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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;… See more

Latest Information Update: 05 Nov 2023

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At a glance

  • Originator Astellas Pharma
  • Developer Astellas Pharma; LEO Pharma; Mallinckrodt plc; Roche; Senju Pharmaceutical
  • Class Anti-inflammatories; Antiallergics; Antiasthmatics; Antiglaucomas; Antipsoriatics; Antirheumatics; Eye disorder therapies; Lactones; Macrolides; Skin disorder therapies; Urologics; Vascular 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 - Lupus nephritis; 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
  • Registered Lung transplant rejection
  • Suspended Dry eyes
  • No development reported Eye disorders; Psoriasis
  • Discontinued Open-angle glaucoma

Most Recent Events

  • 30 Dec 2021 Maruho completes a phase I trial of Tacrolicus in Atopic dermatitis, In Japan (Topical), prior to December 2021 (JapicCTI205315)
  • 04 Oct 2021 Health Canada approves an update in product monograph of tacrolimus (Topical, Ointment)
  • 20 Jul 2021 Registered for Lung transplant rejection (In adolescents, In adults, In children, In infants, In neonates, In the elderly, Prevention, Combination therapy) in USA (unspecified route)

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