andexanet alfa

Trade name: Andexxa

Recombinant proteinexperimental

Clinical trial activity

15 trials · 4 clinical orgs · 0 marketing orgs

Phase 1
3
Phase 2
11
Phase 3
5
Phase 4
1

Earliest trial started Jun 30, 2012 (NCT03218241)

Timeline

2010s

  1. Jan 1, 2012

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2012

    Earliest Phase 2 Sponsor(trial)

  3. Jan 1, 2014

    Earliest Phase 3 Sponsor(trial)

Indications

Approved for

Mechanism of action

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Multi-specific
No

Oral

No

Parenteral

No

Topical

No

Black box warning

Sources

Also known as

  • adenexanet alfa
  • andexanet
  • andexanet
  • andexanet alfa
  • andexanet alfa
  • andexanet alfa
  • prt064445
  • prt064445
  • prt-064445
  • prt4445
  • prt-4445
  • r-antidote
  • rfxa inhibitor antidote

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07312851Phase 1Jan 12, 2026AstraZeneca, Parexel
NCT05926349Phase 3Oct 20, 2023AstraZeneca
NCT04233073Phase 3Dec 13, 2019Portola Pharmaceuticals
NCT03661528Phase 4Jan 1, 2019McMaster University, Portola Pharmaceuticals
NCT03310021Phase 2Aug 28, 2017Portola Pharmaceuticals
NCT03083704Phase 1Feb 26, 2017Portola Pharmaceuticals
NCT03330457Phase 2Aug 30, 2015Portola Pharmaceuticals
NCT02329327Phase 3Jan 1, 2015McMaster University, Portola Pharmaceuticals
NCT02220725Phase 3May 1, 2014Portola Pharmaceuticals
NCT02207725Phase 3Mar 1, 2014Portola Pharmaceuticals
NCT03551730Phase 2Dec 31, 2012Portola Pharmaceuticals
NCT03551743Phase 2Dec 31, 2012Portola Pharmaceuticals
NCT03578146Phase 2Dec 31, 2012Portola Pharmaceuticals
NCT01758432Phase 2Dec 1, 2012Portola Pharmaceuticals
NCT03218241Phase 1Jun 30, 2012Portola Pharmaceuticals
Showing 15 of 15 trials
Page 1 / 1

Organizations

Research & Development (4)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Portola PharmaceuticalsFor profit131342012
AstraZenecaFor profit2222023
McMaster UniversityAcademic/Hospital2022015
ParexelFor profit1012026
4 organizations
Page 1 / 1