XEOMIN

(IncobotulinumtoxinA)

Phase 3Small molecule

XEOMIN is a small molecule that works as a Synaptosomal Nerve-Associated Protein 25 (SNAP-25) Inhibitor.[2] It is being investigated across 30 indications, with its most advanced program in Phase 3.[1]

XEOMIN is one of 506 small molecule programs targeting Snoring. It is currently in Phase 3.

Indications

Total Trials

Active Trials

505

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

SnoringActive, not recruiting

Cervical DystoniaActive, not recruiting

Spastic Cerebral PalsyActive, not recruiting

Cerebral PalsyActive, not recruiting

Trigeminal NeuralgiaActive, not recruiting

SpasticityUnknown

StrokeActive, not recruiting

Peripheral NeuropathyActive, not recruiting

TremorActive, not recruiting

RosaceaActive, not recruiting

SnoringPhase 2

Active, not recruiting

Cervical DystoniaPhase 3

Active, not recruiting

Spastic Cerebral PalsyPhase 2

Active, not recruiting

Cerebral PalsyPhase 3

Active, not recruiting

Trigeminal NeuralgiaPhase 2

Active, not recruiting

SpasticityPreclinical

Unknown

StrokePhase 3

Active, not recruiting

Peripheral NeuropathyPhase 2

Active, not recruiting

TremorPhase 2

Active, not recruiting

RosaceaPhase 2

Active, not recruiting

Showing 10 of 28 indications

Competition

Competitive Landscape

560 competitors in Multiple Sclerosis

#DrugCompanyPhaseTrials

XEOMIN

MMerz Pharmaceuticals GmbH

Phase 3

37 2

Betaseron

Bayer

Preclinical

16 3

Kesimpta

Novartis

Preclinical

15 4

Tysabri

Biogen

Preclinical

14 5

Avonex

EMD Serono

Preclinical

22 6

Zinbryta

Roche

Preclinical

2 7

Flomax

Sanofi

Preclinical

1 8

Pred Forte

Myfortic

Novantrone

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

Timeline

Expected Milestones

Q3 2026

Phase 3Recruiting

Migraine

NCT05598723

Q4 2027

Phase 3Recruiting

Episodic Migraine

NCT07018700

Q1 2028

Phase 3Recruiting

Chronic Migraine

NCT07018713

Q3 2028

Phase 3Recruiting

Primary Dysmenorrhea

NCT06995287

Clinical

Trials by Indication[1]

Glabellar Frown Lines5 trials

The Treatment of Glabellar Frown Lines

Completed·MMerz North America, Inc.·Phase 4·NCT02096081·250 enrolled

Safety and Efficacy of NT 201 (IncobotulinumtoxinA [Xeomin]) in the Treatment of Glabellar Frown Lines

Completed·MMerz Pharmaceuticals GmbH·Phase 3·NCT00512135·801 enrolled

IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Glabellar Frown Lines

Completed·MMerz Pharmaceuticals GmbH·Phase 3·NCT00430963·256 enrolled

Show 2 more trials

IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Glabellar Frown Lines

Completed·MMerz Pharmaceuticals GmbH·Phase 3·NCT00770211·271 enrolled

IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Glabellar Frown Lines No. 2

Completed·MMerz Pharmaceuticals GmbH·Phase 3·NCT00770029·276 enrolled

Spasticity5 trials

Effect of Video Game-assisted and BoNT-A Injection Therapy on Spasticity, Activity and Participation in CP Patients

Unknown status·SSunnaas Rehabilitation Hospital·N/A·NCT04290169·25 enrolled

Efficacy and Safety Dose Titration Study of Botulinum Toxin Type A to Treat Spasticity in the Leg and Arm

Completed·MMerz Pharmaceuticals GmbH·Phase 3·NCT01603459·155 enrolled

Efficacy and Safety Study of Botulinum Toxin Type A Against Placebo to Treat Spasticity in the Arm After a Stroke

Completed·MMerz Pharmaceuticals GmbH·Phase 3·NCT01392300·317 enrolled

Show 2 more trials

Efficacy and Safety Study of Botulinum Toxin Type A Against Placebo to Treat Spasticity in the Leg After a Stroke

Completed·MMerz Pharmaceuticals GmbH·Phase 3·NCT01464307·290 enrolled

IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Post-stroke Spasticity of the Upper Limb

Completed·MMerz Pharmaceuticals GmbH·Phase 3·NCT00432666·148 enrolled

Cerebral Palsy3 trials

Dose-response Study of Efficacy and Safety of Botulinum Toxin Type A to Treat Spasticity of the Leg(s) in Cerebral Palsy

Completed·MMerz Pharmaceuticals GmbH·Phase 3·NCT01893411·311 enrolled

Long-term Open-label Study of Botulinumtoxin Type A to Treat Spasticity of Leg(s) or Leg(s) and Arm in Cerebral Palsy

Completed·MMerz Pharmaceuticals GmbH·Phase 3·NCT01905683·370 enrolled

Dose-response Study of Efficacy and Safety of Botulinum Toxin Type A to Treat Spasticity of the Arm(s) or of Arm(s) and Leg(s) in Cerebral Palsy

Completed·MMerz Pharmaceuticals GmbH·Phase 3·NCT02002884·351 enrolled

Tremor2 trials

Investigation of the Efficacy and Safety of IncobotulinumtoxinA (Xeomin) in Parkinson's Tremor: A Customized Approach

Completed·YYale University·Phase 2·NCT02419313·33 enrolled

Botulinum Toxin A to Treat Arm Tremor

Completed·MMerz Pharmaceuticals GmbH·Phase 2·NCT02207946·30 enrolled

Efficacy and Safety2 trials

Efficacy and Safety of NT 201 in the Treatment of Lateral Periorbital Wrinkles

Completed·MMerz Pharmaceuticals GmbH·Phase 3·NCT00541723·111 enrolled

Efficacy and Safety Study of Botulinum Toxin Type A Against Placebo to Treat Abnormal Contraction or Twitch of the Eyelid

Completed·MMerz Pharmaceuticals GmbH·Phase 3·NCT01896895·61 enrolled

19 more indications

Cancer Pain1 trial

IncobotulinumtoxinA for Treatment of Focal Cancer Pain After Surgery and/or Radiation

Terminated·YYale University·Phase 2·NCT01931865·12 enrolled

Restless Leg Syndrome1 trial

Investigation of Efficacy of incobotulinumtoxinA (Xeomin) in Relieving Symptoms of Restless Leg Syndrome.

Completed·YYale University·Phase 2·NCT01931878·24 enrolled

Trigeminal Neuralgia1 trial

Incobotulinum Toxin for the Treatment of Trigeminal Neuralgia

Terminated·TThomas Jefferson University·Phase 2·NCT02088632·6 enrolled

Glabellar Lines1 trial

Xeomin Treatment of Glabellar Lines Using OLD Versus COLD

Unknown status·CClinical Testing of Beverly Hills·Phase 1·NCT05305768·40 enrolled

Treatment1 trial

Comparison of Escalating Doses of IncobotulinumtoxinA (Xeomin®) in the Treatment of Glabellar Rhytids

Unknown status·TThe Maas Clinic·Phase 4·NCT01583478·15 enrolled

Injury1 trial

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

Completed·MMerz Therapeutics GmbH·Phase 2·NCT06091020·123 enrolled

Skin Quality1 trial

Effects of Microtox on Facial Skin Quality, Fine Wrinkles, and Texture

Completed·KKalpna Kay Durairaj, MD, FACS·Phase 1·NCT06604832·20 enrolled

Rosacea1 trial

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

Completed·DDeNova Research·Phase 2·NCT01614743·9 enrolled

Peripheral Neuropathy1 trial

Botulinum Toxin A for the Treatment of Chemotherapy Induced Peripheral Neuropathy

Unknown status·MMedical College of Wisconsin·Phase 2·NCT03571334·40 enrolled

Chronic Troublesome Sialorrhea1 trial

Clinical Study to Investigate the Efficacy and Safety of Two Dose Levels of NT 201 Versus Placebo in Treating Chronic Troublesome Sialorrhea in Various Neurological Conditions

Completed·MMerz Pharmaceuticals GmbH·Phase 3·NCT02091739·184 enrolled

Blepharospasm1 trial

IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Blepharospasm

Completed·MMerz Pharmaceuticals GmbH·Phase 3·NCT00406367·109 enrolled

Cervical Dystonia1 trial

IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Cervical Dystonia

Completed·MMerz Pharmaceuticals GmbH·Phase 3·NCT00407030·233 enrolled

Migraine1 trial

BOTOX® vs. XEOMIN® for Chronic Migraine

Recruiting·—·Phase 3·NCT05598723·128 enrolled

Snoring1 trial

Dose Finding Study for a Botulinum Toxin Type A Injection to Treat Habitual Snoring

Terminated·MMerz Pharmaceuticals GmbH·Phase 2·NCT01515371·8 enrolled

Concentration1 trial

A Study to Evaluate the Distribution of Botulinum Neurotoxin Type A Administered as Intradermal Injections, Comparing Different Doses, Concentrations, and Delivery Methods

Completed·MMerz Pharmaceuticals GmbH·Phase 1·NCT05585398·40 enrolled

Primary Dysmenorrhea1 trial

Evaluation of the Analgesic Effect of Intramyometrial Botulinum Toxin Injection Via Hysteroscopy in Pelvic Pain Suggestive of Dysmenorrhea: A Prospective, Multicenter, Double-Blind, Randomized Placebo-Controlled Study.

Recruiting·NNantes University Hospital·Phase 3·NCT06995287·222 enrolled

Chronic Migraine1 trial

A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter, Clinical Trial With Extension Period to Evaluate the Efficacy and Safety of Xeomin® Injections for the Prevention of Chronic Migraine

Recruiting·MMerz Therapeutics GmbH·Phase 3·NCT07018713·780 enrolled

Episodic Migraine1 trial

Recruiting·MMerz Therapeutics GmbH·Phase 3·NCT07018700·990 enrolled

Unspecified2 trials

Longitudinal Evaluation and Real-world Evidence of NT201

Terminated·MMerz North America, Inc.··NCT05222607·11 enrolled

Effects of Botulinum Neurotoxin Type A (BoNT/A) Free of Complexing Proteins in the Spastic Equinovarus Foot

Completed·PParc de Salut Mar·Phase 4·NCT03044080·20 enrolled

Regulatory

FDA Approval Timeline[4]

Jul 30, 2010

XEOMIN

BLA BLA125360

Sources

References

[1]
ClinicalTrials.gov — 37 trial records for IncobotulinumtoxinA. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — IncobotulinumtoxinA compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for IncobotulinumtoxinA. EMBL-EBI & Wellcome Sanger Institute.
[4]
OpenFDA — FDA approval records (BLA BLA125360). U.S. Food & Drug Administration.
[5]
SEC EDGAR — Merz Pharmaceuticals GmbH company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Synaptosomal Nerve-Associated Protein 25 (SNAP-25) Inhibitor[2]
Modality: Small molecule[2]
Highest Phase: Phase 3[1]
Company: MMerz Pharmaceuticals GmbH

XEOMIN

Status by Indication[3][1]

Competitive Landscape

Expected Milestones

Q3 2026

Q4 2027

Q1 2028

Q3 2028

Trials by Indication[1]

Glabellar Frown Lines5 trials

Spasticity5 trials

Cerebral Palsy3 trials

Tremor2 trials

Efficacy and Safety2 trials

Cancer Pain1 trial

Restless Leg Syndrome1 trial

Trigeminal Neuralgia1 trial

Glabellar Lines1 trial

Treatment1 trial

Injury1 trial

Skin Quality1 trial

Rosacea1 trial

Peripheral Neuropathy1 trial

Chronic Troublesome Sialorrhea1 trial

Blepharospasm1 trial

Cervical Dystonia1 trial

Migraine1 trial

Snoring1 trial

Concentration1 trial

Primary Dysmenorrhea1 trial

Chronic Migraine1 trial

Episodic Migraine1 trial

Unspecified2 trials

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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