Incobotulinumtoxin A is under clinical development by Merz Pharma GmbH & Co and currently in the Phase II and Phase III in clinical pathway. The characteristics of the clinical trial as well as other attributes related to the drug, regulations, and company play a fundamental role in ensuring the likelihood of transition that the drug moves from its current development stage to next.

According to GlobalData, the latest event to affect Incobotulinumtoxin A’s likelihood of approval (LoA) and phase transition for Lower Limb Muscle Spasticity took place on 24 Jun 2021, which increased the likelihood that the drug progresses to the next phase in its clinical pathway and increased the likelihood of final approval for this indication.

GlobalData uses proprietary data and analytics to provide a complete picture of this assessment in their Incobotulinumtoxin A Likelihood of Approval (LoA) and Phase Transition Success Rate (PTSR) Report.

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 and subcutaneous routes.

Hemifacial Spasm

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.

Quick View Incobotulinumtoxin A LOA Data

Report Segments
  • Innovator (NME)
Drug Name
  • Incobotulinumtoxin A
Administration Pathway
  • Intramuscular
  • Parenteral
  • Subcutaneous
Therapeutic Areas
  • Cardiovascular
  • Central Nervous System
  • Dermatology
  • Mouth and Dental Disorders
  • Musculoskeletal Disorders
  • Ophthalmology
  • Respiratory
Key Developers
  • Sponsor Company: Merz Pharma GmbH & Co
  • Originator: BIOTECON Therapeutics
Highest Development Stage
  • Marketed

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.