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tacrolimus + steroid — Competitive Intelligence Brief

tacrolimus + steroid (tacrolimus + steroid) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: immunosuppressant. Area: Immunology.

phase 3 immunosuppressant calcineurin Immunology Small molecule Live · refreshed every 30 min

Target snapshot

tacrolimus + steroid (tacrolimus + steroid) — Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan. Tacrolimus is an immunosuppressant that inhibits calcineurin, a protein phosphatase involved in the activation of T-lymphocytes, while steroids reduce inflammation and suppress the immune system.

Comparator set (6 drugs)

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DrugGenericSponsorPhaseClassTargetApproval / PDUFA
tacrolimus + steroid TARGET tacrolimus + steroid Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan phase 3 immunosuppressant calcineurin
Sandimmune cyclosporine Novartis AG (originally Sandoz) marketed Calcineurin inhibitor (immunosuppressant) Calcineurin subunit B type 1, Canalicular multispecific organic anion transporter 1, Canalicular multispecific organic anion transporter 2 1983-11-14
CYCLOSPORINE CYCLOSPORINE marketed Calcineurin Inhibitor Immunosuppressant [EPC] calcineurin 1983-01-01
Maintenance of immediate-release tacrolimus Maintenance of immediate-release tacrolimus Massachusetts General Hospital marketed Calcineurin inhibitor Calcineurin (via FKBP12 binding)
Tacrolimus (TAC) Tacrolimus (TAC) ITB-Med LLC marketed Calcineurin inhibitor Calcineurin (protein phosphatase 2B)
Basiliximab, Tacrolimus, MMF, Prednisolon Basiliximab, Tacrolimus, MMF, Prednisolon University Hospital Freiburg marketed Immunosuppressive combination regimen IL-2 receptor (basiliximab), calcineurin (tacrolimus), IMPDH (MMF), glucocorticoid receptor (prednisolone)
Elidel-Creme Elidel-Creme Technische Universität Dresden marketed Calcineurin inhibitor (topical immunosuppressant) Calcineurin; macrophilin-12

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

Sponsor landscape (immunosuppressant class)

  1. Assistance Publique - Hôpitaux de Paris · 1 drug in this class
  2. Centre Hospitalier Universitaire, Amiens · 1 drug in this class
  3. DH Bio Co., Ltd. · 1 drug in this class
  4. Glenmark Pharmaceuticals Ltd. India · 1 drug in this class
  5. Palvella Therapeutics, Inc. · 1 drug in this class
  6. Pfizer · 1 drug in this class
  7. Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan · 1 drug in this class
  8. University of California, San Francisco · 1 drug in this class
  9. Vanderbilt-Ingram Cancer Center · 1 drug in this class

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Cite this brief

Drug Landscape (2026). tacrolimus + steroid — Competitive Intelligence Brief. https://druglandscape.com/ci/tacrolimus-steroid. Accessed 2026-06-10.

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing