Incobotulinumtoxin A is under clinical development by Merz Pharma GmbH & Co and currently in Phase III for Lower Limb Muscle Spasticity. According to GlobalData, Phase III drugs for Lower Limb Muscle Spasticity have a 100% phase transition success rate (PTSR) indication benchmark for progressing into Pre-Registration. GlobalData’s report assesses how Incobotulinumtoxin A’s drug-specific PTSR and Likelihood of Approval (LoA) scores compare to the indication benchmarks. Buy the report here.

GlobalData tracks drug-specific phase transition and likelihood of approval scores, in addition to indication benchmarks based off 18 years of historical drug development data. Attributes of the drug, company and its clinical trials play a fundamental role in drug-specific PTSR and likelihood of approval.

Incobotulinumtoxin A overview

Incobotulinumtoxin A (Xeomin/Xeomeen/Bocouture) belongs to musculoskeletal system agent. Incobotulinumtoxin A the active ingredient in the formulation is botulinum toxin type A produced from fermentation of Hall strain. It is formulated as lyophilized powder for solution for intramuscular route of administration. Incobotulinumtoxin A is indicated for the treatment of adults with cervical dystonia to decrease the severity of abnormal head position and neck pain in both botulinum toxin-naïve and previously treated patients and for the treatment of adults with blepharospasm who were previously treated with onabotulinumtoxinA (Botox). It is indicated for the treatment of upper limb spasticity and also indicated for the treatment of upper limb spasticity in pediatric patients 2 to 17 years of age, excluding spasticity caused by cerebral palsy. 

It is under development for the treatment of prevention of hypersalivation, atrial fibrillation (AF) after cardiac surgery, lateral epicondylitis, essential tremor of the upper limb, upper limb spasticity, hemifacial spasm and lower limb spasticity. The drug candidate is also under development for the treatment of degenerative rotator cuff disease and androgenic alopecia. The drug candidate was also under development for treatment of snoring, notalgia paresthetica, brachial plexus neuritis, rosacea, focal cancer pain, foot dystonia in parkinson disease, trigeminal neuralgia, restless leg syndrome and spastic equine and equinovarus foot deformation in pediatric cerebral palsy and paratonic rigidity in people with advanced cognitive impairment. It is administered through intramuscular, intradermal and subcutaneous routes.

Merz Pharma GmbH & Co overview

Merz Pharma GmbH & Co (Merz) develops aesthetics for body and skin care and neurotoxins to treat neurological diseases. The company operates through aesthetics, therapeutics and consumer care divisions. It offers dermal fillers, skin tightening and lifting devices, ointments, tablets, injectables and nutritional supplements. Merz is also investigating therapies to treat adult lower-limb spasticity, sialorrhea, pediatric spasticity associated with cerebral palsy and other neurological diseases. The company has operations in Asia Pacific, Europe, the Middle East, North and Latin America. Merz is headquartered in Frankfurt, Hesse, Germany

For a complete picture of Incobotulinumtoxin A’s drug-specific PTSR and LoA scores, buy the report here.


GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in its clinical pathway (PTSR), as well as how likely the drug will be approved (LoA). This is based on a proprietary algorithm built from the drugs’ sales forecast, regulatory milestones, cost forecasts, WACC rate and other proprietary data sources found on GlobalData’s Pharmaceutical Intelligence Center.