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: 04 Nov 2018

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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 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
  • Phase I Psoriasis
  • Preclinical Eye-Disorders
  • Suspended Dry eyes

Most Recent Events

  • 24 Sep 2018 LEO Pharma plans a phase I trial for Healthy volunteers in Germany in October 2018 (NCT03673527)
  • 10 Sep 2018 Astellas Pharma completes a phase III trial in Lupus nephritis in China (NCT02457221)
  • 03 Apr 2018 Astellas Pharma completes a phase III trial for Transplant rejection in Canada (NCT00933231)
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