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Elidel® (pimecrolimus) 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) in patients ≥2 years of age, Short-term and intermittent long-term treatment of mild to moderate atopic dermatitis.
At a glance
| Generic name | Elidel® (pimecrolimus) Cream |
|---|---|
| Sponsor | Glenmark Pharmaceuticals Ltd. India |
| Drug class | Calcineurin inhibitor (topical immunosuppressant) |
| Target | Calcineurin (via macrophilin-12 binding) |
| Modality | Small molecule |
| Therapeutic area | Dermatology/Immunology |
| Phase | Phase 3 |
Mechanism of action
Pimecrolimus binds to macrophilin-12 and inhibits calcineurin, a phosphatase required for T-cell receptor signaling and transcription factor activation. This prevents the release of pro-inflammatory cytokines (IL-2, TNF-α, IFN-γ) from T cells and mast cells, reducing skin inflammation. Unlike topical corticosteroids, it does not cause skin atrophy and is suitable for use on sensitive areas including the face.
Approved indications
- Atopic dermatitis (eczema) in patients ≥2 years of age
- Short-term and intermittent long-term treatment of mild to moderate atopic dermatitis
Common side effects
- Application site burning/irritation
- Headache
- Nasopharyngitis
- Skin infection
- Pruritus
Key clinical trials
- LEO 29102 Cream in the Treatment of Atopic Dermatitis (PHASE2)
- Observational Study to Evaluate Use of Elidel® in South and East Asian Pediatric Patients With Atopic Dermatitis.
- Observational Study to Evaluate the Actual Use of Elidel® in Chinese Patients With Mild to Moderate Atopic Dermatitis
- Bioequivalence Study of Pimecrolimus Cream, 1% and Elidel® Cream, 1% in Mild to Moderate Atopic Dermatitis (PHASE3)
- Study of Equivalence of Generic Pimecrolimus Cream 1% and Elidel® 1% in Subjects With Mild to Moderate Atopic Dermatitis (PHASE3)
- Study of Generic Pimecrolimus Cream, 1% in the Treatment of Mild to Moderate Atopic Dermatitis (PHASE3)
- Cutaneous Lupus Erythematosus and Elidel (NA)
- Safety and Bioequivalence of Pimecrolimus Cream 1% and Elidel R in Treatment of Mild to Moderate 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:
- Elidel® (pimecrolimus) Cream CI brief — competitive landscape report
- Elidel® (pimecrolimus) Cream updates RSS · CI watch RSS
- Glenmark Pharmaceuticals Ltd. India portfolio CI