Drug Profile


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: 10 Sep 2017

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At a glance

  • Originator Astellas Pharma
  • Developer Astellas Pharma; LEO Pharma; Roche; Senju Pharmaceutical; Sucampo Pharmaceuticals
  • Class Lactones; Macrolides
  • 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

  • 01 Jul 2017 Preregistration for Transplant rejection (In adolescents, In children, In infants, In neonates) in USA (PO; granules) (Astellas Pharma pipeline, August 2017)
  • 03 Jan 2017 NCT02953873 - did not add this P IV trial
  • 30 Sep 2016 Phase-III clinical trials in Atopic dermatitis (In children) in Brazil (Topical) (EudraCT2016-001160-11)
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