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 5 indications, with its most advanced program in Phase 3.[1]

XEOMIN is one of 129 small molecule programs targeting Erectile Dysfunction. It is currently in Phase 3.

Indications

Total Trials

Active Trials

128

Competitors

FDA Application

NDA/BLA/ANDA regulatory filings

Pipeline

Status by Indication[3][1]

Indication

Erectile DysfunctionNot yet recruiting

Cervical CancerUnknown

Multiple SclerosisActive, not recruiting

Chronic MigraineRecruiting

Primary DysmenorrheaRecruiting

Erectile DysfunctionPhase 2

Not yet recruiting

Cervical CancerPreclinical

Unknown

Multiple SclerosisPreclinical

Active, not recruiting

Chronic MigrainePhase 3

Recruiting

Primary DysmenorrheaPhase 3

Recruiting

Competition

Competitive Landscape

138 competitors in Multiple Sclerosis

#DrugCompanyPhaseTrials

XEOMIN

MMerz Pharmaceuticals GmbH

Phase 3

38 2

Cytoxan

BBaxter Healthcare Corporation

Phase 3

9 3

Questran

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Phase 3

2 4

Versed

CConrado Roberto Hoffmann Filho

Phase 3

2 5

Clemastine Fumarate

Novartis

Phase 3

2 6

Mayzent

Novartis

Phase 3

2 7

Antihistamine

Arrowhead Pharmaceuticals

Phase 3

2 8

Recombinant Zoster Vaccine

MMAXVAX Biotechnology Limited Liability Company

Phase 3

1 9

MRI Contrast-Enhancing Agents

Sanofi

Phase 3

3 10

Frexalimab

Sanofi

Phase 3

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

Timeline

Expected Milestones

Q3 2027

Phase 3Recruiting

Chronic Migraine

NCT05598723

Phase 3Active, not recruiting

Episodic Migraine

NCT07018700

Phase 3Active, not recruiting

Chronic Migraine

NCT07018713

Q3 2028

Phase 2Not yet recruiting

Erectile Dysfunction

NCT07537855

Phase 3Recruiting

Primary Dysmenorrhea

NCT06995287

Clinical

Trials by Indication[1]

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

Glabellar Frown Lines5 trials

The Treatment of Glabellar Frown Lines

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

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

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

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

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

Show 2 more trials

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

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

Cerebral Palsy3 trials

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

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

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

Chronic Migraine2 trials

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

Active, not recruiting·MMerz Therapeutics GmbH·Phase 3·NCT07018713·808 enrolled

A Randomized, Double-Blind Study on the Effect of OnabotulinumtoxinA (BOTOX®) vs. IncobotulinumtoxinA (XEOMIN®) Botulinum Toxin in Adults With Chronic Migraine

Recruiting·NNaval Medical Center Camp Lejeune·Phase 3·NCT05598723·128 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

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

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

Cancer Pain1 trial

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

Terminated·YYale University·Phase 2·NCT01931865·12 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

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

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

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

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

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

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

Episodic Migraine1 trial

Active, not recruiting·MMerz Therapeutics GmbH·Phase 3·NCT07018700·997 enrolled

Erectile Dysfunction1 trial

Clinical Efficacy of Intracavernosal Xeomin as an Adjunctive Therapy to on Demand Tadalafil 20 mg for the Treatment of Mild to Moderate Erectile Dysfunction: A Randomized Crossover Pilot Study

Not yet recruiting·NNorthwestern University·Phase 2·NCT07537855·30 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

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 — 38 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 2027

Q3 2028

Trials by Indication[1]

Spasticity5 trials

Glabellar Frown Lines5 trials

Cerebral Palsy3 trials

Tremor2 trials

Efficacy and Safety2 trials

Chronic Migraine2 trials

Injury1 trial

Treatment1 trial

Restless Leg Syndrome1 trial

Cancer Pain1 trial

Snoring1 trial

Skin Quality1 trial

Rosacea1 trial

Concentration1 trial

Trigeminal Neuralgia1 trial

Glabellar Lines1 trial

Peripheral Neuropathy1 trial

Blepharospasm1 trial

Cervical Dystonia1 trial

Chronic Troublesome Sialorrhea1 trial

Episodic Migraine1 trial

Erectile Dysfunction1 trial

Primary Dysmenorrhea1 trial

Unspecified2 trials

FDA Approval Timeline[4]

References

Drug Info

Quick Facts

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