Bevyxxa

(Betrixaban)

Phase 2Small molecule

PPortola Pharmaceuticals

Bevyxxa is one of 23 small molecule programs targeting Atrial Fibrillation. It is currently in Phase 2.

Indications

Total Trials

Active Trials

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Atrial FibrillationActive, not recruiting

Atrial FibrillationPhase 2

Active, not recruiting

Competition

Competitive Landscape

376 competitors in Atrial Fibrillation

#DrugCompanyPhaseTrials

Bevyxxa

PPortola Pharmaceuticals

Phase 2

1 2

Xylocaine

MMEDRx USA, Inc.

Preclinical

1 3

Anticoagulants

Sanofi

Preclinical

2 4

Direct Anticoagulant

Bayer

Preclinical

1 5

SGLT2 Inhibitor

Eli Lilly

Preclinical

1 6

Statin

Bristol-Myers Squibb

Preclinical

1 7

Warfarin Sodium

Boehringer Ingelheim

Preclinical

3 8

Magnesium SO4

HHospital de Base

Preclinical

2 9

Medication

NNYU Langone Health

Preclinical

1 10

Anticoagulation

HHospital Álvaro Cunqueiro

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Clinical

Trials by Indication[1]

Factor Xa Inhibitor2 trials

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

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

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

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

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

Tics1 trial

A Bioequivalence Study to Compare the Pharmacokinetics of Two Betrixaban Formulations

Completed·PPortola Pharmaceuticals·Phase 1·NCT02596100·52 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

5 more indications

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

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

Pediatric1 trial

Study Evaluating Betrixaban in Pediatric Participants

Terminated· AstraZeneca logo

AstraZeneca·Phase 1·NCT03346083·21 enrolled

Prevention1 trial

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

Completed·PPortola Pharmaceuticals·Phase 3·NCT01583218·7,513 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[4]

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]
Open Targets Platform — Drug–disease associations for Betrixaban. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA208383). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Bevyxxa. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Portola Pharmaceuticals company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: PPortola Pharmaceuticals

Patent Landscape[5]

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

Bevyxxa

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Factor Xa Inhibitor2 trials

Renal Impairment1 trial

Hepatic Impairment1 trial

Tics1 trial

Atrial Fibrillation1 trial

PK/PD1 trial

ESS1 trial

Pediatric1 trial

Prevention1 trial

Unspecified1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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