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tacrolimus ointment 0.1%
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), Other inflammatory skin conditions (off-label use in vitiligo, psoriasis, lichen planus).
At a glance
| Generic name | tacrolimus ointment 0.1% |
|---|---|
| Also known as | Protopic, Protopic® 0.1%, Protopic 0.1% |
| Sponsor | Hospital de Clinicas de Porto Alegre |
| 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 (IL-2, TNF-α, IFN-γ) produced by T lymphocytes, thereby reducing the inflammatory response in atopic dermatitis and other inflammatory skin conditions.
Approved indications
- Atopic dermatitis (eczema)
- Other inflammatory skin conditions (off-label use in vitiligo, psoriasis, lichen planus)
Common side effects
- Burning or stinging sensation at application site
- Pruritus
- Erythema
- Skin irritation
- Folliculitis
Key clinical trials
- Comparative Evaluation of the Safety and Effectiveness of Crisaborole Ointment (2%) Versus Tacrolimus Ointment (0.1%) for the Topical Treatment of Atopic Dermatitis (PHASE4)
- Nevus Removal vs. Conservative Treatment in Halo Nevus With Vitiligo: A Randomized Study (NA)
- The Efficacy of Selenium as an Alternative or Complementary Topical Treatment of Oral Lichen Planus (PHASE4)
- Crisaborole 2% Versus Tacrolimus 0.1% in Children With Mild to Moderate Atopic Dermatitis (PHASE3)
- Evaluation of the Efficacy of 0.08% Tacrolimus Nanoencapsulated Aqueous Solution Spray Vs. 0.1% Free Tacrolimus Commercial Ointment in the Treatment of Oral Lichen Planus (PHASE1, PHASE2)
- 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)
- Efficacy and Safety of 308-nm Excimer Lamp Combined With Tacrolimus vs Tacrolimus as Monotherapy in Treating Vitiligo on Children (NA)
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 0.1% CI brief — competitive landscape report
- tacrolimus ointment 0.1% updates RSS · CI watch RSS
- Hospital de Clinicas de Porto Alegre portfolio CI