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Last Updated: February 11, 2025

CLINICAL TRIALS PROFILE FOR ZYCLARA


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All Clinical Trials for Zyclara

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01229319 ↗ Imiquimod 3.75% Cream in Combination With Cryotherapy in the Treatment of Hypertrophic Actinic Keratoses Unknown status Graceway Pharmaceuticals, LLC Phase 4 2010-10-01 Actinic keratoses (AK) are common cutaneous lesions associate with chronic ultraviolet radiation exposure. While most authorities consider AK as a pre-malignant lesion, some consider it as an incipient squamous cell carcinoma (SCC). In addition, the skin around clinically obvious AK lesions has been subject to the same chronic ultraviolet exposure, resulting in genetic damage and mutations, resulting in "field cancerization." Subclinical AKs may progress to clinical AKs, or even de novo invasive SCCs. Among the current therapies for the treatment of AK are excisional surgery, cryosurgery, electrodessication and curettage, topical chemotherapy and light therapies. With cryotherapy, treated lesion clearance rates at 3 months post-treatment after double-freeze thaw cryotherapy has been reported to be around 76-88%; Overall lesion clearance rate at approximately 5 months post-cryosurgery has been reported to be 35-51%. Imiquimod is a topical immune response modifier and a 5% formulation has been approved for the treatment of AKs in the US as a 2x/week for 16 week regimen and in Europe as a 3x/week for 4 week regimen for 1 or 2 courses of therapy. Topical imiquimod treatment may also reduce subclinical lesions in the treatment area, resulting in fewer "new" AK lesions developing over the same period of time when compared to focal treatment. In a comparison of cryosurgery versus imiquimod for the treatment of AKs, Krawtchenko et al reported initial complete clearance rates of 68 and 85% by clinical assessment, respectively. However, the treatment field sustained clearance rate was 4% versus 73%, respectively. Tan et al reported that while application of imiquimod or vehicle following cryosurgery resulted in comparable target AK clearance rates at 12 weeks of 79% versus 76%, respectively, the imiquimod group had fewer total AKs and fewer subclinical AKs. Imiquimod cream at a concentration of 3.75% has been found in Phase 3 studies to be superior to placebo cream with respect to clearance of AKs using a regimen of up to 2 packets (250 mg of cream per packet, 500 mg total) applied daily to the entire face (approximately 200 cm2) for two 2-week treatment cycles separated by a 2-week no-treatment period. This study aims to examine the benefit of cryotherapy in combination with imiquimod 3.75% compared to cryotherapy alone.
NCT01229319 ↗ Imiquimod 3.75% Cream in Combination With Cryotherapy in the Treatment of Hypertrophic Actinic Keratoses Unknown status Frankel, Amylynne, M.D. Phase 4 2010-10-01 Actinic keratoses (AK) are common cutaneous lesions associate with chronic ultraviolet radiation exposure. While most authorities consider AK as a pre-malignant lesion, some consider it as an incipient squamous cell carcinoma (SCC). In addition, the skin around clinically obvious AK lesions has been subject to the same chronic ultraviolet exposure, resulting in genetic damage and mutations, resulting in "field cancerization." Subclinical AKs may progress to clinical AKs, or even de novo invasive SCCs. Among the current therapies for the treatment of AK are excisional surgery, cryosurgery, electrodessication and curettage, topical chemotherapy and light therapies. With cryotherapy, treated lesion clearance rates at 3 months post-treatment after double-freeze thaw cryotherapy has been reported to be around 76-88%; Overall lesion clearance rate at approximately 5 months post-cryosurgery has been reported to be 35-51%. Imiquimod is a topical immune response modifier and a 5% formulation has been approved for the treatment of AKs in the US as a 2x/week for 16 week regimen and in Europe as a 3x/week for 4 week regimen for 1 or 2 courses of therapy. Topical imiquimod treatment may also reduce subclinical lesions in the treatment area, resulting in fewer "new" AK lesions developing over the same period of time when compared to focal treatment. In a comparison of cryosurgery versus imiquimod for the treatment of AKs, Krawtchenko et al reported initial complete clearance rates of 68 and 85% by clinical assessment, respectively. However, the treatment field sustained clearance rate was 4% versus 73%, respectively. Tan et al reported that while application of imiquimod or vehicle following cryosurgery resulted in comparable target AK clearance rates at 12 weeks of 79% versus 76%, respectively, the imiquimod group had fewer total AKs and fewer subclinical AKs. Imiquimod cream at a concentration of 3.75% has been found in Phase 3 studies to be superior to placebo cream with respect to clearance of AKs using a regimen of up to 2 packets (250 mg of cream per packet, 500 mg total) applied daily to the entire face (approximately 200 cm2) for two 2-week treatment cycles separated by a 2-week no-treatment period. This study aims to examine the benefit of cryotherapy in combination with imiquimod 3.75% compared to cryotherapy alone.
NCT01502020 ↗ A Bioequivalence Study With Clinical Endpoints Comparing Generic Imiquimod Cream, 3.75% and Zyclara™ (Imiquimod) Cream, 3.75% in Subjects With Actinic Keratoses Completed Actavis Mid-Atlantic LLC N/A 2011-02-01 Zyclara™ (imiquimod) Cream, 3.75% is approved by the FDA for the treatment of actinic keratoses on the full face or balding scalp. Zyclara is applied once daily for two, 2-week treatment cycles separated by a 2-week no treatment applied interval. A generic imiquimod cream, 3.75% has been developed by Actavis Mid-Atlantic LLC for the topical treatment of clinically typical, visible or palpable actinic keratoses (AK) of the full face or balding scalp. The current clinical study is designed to evaluate the therapeutic equivalence of this formulation with the currently marketed Zyclara™ (imiquimod) cream, 3.75% formulation (Graceway Pharmaceuticals LLC).
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Zyclara

Condition Name

Condition Name for Zyclara
Intervention Trials
Actinic Keratosis 4
High Grade Cervical Intraepithelial Neoplasia 1
Stage IVB Colorectal Cancer AJCC v7 1
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Condition MeSH

Condition MeSH for Zyclara
Intervention Trials
Keratosis, Actinic 5
Keratosis 5
Neoplasms 1
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Clinical Trial Locations for Zyclara

Trials by Country

Trials by Country for Zyclara
Location Trials
United States 49
Denmark 1
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Trials by US State

Trials by US State for Zyclara
Location Trials
Florida 4
Texas 4
Indiana 3
Illinois 3
Pennsylvania 3
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Clinical Trial Progress for Zyclara

Clinical Trial Phase

Clinical Trial Phase for Zyclara
Clinical Trial Phase Trials
Phase 4 1
Phase 3 2
Phase 1 3
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Clinical Trial Status

Clinical Trial Status for Zyclara
Clinical Trial Phase Trials
Completed 4
Active, not recruiting 2
Recruiting 2
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Clinical Trial Sponsors for Zyclara

Sponsor Name

Sponsor Name for Zyclara
Sponsor Trials
National Cancer Institute (NCI) 4
M.D. Anderson Cancer Center 1
Mayo Clinic 1
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Sponsor Type

Sponsor Type for Zyclara
Sponsor Trials
Industry 5
Other 5
NIH 4
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Clinical Trials, Market Analysis, and Projections for Zyclara (Imiquimod)

Introduction to Zyclara (Imiquimod)

Zyclara, also known by its active ingredient imiquimod, is a topical cream used primarily for the treatment of actinic keratosis (AK), a precursor to skin cancer. It functions as an antitumor agent by inducing the release of cytokines such as alpha interferon, which helps in the immune response against abnormal cells.

Clinical Trials Overview

Study Design and Participants

Zyclara has been evaluated in several clinical trials to assess its efficacy and safety. Two double-blind, randomized, vehicle-controlled clinical trials involved 319 subjects with AK. Participants applied either Zyclara 3.75% or 2.5% cream, or a vehicle cream, to the affected area (either the entire face or balding scalp) for two 2-week treatment cycles separated by a 2-week no-treatment period[1][4].

Efficacy Outcomes

The efficacy of Zyclara was measured by the complete and partial clearance rates of AK lesions. Complete clearance required the absence of any lesions in the treatment area, including those that appeared during therapy. The complete clearance rates for Zyclara 3.75% were 26% and 46% in Studies AK1 and AK2, respectively, compared to 3% and 10% for the vehicle group. Partial clearance rates, defined as a reduction of 75% or more in baseline AK lesions, were 46% and 73% for Zyclara 3.75% in the same studies[1][4].

Adverse Reactions

Common adverse reactions associated with Zyclara include local skin reactions such as erythema, scabbing, and exfoliation/application site dryness. Systemic adverse reactions reported include headache, fatigue, nausea, and application site irritation. Despite these reactions, only 11% of patients required treatment interruptions due to local adverse reactions[1][4].

Market Analysis

Global Immunotherapy Market

The global immunotherapy drugs market, which includes Zyclara, is experiencing significant growth. In 2024, the market size was valued at over USD 282 billion and is projected to exceed USD 1.58 trillion by 2036, growing at a CAGR of more than 15.2%[2].

Cancer Immunotherapy Segment

Within the immunotherapy market, the cancer segment is the largest and most rapidly growing. This segment is driven by the increasing prevalence of cancer worldwide and the rising demand for oncology biosimilars and monoclonal antibodies. In 2019, cancer immunotherapy drugs generated about $75 billion and are forecast to surpass $143 billion by 2025[5].

Regional Market Dynamics

North America is expected to account for the largest revenue share in the global immunotherapy drugs market by 2036, due to the presence of several key players and the high incidence of new cancer cases in the region[2].

Market Projections for Zyclara

Specific Market Segment

While Zyclara is a part of the broader immunotherapy market, its specific segment within the actinic keratosis treatment market is significant. Given its efficacy and safety profile, Zyclara is expected to maintain a strong position in the treatment of AK.

Growth Drivers

The growth of the market for Zyclara is driven by several factors:

  • Increasing Prevalence of AK: As the population ages, the incidence of AK is expected to rise, increasing the demand for effective treatments like Zyclara.
  • Advancements in Immunotherapy: Continued research and advancements in immunotherapy will likely enhance the efficacy and safety of Zyclara, making it a preferred treatment option.
  • Regulatory Approvals: Ongoing regulatory approvals and expansions of indications can further boost the market for Zyclara[1][2][5].

Competitive Landscape

Key Competitors

The market for AK treatments includes other topical and systemic therapies. However, Zyclara's unique mechanism of action and established efficacy make it a competitive player. Other immunotherapy drugs, such as those used in cancer treatment, also contribute to the overall competitive landscape but are not direct competitors for AK treatment[5].

Future Outlook

Research and Development

Ongoing research in immunotherapy is expected to lead to new and improved treatments for AK and other skin conditions. This could include combination therapies or new formulations of imiquimod that enhance its efficacy and reduce side effects.

Market Expansion

As the global immunotherapy market expands, Zyclara is likely to benefit from increased awareness and adoption of immunotherapy treatments. This expansion could also lead to new indications for Zyclara beyond AK, further growing its market share.

Key Takeaways

  • Efficacy: Zyclara has demonstrated significant efficacy in treating actinic keratosis, with complete and partial clearance rates superior to vehicle controls.
  • Safety: Common adverse reactions include local skin reactions and some systemic effects, but treatment interruptions are relatively rare.
  • Market Growth: The global immunotherapy market is growing rapidly, driven by the increasing prevalence of cancer and other diseases, and Zyclara is well-positioned within this market.
  • Future Outlook: Continued research and regulatory approvals are expected to enhance Zyclara's market presence and potentially expand its indications.

FAQs

What is Zyclara used for?

Zyclara is used for the treatment of actinic keratosis (AK), a precursor to skin cancer.

What are the common adverse reactions associated with Zyclara?

Common adverse reactions include local skin reactions such as erythema, scabbing, and exfoliation/application site dryness, as well as systemic effects like headache and fatigue.

How effective is Zyclara in treating AK?

Zyclara has shown significant efficacy in clinical trials, with complete clearance rates ranging from 26% to 46% and partial clearance rates of up to 73%.

What is the projected growth of the immunotherapy market?

The global immunotherapy market is projected to grow from USD 282 billion in 2024 to over USD 1.58 trillion by 2036, at a CAGR of more than 15.2%.

What are the key drivers of the market growth for Zyclara?

Key drivers include the increasing prevalence of AK, advancements in immunotherapy, and ongoing regulatory approvals.

Sources

  1. FDA Label for Zyclara: "ZYCLARA (imiquimod) cream, 3.75% for topical use" - FDA[1].
  2. Immunotherapy Drugs Market Report: "Immunotherapy Drugs Market Size & Share, Growth Trends 2037" - Research Nester[2].
  3. U.S. Clinical Trials Market Report: "U.S. Clinical Trials Market Size Industry Analysis Report, 2033" - Biospace[3].
  4. European Medicines Agency Product Information for Zyclara: "Zyclara, INN-imiquimod" - European Medicines Agency[4].
  5. Global Cancer Immunotherapy Market Analysis: "Global Cancer Immunotherapy Market Analysis & Forecast to 2025" - Research and Markets[5].

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