PIMECROLIMUS
Pimecrolimus cream (1%) is a topical calcineurin inhibitor indicated as second-line therapy for the short-term and non-continuous chronic treatment of mild to moderate atopic dermatitis. It is intended for use in non-immunocompromised adults and children aged 2 years and older who have failed to respond adequately to other topical prescription treatments or when those therapies are not advisable.
How PIMECROLIMUS Works
Pimecrolimus is a calcineurin inhibitor immunosuppressant. It binds with high affinity to macrophilin-12 (FKBP-12), which inhibits the calcium-dependent phosphatase, calcineurin. This inhibition blocks the transcription of early cytokines and prevents T-cell activation. Specifically, it inhibits the synthesis of Interleukin-2, interferon-gamma, Interleukin-4, and Interleukin-10. Additionally, pimecrolimus prevents the release of inflammatory cytokines and mediators from mast cells. While these effects are observed, the precise mechanism of action in treating atopic dermatitis is not fully established.
Details
- Status
- Prescription
- First Approved
- 2018-12-27
- Routes
- TOPICAL
- Dosage Forms
- CREAM
PIMECROLIMUS Approval History
What PIMECROLIMUS Treats
1 indicationsPIMECROLIMUS is approved for 1 conditions since its original approval in 2018. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Atopic Dermatitis
PIMECROLIMUS 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 t...
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 )
PIMECROLIMUS 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 PIMECROLIMUS's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications PIMECROLIMUS 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.
PIMECROLIMUS FDA Label Details
Indications & Usage
PIMECROLIMUS 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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ELIDEL
Full clinical data, patents, trials, and competitive landscape for pimecrolimus.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.