Xeomin (incobotulinumtoxina)
Xeomin is indicated for the treatment of Chronic Sialorrhea; Upper Limb Spasticity; Cervical Dystonia; Blepharospasm; Glabellar Lines; Horizontal Forehead Lines; Lateral Canthal Lines.
How Xeomin Works
Xeomin blocks cholinergic transmission at neuromuscular and salivary neuroglandular junctions by inhibiting the release of the neurotransmitter acetylcholine. The neurotoxin binds to cholinergic nerve terminals and enters the cell, where it enzymatically cleaves SNAP25, a protein essential for acetylcholine release. By preventing this release, the drug inhibits muscle contraction and glandular secretion until impulse transmission is re-established through the formation of new nerve endings.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2010-07-30
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
Xeomin Approval History
What Xeomin Treats
7 indicationsXeomin is approved for 7 conditions since its original approval in 2010. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Chronic Sialorrhea
- Upper Limb Spasticity
- Cervical Dystonia
- Blepharospasm
- Glabellar Lines
- Horizontal Forehead Lines
- Lateral Canthal Lines
Xeomin Boxed Warning
DISTANT SPREAD OF TOXIN EFFECT Postmarketing reports indicate that the effects of XEOMIN 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 c...
WARNING: DISTANT SPREAD OF TOXIN EFFECT Postmarketing reports indicate that the effects of XEOMIN 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, including lower limb spasticity in children, and in approved indications, cases of spread of effect have been reported at doses comparable to those used to treat cervical dystonia and at lower doses [see Warnings and Precautions (5.1) ] . WARNING: DISTANT SPREAD OF TOXIN EFFECT See full prescribing information for complete boxed warning. The effects of XEOMIN 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 also occur in adults, particularly in those patients who have underlying conditions that would predispose them to these symptoms. ( 5.1 )
Xeomin 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.
Drugs Similar to Xeomin
3 of 6FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
21 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT07018713 MINT-C | M602011084 2024-515682-34-00 | Ph 3 | recruiting | A Clinical Trial to Evaluate Efficacy and Safety of Xeomin® Injections for Preventing Chronic Migraine |
| NCT07018700 MINT-E | M602011085 2024-515715-22-00 | Ph 3 | recruiting | A Clinical Trial to Evaluate Efficacy and Safety of Xeomin® Injections for Preventing Episodic Migraine |
| NCT06091020 PaiNT | M602011079 2022-501461-52-00 | Ph 2 | completed | A Clinical Trial to Investigate Efficacy and Safety of NT 201 Injections Compared With Placebo Injections in Participants Aged 18 Years and Older With Chronic Nerve Pain After Shingles or Nerve Injury |
| NCT03977493 | NSI-BTX-001 | Ph 3 | recruiting | IncobotulinumtoxinA (Xeomin) to Treat Focal Hand Dystonia |
| NCT06995287 HYSTEROXINE | RC24_0428 2025-520638-53-00 | Ph 3 | recruiting | Evaluation of the Analgesic Effect of Intramyometrial Botulinum Toxin Injection Via Hysteroscopy in Severe Primary Dysmenorrhea |
| NCT06604832 | KDEJ24 | Ph 1 | completed | Effects of Microtox on Facial Skin Quality, Fine Wrinkles, and Texture |
| NCT02088632 results posted | XEO/SDS/01 | Ph 2 | terminated | Incobotulinum Toxin for the Treatment of Trigeminal Neuralgia |
| NCT05585398 | M602011074 2021-005901-29 | Ph 1 | completed | A Study to Evaluate the Distribution of Botulinum Neurotoxin Type A Administered as Intradermal Injections, Comparing Different Doses, Concentrations, and Delivery Methods |
| NCT02207946 results posted | MRZ60201_2094_1 | Ph 2 | completed | Botulinum Toxin A to Treat Arm Tremor |
| NCT01614743 results posted | ROS-INC-12 | Ph 2 | completed | A Double-Blinded, Randomized Placebo Controlled Pilot Study Comparing the Efficacy and Safety of IncobotulinumtoxinA Versus Saline Injections to the Cheek Region in Patients With Rosacea |
| NCT01728337 results posted | 12-2012 | Ph 4 | completed | Phase IV Study On Muscle Activity Of Two Commercial Preparations Of Botulinum |
| NCT03044080 | PSM/RHB/NR22 | Ph 4 | completed | Effects of Botulinum Neurotoxin Type A (BoNT/A) Free of Complexing Proteins in the Spastic Equinovarus Foot |
| NCT02096081 results posted | MUS 60201_4096_1 | Ph 4 | completed | The Treatment of Glabellar Frown Lines |
| NCT01603459 results posted | MRZ60201_3053_1 2010-020886-26 | Ph 3 | completed | Efficacy and Safety Dose Titration Study of Botulinum Toxin Type A to Treat Spasticity in the Leg and Arm |
| NCT02188277 XEBEC | MRZ-R-201212_01001_N_2 | Ph 2 | completed | Treatment With Xeomin Versus Botox in Children With Spastic Equine and Equinovarus Foot Deformation in Pediatric Cerebral Palsy |
| NCT01678001 Xeomin | MRZ IIT - 2011 - 009 | Ph 4 | completed | Treatment of Plantar Fasciitis With Xeomin |
| NCT01931878 results posted | 1206010332 | Ph 2 | completed | Investigation of Efficacy of incobotulinumtoxinA (Xeomin) in Relieving Symptoms of Restless Leg Syndrome. |
| NCT02419313 results posted | 1206010370 | Ph 2 | completed | Investigation of the Efficacy and Safety of IncobotulinumtoxinA (Xeomin) in Parkinson's Tremor: A Customized Approach |
| NCT01931865 results posted | 1205010328 | Ph 2 | terminated | IncobotulinumtoxinA for Treatment of Focal Cancer Pain After Surgery and/or Radiation |
| NCT01515371 | MRZ 60201-2069-1 2011-001779-38 | Ph 2 | terminated | Dose Finding Study for a Botulinum Toxin Type A Injection to Treat Habitual Snoring |
| NCT01098019 | Inno-6014 | Ph 3 | completed | Treatment of Notalgia Paresthetica With Xeomin |
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.
Xeomin FDA Label Details
Indications & Usage
FDA Label (PDF)Xeomin is indicated for the treatment of Chronic Sialorrhea; Upper Limb Spasticity; Cervical Dystonia; Blepharospasm; Glabellar Lines; Horizontal Forehead Lines; Lateral Canthal Lines.
WARNING: DISTANT SPREAD OF TOXIN EFFECT Postmarketing reports indicate that the effects of XEOMIN 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, blu...
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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