Asundexian Explained

Legal Status:Investigational
Cas Number:2064121-65-7
Pubchem:135206011
Unii:LA585UM8DE
Kegg:D12838
Chemspiderid:115009501
Stdinchi:1S/C26H21ClF4N6O4/c1-3-19(25(40)33-14-5-6-15(24(32)39)18(28)9-14)36-11-21(41-2)17(10-23(36)38)16-8-13(27)4-7-20(16)37-12-22(34-35-37)26(29,30)31/h4-12,19H,3H2,1-2H3,(H2,32,39)(H,33,40)/t19-/m0/s1
Stdinchikey:XYWIPYBIIRTJMM-IBGZPJMESA-N
Smiles:CC[C@@H](C(=O)NC1=CC(=C(C=C1)C(=O)N)F)N2C=C(C(=CC2=O)C3=C(C=CC(=C3)Cl)N4C=C(N=N4)C(F)(F)F)OC
Iupac Name:4-(2S)-2-[4-[5-Chloro-2-[4-(trifluoromethyl)triazol-1-yl]phenyl]-5-methoxy-2-oxopyridin-1-yl]butanoylamino]-2-fluorobenzamide
C:26
H:21
Cl:1
F:4
N:6
O:4

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. However, a phase III trial, OCEANIC-AF, 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]

Notes and References

  1. Heitmeier . Stefan . Visser . Mayken . Tersteegen . Adrian . Dietze-Torres . Julia . Glunz . Julia . Gerdes . Christoph . Laux . Volker . Stampfuss . Jan . Roehrig . Susanne . Pharmacological profile of asundexian, a novel, orally bioavailable inhibitor of factor XIa . Journal of Thrombosis and Haemostasis . June 2022 . 20 . 6 . 1400–1411 . 10.1111/jth.15700. 35289054 . 9313898 .
  2. Web site: 2022-08-28 . Bayer initiates landmark Phase III study program to investigate oral FXIa inhibitor asundexian . 2023-12-27 . Bayer . Press release.
  3. Web site: AntiCoagulation via Inhibition of FXIa by the Oral Compound BAY 2433334 – Non-cardioembolic Stroke . 2023-12-26 . American College of Cardiology.
  4. Rao . Sunil V. . Kirsch . Bodo . Bhatt . Deepak L. . Budaj . Andrzej . Coppolecchia . Rosa . Eikelboom . John . James . Stefan K. . Jones . W. Schuyler . Merkely . Bela . Keller . Lars . Hermanides . Renicus S. . Campo . Gianluca . Ferreiro . José Luis . Shibasaki . Taro . Mundl . Hardi . 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 . Circulation . en . 146 . 16 . 1196–1206 . 10.1161/CIRCULATIONAHA.122.061612 . 0009-7322. free . 36030390 . 11392/2520330 . free .
  5. Web site: The Next Wave of Anticoagulation: Results of PACIFIC-AF and the Future Role of Factor XIa Inhibition in Atrial Fibrillation . 2023-12-26 . American College of Cardiology.
  6. Web site: 2023-11-19 . OCEANIC-AF study stopped early due to lack of efficacy . 2023-12-27 . Bayer . Press release.

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