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Topical tacrolimus
Topical tacrolimus suppresses local immune responses by inhibiting calcineurin and T-cell activation in the skin.
Topical tacrolimus suppresses local immune responses by inhibiting calcineurin and T-cell activation in the skin. Used for Atopic dermatitis (eczema), Allergic contact dermatitis, Vitiligo.
At a glance
| Generic name | Topical tacrolimus |
|---|---|
| Also known as | Tacrolimus eye drops |
| Sponsor | The Catholic University of Korea |
| Drug class | Calcineurin inhibitor |
| Target | Calcineurin (protein phosphatase 2B) |
| Modality | Small molecule |
| Therapeutic area | Dermatology |
| Phase | FDA-approved |
Mechanism of action
Tacrolimus is a calcineurin inhibitor that blocks T-cell proliferation and cytokine production when applied topically. By reducing local inflammatory immune responses without systemic immunosuppression, it alleviates inflammatory skin conditions. The drug is particularly useful for atopic dermatitis and other eczematous conditions where T-cell-mediated inflammation is pathogenic.
Approved indications
- Atopic dermatitis (eczema)
- Allergic contact dermatitis
- Vitiligo
Common side effects
- Application site burning or stinging
- Pruritus
- Skin irritation
- Headache
Key clinical trials
- Enhanced Dermatological Care to Reduce Rash and Paronychia in Epidermal Growth Factor Receptor (EGRF)-Mutated Non-Small Cell Lung Cancer (NSCLC) Treated First-line With Amivantamab Plus Lazertinib (PHASE2)
- Tacrolimus Toothpaste for Management of Oral Chronic Graft vs. Host Disease (cGVHD) (PHASE1)
- Comparative Evaluation of the Safety and Effectiveness of Crisaborole Ointment (2%) Versus Tacrolimus Ointment (0.1%) for the Topical Treatment of Atopic Dermatitis (PHASE4)
- A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab on Background Topical Corticosteroids Therapy in Participants Aged 12 Years and Older With Moderate-to-severe AD Who Have Had an Inadequate Response to Prior Biologic Therapy or an Oral JAK Inhibitor (PHASE3)
- 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)
- Photobiomodulation in Combination With Topical Cyclosporine A or Tacrolimus (EARLY_PHASE1)
- COMPARISON OF EFFICACY AND SAFETY OF NARROWBAND UVB WITH 0.1% TACROLIMUS VS NARROWBAND UVB WITH 0.005% CALCIPOTRIOL IN TREATMENT OF VITILIGO (EARLY_PHASE1)
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:
- Topical tacrolimus CI brief — competitive landscape report
- Topical tacrolimus updates RSS · CI watch RSS
- The Catholic University of Korea portfolio CI