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Last Updated: April 14, 2025

CLINICAL TRIALS PROFILE FOR CONDYLOX


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All Clinical Trials for CONDYLOX

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT03532776 ↗ Comparison Between Podofilox Topical Gel 0.5% and Allergan's Condylox® Gel 0.5% for External Anogenital Warts Completed bioRASI, LLC Phase 3 2018-04-20 A clinical endpoint bioequivalence (BE) study for a Podofilox Gel 0.5% formulation for the treatment of external anogenital warts in comparison to Condylox® Gel 0.5% that follows the study design and recommendations according to Office of Generic Drugs (OGD) of U.S. Food and Drug Administration (FDA) Draft Guidance for Podofilox recommendations
NCT03532776 ↗ Comparison Between Podofilox Topical Gel 0.5% and Allergan's Condylox® Gel 0.5% for External Anogenital Warts Completed Hyloris Developments SA Phase 3 2018-04-20 A clinical endpoint bioequivalence (BE) study for a Podofilox Gel 0.5% formulation for the treatment of external anogenital warts in comparison to Condylox® Gel 0.5% that follows the study design and recommendations according to Office of Generic Drugs (OGD) of U.S. Food and Drug Administration (FDA) Draft Guidance for Podofilox recommendations
NCT03532776 ↗ Comparison Between Podofilox Topical Gel 0.5% and Allergan's Condylox® Gel 0.5% for External Anogenital Warts Completed Dermax SA Phase 3 2018-04-20 A clinical endpoint bioequivalence (BE) study for a Podofilox Gel 0.5% formulation for the treatment of external anogenital warts in comparison to Condylox® Gel 0.5% that follows the study design and recommendations according to Office of Generic Drugs (OGD) of U.S. Food and Drug Administration (FDA) Draft Guidance for Podofilox recommendations
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 3 of 3 entries

Clinical Trial Conditions for CONDYLOX

Condition Name

10-0.100.10.20.30.40.50.60.70.80.911.1External Anogenital Warts[disabled in preview]
Condition Name for CONDYLOX
Intervention Trials
External Anogenital Warts 1
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Condition MeSH

110-0.100.10.20.30.40.50.60.70.80.911.1WartsCondylomata Acuminata[disabled in preview]
Condition MeSH for CONDYLOX
Intervention Trials
Warts 1
Condylomata Acuminata 1
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Clinical Trial Locations for CONDYLOX

Trials by Country

+
Trials by Country for CONDYLOX
Location Trials
United States 3
Ukraine 1
Russian Federation 1
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Trials by US State

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Trials by US State for CONDYLOX
Location Trials
Texas 1
Pennsylvania 1
Florida 1
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Clinical Trial Progress for CONDYLOX

Clinical Trial Phase

100.0%0-0.100.10.20.30.40.50.60.70.80.911.1Phase 3[disabled in preview]
Clinical Trial Phase for CONDYLOX
Clinical Trial Phase Trials
Phase 3 1
[disabled in preview] 0
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Clinical Trial Status

100.0%0-0.100.10.20.30.40.50.60.70.80.911.1Completed[disabled in preview]
Clinical Trial Status for CONDYLOX
Clinical Trial Phase Trials
Completed 1
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Clinical Trial Sponsors for CONDYLOX

Sponsor Name

trials000111112222bioRASI, LLCHyloris Developments SADermax SA[disabled in preview]
Sponsor Name for CONDYLOX
Sponsor Trials
bioRASI, LLC 2
Hyloris Developments SA 1
Dermax SA 1
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Sponsor Type

75.0%25.0%000.511.522.53IndustryOther[disabled in preview]
Sponsor Type for CONDYLOX
Sponsor Trials
Industry 3
Other 1
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Clinical Trials, Market Analysis, and Projections for Condylox (Podofilox)

Introduction

Condylox, known generically as podofilox, is a crucial medication in the treatment of genital warts, a common sexually transmitted infection caused by the Human Papillomavirus (HPV). This article delves into the clinical trials, market analysis, and future projections for this drug.

Clinical Trials and Efficacy

Historical Clinical Trials

Podofilox has been extensively studied in clinical trials to establish its efficacy and safety. A notable double-blind, randomized trial involved 72 women with external genital warts, where patients applied 0.5% podofilox gel twice daily for 3 consecutive days, followed by 4 days without treatment. This cycle was repeated for up to 4 weeks. The results showed that podofilox cleared 74% of the total wart count, compared to an 18% regression in the placebo group[4].

Safety and Side Effects

Clinical trials have consistently shown that podofilox is safe and effective with minimal systemic effects. Local side effects are typically minor and transient, making it a preferred treatment option for patients[4].

Market Analysis

Global Market Size and Growth

The global genital warts treatment market, in which podofilox is a key player, is projected to grow significantly. By 2033, the market is expected to reach approximately USD 2,891.9 million from USD 1,792.4 million in 2023, with a Compound Annual Growth Rate (CAGR) of 4.9%[2].

Market Share by Drug Type

Podofilox competes with other drugs such as imiquimod, podophyllin, and trichloroacetic acid. While imiquimod currently leads the market with a 38% share, podofilox remains a significant player due to its efficacy in treating genital warts[5].

Distribution Channels

The distribution of podofilox is primarily through hospital pharmacies, retail pharmacies, and online pharmacies. Hospital pharmacies hold the largest market share, accounting for about 49% of the genital warts treatment market[5].

Market Dynamics

Drivers

The growth of the podofilox market is driven by several factors:

  • Increasing Awareness: Growing awareness about HPV and genital warts.
  • Effective Treatments: Availability of effective treatments like podofilox.
  • Healthcare Infrastructure: Improvements in healthcare infrastructure in emerging nations[5].

Restraints

Despite the growth drivers, there are several restraints:

  • High Treatment Costs: High costs associated with treatments can limit access.
  • Social Stigma: Social stigma associated with genital warts can reduce treatment seeking.
  • Logistical Issues: Logistical challenges, including the need for cold storage for related vaccines, can complicate delivery[5].

Regional Insights

Global Market

The global genital warts treatment market is dominated by North America, which holds around 38% of the market share. This is due to the high prevalence of HPV infections and the well-developed healthcare infrastructure in the region[5].

Asia-Pacific

The Asia-Pacific region, particularly countries like China and India, is expected to see significant growth. Urbanization, industrialization, and increasing healthcare spending are driving factors in this region[5].

Generic Version and FDA Approval

Recently, Padagis received FDA approval to market Podofilox Gel, the first generic version of Condylox Gel 0.5% in the US. This development is expected to increase accessibility and potentially reduce costs for patients, further driving market growth[1].

Pricing Trends

Current Pricing

As of the latest data, the cost for podofilox topical 0.5% gel is around $591 for a 3.5-gram supply, and for the 0.5% topical solution, it is approximately $43.41 for 3.5 milliliters. These prices are subject to variation based on the pharmacy and location[5].

Future Pricing Trends

Given the growing demand for genital warts treatments and the increasing prevalence of HPV infections, the prices of podofilox may see stable or slightly increased trends. However, competition from other treatment options and the introduction of generic versions could keep prices competitive[5].

Medical Applications and Usage

Medical Uses

Podofilox is primarily used to treat genital warts (condylomata acuminata) and is part of the topical keratolytics drug class. It also has various other medical applications, including as a vesicant, purgative, antirheumatic, antiviral, and antitumor agent[5].

Usage Trends

The growing demand for podofilox in treating HPV infections and other medical conditions is expected to drive market growth. The product is often applied under the supervision of healthcare professionals to control side effects, underscoring its importance in clinical settings[5].

Key Takeaways

  • Market Growth: The genital warts treatment market, including podofilox, is expected to grow at a CAGR of 4.9% from 2023 to 2033.
  • Pricing: Current prices range from $43.41 for a 3.5ml solution to $591 for a 3.5g gel, with potential for stable or slightly increased prices.
  • Distribution: Hospital pharmacies dominate the distribution channels, holding 49% of the market share.
  • Regional Insights: North America leads the market, but the Asia-Pacific region is expected to see significant growth.
  • Medical Applications: Podofilox is crucial in treating genital warts and has various other medical uses.

FAQs

What is Condylox (Podofilox) used for?

Condylox, or podofilox, is primarily used for the topical treatment of anogenital warts (external genital warts and perianal warts)[1].

How is Podofilox applied?

Podofilox gel is applied twice daily with the applicator tip or finger for 3 consecutive days, followed by 4 consecutive days without treatment. This cycle may be repeated until there is no visible wart tissue or for a maximum of 4 cycles[1].

What are the common side effects of Podofilox?

Local side effects are typically minor and transient, including redness, itching, and burning at the application site. There is no evidence of systemic effects[4].

Is Podofilox available in generic form?

Yes, Padagis has received FDA approval to market the first generic version of Condylox Gel 0.5% in the US[1].

What is the current market size and growth projection for the genital warts treatment market?

The global genital warts treatment market is expected to grow from USD 1,792.4 million in 2023 to USD 2,891.9 million by 2033, with a CAGR of 4.9%[2].

Sources

  1. First Generic Version of Condylox Gel Gets FDA Approval - eMPR.com
  2. Genital Warts Treatment Market Size, Share | CAGR of 4.9% - Market.US
  3. Clinical Trials Market Size, Share, Trends and Revenue Forecast - MarketsandMarkets
  4. A double-blind, randomized trial of 0.5% podofilox and placebo for ... - PubMed
  5. Drug prices and trends for PODOFILOX - DrugPatentWatch

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