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pimecrolimus active cream
Pimecrolimus is a calcineurin inhibitor that suppresses T-cell activation and inflammatory cytokine production in the skin.
Pimecrolimus is a calcineurin inhibitor that suppresses T-cell activation and inflammatory cytokine production in the skin. Used for Atopic dermatitis (eczema), Mild to moderate atopic dermatitis in pediatric and adult patients.
At a glance
| Generic name | pimecrolimus active cream |
|---|---|
| Also known as | Elidel 1% cream Novartis Pharmaceuticals |
| Sponsor | Children's Hospital of Michigan |
| Drug class | Calcineurin inhibitor (topical immunosuppressant) |
| Target | Calcineurin (protein phosphatase 2B) |
| Modality | Small molecule |
| Therapeutic area | Dermatology / Immunology |
| Phase | FDA-approved |
Mechanism of action
Pimecrolimus binds to calcineurin and inhibits its phosphatase activity, preventing the 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 local immune activation and inflammation in atopic dermatitis and other inflammatory skin conditions.
Approved indications
- Atopic dermatitis (eczema)
- Mild to moderate atopic dermatitis in pediatric and adult patients
Common side effects
- Application site burning or irritation
- Pruritus
- Skin infection (secondary bacterial or viral)
- Headache
Key clinical trials
- A Multi-Centre Clinical Trial to Evaluate a Left-Right Design in Adults With Mild to Moderate Atopic Dermatitis (PHASE1)
- A Study to Evaluate the Safety, Tolerability and Pharmacokinetic Properties of IN-A002 Ointment in Healthy Adult Male Volunteers and Mild to Moderate Atopic Dermatitis Patients (PHASE1)
- A 4 Week Study of Elidel (Pimecrolimus) for the Treatment of Seborrheic Dermatitis (PHASE2)
- A Study of Crisaborole Ointment 2%; Crisaborole Vehicle; TCS and TCI in Subjects Aged ≥ 2 Years, With Mild-moderate AD (PHASE4)
- Study of Equivalence of Generic Pimecrolimus Cream 1% and Elidel® 1% in Subjects With Mild to Moderate Atopic Dermatitis (PHASE3)
- Safety and Bioequivalence of Pimecrolimus Cream 1% and Elidel R in Treatment of Mild to Moderate Atopic Dermatitis (PHASE3)
- Evaluation of the Antipruritic Effect of Elidel (Pimecrolimus) in Non-atopic Pruritic Disease (PHASE2)
- Study of Pimecrolimus Treatment for Atopic Dermatitis of African American Children (PHASE4)
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:
- pimecrolimus active cream CI brief — competitive landscape report
- pimecrolimus active cream updates RSS · CI watch RSS
- Children's Hospital of Michigan portfolio CI