Trial Profile

BOTOX® (onabotulinumtoxinA) for the Reduction of Masseter Muscle Prominence: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study

Status: Completed

Phase of Trial: Phase III

Latest Information Update: 10 Aug 2026

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At a glance

Drugs Botulinum Toxin A (Primary)
Indications Hypertrophy
Focus Adverse reactions; Registrational; Therapeutic Use
Acronyms MMP US P3 417
Sponsors AbbVie

Most Recent Events

04 Aug 2026 According to an AbbVie media release, the U.S. Food and Drug Administration (FDA) has accepted for review its supplemental Biologics License Application (sBLA) for BOTOX,which is is supported by two Phase 3 clinical studies (M21-416 and M21-417).
17 Nov 2025 Status changed from active, no longer recruiting to completed.
12 Aug 2025 Planned End Date changed from 1 Jan 2026 to 1 Nov 2025.

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