Drugs / Polidocanol
Polidocanol
also known as
Lauromacrogol · Varithena · 10XB-101 · PEM · Aethoxyskerol · Asclera · Atossisclerol 3% · Lauromacrogol 400 (INN) · +1 more
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | ASCLERA | — | 2010-03-30 | fda.gov ↗ |
Trials 22 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT01428076 | Aug 2011 → Jan 2012 | varicose disease | Boston Scientific Corporation | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT00399451 | Dec 2006 → Jun 2009 | obstructive sleep apnea syndrome | Liaoyang Central Hospital | Unknown | No outcome recorded |
| Phase 28 trials | ||||||
| Phase 2 | NCT05760248 | May 2023 → Jan 2025 | subcutaneous tissue disorder | 10xBio, LLC | Completed | No outcome recorded |
| Phase 2 | NCT05154955 | Oct 2021 → Mar 2024 | — | 10xBio, LLC | Completed | No outcome recorded |
| Phase 2 | NCT03754140 | May 2020 → Dec 2022 | metastatic melanoma | Melanoma Institute Australia | Withdrawn | No outcome recorded |
| Phase 2 | NCT04258761 | Oct 2019 → Jun 2022 | — | 10xBio, LLC | Completed | No outcome recorded |
| Phase 2 | NCT03791775 | Jan → Jun 2019 | internal hemorrhoid | Societa Italiana di Chirurgia ColoRettale | Completed | No outcome recorded |
| Phase 2 | NCT04091763 | Aug 2018 → Jul 2020 | internal hemorrhoid | University of Porto | Completed | No outcome recorded |
| Phase 2 | NCT00928421 | Jun → Dec 2009 | varicose disease | Boston Scientific Corporation | Completed | No outcome recorded |
| Phase 2 | NCT00442364 | Mar 2007 → Jun 2008 | varicose disease | Boston Scientific Corporation | Completed | No outcome recorded |
| Phase 34 trials | ||||||
| Phase 3 | NCT01072877 | Dec 2010 → Dec 2011 | varicose disease | Boston Scientific Corporation | Completed | No outcome recorded |
| Phase 3 | NCT01231373 | Nov 2010 → Sep 2011 | varicose disease | Boston Scientific Corporation | Completed | No outcome recorded |
| Phase 3 | NCT01197833 | Sep 2010 → Mar 2012 | varicose disease, venous insufficiency | Boston Scientific Corporation | Completed | No outcome recorded |
| Phase 3 | NCT00348764 | Mar 2004 → Dec 2006 | venous insufficiency | University Hospital, Grenoble | Completed | No outcome recorded |
| Phase 44 trials | ||||||
| Phase 4 | NCT05798936 | Apr 2023 → May 2025 | benign thyroid gland neoplasm | Assiut University | Unknown | No outcome recorded |
| Phase 4 | NCT02988063 | Apr → Sep 2017 | ulcer of lower limbs, varicose disease, venous insufficiency | OhioHealth | Withdrawn | No outcome recorded |
| Phase 4 | NCT02154789 | Jul → Oct 2015 | ganglion or cyst of synovium/tendon/bursa | University of Edinburgh | Terminated | No outcome recorded |
| Phase 4 | NCT02462720 | May → Dec 2015 | varicose disease | Boston Scientific Corporation | Completed | No outcome recorded |
| Phase not applicable4 trials | ||||||
| — | NCT07276243 | Mar 2026 → Aug 2027 expected | varicose disease | Hospital Universitario Pedro Ernesto | Recruiting | No outcome recorded |
| — | NCT02557542 | Oct 2015 → Mar 2021 | varicose disease | Imperial College London | Terminated | No outcome recorded |
| — | NCT01923064 | Oct → Dec 2013 | portal hypertension | Shanghai Zhongshan Hospital | Completed | No outcome recorded |
| — | NCT06192472 | Apr 2013 → Jul 2015 | varicose disease | University of Surrey | Completed | No outcome recorded |
Also used as a comparator or background therapy in 17 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT06132165 Comparator | Mar 2024 → Jul 2025 | neurofibromatosis type 1 | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 1 | NCT06120036 Comparator | Dec 2022 → Jan 2025 | neurofibromatosis type 1 | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 22 trials | ||||||
| Phase 2 | NCT07307131 Comparator | Sep 2024 → Mar 2025 | common wart, human papilloma virus infection | Benha University | Completed | No outcome recorded |
| Phase 2 | NCT01185951 Comparator | Jan 2007 → Aug 2010 | disease of the tendon, epicondylitis | Hannover Medical School | Unknown | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT04675177 Comparator | Sep 2019 → Feb 2020 | hemorrhoid | University of Porto | Completed | No outcome recorded |
| Phase 2/3 | NCT00758420 Comparator | Oct 2008 → Jul 2009 | varicose disease | Boston Scientific Corporation | Completed | No outcome recorded |
| Phase 46 trials | ||||||
| Phase 4 | NCT07561320 Background | May 2026 → Aug 2027 expected | varicose disease | Antonio Eduardo Zerati | Recruiting | No outcome recorded |
| Phase 4 | NCT05312970 Comparator | Feb 2023 → Apr 2024 | varicose disease | Boston Scientific Corporation | Terminated | No outcome recorded |
| Phase 4 | NCT04398823 Comparator | May → Dec 2020 | internal hemorrhoid | Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | Unknown | No outcome recorded |
| Phase 4 | NCT02657252 Comparator | Jan 2015 → Sep 2016 | telangiectasis, varicose disease | UPECLIN HC FM Botucatu Unesp | Completed | No outcome recorded |
| Phase 4 | NCT02054325 Comparator | Sep 2012 → Dec 2014 | varicose disease | UPECLIN HC FM Botucatu Unesp | Completed | No outcome recorded |
| Phase 4 | NCT00377910 Comparator | Mar 2008 → Jan 2009 | tendinosis | Northern Orthopaedic Division, Denmark | Completed | No outcome recorded |
| Phase not applicable5 trials | ||||||
| — | NCT07606391 Comparator | Aug 2026 overdue | reactive cutaneous fibrous lesion | Sohag University | Not yet recruiting | No outcome recorded |
| — | NCT05468450 Comparator | Jul 2015 → Aug 2016 | varicose disease | French Society of Phlebology | Completed | No outcome recorded |
| — | NCT02468180 Comparator | Jun 2015 → Jul 2022 | — | West China Hospital | Unknown | No outcome recorded |
| — | NCT02468167 Comparator | Jun 2015 → Jul 2020 | — | West China Hospital | Unknown | No outcome recorded |
| — | NCT02468206 Comparator | Jun 2015 → Feb 2018 | — | West China Hospital | Completed | No outcome recorded |
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 41 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Polidocanol | “Varithena® (polidocanol injectable foam) 1%” NCT05312970 ↗27“1. drug: Polidocanol” NCT00377910 ↗ |
| Known as | 10XB-101 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04258761 ↗ |
| Known as | Aethoxyskerol | “The two surfactant sclerosants most widely used are sodium tetradecyl sulphate (STS, STD®, Sotradecol or Fibro-vein) and polidocanol (Macrogol 400 Ph Eur, Aethoxyskerol®).” NCT00442364 ↗ |
| Known as | Asclera | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06120036 ↗ |
| Known as | Atossisclerol 3% | “Patients enrolled in the study, according to the inclusion and exclusion criteria, will undergo sclerotherapy performed with polidocanol foam (Atossisclerol® 3%, Chemische...” NCT03791775 ↗ |
| Known as | Lauromacrogol | ClinicalTrials.gov intervention name — accepted as the source's own label NCT01923064 ↗ |
| Known as | Lauromacrogol 400 (INN) | “polidocanol (Lauromacrogol 400 (INN)” NCT03791775 ↗ |
| Known as | Macrogol 400 Ph Eur | “The two surfactant sclerosants most widely used are sodium tetradecyl sulphate (STS, STD®, Sotradecol or Fibro-vein) and polidocanol (Macrogol 400 Ph Eur, Aethoxyskerol®).” NCT00442364 ↗ |
| Known as | PEM | “pharmaceutical-grade polidocanol endovenous microfoam (PEM, now approved in the United States as Varithena [polidocanol injectable foam], BTG International Ltd.” PMID 26384639 ↗ Sep 20152“Polidocanol endovenous microfoam (PEM) is an injectable foam medication that is used to treat symptoms of venous disease, including venous leg ulcers (VLUs).” NCT02988063 ↗ “Polidocanol Endovenous Microfoam (PEM) compared to vehicle (inactive solution)” NCT01197833 ↗ |
| Known as | Varithena | “pharmaceutical-grade polidocanol endovenous microfoam (PEM, now approved in the United States as Varithena [polidocanol injectable foam], BTG International Ltd.” PMID 26384639 ↗ Sep 20153“treatment with polidocanol endovenous microfoam (Varithena; Provensis Ltd, a BTG International group company)” PMID 26992303 ↗ May 2015 “Varithena® (polidocanol injectable foam) 1%” NCT05312970 ↗ |
| Modality | Other / unclassified | “The polidocanol is a non-ionic detergent” NCT03791775 ↗ |
| Route | Intravenous | “maximum of 20ml injected into affected great saphenous vein.” NCT00442364 ↗ |