Andexanet alfa
Highest phase reached
Approved
Drug type
Protein
First approval year
2019
- First approval year
- 2019
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Protein
- Drug name
- Andexanet alfa
- ondexxya
- Ondexxya
- 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.
- CAS registry numbers
- 1262449-58-0
- ChEMBL ID
- CHEMBL3301583
- RxNorm IDs (RxCUI)
- 2045114
- FDA ingredient codes (UNII)
- BI009E452R
- V03AB
- V03AB38
Sources for recorded values
- 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
- 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 name
- andexanet alfa
- Type
- Peptide
- Approval recorded by Guide to Pharmacology
- Yes
- 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
- 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
- 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
- Warning
- Black Box Warning
- Effect
- cardiotoxicity
- Warning
- Black Box Warning
- Effect
- gastrointestinal toxicity
- Warning
- Black Box Warning
- Effect
- hematological toxicity
- 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
- 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
- NCT03083704
- NCT03310021
- NCT03330457
- Dose
- 400 mg or 800 mg
- Route
- Intravenous
- How often
- Initial bolus followed by infusion for 120 minutes
- Administer as an IV bolus at 30 mg/min
- Followed by continuous infusion at 4 mg/min or 8 mg/min for 120 minutes
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Natural product
- No
Sequences
- Component
- Sequence
- Type
- Protein
- Sequence
- ANSFLFWNKYKDGDQCETSPCQNQGKCKDGLGEYTCTCLEGFEGKNCELFTRKLCSLDNGDCDQFCHEEQNSVVCSCARGYTLADNGKACIPTGPYPCGKQTLERIVGGQECKDGECPWQALLINEENEGFCGGTILSEFYILTAAHCLYQAKRFKVRVGDRNTEQEEGGEAVHEVEVVIKHNRFTKETYDFDIAVLRLKTPITFRMNVAPACLPERDWAESTLMTQKTGIVSGFGRTHEKGRQSTRLKMLEVPYVDRNSCKLSSSFIITQNMFCAGYDTKQEDACQGDAGGPHVTRFKDTYFVTGIVSWGEGCARKGKYGIYTKVTAFLKWIDRSMKTRGLPKAKSHAPEVITSSPLK
- 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
- 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 Tissue factor pathway inhibitor inhibitor