Andexanet Alfa

Summary

Andexanet Alfa (CHEMBL3301583) is an approved protein (ATC V03AB38); indicated across 2 conditions.

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Protein
• ATC class: V03AB38
• Indications: 2 conditions
• Clinical trials: 12

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL3301583
Name	Andexanet Alfa
Type	Protein
Max phase	4
ATC	V03AB38

Also known as: Andexanet alfa, Andexxa, Ondexxya, PRT-064445, PRT-4445, PRT064445, rfXa Inhibitor Antidote, ANDEXANET ALFA

Targets

Targets

No target linkage available.

Bioactivity

No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).

Target pathways

No target-pathway data for this drug (no mapped target genes).

Indications & clinical

Indications

2 indication records carry no mapped disease name (EFO/MeSH-only); none shown.

Clinical trials

Total trials: 12.

Phase distribution

Phase	Trials
PHASE2	6
PHASE1	2
Not specified	2
PHASE4	1
PHASE3	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT03661528	PHASE4	COMPLETED	Trial of Andexanet Alfa in ICrH Patients Receiving an Oral FXa Inhibitor
NCT05926349	PHASE3	WITHDRAWN	A Study of Andexanet Alfa in Patients Requiring Urgent Surgery or Procedure
NCT01758432	PHASE2	COMPLETED	Phase 2 Healthy Volunteer Study to Evaluate the Ability of PRT064445 to Reverse the Effects of Several Blood Thinner Drugs on Laboratory Tests (Module 1 of 4)
NCT03310021	PHASE2	COMPLETED	A Healthy Volunteer Pharmacokinetics (PK)/Pharmacodynamics (PD), Safety and Tolerability Study of Andexanet in Healthy Japanese and Caucasian Subjects
NCT03551730	PHASE2	COMPLETED	Phase 2 Healthy Volunteer Study to Evaluate the Ability of PRT064445 to Reverse the Effects of Several Blood Thinner Drugs on Laboratory Tests (Module 3 of 4)
NCT03551743	PHASE2	COMPLETED	Phase 2 Healthy Volunteer Study to Evaluate the Ability of PRT064445 to Reverse the Effects of Several Blood Thinner Drugs on Laboratory Tests (Module 4 of 4)
NCT03578146	PHASE2	COMPLETED	Phase 2 Healthy Volunteer Study to Evaluate the Ability of PRT064445 to Reverse the Effects of Several Blood Thinner Drugs on Laboratory Tests (Module 2 of 4)
NCT04233073	PHASE2	TERMINATED	Trial of Andexanet in Patients Receiving an Oral FXa Inhibitor Who Require Urgent Surgery
NCT07312851	PHASE1	RECRUITING	A Study to Investigate Andexanet Dosing and the Interaction Between Andexanet and Subsequent Enoxaparin in Healthy Participants
NCT03218241	PHASE1	COMPLETED	Single Ascending Dose Study of PRT064445, a Factor Xa (fXa) Inhibitor Antidote
NCT05548777	Not specified	COMPLETED	Andexanet Alfa and 4F-PCC Use in Patients Hospitalised With an Anticoagulant-related Major Bleed
NCT05898412	Not specified	COMPLETED	Retrospective Study on Characteristics and Outcomes in Hospitalised Patients Treated With Ondexxya

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

Pharmacogenomics

No PharmGKB pharmacogenomic data curated for this drug.

Related molecules

Related molecules

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).