CDEK
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antihemophilic factor viii (Recombinant), single chain

Trade name: Afstyla

Recombinant proteinapproved

Approved

May 25, 2016

Clinical trial activity

7 trials · 4 clinical orgs · 1 marketing orgs

Phase 1
0
Phase 2
5
Phase 3
6
Phase 4
0

Earliest trial started Feb 1, 2012 (NCT01486927)

Timeline

2010s

  1. Jan 1, 2012

    CSL Behring — Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2014

    CSL Behring — Earliest Phase 3 Sponsor(trial)

  3. May 25, 2016

    CSL Behring — Earliest FDA Approval

  4. May 25, 2016

    CSL Behring — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedMay 25, 2016

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Multi-specific
No

Oral

No

Parenteral

No

Topical

No

Sources

Also known as

  • lonoctocog alfa
  • rviii-singlechain
  • simoctocog alfa

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06998524Phase 3Jun 27, 2025Roche
NCT06938659Phase 2/Phase 3 (Phase 3)Jun 1, 2025Dhaka Medical College
NCT06738485Phase 3Jan 31, 2025CSL Behring
NCT04592692Phase 2Dec 23, 2019Ascension Health
NCT02172950Phase 3Oct 1, 2014CSL Behring
NCT02093897Phase 3Mar 1, 2014CSL Behring
NCT01486927Phase 2/Phase 3 (Phase 3)Feb 1, 2012CSL Behring
Showing 7 of 7 trials
Page 1 / 1

Organizations

Research & Development (4)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
CSL BehringFor profit4412012
Ascension HealthAcademic/Hospital1112019
Dhaka Medical CollegeAcademic/Hospital1112025
RocheFor profit1112025
4 organizations
Page 1 / 1

Marketing (1)

OrganizationOrg typeRelationshipDate
CSL BehringFor profitNDAMay 25, 2016