antihemophilic factor viii (Recombinant), porcine sequence

Trade name: Obizur

Recombinant proteinapproved

Approved

Oct 23, 2014

Susoctocog alfa, sold under the brand name Obizur, is a medication used for the treatment of bleeding episodes in adults with acquired haemophilia, a bleeding disorder caused by the spontaneous development of antibodies that inactivate factor VIII. — Wikipedia

Clinical trial activity

6 trials · 4 clinical orgs · 2 marketing orgs

Phase 1
0
Phase 2
3
Phase 3
4
Phase 4
0

Earliest trial started May 1, 2005 (NCT00245245)

Timeline

2000s

  1. Jan 1, 2005

    Earliest Phase 2 Sponsor(trial)

2010s

  1. Jan 1, 2011

    Earliest Phase 3 Sponsor(trial)

  2. Oct 23, 2014

    Earliest FDA Approval

  3. Oct 23, 2014

    Takeda — NDA Secondary Org

  4. Oct 24, 2014

    Baxter — First NDA Organization

  5. Oct 24, 2014

    Baxter — NDA Organization

Indications

Approved for

Mechanism of action

Approval history

  • approvedOct 23, 2014

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Multi-specific
No

Oral

No

Parenteral

No

Topical

No

Sources

Also known as

  • antihemophilic factor (recombinant), porcine sequence
  • obi-1
  • obizur
  • obizur
  • obizur
  • obizur
  • porcine coagulation factor viii
  • recombinant porcine antihemophilic factor
  • susoctocog alfa
  • susoctocog alfa
  • susoctocog alfa
  • susoctocog alfa

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT04580407Phase 2/Phase 3 (Phase 3)Dec 15, 2020Takeda
NCT02895945Phase 3Dec 22, 2016Baxalta
NCT01968655N/AOct 21, 2013Baxalta
NCT01434511Phase 3Aug 1, 2011Baxalta
NCT01178294Phase 2/Phase 3 (Phase 3)Nov 1, 2010Baxalta
NCT00245245Phase 2May 1, 2005Ipsen, Octagen
Showing 6 of 6 trials
Page 1 / 1

Organizations

Research & Development (4)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
BaxaltaFor profit4422010
IpsenFor profit1012005
OctagenFor profit1112005
TakedaFor profit1112020
4 organizations
Page 1 / 1

Marketing (2)

OrganizationOrg typeRelationshipDate
BaxterFor profitNDAOct 24, 2014
TakedaFor profitNDA2Oct 23, 2014