The drug has undergone
clinical trials for prevention of embolism after
knee surgery[5] and for prevention of
stroke following non-valvular
atrial fibrillation.[6][7] Betrixaban was also studied in a large phase III clinical trial for extended duration
thromboprophylaxis in acute ill patients.[8] Previously
apixaban and
rivaroxaban have failed to show positive risk/benefit ratio in this indication compared to
enoxaparin.[9][10][non-primary source needed] APEX trial compared betrixaban with
enoxaparin and included 7513 patients. Lower rate of VTE events was found in betrixaban arm with no increase in major bleedings compared to enoxaparin.[11] Based on these results betrixaban was approved by FDA on June 23, 2017, becoming the first DOAC approved for extended prophylaxis in hospitalized patients.[12]
Betrixaban has been also reviewed by
EMA but didn't receive marketing approval in
EU mainly due to concerns of increased bleeding risk and absence of reversal agent.[13]
^Eriksson BI, Quinlan DJ, Weitz JI (2009). "Comparative pharmacodynamics and pharmacokinetics of oral direct thrombin and factor xa inhibitors in development". Clinical Pharmacokinetics. 48 (1): 1–22.
doi:
10.2165/0003088-200948010-00001.
PMID19071881.
S2CID35948814.
^Turpie AG, Bauer KA, Davidson BL, Fisher WD, Gent M, Huo MH, et al. (January 2009). "A randomized evaluation of betrixaban, an oral factor Xa inhibitor, for prevention of thromboembolic events after total knee replacement (EXPERT)". Thrombosis and Haemostasis. 101 (1): 68–76.
doi:
10.1160/th08-07-0460.
PMID19132191.
S2CID21670373.
^Piccini JP, Lopes RD, Mahaffey KW (July 2010). "Oral factor Xa inhibitors for the prevention of stroke in atrial fibrillation". Current Opinion in Cardiology. 25 (4): 312–320.
doi:
10.1097/HCO.0b013e32833a524f.
PMID20520539.
S2CID25718628.
^Cohen AT, Spiro TE, Büller HR, Haskell L, Hu D, Hull R, et al. (February 2013). "Rivaroxaban for thromboprophylaxis in acutely ill medical patients". The New England Journal of Medicine. 368 (6): 513–523.
doi:
10.1056/nejmoa1111096.
hdl:10447/96593.
PMID23388003.
^Goldhaber SZ, Leizorovicz A, Kakkar AK, Haas SK, Merli G, Knabb RM, Weitz JI (December 2011). "Apixaban versus enoxaparin for thromboprophylaxis in medically ill patients". The New England Journal of Medicine. 365 (23): 2167–2177.
doi:
10.1056/nejmoa1110899.
hdl:2437/127244.
PMID22077144.