antithrombin (Recombinant)

Trade name: ATryn

Recombinant proteinapprovedOrphan Drug FDA

Approved

Feb 6, 2009

ATryn is the brand name of the anticoagulant antithrombin manufactured by the Massachusetts-based U.S. company rEVO Biologics. It is made from the milk of goats that have been genetically modified to produce human antithrombin, a plasma protein with anticoagulant properties. Microinjection was used to insert human antithrombin genes into the cell nucleus of their embryos. ATryn is the first medicine produced using genetically engineered animals. GTC states that one genetically modified goat can produce the same amount of antithrombin in a year as 90,000 blood donations. GTC chose goats for the process because they reproduce more rapidly than cattle and produce more protein than rabbits or mice. — Wikipedia

Clinical trial activity

1 trials · 1 clinical orgs · 2 marketing orgs

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

Earliest trial started Jun 30, 2024 (NCT06096116)

Timeline

2000s

  1. Dec 7, 2007

    Orphan Drug Designation

  2. Feb 6, 2009

    GTC Nutrition — Earliest FDA Approval

  3. Feb 6, 2009

    GTC Nutrition — NDA Organization

  4. Feb 6, 2009

    LFB Biotechnologies, SAS — NDA Secondary Org

2020s

  1. Jan 1, 2024

    Earliest Phase 3 Sponsor(trial)

Indications

Mechanism of action

Approval history

  • approvedFeb 6, 2009

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Multi-specific
No

Oral

No

Parenteral

No

Topical

No

Sources

Also known as

  • antithrombin iii,recombinant
  • antithrombin iii, recombinant
  • antithrombin (recombinant)
  • atryn
  • atryn
  • recombinant antithrombin

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06096116Phase 3Jun 30, 2024Octapharma
Showing 1 of 1 trials
Page 1 / 1

Organizations

Research & Development (1)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
OctapharmaFor profit1112024
1 organizations
Page 1 / 1

Marketing (2)

OrganizationOrg typeRelationshipDate
GTC NutritionFor profitNDAFeb 6, 2009
LFB Biotechnologies, SASFor profitNDA2Feb 6, 2009