You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: July 12, 2025

CLINICAL TRIALS PROFILE FOR POLIDOCANOL


✉ Email this page to a colleague

« Back to Dashboard


All Clinical Trials for Polidocanol

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00161915 ↗ Efficacy and Safety of Endoscopic Injection of Fibrin Sealant Versus Endoscopic Ligature for Bleeding Esophageal Varices Completed Baxter Healthcare Corporation Phase 3 2000-12-01 The purpose of this study was to assess whether endoscopic sclerotherapy with Fibrin Sealant was superior to ligature, with or without Polidocanol, in achieving hemostasis in bleeding esophageal varices and preventing rebleeding. Therapeutic success was defined as survival of the first seven days without clinically significant bleeding.
NCT00377910 ↗ The Efficacy of Polidocanol Injections as a Treatment of Chronic Achilles. Tendinopathy Completed Aarhus University Hospital Phase 4 2008-03-01 Chronic achilles tendinopathy is a common disease especially in adults. The golden standard in treatment has up to now been excentric exercises but with varying success. A new hypothesis is that this chronic pain is due to neo vascularisation. In a pilot study sclerosing injections with polidocanol have had a successful efficacy. Our aim is to study the efficacy of polidocanol as a treatment in a randomised controlled setting on a larger scale.
NCT00377910 ↗ The Efficacy of Polidocanol Injections as a Treatment of Chronic Achilles. Tendinopathy Completed Northern Orthopaedic Division, Denmark Phase 4 2008-03-01 Chronic achilles tendinopathy is a common disease especially in adults. The golden standard in treatment has up to now been excentric exercises but with varying success. A new hypothesis is that this chronic pain is due to neo vascularisation. In a pilot study sclerosing injections with polidocanol have had a successful efficacy. Our aim is to study the efficacy of polidocanol as a treatment in a randomised controlled setting on a larger scale.
NCT00399451 ↗ Polidocanol Sclerotherapy of Pharynges for Obstructive Sleep Apnea (OSA) and Snoring Subjects(SS) Unknown status Liaoyang Central Hospital Phase 1/Phase 2 2006-12-01 The aim of this prospective study is to evaluate the results of polidocanol sclerotherapy of pharynx for OSAS & SS,to reduce pharyngeal compliance.
NCT00442364 ↗ Safety Study of Varisolve® Procedure for Treatment of Varicose Veins in Patients With Right-to-left Cardiac Shunt Completed Boston Scientific Corporation Phase 2 2007-03-01 The purpose of this study is to determine the safety of the Varisolve® procedure in patients with right-to-left cardiac shunt (a defect in the heart).
NCT00442364 ↗ Safety Study of Varisolve® Procedure for Treatment of Varicose Veins in Patients With Right-to-left Cardiac Shunt Completed BTG International Inc. Phase 2 2007-03-01 The purpose of this study is to determine the safety of the Varisolve® procedure in patients with right-to-left cardiac shunt (a defect in the heart).
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Polidocanol

Condition Name

Condition Name for Polidocanol
Intervention Trials
Varicose Veins 10
Neurofibromatosis 1 2
Varicose Ulcer 1
Chronic Achilles Tendinopathy 1
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Condition MeSH

Condition MeSH for Polidocanol
Intervention Trials
Varicose Veins 13
Hemorrhoids 3
Neurofibroma 2
Tendinopathy 2
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Locations for Polidocanol

Trials by Country

Trials by Country for Polidocanol
Location Trials
United States 40
United Kingdom 2
Portugal 2
Germany 2
Brazil 2
This preview shows a limited data set
Subscribe for full access, or try a Trial

Trials by US State

Trials by US State for Polidocanol
Location Trials
Washington 6
North Carolina 4
Florida 3
New York 3
California 3
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Progress for Polidocanol

Clinical Trial Phase

Clinical Trial Phase for Polidocanol
Clinical Trial Phase Trials
Phase 4 8
Phase 3 4
Phase 2/Phase 3 2
[disabled in preview] 11
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Status

Clinical Trial Status for Polidocanol
Clinical Trial Phase Trials
Completed 15
Unknown status 4
Not yet recruiting 3
[disabled in preview] 4
This preview shows a limited data set
Subscribe for full access, or try a Trial

Clinical Trial Sponsors for Polidocanol

Sponsor Name

Sponsor Name for Polidocanol
Sponsor Trials
BTG International Inc. 9
Boston Scientific Corporation 7
Johns Hopkins University 2
[disabled in preview] 6
This preview shows a limited data set
Subscribe for full access, or try a Trial

Sponsor Type

Sponsor Type for Polidocanol
Sponsor Trials
Other 38
Industry 8
[disabled in preview] 0
This preview shows a limited data set
Subscribe for full access, or try a Trial

Polidocanol: Clinical Trials, Market Analysis, and Projections

Last updated: December 31, 2024

Clinical Trials and Efficacy

Polidocanol, a sclerosing agent, has been extensively studied in various clinical trials to validate its efficacy and safety, particularly in the treatment of varicose veins and other venous disorders.

VANISH-1 and VANISH-2 Trials

The VANISH-1 and VANISH-2 trials were pivotal in establishing the efficacy of polidocanol endovenous microfoam. These randomized, multicenter controlled trials demonstrated significant improvements in symptoms and the appearance of varicose veins. Patients treated with Varithena (polidocanol injectable foam) showed a meaningful reduction in VVSymQ scores, indicating improved symptoms, and independent photography reviews revealed superior improvement in the appearance of varicose veins compared to placebo[1].

Real-World Outcomes

Beyond clinical trials, real-world studies have reinforced the safety and efficacy of polidocanol. For instance, a study comparing polidocanol endovenous microfoam to endovenous laser ablation (EVLA) found that polidocanol was comparable in safety and efficacy, with a high rate of reflux elimination in both treatment groups (93.5% for Varithena and 92.8% for EVLA)[1].

Additional Clinical Findings

Retrospective patient chart reviews have also shown promising results, with complete elimination of venous valvular reflux and vein closure in 94.4% of patients treated with polidocanol. Furthermore, patients treated with a combination of endovenous thermal ablation (ETA) and polidocanol required fewer retreatments compared to those treated solely with ETA[1].

Market Analysis

The market for polidocanol is driven by several key factors, including increasing awareness of non-invasive treatment options and technological advancements in healthcare.

Market Drivers

  • Rising Awareness and Advancements: The growing awareness of non-invasive treatment options and advancements in healthcare technology have significantly fueled the uptake of polidocanol injections. This trend is expected to continue as more patients seek less invasive and more effective treatments for venous disorders[5].
  • Regulatory Approvals: Regulatory approvals and incentives have encouraged pharmaceutical companies to invest in this niche market, further expanding the availability and adoption of polidocanol[5].

Market Restraints

  • Regulatory Hurdles: Despite the growth potential, the market faces regulatory hurdles that affect the approval and distribution of polidocanol injections worldwide. These challenges can slow down market expansion and limit access to the drug in certain regions[5].
  • Product Awareness and Education: Issues related to product awareness and education among healthcare professionals can also hinder the market growth. Enhancing practitioner education and training programs is crucial to improve technique and patient outcomes[5].

Market Opportunities

  • Global Market Growth: The increasing incidence of venous disorders globally presents a significant opportunity for growth. Expanding into new markets, particularly in regions with high prevalence rates, can drive market expansion[5].
  • Aesthetic and Cosmetic Procedures: The growing demand for aesthetic and cosmetic procedures also offers a potential market for polidocanol, as it is used in treating spider veins and other cosmetic venous issues[5].

Market Projections

Market Size and Growth

The polidocanol injection market is projected to grow significantly over the next few years, driven by the increasing demand for non-invasive treatments and the expanding global healthcare market. The market size is expected to increase as more patients opt for polidocanol-based treatments over traditional surgical methods[5].

Geographic Markets

  • Americas: The Americas region, particularly the United States, is expected to remain a key market due to high awareness and adoption rates of advanced medical treatments.
  • Asia-Pacific: The Asia-Pacific region is anticipated to show rapid growth due to increasing healthcare spending and a rising awareness of non-invasive treatment options.
  • Europe, Middle East & Africa: This region will also see significant growth, driven by regulatory approvals and the expanding healthcare infrastructure[5].

Competitive Landscape

The competitive landscape of the polidocanol market is characterized by a few key players, including manufacturers of branded products like Varithena and Asclera. Market share analysis indicates that these brands dominate the market, but there is room for new entrants and innovative products. The competitive assessment highlights the importance of strategic approaches, product range, and regulatory approvals in gaining a competitive edge[5].

Off-Label Uses and Future Perspectives

Off-Label Uses

Polidocanol has several off-label uses that are underappreciated but show promising results. These include treatments for esophageal and gastric varices, tendinopathy, vascular malformations, varicocele, and other conditions. While these uses are not yet widely recognized, they offer potential future applications and market expansion opportunities[3].

Future Perspectives

The future of polidocanol looks promising, with ongoing research and development aimed at optimizing its use and expanding its applications. Randomized clinical trials are needed to confirm the efficacy and safety of polidocanol in various off-label uses, which could further broaden its market potential[3].

"Polidocanol as a minimal-invasive method (having similar outcomes like the prevalent surgeries) may reduce the rate of complications. Furthermore, for determining the most appropriate method and dosage, randomized clinical trials are needed, confirming and providing more clear instructions for different conditions."[3]

Key Takeaways

  • Clinical Efficacy: Polidocanol has been proven effective in treating varicose veins through clinical trials and real-world outcomes.
  • Market Growth: The market is driven by increasing awareness of non-invasive treatments and technological advancements.
  • Regulatory Challenges: Regulatory hurdles and product awareness issues are key restraints to market growth.
  • Global Expansion: The market is expected to grow globally, with significant opportunities in the Americas, Asia-Pacific, and Europe, Middle East & Africa regions.
  • Off-Label Uses: Polidocanol has several promising off-label uses that could expand its market potential.

FAQs

What are the main clinical trials that have validated the efficacy of polidocanol?

The VANISH-1 and VANISH-2 trials are the main clinical trials that have validated the efficacy of polidocanol in treating varicose veins.

What are the key drivers of the polidocanol market?

The key drivers include rising awareness of non-invasive treatment options, technological advancements in healthcare, and regulatory approvals.

What are some of the off-label uses of polidocanol?

Off-label uses include treatments for esophageal and gastric varices, tendinopathy, vascular malformations, varicocele, and other conditions.

How does polidocanol compare to other treatments like endovenous laser ablation (EVLA)?

Polidocanol has been shown to be comparable in safety and efficacy to EVLA, with high rates of reflux elimination in both treatment groups.

What are the main challenges facing the polidocanol market?

Regulatory hurdles, issues related to product awareness and education among healthcare professionals, and mitigating side effects are the main challenges.

Sources

  1. Varithena Clinical Evidence: "Clinical Evidence: Validating efficacy and safety | Varithena™"
  2. Research and Markets: "Global and Chinese Polidocanol (CAS 9002-92-0) Industry - 2015"
  3. Eurekaselect: "An Evidence-Based Review of Off-Label Uses of Polidocanol"
  4. Drugs.com: "Asclera Alternatives Compared - Drugs.com"
  5. 360iResearch: "Polidocanol Injection Market Size & Share 2025-2030"

More… ↓

⤷  Try for Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.