Chemistry:Asundexian
Asundexian is a Factor XIa inhibitor developed by Bayer to prevent stroke.[1]
Clinical trial(s)
Asundexian efficacy and safety in patients have been evaluated in two clinical trial programs: phase IIb PACIFIC and phase III OCEANIC.[2] In the phase IIb PACIFIC clinical trial programs, asundexian consistently showed no difference in bleeding rate compared with placebo[3][4] and reduced the risk of bleeding compared with apixaban.[5] All three trials in the programs were not powered to show efficacy of asundexian.[2] However, a phase III trial, OCEANIC-AF, demonstrated a hazard ratio of 3.8 for stroke or systemic embolism with asundexian vs apixaban, so it was stopped due to a "lack of efficacy." The remaining active study OCEANIC-STROKE was recommended to continue as planned. Bayer is reevaluating the design of the OCEANIC-AFINA based on the findings of the OCEANIC trial.[6]
In February 2026, the OCEANIC-STROKE trial was completed. This was a multicentre, randomised, double-blind, placebo-controlled study involving 12,000 people worldwide who had suffered a non-cardioembolic ischaemic stroke or a transient ischaemic attack. The trial revealed a 26% reduction in the rate of recurrence without major bleeding, a typical complication of antithrombotic drugs.[7][8][9]
References
- ↑ Heitmeier, Stefan; Visser, Mayken; Tersteegen, Adrian; Dietze-Torres, Julia; Glunz, Julia; Gerdes, Christoph; Laux, Volker; Stampfuss, Jan et al. (June 2022). "Pharmacological profile of asundexian, a novel, orally bioavailable inhibitor of factor XIa". Journal of Thrombosis and Haemostasis 20 (6): 1400–1411. doi:10.1111/jth.15700. PMID 35289054.
- ↑ 2.0 2.1 "Bayer initiates landmark Phase III study program to investigate oral FXIa inhibitor asundexian". 2022-08-28. https://www.bayer.com/media/en-us/bayer-initiates-landmark-phase-iii-study-program-to-investigate-oral-fxia-inhibitor-asundexian/.
- ↑ "AntiCoagulation via Inhibition of FXIa by the Oral Compound BAY 2433334 – Non-cardioembolic Stroke". https://www.acc.org/Latest-in-Cardiology/Clinical-Trials/2022/08/27/04/10/http%3a%2f%2fwww.acc.org%2fLatest-in-Cardiology%2fClinical-Trials%2f2022%2f08%2f27%2f04%2f10%2fPACIFIC-STROKE.
- ↑ Rao, Sunil V.; Kirsch, Bodo; Bhatt, Deepak L.; Budaj, Andrzej; Coppolecchia, Rosa; Eikelboom, John; James, Stefan K.; Jones, W. Schuyler et al. (2022-10-18). "A Multicenter, Phase 2, Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Dose-Finding Trial of the Oral Factor XIa Inhibitor Asundexian to Prevent Adverse Cardiovascular Outcomes After Acute Myocardial Infarction" (in en). Circulation 146 (16): 1196–1206. doi:10.1161/CIRCULATIONAHA.122.061612. ISSN 0009-7322. PMID 36030390.
- ↑ "The Next Wave of Anticoagulation: Results of PACIFIC-AF and the Future Role of Factor XIa Inhibition in Atrial Fibrillation". https://www.acc.org/Latest-in-Cardiology/Articles/2022/06/17/11/54/http%3a%2f%2fwww.acc.org%2fLatest-in-Cardiology%2fArticles%2f2022%2f06%2f17%2f11%2f54%2fThe-Next-Wave-of-Anticoagulation.
- ↑ "OCEANIC-AF study stopped early due to lack of efficacy". 2023-11-19. https://www.bayer.com/media/en-us/oceanic-af-study-stopped-early-due-to-lack-of-efficacy/.
- ↑ doi:10.1056/NEJMoa2407105
- ↑ "Ictus ischemico, i risultati della ricerca su un nuovo farmaco sperimentale: recidive ridotte del 26%" (in it). https://www.ausl.bologna.it/news/current/ictus-ischemico-i-risultati-della-ricerca-su-un-nuovo-farmaco-sperimentale-recidive-ridotte-del-26.
- ↑ "Bayer’s asundexian demonstrated a substantial 26% reduction in stroke after a non-cardioembolic ischemic stroke or high-risk transient ischemic attack, with no increase in ISTH major bleeding versus placebo". https://www.bayer.com/en/us/news-stories/asundexian-after-a-non-cardioembolic-ischemic-stroke.
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