New Drug Approvals


Betrixaban:PRT-54021, PRT-021, MK-4448, PRT-054021

N- (5- chloro-2-pyridyl) -2 – [[4 – [(dimethylamino) methyl] benzoyl] amino] -5 – methoxy – benzamide

CAS 330942-05-7

MW 451.91, C23H22ClN5O3

Venous Thromboembolism (VTE)

Millennium INNOVATOR

Takeda Pharmaceutical Co Ltd

Lee’s Pharmaceutical Holdings (Hong Kong) Ltd; Portola Pharmaceuticals Inc…DEVELOPERS

PHASE 3  for Venous Thromboembolism (VTE)

Patents CN1391555A, CN102336702A, CN101595092A, CN102762538A

Portola Pharmaceuticals, under license from Takeda (formerly known as Millennium Pharmaceuticals), is developing betrixaban (was reported to be in phase III in November 2015), for treating venous thrombosis

In October 2015, betrixaban was granted Fast Track designation by the FDA for extended-duration prevention of VTE or blood clots in acute medically ill patients

Betrixaban (INN, codenamed PRT-054,021) is an anticoagulant drug which acts as a direct factor Xa inhibitor.[1] It is potent, orally active and highly selective for factor Xa, being selected from…

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