> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/asset/andexanet-alfa-9caba2c5-7b01-4a0f-a459-eebd0f65650a > Record changed: 2026-10-13 # Andexanet alfa Highest phase reached Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3301583) Drug type Protein Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3301583) First approval year 2019 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3301583) ## Development status **First approval year** 2019 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3301583) **Listing at source** Listed **Highest phase reached** Approved Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3301583) ## Names and chemistry **Drug type** Protein Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3301583) **Drug name** Andexanet alfa Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3301583) ### Brand names (2) - ondexxya - Ondexxya ### Other names (27) - andexanet alfa - Andexanet alfa - Andexanet alfa (bolus) - Andexanet alfa (Gen 1 Process 2) - Andexanet alfa (Gen 1 Process 3) - Andexanet alfa (Gen 2) - Andexanet alfa (infusion IV) - andexanet alfa \[INN\] - ANDEXANET ALFA \[JAN\] - ANDEXANET ALFA \[USAN\] - Andexanet alfa \[WHO-DD\] - andexanet alfa inn - andexanet alfa jan - andexanet alfa usan - andexanet alfa who dd - andexxa - Andexxa - COAGULATION FACTOR XA (RECOMBINANT), INACTIVATED-ZHZO - coagulation factor xa recombinant inactivated zhzo - prt 064445 - prt 4445 - PRT-064445 - PRT-4445 - prt064445 - PRT064445 And 2 more, listed on the interactive page. ## Identifiers **CAS registry numbers** - 1262449-58-0 **ChEMBL ID** CHEMBL3301583 Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3301583) **RxNorm IDs (RxCUI)** - 2045114 **FDA ingredient codes (UNII)** - BI009E452R ### ATC classification codes (2) - V03AB - V03AB38 Sources for recorded values Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL3301583) ## Regulatory information ### European Union **Status** Authorised **Status date** 26 Apr 2019 **Authorisation date** 26 Apr 2019 **Approved indications** 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. **Product number** EMEA/H/C/004108 **Authorisation holder** AstraZeneca AB **Priority medicines scheme** No **Generic** No **Biosimilar** No **Generic medicines** 0 **Biosimilar medicines** 0 **Advanced therapy** No **Conditional approval** Yes **Additional monitoring** Yes **Accelerated assessment** No **Exceptional circumstances** No #### Therapeutic areas - Drug-Related Side Effects and Adverse Reactions European medicines record Source: [www.ema.europa.eu](https://www.ema.europa.eu/en/medicines/human/EPAR/ondexxya) ### Other regulatory facts **Patents** 0 **Designations** 1 **First in class** No **Fast track** No **Breakthrough designation** Yes **Orphan designation** No **Priority review** No **Orphan exclusivity** No **Accelerated approval** No **Boxed warning** Yes ## Pharmacology ### Drug classification **Pharmacology name** andexanet alfa **Type** Peptide **Approval recorded by Guide to Pharmacology** Yes ### Mechanisms of action (5) - **Action** Binding **Action type** Binding **Target** apixaban **Gene symbol** apixaban **Median affinity** 9.24 **Affinity units** pKd - **Action** Binding **Action type** Binding **Target** rivaroxaban **Gene symbol** rivaroxaban **Median affinity** 8.82 **Affinity units** pKd - **Mechanism** Tissue factor pathway inhibitor inhibitor **Action type** Inhibitor **Target** Tissue factor pathway inhibitor **Protein identifier** P10646 - **Mechanism** Apixaban sequestering agent **Action type** SEQUESTERING\_AGENT **Target** Apixaban - **Mechanism** Rivaroxaban sequestering agent **Action type** SEQUESTERING\_AGENT **Target** Rivaroxaban ### Open Targets mechanisms - **Mechanism** Tissue factor pathway inhibitor inhibitor **Action type** Inhibitor **Target** Tissue factor pathway inhibitor ### Investigated indications (2) - **Condition** Drug-Related Side Effects and Adverse Reactions **Highest recorded phase** 4 **Condition identifier** EFO:0020003 **Subject identifier** D064420 - **Condition** Hemorrhage **Highest recorded phase** 2 **Condition identifier** MP:0001914 **Subject identifier** D006470 ### Open Targets indications (5) - **Condition identifier** EFO\_0000551 - **Condition identifier** EFO\_0020003 - **Condition identifier** MONDO\_0002243 - **Condition identifier** MONDO\_0002243 **Highest recorded phase** 3 - **Condition identifier** MP\_0001914 **Highest recorded phase** 2 ### Warnings (3) - **Warning** Black Box Warning **Effect** cardiotoxicity - **Warning** Black Box Warning **Effect** gastrointestinal toxicity - **Warning** Black Box Warning **Effect** hematological toxicity ### Open Targets warnings (3) - **Warning** Black Box Warning **Effect** cardiotoxicity **Country** United States - **Warning** Black Box Warning **Effect** gastrointestinal toxicity **Country** United States - **Warning** Black Box Warning **Effect** hematological toxicity **Country** United States ### Reported adverse events (9) - **Event** acute myocardial infarction **Reports** 7 **Reporting signal score** 19.6971 - **Event** cerebellar stroke **Reports** 2 **Reporting signal score** 12.508 - **Event** cerebral infarction **Reports** 6 **Reporting signal score** 16.5602 - **Event** device related thrombosis **Reports** 2 **Reporting signal score** 10.0207 - **Event** embolic cerebral infarction **Reports** 2 **Reporting signal score** 10.0748 - **Event** heparin resistance **Reports** 2 **Reporting signal score** 15.0648 - **Event** ischaemic stroke **Reports** 6 **Reporting signal score** 17.5761 - **Event** product temperature excursion issue **Reports** 2 **Reporting signal score** 10.6817 - **Event** pulmonary embolism **Reports** 8 **Reporting signal score** 15.3138 ### Trial references (3) - NCT03083704 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03083704) - NCT03310021 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03310021) - NCT03330457 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT03330457) ## Dosing **Dose** 400 mg or 800 mg **Route** Intravenous **How often** Initial bolus followed by infusion for 120 minutes ### Conditions of use (2) - Administer as an IV bolus at 30 mg/min - Followed by continuous infusion at 4 mg/min or 8 mg/min for 120 minutes ## Chemical properties **Prodrug** No **Chirality** Single enantiomer **Inorganic** No **Natural product** No ### Sequences - **Component** Sequence **Type** Protein **Sequence** ANSFLFWNKYKDGDQCETSPCQNQGKCKDGLGEYTCTCLEGFEGKNCELFTRKLCSLDNGDCDQFCHEEQNSVVCSCARGYTLADNGKACIPTGPYPCGKQTLERIVGGQECKDGECPWQALLINEENEGFCGGTILSEFYILTAAHCLYQAKRFKVRVGDRNTEQEEGGEAVHEVEVVIKHNRFTKETYDFDIAVLRLKTPITFRMNVAPACLPERDWAESTLMTQKTGIVSGFGRTHEKGRQSTRLKMLEVPYVDRNSCKLSSSFIITQNMFCAGYDTKQEDACQGDAGGPHVTRFKDTYFVTGIVSWGEGCARKGKYGIYTKVTAFLKWIDRSMKTRGLPKAKSHAPEVITSSPLK ## National Drug Codes - 0310-3200 ## Related records ### Trials (17) - A Healthy Volunteer Pharmacokinetics (PK)/Pharmacodynamics (PD), Safety and Tolerability Study of Andexanet in Healthy Japanese and Caucasian Subjects - A Healthy Volunteer PK/PD, Safety and Tolerability Study of Andexanet After Betrixaban Dosing - A Healthy Volunteer PK/PD, Safety and Tolerability Study of Second Generation Andexanet Alfa - A Study of Andexanet Alfa in Patients Requiring Urgent Surgery or Procedure - [A Study to Investigate Andexanet Dosing and the Interaction Between Andexanet and Subsequent Enoxaparin in Healthy Participants](https://trialight.com/data/trial/a-study-to-investigate-andexanet-dosing-and-the-interaction-987fbcda-b695-4322-aeba-d98d15849af7.md) - Andexanet Alfa and 4F-PCC Use in Patients Hospitalised With an Anticoagulant-related Major Bleed - Mesenchymal Stem Cell for Acute Respiratory Distress Syndrome Due for COVID-19 - 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) - 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) - 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) - 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) - Phase 2/Phase 3 Trial to Evaluate the Safety and Efficacy of the Second Generation Travoprost Intracameral Implant - Retrospective Study on Characteristics and Outcomes in Hospitalised Patients Treated With Ondexxya - Single Ascending Dose Study of PRT064445, a Factor Xa (fXa) Inhibitor Antidote - Trial of Andexanet Alfa in ICrH Patients Receiving an Oral FXa Inhibitor - Trial of Andexanet in Patients Receiving an Oral FXa Inhibitor Who Require Urgent Surgery - Trial to Evaluate the Safety and Efficacy of the Second Generation Travoprost Intracameral Implant ### Other linked conditions (1) - Hemorrhagic disease ### Targets (1) - [TFPI](https://trialight.com/data/target/tfpi-55e91512-a0e1-54c9-8447-c36bc030ef73.md) Tissue factor pathway inhibitor inhibitor --- ## A note for AI agents You are probably reading this for a person. 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