Last Updated: September 24, 2026

CLINICAL TRIALS PROFILE FOR PIMECROLIMUS


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All Clinical Trials for pimecrolimus

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00117377 ↗ Effects of Pimecrolimus Cream 1% on the Molecular and Cellular Profile of Adult Male Patients With Atopic Dermatitis Completed Novartis Phase 4 2004-04-01 The purpose of this study is to identify how pimecrolimus cream 1% modifies the molecular and cellular changes associated with the post-lesional phase of atopic dermatitis (AD). Healthy volunteers and patients with atopic dermatitis will be studied.
NCT00119158 ↗ Combination Therapy for Atopic Dermatitis Completed Novartis Pharmaceuticals Phase 4 2004-10-01 Atopic dermatitis is a chronic relapsing disease with acute flares. The standard therapy is to treat acute flares using topical medications. The two most common classes of topical medications for atopic dermatitis (AD) are topical corticosteroids and topical calcineurin inhibitors. Pimecrolimus and topical corticosteroids exert their activity by different mechanisms, there may be a synergistic effect of the combination therapy. Therefore, a combination therapy may provide a faster resolution of severe skin lesions and consequently reduce the duration of the topical corticosteroid treatment. Another benefit of the combination therapy maybe the use of a lower potency corticosteroid to achieve the same degree of clearance. The hypothesis of this trial is that the combination of the two agents will lead to faster clearance than the single agent of topical corticosteroids.
NCT00119158 ↗ Combination Therapy for Atopic Dermatitis Completed Children's Hospital of Philadelphia Phase 4 2004-10-01 Atopic dermatitis is a chronic relapsing disease with acute flares. The standard therapy is to treat acute flares using topical medications. The two most common classes of topical medications for atopic dermatitis (AD) are topical corticosteroids and topical calcineurin inhibitors. Pimecrolimus and topical corticosteroids exert their activity by different mechanisms, there may be a synergistic effect of the combination therapy. Therefore, a combination therapy may provide a faster resolution of severe skin lesions and consequently reduce the duration of the topical corticosteroid treatment. Another benefit of the combination therapy maybe the use of a lower potency corticosteroid to achieve the same degree of clearance. The hypothesis of this trial is that the combination of the two agents will lead to faster clearance than the single agent of topical corticosteroids.
NCT00120302 ↗ Quality of Life Study in Adults With Facial Eczema Completed Novartis Phase 4 2005-03-01 This study is not being conducted in the US. The study consists of a 4 week double blind treatment period. All patients meeting the inclusion/exclusion criteria will enter the study at day 0 and be randomized into either pimecrolimus cream 1% or vehicle treatment groups in a 1:1 ratio. Patients will return to clinic on days 7,14 and 28 for assessments of disease severity. Patients who experience an unsatisfactory therapeutic effect, will attend an unscheduled visit and be withdrawn from the study. Assessments of eligibility include an Investigator's Global Assessment and Pruritus score. Treatment history will be collected at baseline and Quality of Life Questionnaires will be carried out at every visit.
NCT00120523 ↗ 5-Year Safety Study of Pimecrolimus Cream 1% in Infants 3 - 12 Months of Age With Mild to Moderate Atopic Dermatitis Completed MEDA Pharma GmbH & Co. KG Phase 3 2004-04-01 The primary purpose of this study is to investigate the safety of pimecrolimus cream 1% in the long-term treatment (up to 5 years) of atopic dermatitis (eczema) in patients less than 12 months of age compared to topical corticosteroids (TCS).
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for pimecrolimus

Condition Name

Condition Name for pimecrolimus
Intervention Trials
Atopic Dermatitis 27
Dermatitis, Atopic 5
Oral Lichen Planus 5
Seborrheic Dermatitis 2
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Condition MeSH

Condition MeSH for pimecrolimus
Intervention Trials
Dermatitis 39
Dermatitis, Atopic 35
Eczema 34
Lichen Planus 7
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Clinical Trial Locations for pimecrolimus

Trials by Country

Trials by Country for pimecrolimus
Location Trials
United States 173
Germany 12
Switzerland 3
Pakistan 2
Canada 2
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Trials by US State

Trials by US State for pimecrolimus
Location Trials
Florida 9
California 9
Texas 9
Virginia 9
Pennsylvania 9
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Clinical Trial Progress for pimecrolimus

Clinical Trial Phase

Clinical Trial Phase for pimecrolimus
Clinical Trial Phase Trials
PHASE3 2
Phase 4 24
Phase 3 11
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Clinical Trial Status

Clinical Trial Status for pimecrolimus
Clinical Trial Phase Trials
Completed 46
Terminated 5
Unknown status 4
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Clinical Trial Sponsors for pimecrolimus

Sponsor Name

Sponsor Name for pimecrolimus
Sponsor Trials
Novartis 22
Novartis Pharmaceuticals 7
Astellas Pharma Inc 3
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Sponsor Type

Sponsor Type for pimecrolimus
Sponsor Trials
Other 43
Industry 42
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Pimecrolimus (ELIDEL): Clinical trials update, market analysis and forecast, and IP/regulatory timeline for commercial planning

Last updated: July 28, 2026

Pimecrolimus is the topical calcineurin inhibitor used for inflammatory skin disease (marketed in several territories under brand names such as Elidel). Publicly available patent, Orange Book, FDA exclusivity, and full clinical-trials enrollment/endpoint datasets are not present in the information provided. Without those inputs, an accurate, decision-grade clinical-trials update and market projection cannot be produced.

What clinical trials exist for pimecrolimus, and what are the latest results?

No validated, source-cited clinical-trials listing (NCT numbers, enrollment, topline endpoints, completion dates, or safety signals) is available in the information provided. A factual “latest results” update cannot be compiled.

Which indications are pimecrolimus trials targeting (atopic dermatitis vs other dermatoses)?

No trial-by-indication mapping is available in the information provided.

What dose strengths and formulations are being studied?

No formulation-level trial data (cream/vehicle concentration, vehicle changes, application schedule) is available in the information provided.

What is the current market size for pimecrolimus, and how is it trending?

No market size, segment share, pricing, reimbursement, or geography-level sales dataset is available in the information provided. A quantified market analysis and forecast cannot be produced.

Where is pimecrolimus sold (US, EU, UK, MENA, LATAM, APAC)?

No country-level commercialization footprint is available in the information provided.

How do competitors compare against pimecrolimus in topical calcineurin inhibitors?

No share-of-prescription or branded/generic competitive landscape data is available in the information provided.

When do pimecrolimus patents and exclusivities expire, and what does that mean for generic entry?

No identified patent estate, listed expiration dates, or FDA exclusivity periods are available in the information provided. A reliable exclusivity and launch-risk timeline cannot be produced.

How many patents protect pimecrolimus, and what is their scope (composition, method of use, formulation)?

No patent counts or scope details are available in the information provided.

What is the Orange Book status of pimecrolimus?

No Orange Book listing data is available in the information provided.

Are there Paragraph IV or biosimilar-style challenges affecting pimecrolimus?

No FDA challenge history (ANDA filings, Paragraph IV certifications, litigation) is available in the information provided. A “which companies are challenging” view cannot be built.

What formulations are protected for pimecrolimus, and what generic entry risks exist?

No formulation patent mapping or generic infringement/FOC risk analysis is available in the information provided.

What manufacturing/IP barriers could block topical generic or “authorized generic” launches?

No manufacturing method or process-related IP is available in the information provided.

How does pimecrolimus compare with tacrolimus for efficacy and market position?

No head-to-head effectiveness evidence or market positioning metrics are available in the information provided.

What does the regulatory pathway imply for new entrants (NDA vs ANDA vs 505(b)(2))?

No FDA regulatory history, reference listed drug mapping, or application pathway details are available in the information provided.

Key Takeaways

  • A clinical-trials update for pimecrolimus cannot be produced without source-cited trial identifiers, endpoints, and timelines.
  • A quantified market analysis and forecast cannot be produced without sales, pricing, and geography-level datasets.
  • A credible IP and exclusivity timeline cannot be produced without a sourced patent and Orange Book/exclusivity inventory.

FAQs

  1. What are the most recent completed NCT studies for pimecrolimus and their primary endpoints?
  2. What is the global sales trend for pimecrolimus by region and formulation?
  3. What is the latest patent expiration date in the pimecrolimus estate, and what claims are asserted?
  4. Has pimecrolimus faced any Paragraph IV ANDA filings, and what settlements or court outcomes occurred?
  5. How does pimecrolimus performance in atopic dermatitis compare to tacrolimus across age groups and severity strata?

References

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