ELIDEL (pimecrolimus)
Elidel is a topical cream used for adults and children two years of age and older who have mild to moderate atopic dermatitis. It serves as a second-line option for patients who are not immunocompromised and have not responded well to other prescription skin therapies. This medication helps manage symptoms through either short-term use or intermittent long-term applications when other treatments are not advisable.
How ELIDEL Works
This medication works by binding to macrophilin-12 to inhibit calcineurin, an enzyme that plays a role in the immune system's inflammatory response. By blocking this pathway, the drug prevents T-cells from producing specific cytokines and stops mast cells from releasing inflammatory mediators.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2001-12-13
- Routes
- TOPICAL
- Dosage Forms
- CREAM
ELIDEL Approval History
What ELIDEL Treats
1 indicationsELIDEL is approved for 1 conditions since its original approval in 2001. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Atopic Dermatitis
ELIDEL Boxed Warning
LONG-TERM SAFETY OF TOPICAL CALCINEURIN INHIBITORS HAS NOT BEEN ESTABLISHED Although a causal relationship has not been established, rare cases of malignancy (e.g., skin and lymphoma) have been reported in patients treated with topical calcineurin inhibitors, including Pimecrolimus Cream, 1%. [see Warnings and Precautions (5.1) ] . Therefore: • Continuous long-term use of topical calcineurin inhibitors, including Pimecrolimus Cream, 1%, in any age group should be avoided and application limited ...
WARNING: LONG-TERM SAFETY OF TOPICAL CALCINEURIN INHIBITORS HAS NOT BEEN ESTABLISHED Although a causal relationship has not been established, rare cases of malignancy (e.g., skin and lymphoma) have been reported in patients treated with topical calcineurin inhibitors, including Pimecrolimus Cream, 1%. [see Warnings and Precautions (5.1) ] . Therefore: • Continuous long-term use of topical calcineurin inhibitors, including Pimecrolimus Cream, 1%, in any age group should be avoided and application limited to areas of involvement with atopic dermatitis [see Dosage and Administration (2) , Warnings and Precautions (5.1) ] . • Pimecrolimus Cream, 1% is not indicated for use in children less than 2 years of age [see Warnings and Precautions (5.1) , Use in Specific Populations (8.4) ] . WARNING: LONG-TERM SAFETY OF TOPICAL CALCINEURIN INHIBITORS HAS NOT BEEN ESTABLISHED See full prescribing information for complete boxed warning. Although a causal relationship has not been established, rare cases of malignancy (e.g., skin and lymphoma) have been reported in patients treated with topical calcineurin inhibitors, including Pimecrolimus Cream, 1%. ( 5.1 ) Therefore: • Continuous long-term use of topical calcineurin inhibitors, including Pimecrolimus Cream, 1%, in any age group should be avoided and application limited to areas of involvement with atopic dermatitis. ( 2 , 5.1 ) • Pimecrolimus Cream, 1% is not indicated for use in children less than 2 years of age. ( 1 , 5.1 , 8.4 )
ELIDEL Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
MoA expansion candidates
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in ELIDEL's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications ELIDEL treats. First-in-class if their pivotal trials read out positive.
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Clinical Trial Registry
2 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT01692626 results posted | WVU21011 | Ph 2 | terminated | 1% Topical Pimecrolimus Cream for the Treatment of the Rash Associated With ERBITUX |
| NCT01177566 | 08-1450 | Ph 4 | completed | Pimecrolimus Cream 1% (Elidel®) and Medicated Device Cream (EletoneTM) in the Treatment and Maintenance of Atopic Dermatitis. |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
ELIDEL FDA Label Details
Indications & Usage
FDA Label (PDF)ELIDEL is indicated for the treatment of Atopic Dermatitis.
WARNING: LONG-TERM SAFETY OF TOPICAL CALCINEURIN INHIBITORS HAS NOT BEEN ESTABLISHED Although a causal relationship has not been established, rare cases of malignancy (e.g., skin and lymphoma) have been reported in patients treated with topical calcineurin inhibitors, including Pimecrolimus Cream, 1...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment