drugset
Drugs / Botulinic toxin
last change Aug 2026 re-read 9 days ago

Botulinic toxin

also known as Botox
Developed for
clubfoot · epidermolysis bullosa simplex
Investigated by
Allergan · University Hospital, Limoges · University Hospital, Toulouse

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Filed masticatory muscles, hypertrophy of 1 milestone
Filed US (FDA) BOTOX® Cosmetic masticatory muscles, hypertrophy of 2026-08-04

“today announced the U.S. Food and Drug Administration (FDA) has accepted for review its supplemental Biologics License Application (sBLA) for BOTOX® Cosmetic” abbvie.com ↗
Filed spastic ataxia 1 milestone
Filed US (FDA) BOTOX® spastic ataxia 2019-03-07

“Additionally, the FDA is reviewing Allergan's sBLA for the use of BOTOX® to treat pediatric patients with lower limb spasticity” abbvie.com ↗

“The FDA is also reviewing an additional sBLA for the use of BOTOX® to treat pediatric patients with lower limb spasticity” abbvie.com ↗

“FDA has accepted the company's supplemental biologics license applications (sBLAs) to expand the BOTOX®” abbvie.com ↗

Trials 2

today NCT03453632 · Ph 2/3 NCT00199589 · not/applicable
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 2/31 trial
Phase 2/3 NCT03453632 Jun 2018 → Jan 2025 epidermolysis bullosa simplex University Hospital, Toulouse Completed No outcome recorded
Phase not applicable1 trial
— NCT00199589 Oct 2002 → Dec 2007 clubfoot University Hospital, Limoges Completed No outcome recorded

News releases announcing trial results or a regulatory action · 7

DateIssuerRelease
2026-08-04 AbbVie Regulatory Allergan Aesthetics Announces U.S. FDA Acceptance of Supplemental Biologics License Application for BOTOX® Cosmetic for Masseter Muscle Prominence abbvie.com ↗
2026-03-26 AbbVie Results Allergan Aesthetics Reinforces Scientific Differentiation and Leadership with 21 Evidence-Based E-Posters at the 2026 Aesthetic & Anti-Aging Medicine World Congress (AMWC) abbvie.com ↗
2024-10-18 AbbVie Regulatory BOTOX® Cosmetic (onabotulinumtoxinA) Receives FDA Approval for Moderate to Severe Vertical Bands Connecting the Jaw and Neck (Platysma Bands) abbvie.com ↗
Today, Allergan Aesthetics, an AbbVie company (NYSE: ABBV), announced the U.S. FDA approval of BOTOX ® Cosmetic for temporary improvement in the appearance of moderate to severe vertical bands connecting the jaw and neck (platysma bands) in adults.
2023-09-18 AbbVie Results Allergan Aesthetics Announces Positive Topline Results from Second Phase 3 Study of OnabotulinumtoxinA (BOTOX® Cosmetic) for the Treatment of Platysma Prominence abbvie.com ↗
All primary and secondary endpoints were met for second Phase 3 study (M21-310) and results were consistent with findings from first Phase 3 study (M21-309).
2020-07-09 AbbVie Regulatory FDA Approves Expanded BOTOX® (onabotulinumtoxinA) Label for the Treatment of Pediatric Patients with Spasticity abbvie.com ↗
2018-09-14 AbbVie Results Allergan Highlights Key Growth Drivers for Medical Aesthetics abbvie.com ↗
The study met its primary endpoint confirming long-held belief that higher doses of botulinum toxin produce greater duration of treatment effect.
2018-09-14 AbbVie Results Allergan Announces Results of Higher Dose BOTOX® Cosmetic (onabotulinumtoxinA) for the Treatment of Moderate to Severe Glabellar Lines abbvie.com ↗
Allergan plc (NYSE: AGN) today announced clinical study results of higher doses of BOTOX® Cosmetic compared to BOTOX® Cosmetic 20 unit dose at week 24 in patients with moderate to severe glabellar lines.

All press releases naming this drug 38 releases

DateIssuerRelease

Evidence & citations 3 cited values

Every value below carries the sentence it was read from. 2 sources stand behind the page.

FieldValueCited text
Known as Botulinic toxin ClinicalTrials.gov intervention name — accepted as the source's own label NCT00199589 ↗
1

NCT03453632 ↗
Known as Botox “Botulinic toxin (Botox)” NCT00199589 ↗
Route Intramuscular “intramuscular injections of botulinum toxin” NCT00199589 ↗