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Bevyxxa

(Betrixaban)

Small molecule

PPortola Pharmaceuticals

0

Indications

11

Total Trials

0

Active Trials

0

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

5

Patents

Clinical

Trials by Indication[1]

Factor Xa Inhibitor2 trials

Phase 2 Study of the Safety, Tolerability and Pilot Efficacy of Oral Factor Xa Inhibitor Betrixaban Compared to Warfarin

Completed·PPortola Pharmaceuticals·Phase 2·NCT00742859·508 enrolled

Factor Xa Inhibitor, PRT054021, Against Enoxaparin for the Prevention of Venous Thromboembolic Events (EXPERT)

Completed·PPortola Pharmaceuticals·Phase 2·NCT00375609·215 enrolled

Atrial Fibrillation1 trial

Evaluate the Pharmacokinetics and Safety of MK-4448 in Participants With Nonvalvular Atrial Fibrillation or Atrial Flutter

Completed·PPortola Pharmaceuticals·Phase 2·NCT01229254·189 enrolled

ESS1 trial

An Open-Label, Single-Dose, Mass-Balance Study to Assess the Disposition of 14C-Labeled PRT054021 in Healthy Male Subjects

Completed·PPortola Pharmaceuticals·Phase 1·NCT01765855·5 enrolled

PK/PD1 trial

A Healthy Volunteer PK/PD, Safety and Tolerability Study of Andexanet After Betrixaban Dosing

Terminated·PPortola Pharmaceuticals·Phase 2·NCT03330457·18 enrolled

Hepatic Impairment1 trial

The Effect o f Hepatic Impairment on the Pharmacokinetics and Pharmacodynamics of Betrixiban, an Oral FXa Antagonist

Completed·PPortola Pharmaceuticals·Phase 1·NCT03397888·32 enrolled

5 more indications

Prevention1 trial

Acute Medically Ill VTE Prevention With Extended Duration Betrixaban Study (The APEX Study)

Completed·PPortola Pharmaceuticals·Phase 3·NCT01583218·7,513 enrolled

Renal Impairment1 trial

A Study to Determine the Pharmacokinetics, Pharmacodynamics, and Tolerabiltiy of Betrixaban in Patients With Mild, Moderate, and Severe Renal Impairment

Completed·PPortola Pharmaceuticals·Phase 1·NCT00999336·32 enrolled

Pediatric1 trial

Study Evaluating Betrixaban in Pediatric Participants

Terminated· AstraZeneca logo

AstraZeneca·Phase 1·NCT03346083·21 enrolled

Tics1 trial

A Bioequivalence Study to Compare the Pharmacokinetics of Two Betrixaban Formulations

Completed·PPortola Pharmaceuticals·Phase 1·NCT02596100·52 enrolled

Unspecified1 trial

A Human Phase I Absolute Bioavailability Study of PRT054021 in Healthy Male Volunteers

Completed·PPortola Pharmaceuticals·Phase 1·NCT01765868·8 enrolled

Regulatory

FDA Approval Timeline[3]

Jun 23, 2017

BEVYXXA

NDA NDA208383

Sources

References

[1]
ClinicalTrials.gov — 11 trial records for Betrixaban. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Betrixaban compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
OpenFDA — FDA approval records (NDA NDA208383). U.S. Food & Drug Administration.
[4]
FDA Orange Book — Patent and exclusivity data for Bevyxxa. U.S. Food & Drug Administration.
[5]
SEC EDGAR — Portola Pharmaceuticals company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Company: PPortola Pharmaceuticals

Patent Landscape[4]

Patent Cliff

Nov 7, 2026

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9555023Nov 7, 2026

7598276Nov 8, 2026

8557852Sep 8, 2028

8987463Dec 28, 2030

8404724Mar 29, 2031

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