A Phase 3 study to compare ABP-450 (prabotulinumtoxinA) with BOTOX® (onabotulinumtoxinA) as the reference product

Status: Planning

Phase of Trial: Phase III

Latest Information Update: 19 Nov 2024

Price :

Note:

Adis is an information provider.
Final gross price and currency may vary according to local VAT and billing address.
Your purchase entitles you to full access to the information contained in our trial profile at the time of purchase.
A link to download a PDF version of the trial profile will be included in your email receipt.

Drugs Botulinum-Toxin-A (Primary)
Indications Blepharospasm; Facial wrinkles; Gastroparesis; Glabellar lines; Hypertrophy; Migraine; Muscle spasticity; Post-traumatic stress disorders; Torticollis
Focus Therapeutic Use

13 Nov 2024 According to AEON Biopharma media release, the company Actively planning primary comparative analytical studies to fulfill the standard regulatory requirements for a comparative analytical assessment (CAA), which are expected to commence in the fourth quarter of 2024, also company Plans to hold a Biosimilar Biological Product Development (BPD) Type 2 meeting with FDA in 2025 to discuss the outcome from these studies and determine the next steps in development.
08 Oct 2024 New trial record

If your organization or you do not have a subscription, try one of the following:

Contacting your organization’s admin about adding this content to your AdisInsight subscription
Buying a PDF version of any individual profile
Request a free trial

If your organization has a subscription, there are several access options, even while working remotely:

Working within your organization’s network
Login with username/password or try to access via your institution
Persisted access using your organization’s identifier stored in your user browser for 90 days

For assistance, contact us at asktheexpert.adisinsight@springer.com