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Protopic (R)
Protopic (tacrolimus) is a calcineurin inhibitor that suppresses T-cell activation and cytokine production to reduce inflammatory skin responses.
Protopic (tacrolimus) is a calcineurin inhibitor that suppresses T-cell activation and cytokine production to reduce inflammatory skin responses. Used for Atopic dermatitis (eczema), Other inflammatory skin conditions (off-label use in vitiligo, psoriasis).
At a glance
| Generic name | Protopic (R) |
|---|---|
| Also known as | Tacrolimus |
| Sponsor | University Hospital, Rouen |
| Drug class | Calcineurin inhibitor |
| Target | Calcineurin (protein phosphatase 2B) |
| Modality | Small molecule |
| Therapeutic area | Dermatology/Immunology |
| Phase | Phase 3 |
Mechanism of action
Tacrolimus binds to FKBP12 and inhibits calcineurin phosphatase, preventing dephosphorylation and nuclear translocation of NFAT transcription factors. This blocks T-cell proliferation and the production of inflammatory cytokines (IL-2, TNF-α, IFN-γ) that drive atopic dermatitis and other inflammatory skin conditions. The topical formulation allows localized immunosuppression with reduced systemic exposure.
Approved indications
- Atopic dermatitis (eczema)
- Other inflammatory skin conditions (off-label use in vitiligo, psoriasis)
Common side effects
- Application site burning or irritation
- Pruritus
- Skin erythema
- Headache
Key clinical trials
- Combination Chemotherapy With or Without Donor Stem Cell Transplant in Treating Patients With Acute Lymphoblastic Leukemia (PHASE2)
- Tocilizumab in Lung Transplantation (PHASE2)
- Valganciclovir Prophylaxis Versus Preemptive Therapy for Cytomegalovirus in Living Donor Kidney Transplant Recipients (PHASE4)
- Screening for Subclinical Antibody Mediated Rejection and Efficacy of Belatacept in the Context of de Novo Donor Specific Antibody After Kidney Transplantation (BELA-M-R) (PHASE2, PHASE3)
- Total Marrow and Lymphoid Irradiation Before Donor Transplant and Cyclophosphamide in Treating Patients With Acute Myeloid Leukemia (PHASE1)
- Phase 1 Study of Chemotherapy Plus HLA-mismatched GPBMC Infusion Bridging to Allo-HSCT for R/R Leukemia (PHASE1)
- Sorafenib, Busulfan and Fludarabine in Treating Patients With Recurrent or Refractory Acute Myeloid Leukemia Undergoing Donor Stem Cell Transplant (PHASE1, PHASE2)
- Bone Marrow Transplantation vs Standard of Care in Patients With Severe Sickle Cell Disease (BMT CTN 1503) (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Protopic (R) CI brief — competitive landscape report
- Protopic (R) updates RSS · CI watch RSS
- University Hospital, Rouen portfolio CI