Asclera

(Polidocanol)

Phase 2Small molecule

BBoston Scientific Corporation

Asclera is one of 80 small molecule programs targeting Cutaneous Melanoma. It is currently in Phase 2.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[3][1]

Indication

Cutaneous MelanomaActive, not recruiting

Neurofibromatosis Type 1Active, not recruiting

Cutaneous MelanomaPhase 2

Active, not recruiting

Neurofibromatosis Type 1Phase 1

Active, not recruiting

Competition

Competitive Landscape

91 competitors in Cutaneous Melanoma

#DrugCompanyPhaseTrials

Tafinlar

Novartis

Phase 3

3 2

Keytruda

Merck & Co.

Phase 3

2 3

DTIC-Dome

Bayer

Phase 3

2 4

Yervoy

Bristol-Myers Squibb

Phase 3

2 5

Opdivo

Bristol-Myers Squibb

Phase 3

2 6

Taxol

Teva

Phase 3

1 7

Intron a

PEG-Intron

Amtagvi

IIovance Biotherapeutics, Inc.

Phase 3

1 10

Zelboraf

CConrado Roberto Hoffmann Filho

Phase 3

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Clinical

Trials by Indication[1]

Treatment2 trials

An Assessment of Intra-lesional 3% Polidocanol Solution in the Treatment of Digital Myxoid Cyst

Terminated·UUniversity of Edinburgh·Phase 4·NCT02154789·10 enrolled

Comparative Study of Polidocanol and Absolute Alcohol for Percutaneous us Guided Treatment of Benign Thyroid Cyst

Unknown status·—·Phase 4·NCT05798936·30 enrolled

Neurofibromatosis Type 11 trial

Efficacy of Skin Cooling in Reducing Pain Associated With Non-invasive Treatments of Neurofibromatosis Type 1 Cutaneous Neurofibromas

Completed·MMassachusetts General Hospital·Phase 1·NCT06132165·13 enrolled

Combination Therapy1 trial

TENDOSHOCK-2010 Combination Therapy for Athletic Tendinopathies

Unknown status·HHannover Medical School·Phase 2·NCT01185951·114 enrolled

Cutaneous Melanoma1 trial

Intralesional Sclerosant for in Transit and Cutaneous Melanoma Metastases

Withdrawn·MMelanoma Institute Australia·Phase 2·NCT03754140

Regulatory

FDA Approval Timeline[4]

Mar 30, 2010

ASCLERA

NDA NDA021201

Dec 21, 2017

VARITHENA

NDA NDA205098

Sources

References

[1]
ClinicalTrials.gov — 5 trial records for Polidocanol. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Polidocanol compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Polidocanol. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA NDA205098). U.S. Food & Drug Administration.
[5]
FDA Orange Book — Patent and exclusivity data for Asclera. U.S. Food & Drug Administration.
[6]
SEC EDGAR — Boston Scientific Corporation company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Highest Phase: Phase 2[1]
Company: BBoston Scientific Corporation

Patent Landscape[5]

Patent Cliff

Nov 19, 2027

Earliest patent expiration — generic entry possible after this date

Patent #Expires

7814943Nov 19, 2027

9480652May 12, 2032

Asclera

Status by Indication[3][1]

Competitive Landscape

Trials by Indication[1]

Treatment2 trials

Neurofibromatosis Type 11 trial

Combination Therapy1 trial

Cutaneous Melanoma1 trial

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Patent Landscape[5]

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