CLINICAL TRIALS PROFILE FOR ELIDEL

All Clinical Trials for Elidel

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.

Clinical Trial Conditions for Elidel

Condition Name

Condition Name for Elidel
Intervention	Trials
Atopic Dermatitis	23
Dermatitis, Atopic	4
Perioral Dermatitis	1
Pityriasis Alba	1

Condition MeSH

Condition MeSH for Elidel
Intervention	Trials
Dermatitis	30
Dermatitis, Atopic	28
Eczema	28
Lupus Erythematosus, Systemic	2

Clinical Trial Locations for Elidel

Trials by Country

Trials by Country for Elidel
Location	Trials
United States	164
Germany	15
Italy	4
Canada	3
United Kingdom	3

Trials by US State

Trials by US State for Elidel
Location	Trials
California	10
Texas	9
Virginia	9
North Carolina	9
Florida	9

Clinical Trial Progress for Elidel

Clinical Trial Phase

Clinical Trial Phase for Elidel
Clinical Trial Phase	Trials
Phase 4	15
Phase 3	10
Phase 2/Phase 3	1

Clinical Trial Status

Clinical Trial Status for Elidel
Clinical Trial Phase	Trials
Completed	33
Terminated	3
Withdrawn	1

Clinical Trial Sponsors for Elidel

Sponsor Name

Sponsor Name for Elidel
Sponsor	Trials
Novartis	13
Novartis Pharmaceuticals	4
Astellas Pharma Inc	3

Sponsor Type

Sponsor Type for Elidel
Sponsor	Trials
Industry	34
Other	17

Elidel: Clinical Trials Update, Market Analysis, and Projections

Introduction to Elidel

Elidel, also known as pimecrolimus, is a topical calcineurin inhibitor used primarily for the treatment of mild to moderate atopic dermatitis (AD) in non-immunocompromised patients. It is formulated as a 1% cream for topical and cutaneous application[2].

Clinical Trials and Regulatory Updates

Current Status of Clinical Trials

As of the latest updates, there are no new clinical trials specifically focused on Elidel that have been initiated recently. However, the broader landscape of atopic dermatitis treatment includes numerous ongoing trials. The global atopic dermatitis treatment market is witnessing a surge in clinical trials, with over 153 trials in various development phases, primarily in Phase II[3].

Regulatory Decision on Elidel

In a recent development, Bausch Health, Canada Inc., the manufacturer of Elidel, submitted a Supplemental New Drug Submission (SNDS) to Health Canada to remove the second-line therapy limitation from the indication for Elidel. However, the company cancelled this submission before a final decision was issued by Health Canada. At the time of cancellation, Health Canada was unable to establish a positive benefit-risk-uncertainty profile for the proposed revised indication[1].

Safety and Efficacy Concerns

Long-term Safety Profile

The European Medicines Agency (EMA) has been monitoring the safety profile of Elidel, along with another topical calcineurin inhibitor, tacrolimus. A safety signal indicating a potential risk of skin cancer and lymphoma was identified, prompting a review of all available data. While the benefits of using these medicines were deemed to outweigh the risks, the EMA requested additional long-term safety data to ensure the continued acceptability of their safety profiles[4].

Market Analysis

Global Atopic Dermatitis Treatment Market

The global atopic dermatitis treatment market is projected to experience significant growth. By 2031, the market is anticipated to reach $31.7 billion, expanding at a CAGR of 14.1%[5].

Market Drivers and Trends

• Emerging Therapies: The launch of new therapies such as Pfizer’s Eucrisa (crisaborole) and Sanofi’s Dupixent (dupilumab) has significantly altered the market dynamics. These breakthrough therapies are expected to achieve peak annual sales in 2025[5].
• Pipeline Molecules: Several potential candidates are in early-to-late-stage development, which is expected to drive market growth. Novel drugs targeting the IL-13/IL-31 axis and other mechanisms are showing promising results[3].
• Generic Competition: The availability of generics for existing brand leaders like Protopic (tacrolimus) and Elidel (pimecrolimus) is expected to impact their sales negatively[5].

Market Segmentation

The majority of the target market for atopic dermatitis treatments consists of mild-to-moderate cases, with a significant portion being pediatric and adolescent patients. This large under-diagnosed patient pool, combined with a high prevalence among adults and children, fuels the growth of the AD treatment market[5].

Projections for Elidel

Sales Forecast

Given the emergence of new therapies and the availability of generics, the sales of Elidel are expected to decline. The market growth will be driven by newer treatments like dupilumab, while Elidel and other existing brand leaders face increased competition[5].

Impact of Regulatory Decisions

The cancellation of the SNDS to remove the second-line therapy limitation for Elidel does not have an immediate impact on patients accessing the drug under the Special Access Programme (SAP) or via clinical trials. However, it may limit the potential expansion of Elidel's market share without additional regulatory approvals[1].

Key Takeaways

• Clinical Trials: The broader atopic dermatitis treatment landscape is active with numerous clinical trials, but there are no recent updates specific to Elidel.
• Regulatory Status: The SNDS to expand Elidel's indication was cancelled, and Health Canada did not issue a final decision.
• Safety Concerns: Long-term safety data is being monitored due to potential risks of skin cancer and lymphoma.
• Market Growth: The global atopic dermatitis treatment market is expected to grow significantly, driven by new therapies and pipeline molecules.
• Sales Projections: Elidel's sales are anticipated to decline due to generic competition and the emergence of new treatments.

FAQs

What is Elidel used for?

Elidel (pimecrolimus) is used as a second-line therapy for the short-term and intermittent long-term treatment of mild to moderate atopic dermatitis in non-immunocompromised patients 3 months of age and older[1].

Why was the SNDS for Elidel cancelled?

The SNDS was cancelled by the company before a final decision was issued by Health Canada, as the agency could not establish a positive benefit-risk-uncertainty profile for the proposed revised indication[1].

What are the safety concerns associated with Elidel?

There are potential risks of skin cancer and lymphoma associated with the use of Elidel, prompting ongoing monitoring and the collection of additional long-term safety data[4].

How is the global atopic dermatitis treatment market expected to grow?

The global atopic dermatitis treatment market is expected to reach $31.7 billion by 2031, growing at a CAGR of 14.1% driven by new therapies and pipeline molecules[5].

What impact will generic competition have on Elidel sales?

The availability of generics for existing brand leaders like Elidel is expected to negatively impact its sales as patients and prescribers opt for more cost-effective alternatives[5].

Sources

1. Health Canada: Summary of Cancellation for Elidel - Drug and Health Products Portal.
2. GlobalData: Net Present Value Model: Elidel Authorized Generic - Market Analysis.
3. Arizton: Atopic Dermatitis Treatment Market Forecast.
4. European Medicines Agency (EMA): Elidel - referral.
5. iHealthcareAnalyst: Global Atopic Dermatitis Treatment Market $31.7 Billion by 2031.

Last updated: 2025-01-01