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Tacrolimus - Astellas Pharma

Drug Profile

Tacrolimus - Astellas Pharma

Alternative Names: Advagraf; Astagraf XL; FK 506; FK506E; FK506MR; FR 900506; Fujimycin; Graceptor; L 679934; Modified release tacrolimus; Modigraf; MR tacrolimus; MR4; Prograf; PrografXL; Protopic; Protopy; RTU-007; Tacrolimus extended release capsules; Tacrolimus granules; Tacrolimus hydrate; Talymus; Tsukubaenolide

Latest Information Update: 24 Apr 2019

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At a glance

  • Originator Astellas Pharma
  • Developer Astellas Pharma; LEO Pharma; Mallinckrodt plc; Roche; Senju Pharmaceutical
  • Class Antipsoriatics; Lactones; Macrolides; Skin disorder therapies
  • Mechanism of Action Bone morphogenetic protein receptor type II modulators; Calcineurin inhibitors; Cytokine inhibitors; Immunosuppressants; T cell activation inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    Yes - Allergic conjunctivitis; Myasthenia gravis; Interstitial lung diseases
  • New Molecular Entity Yes

Highest Development Phases

  • Marketed Allergic conjunctivitis; Atopic dermatitis; Coronary artery restenosis; Graft-versus-host disease; Interstitial lung diseases; Intestinal transplant rejection; Lupus nephritis; Myasthenia gravis; Rheumatoid arthritis; Transplant rejection; Ulcerative colitis
  • Phase II Open-angle glaucoma
  • Suspended Dry eyes
  • No development reported Eye disorders; Psoriasis

Most Recent Events

  • 18 Mar 2019 Launched for Transplant rejection (Prevention, In adolescents, In children, In infants, In neonates) in USA (PO; Granules)
  • 11 Feb 2019 LEO Pharma completes a phase I trial in Healthy volunteers in Germany (NCT03673527)
  • 28 Jan 2019 No recent reports of development identified for phase-I development in Psoriasis(In adolescents) in Latvia (Topical, Cream)
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