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Tacrolimus Ointment 0.03%
Tacrolimus is a calcineurin inhibitor that suppresses T-cell activation and cytokine production to reduce skin inflammation.
Tacrolimus is a calcineurin inhibitor that suppresses T-cell activation and cytokine production to reduce skin inflammation. Used for Atopic dermatitis (eczema), Vitiligo.
At a glance
| Generic name | Tacrolimus Ointment 0.03% |
|---|---|
| Also known as | Protopic 0.03%, Tarolimus ointment, Protopic® 0.03%, Protopic |
| Sponsor | Astellas Pharma Inc |
| Drug class | Calcineurin inhibitor |
| Target | Calcineurin (via FKBP12 binding) |
| Modality | Small molecule |
| Therapeutic area | Dermatology/Immunology |
| Phase | FDA-approved |
Mechanism of action
Tacrolimus binds to the immunophilin FKBP12 and inhibits calcineurin phosphatase, preventing dephosphorylation and nuclear translocation of NFAT (nuclear factor of activated T cells). This blocks the transcription of pro-inflammatory cytokines such as IL-2, TNF-α, and IFN-γ, thereby reducing T-cell proliferation and inflammatory responses in the skin. When applied topically as an ointment, it provides localized immunosuppression without the systemic effects associated with oral calcineurin inhibitors.
Approved indications
- Atopic dermatitis (eczema)
- Vitiligo
Common side effects
- Application site burning or irritation
- Pruritus
- Erythema
- Headache
Key clinical trials
- Comparative Study of Crisaborole vs. Tacrolimus in Atopic Dermatitis (PHASE4)
- Clinical Assessment of Protopic® Ointment in Deep Partial-Thickness Burns (PHASE1)
- A Comparative Clinical Trial Evaluating the Effect and Safety of Tacrolimus Versus Hydrocortisone (PHASE2)
- Botox Versus Tacrolimus in Psoriasis Vulgaris (PHASE4)
- Tacrolimus for the Treatment of Superficial Kaposiform Hemangioendothelioma and Tufted Angioma (PHASE2)
- Evaluation of Safety & Efficacy for the Prevention of Ocular GVHD With Ophthalmic Tacrolimus vs Cyclosporine in Allo-HSCT (PHASE1, PHASE2)
- Tacrolimus Versus Hydrocortisone in Atopic Dermatitis (PHASE4)
- ASPIRE: PROs & Caregiver Burden in Children With Atopic Dermatitis (PHASE3)
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:
- Tacrolimus Ointment 0.03% CI brief — competitive landscape report
- Tacrolimus Ointment 0.03% updates RSS · CI watch RSS
- Astellas Pharma Inc portfolio CI