023 Apr;258:119-128. doi: 10.1016/j.ahj.2022.12.015. Epub 2022 Dec 31.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	zalunfiban	Small molecule	0.11 mg/kg	Subcutaneous
Subject	zalunfiban	Small molecule	0.13 mg/kg	Subcutaneous

Indications