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Drug

Andexanet alfa

Approved medicine
ClassTissue factor pathway inhibitor inhibitorResearchOngoing clinical research

Also known as Andexxa, Coagulation Factor Xa (Recombinant), Inactivated.

RxNorm2045114ChEMBLCHEMBL3301583ATCV03AB38UNIIBI009E452R
Tissue factor pathway inhibitor
Primary target
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Phase I, Randomized, Single-blind, Placebo-controlled Study to Further Characterize Andexanet Posology and Assess the Interaction Between Andexanet and Subsequent Enoxaparin in Healthy Participants

Clinical trial2026-06-22Completed · ClinicalTrials.gov

A Randomized Clinical Trial of Andexanet Alfa in Acute Intracranial Hemorrhage in Patients Receiving an Oral Factor Xa Inhibitor

Clinical trial2024-07-03Results posted · ClinicalTrials.gov

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of Andexanet Alfa Administered to Healthy Japanese and Caucasian Subjects

Clinical trial2023-02-24Results posted · ClinicalTrials.gov

Prospective, Open-Label Clinical Study of Andexanet Alfa in Patients Receiving FXa (Activated Factor X) Inhibitor Who Require Urgent Surgery

Clinical trial2022-01-25Terminated · ClinicalTrials.gov

Approval: Ondexxya (EMA)

Regulatory2019-04-26EMA

A Phase 1 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Second Generation Andexanet Alfa Administered to Healthy Subjects

Clinical trial2017-09-28Completed · ClinicalTrials.gov

A Randomized, Double-blind, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenously Administered Andexanet After Dosing to Steady-State With Oral Betrixaban in Healthy Subjects

Clinical trial2016-02-22Terminated · ClinicalTrials.gov

A Randomized Study of Andexanet Alfa Compared to Usual Care in Patients Receiving a Factor Xa Inhibitor Who Require Urgent Surgery or Procedure (ANNEXA-RS)

Clinical trial2027-09-07Withdrawn · ClinicalTrials.gov

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Andexanet alfa
Aliases & brands
AndexxaCoagulation Factor Xa (Recombinant), Inactivated
RxNorm CUI
2045114
ChEMBL ID
CHEMBL3301583
ATC codes
V03AB38
UNII
BI009E452R
Primary mechanism
Tissue factor pathway inhibitor inhibitor
Regulatory jurisdictions
ema

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

Tissue factor pathway inhibitor
TFPI · P10646
INHIBITORTissue factor pathway inhibitor inhibitor

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2019-04-26
Latest approval
2019-04-26
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2019-04-26Approval
Approval: Ondexxya (EMA)
Indication: For adult patients treated with a direct factor Xa (FXa) inhibitor (apixaban or rivaroxaban) when reversal of anticoagulation is needed due to life-threatening or uncontrolled… Show full indication

For adult patients treated with a direct factor Xa (FXa) inhibitor (apixaban or rivaroxaban) when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

7 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
7
registered trials across all phases
LATEST COMPLETION 2026
2
Late-stage (III+)
4
Completed
3
Discontinued
PHASE DISTRIBUTIONn = 7
Phase 12Phase 23Phase 31Phase 41

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

A Randomized Clinical Trial of Andexanet Alfa in Acute Intracranial Hemorrhage in Patients Receiving an Oral Factor Xa Inhibitor

CompletedPH IVAlexion Pharmaceuticals, Inc.n=5302023

A Randomized Study of Andexanet Alfa Compared to Usual Care in Patients Receiving a Factor Xa Inhibitor Who Require Urgent Surgery or Procedure (ANNEXA-RS)

WithdrawnPH IIIAstraZeneca2027

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Phase I, Randomized, Single-blind, Placebo-controlled Study to Further Characterize Andexanet Posology and Assess the Interaction Between Andexanet and Subsequent Enoxaparin in Healthy Participants

CompletedPH IAstraZenecan=1912026

A Randomized Clinical Trial of Andexanet Alfa in Acute Intracranial Hemorrhage in Patients Receiving an Oral Factor Xa Inhibitor

CompletedPH IVAlexion Pharmaceuticals, Inc.n=5302023

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics/Pharmacodynamics of Andexanet Alfa Administered to Healthy Japanese and Caucasian Subjects

CompletedPH IIPortola Pharmaceuticalsn=1082019

A Phase 1 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Second Generation Andexanet Alfa Administered to Healthy Subjects

CompletedPH IPortola Pharmaceuticalsn=1532017
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.