Last reviewed · How we verify
Pimecrolimus Cream 1%
Pimecrolimus inhibits T-cell activation and inflammatory cytokine release by binding to calcineurin, thereby reducing skin inflammation in atopic dermatitis.
Pimecrolimus inhibits T-cell activation and inflammatory cytokine release by binding to calcineurin, thereby reducing skin inflammation in atopic dermatitis. Used for Atopic dermatitis (mild to moderate), Atopic dermatitis in patients intolerant to or inadequate responders to conventional topical therapies.
At a glance
| Generic name | Pimecrolimus Cream 1% |
|---|---|
| Also known as | Elidel, ASM981, elidel cream, Eczema, Elidel 1% cream |
| Sponsor | Novartis |
| 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 is a calcineurin inhibitor that selectively suppresses T-lymphocyte activation and prevents the release of inflammatory mediators such as TNF-α, IL-2, and IL-4. By blocking calcineurin-dependent signaling pathways, it reduces the proliferation and activation of immune cells involved in the inflammatory cascade of atopic dermatitis, leading to decreased skin inflammation and pruritus.
Approved indications
- Atopic dermatitis (mild to moderate)
- Atopic dermatitis in patients intolerant to or inadequate responders to conventional topical therapies
Common side effects
- Application site burning or irritation
- Headache
- Nasopharyngitis
- Skin infections
- Pruritus
Key clinical trials
- 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)
- 10 Year Registry of Children (Ages 2-17 Years) With Eczema That Have Used Pimecrolimus
- A Clinical Trial to Compare Topical Agents in Adults With Mild to Moderate Atopic Dermatitis (AD) (PHASE1)
- 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
- 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)
- Vitiligo and the Koebner Phenomenon (Model of Vitiligo Induction and Therapy: a Clinical and Immunological Analysis) (PHASE4)
- A 4 Week Study of Elidel (Pimecrolimus) for the Treatment of Seborrheic Dermatitis (PHASE2)
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 Cream 1% CI brief — competitive landscape report
- Pimecrolimus Cream 1% updates RSS · CI watch RSS
- Novartis portfolio CI