Dysport

ApprovedBiologic

Ipsen

Dysport is one of 47 biologic programs targeting Cervical Dystonia. It is currently in Approved.

Indications

Total Trials

Active Trials

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Cervical DystoniaCompleted

SpasticityRecruiting

Skin CancerTerminated

ErythemaActive, not recruiting

Moderate to Severe Upper Facial LinesActive, not recruiting

Cervical DystoniaApproved

Completed

SpasticityPhase 2

Recruiting

Skin CancerApproved

Terminated

ErythemaPreclinical

Active, not recruiting

Moderate to Severe Upper Facial LinesPreclinical

Active, not recruiting

Competition

Competitive Landscape

22 competitors in Skin Cancer

#DrugCompanyPhaseTrials

Myfortic

Novartis

Approved

1 2

Rapamune

PPrism Pharmaceuticals

Approved

2 3

Prograf

VVeloxis Pharmaceuticals

Approved

1 4

Imuran

LLegacy Health System

Approved

1 5

Farydak

Tarceva

Tylenol

Paraplatin

Dysport

1 10

Peridex

DDexcel Pharma Technologies Ltd.

Phase 3

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

Timeline

Expected Milestones

Q3 2027

PreclinicalActive, not recruiting

Moderate to Severe Upper Facial Lines

NCT04821089

Q1 2029

PreclinicalRecruiting

Spasticity

NCT04752774

Clinical

Trials by Indication[1]

Dystonia1 trial

Abobotulinum Toxin and Neubotulinum Toxin Injection in Cerivical Dystonia

Completed·DDepartment of Medical Services Ministry of Public Health of Thailand·Phase 3·NCT03805152·52 enrolled

Treatment1 trial

Assessment of Gait After Dysport Treatment

Completed·AAlbert Einstein Healthcare Network·Phase 4·NCT03501043·11 enrolled

Botulinum Toxin1 trial

Botulinum Toxin Injection for Functional Popliteal Artery Entrapment Syndrome

Withdrawn·SStanford University·Phase 2·NCT03631966

Randomized Controlled Trial1 trial

The Impact of Botulinum Toxin on Brow Height and Morphology: A Randomized Controlled Trial

Unknown status·SSt Joseph University, Beirut, Lebanon·Phase 4·NCT02942303·30 enrolled

Erythema1 trial

Mirvaso® Gel and Dysport® for Erythema and Flushing of Rosacea

Terminated·SSkin Laser & Surgery Specialists·N/A·NCT03508869·5 enrolled

8 more indications

Spastic Cerebral Palsy1 trial

Botulinum Toxin-A as a Treatment for Chronic Muscle-Related Pain in Adults With Spastic Cerebral Palsy: a Randomized Controlled Trial

Terminated·KKristina Tedroff·Phase 2·NCT02434549·16 enrolled

PrEP1 trial

Phase IV Study On Muscle Activity Of Two Commercial Preparations Of Botulinum

Completed·HHexsel Dermatology Clinic·Phase 4·NCT01728337·80 enrolled

Skin Cancer1 trial

Forehead Scars Following Mohs Micrographic Surgery and Reconstruction for Skin Cancer

Terminated·UUniversity Hospitals Cleveland Medical Center·Phase 4·NCT01459666·9 enrolled

Cervical Dystonia1 trial

A Study to Compare Dysport® and Botox® in the Treatment of Cervical Dystonia

Completed·SSeoul National University Hospital·Phase 4·NCT00950664·103 enrolled

Cerebral Palsy1 trial

Effect of Dysport Injections on Energy Expenditure and Walking Efficiency in Children With Cerebral Palsy

Completed·—·Phase 3·NCT03469999·12 enrolled

Moderate to Severe Upper Facial Lines1 trial

A Phase Ib/II, Multicentre, Double-blind, Randomised, Placebo-controlled, Dose Escalation and Dose-finding Study to Evaluate the Safety and Efficacy of IPN10200 in Improving the Appearance of Moderate to Severe Upper Facial Lines in Adults

Active, not recruiting· Ipsen logo

Ipsen·Preclinical·NCT04821089·727 enrolled

Spasticity1 trial

An Integrated Phase I/II, Multicentre, Double-blind, Randomised, Dysport and Placebo-controlled, Dose Escalation and Dose-finding Study to Evaluate the Safety and Efficacy of IPN10200 in the Treatment of Adult Upper Limb Spasticity.

Recruiting· Ipsen logo

Ipsen·Preclinical·NCT04752774·240 enrolled

Unspecified3 trials

Conversion to Dysport in CD

Unknown status·WWestern University, Canada·N/A·NCT04270214·33 enrolled

Brow Lifting With Dysport

Completed·KKenneth Beer·Phase 4·NCT01401803·24 enrolled

Upper Facial Remodeling With Perlane-L and Dysport

Completed·BBeer, Kenneth R., M.D., PA·Phase 4·NCT01354743·20 enrolled

Regulatory

FDA Approval Timeline[4]

Apr 29, 2009

DYSPORT

NDA BLA125274

Sep 27, 2010

DYSPORT

NDA BLA125274

May 22, 2012

DYSPORT

NDA BLA125274

Jul 15, 2015

DYSPORT

NDA BLA125274

Jul 29, 2016

DYSPORT

NDA BLA125274

Dec 9, 2016

DYSPORT

NDA BLA125274

Jun 14, 2017

DYSPORT

NDA BLA125274

Nov 5, 2018

DYSPORT

NDA BLA125274

Sep 25, 2019

DYSPORT

NDA BLA125274

Jul 8, 2020

DYSPORT

NDA BLA125274

Jan 12, 2023

DYSPORT

NDA BLA125274

Sep 21, 2023

DYSPORT

NDA BLA125274

Sources

References

[1]
ClinicalTrials.gov — 15 trial records for Dysport. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Dysport compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for Dysport. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (NDA BLA125274). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Ipsen company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Biologic[2]
Highest Phase: Approved[1]
Company: Ipsen

Dysport

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2027

Q1 2029

Trials by Indication[1]

Dystonia1 trial

Treatment1 trial

Botulinum Toxin1 trial

Randomized Controlled Trial1 trial

Erythema1 trial

Spastic Cerebral Palsy1 trial

PrEP1 trial

Skin Cancer1 trial

Cervical Dystonia1 trial

Cerebral Palsy1 trial

Moderate to Severe Upper Facial Lines1 trial

Spasticity1 trial

Unspecified3 trials

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

Related News