DYSPORT (abobotulinumtoxina)
DYSPORT is indicated for the treatment of Cervical dystonia in adults; Moderate to severe glabellar lines in adults less than 65 years of age; Spasticity in patients 2 years of age and older.
How DYSPORT Works
This agent works by preventing the release of the neurotransmitter acetylcholine from peripheral cholinergic nerve endings. The toxin binds to specific surface receptors on nerve endings and is internalized, where it cleaves the SNAP25 protein to block the exocytosis of neurotransmitters into the neuromuscular junction. This process results in a localized reduction of muscle activity. Neuromuscular transmission gradually recovers as the junction repairs the cleaved proteins and new nerve endings are established.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2009-04-29
- Patent Cliff
- 2023
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
DYSPORT Approval History
What DYSPORT Treats
3 indicationsDYSPORT is approved for 3 conditions since its original approval in 2009. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Cervical dystonia in adults
- Moderate to severe glabellar lines in adults less than 65 years of age
- Spasticity in patients 2 years of age and older
DYSPORT Boxed Warning
DISTANT SPREAD OF TOXIN EFFECT Postmarketing reports indicate that the effects of DYSPORT and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence and breathing difficulties. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties ...
WARNING: DISTANT SPREAD OF TOXIN EFFECT Postmarketing reports indicate that the effects of DYSPORT and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia, blurred vision, ptosis, dysphagia, dysphonia, dysarthria, urinary incontinence and breathing difficulties. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity but symptoms can also occur in adults treated for spasticity and other conditions, particularly in those patients who have underlying conditions that would predispose them to these symptoms. In unapproved uses and in approved indications, cases of spread of effect have been reported at doses comparable to or lower than the maximum recommended total dose [ see Warnings and Precautions (5.1) ]. WARNING: DISTANT SPREAD OF TOXIN EFFECT See full prescribing information for complete boxed warning The effects of DYSPORT and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These symptoms have been reported hours to weeks after injection. Swallowing and breathing difficulties can be life-threatening and there have been reports of death. The risk of symptoms is probably greatest in children treated for spasticity but symptoms can occur in adults, particularly in those patients who have underlying conditions that would predispose them to these symptoms. ( 5.1 )
DYSPORT Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Clinical Trial Registry
15 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT04752774 LANTIMA | D-FR-10200-001 2020-003623-42 | Ph 1, Ph 2 | recruiting | A Study to Assess the Safety and Efficacy of IPN10200 in Adult Participants With Upper Limb Spasticity. |
| NCT04821089 LANTIC | D-FR-10200-002 2024-512782-14-00 | Ph 1, Ph 2 | active not recruiting | A Study to Assess the Safety and Efficacy of IPN10200 in Adult Participants With Moderate to Severe Upper Facial Lines |
| NCT03935295 | IRB00110399 | Ph 4 | recruiting | Dysport ® as an Adjunctive Treatment to Bracing in the Management of Adolescent Idiopathic Scoliosis |
| NCT05466539 CECS | STUDY00003790 | Ph 4 | completed | Chronic Exertional Compartment Syndrome (CECS) Treated With Abobotulinumtoxin A |
| NCT03687736 DREAM results posted | 43USD1802 | Ph 4 | completed | Subject Satisfaction With AbobutulinumtoxinA Treatment |
| NCT03960957 results posted | 43USD1805 | Ph 3 | completed | Efficacy and Safety of a New Dilution and Injection Volume of AbobotulinumtoxinA for the Treatment of Glabellar Lines |
| NCT04470401 dolomtox | Eduardo Rocha | Ph 4 | completed | The Treatment of Shoulder Pain in Hemiplegic Spastic Patients With Botulinum Toxin A |
| NCT03639766 results posted | BIO-18-14092 | Ph 4 | terminated | The Effect of Abobotulinum Toxin A on the Symptoms of Raynaud's Phenomenon |
| NCT03631966 | 40251 | Ph 2 | withdrawn | Botulinum Toxin Injection for Functional Popliteal Artery Entrapment Syndrome |
| NCT03501043 results posted | 5075 | Ph 4 | completed | Assessment of Gait After Dysport Treatment |
| NCT01728337 results posted | 12-2012 | Ph 4 | completed | Phase IV Study On Muscle Activity Of Two Commercial Preparations Of Botulinum |
| NCT03928496 | Zirovich0002 | Ph 4 | completed | Abobotulinumtoxina Efficacy in Post-Traumatic Headache |
| NCT02907268 results posted | ICLS-06-2013 | Ph 2 | completed | Botulinum Toxin A Single Blind Split-Face Randomized Pilot Study |
| NCT01354743 DPL-2010 | DysportPerlaneL-2010 | Ph 4 | completed | Upper Facial Remodeling With Perlane-L and Dysport |
| NCT01401803 | BrowDysport2011 | Ph 4 | completed | Brow Lifting With Dysport |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
DYSPORT FDA Label Details
Indications & Usage
FDA Label (PDF)DYSPORT is indicated for the treatment of Cervical dystonia in adults; Moderate to severe glabellar lines in adults less than 65 years of age; Spasticity in patients 2 years of age and older.
WARNING: DISTANT SPREAD OF TOXIN EFFECT Postmarketing reports indicate that the effects of DYSPORT and all botulinum toxin products may spread from the area of injection to produce symptoms consistent with botulinum toxin effects. These may include asthenia, generalized muscle weakness, diplopia, bl...
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment