Onabotulinumtoxin A is under clinical development by AbbVie and currently in Phase II for Essential Tremor. According to GlobalData, Phase II drugs for Essential Tremor does not have sufficient historical data to build an indication benchmark PTSR for Phase II. GlobalData uses proprietary data and analytics to create drugs-specific PTSR and LoA in the Onabotulinumtoxin A LoA Report. 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.

Onabotulinumtoxin A overview

Onabotulinumtoxin A (Botox / Vistabel) is a sterile, vacuum-dried purified botulinum toxin type A, produced from fermentation of Hall strain Clostridium botulinum type A. It is formulated as injectable powder solution for intramuscular, transdermal, subcutaneous and intradermal route of administration. Botox is indicated for cervical dystonia, chronic migraine, axillary hyperhidrosis, blepharospasm, strabismus, blepharospasm, muscle spasm, overactive bladder, and urinary incontinence. It is also indicated for focal spasticity, including the treatment of spasticity in ambulant paediatric cerebral palsy patients, wrist and hand disability due to upper limb spasticity and ankle disability due to lower limb spasticity associated with stroke, for the treatment of upper limb spasticity in pediatric patients 2 to 17 years of age.

Botox is under development for the for the treatment of interstitial cystitis/bladder pain syndrome (IC/BPS), cold intolerance secondary to digital amputations and replantations, stress urinary incontinence (SUI), spasticity in pediatric patients 2 years of age and older, including those with lower limb spasticity caused by cerebral palsy, pediatric lower limb spasticity, bilateral masseter muscle hypertrophy (MMH), complex regional pain syndrome, hypertrophic scarring, pediatric patients with neurogenic detrusor overactivity (overactive bladder), essential tremor, episodic migraine prophylaxis, hernia and dentoalveolar neuropathic pain.

It was also under development for the treatment of non-relaxing puborectalis syndrome, benign prostatic hyperplasia, premature ejaculation, neuropathic pain, chronic prostatitis, chronic orchialgia, osteoarthritis pain, major depressive disorder, migraine, carpal tunnel syndrome, scleroderma-associated Raynaud's syndrome, trigeminal neuralgia, severe myofascial pelvic pain, overactive bladder with urinary incontinence due to neurogenic detrusor overactivity and pruritus.

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

This content was updated on 2 September 2023

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GlobalData’s Likelihood of Approval analytics tool dynamically assesses and predicts how likely a drug will move to the next stage in clinical development (PTSR), as well as how likely the drug will be approved (LoA). This is based on a combination of machine learning and a proprietary algorithm to process data points from various databases found on GlobalData’s Pharmaceutical Intelligence Center.