Drugs / Polidocanol
Polidocanol
also known as
Lauromacrogol · Varithena · 10XB-101 · PEM · Aethoxyskerol · Atossisclerol 3% · Lauromacrogol 400 (INN) · Macrogol 400 Ph Eur
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 23
| 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| Phase 2 | NCT03754140 | May 2020 → Dec 2022 | metastatic melanoma | Melanoma Institute Australia | Withdrawn | No outcome recorded |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 · 2 met primary | ||||||
| Phase 3 | NCT01072877 | Dec 2010 → Dec 2011 | varicose disease | Boston Scientific Corporation | Completed | Met primary |
| Phase 3 | NCT01231373 | Nov 2010 → Sep 2011 | varicose disease | Boston Scientific Corporation | Completed | Met primary |
| 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 45 trials | ||||||
| Phase 4 | NCT07793630 | Sep 2026 → Feb 2027 expected | chronic venous insufficiency, telangiectasis | University of Sao Paulo | Recruiting | No outcome recorded |
| 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 Stop: Enrollment |
| 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 Stop: Enrollment |
| — | 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 |
| Comparator or background therapy16 trials | ||||||
| Phase 1 | NCT06132165 Comparator | Mar 2024 → Jul 2025 | neurofibromatosis type 1 | Massachusetts General Hospital | Completed | No outcome recorded |
| 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 2/3 | 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 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 Stop: Enrollment |
| 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 |
| — | 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 |
| — | NCT02468206 Comparator | Jun 2015 → Feb 2018 | — | West China Hospital | 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 |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2021-08-03 | 10xBio, LLC | Results 10xBio Announces the Completion of Phase 2 Clinical Trial of 10XB101 10xbio.com ↗
After a single treatment, a dose dependent reduction in submental fat rating scale was observed by both patients and clinicians with mean grading changes ranging from 0.33 to 1.7. |
| 2019-05-06 | 10xBio, LLC | Results 10xBio Announces the Completion of Phase 1B Clinical Trial of 10XB101 10xbio.com ↗
Results demonstrated excellent safety with all local reactions related to the drug product rated as mild to moderate with resolution shortly after the drug administration and by the end of the study. |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2021-08-03 | 10xBio, LLC | 10xBio Announces the Completion of Phase 2 Clinical Trial of 10XB101 10xbio.com ↗ |
| 2019-05-06 | 10xBio, LLC | 10xBio Announces the Completion of Phase 1B Clinical Trial of 10XB101 10xbio.com ↗ |
Evidence & citations 11 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 ↗ |
| Known as | 10XB-101 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05154955 ↗ |
| 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 | 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 ↗ |