Drugs / GSK1358820
last change May 2026 re-read 3 minutes ago

GSK1358820

also known as BOTOX · Botulinum Toxin Type A

Protein / enzyme biologic

Developed for
overactive bladder · stroke disorder · isolated hyperchlorhidrosis · strabismus
Investigated by
GlaxoSmithKline

Trials 3

201020112012201320142015201620172018201920202021202220232024202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 33 trials · 3 met primary
Phase 3 NCT02849418 Oct 2016 → Mar 2018 overactive bladder GlaxoSmithKline Completed Met primary
Phase 3 NCT02820844 Aug 2016 → Mar 2018 overactive bladder GlaxoSmithKline Completed Met primary
Phase 3 NCT01153815 Apr 2010 → Jun 2011 stroke disorder GlaxoSmithKline Completed Met primary
Comparator or background therapy4 trials
Phase 3 NCT01584843 Comparator May 2012 → Jul 2013 strabismus GlaxoSmithKline Completed No outcome recorded
Phase 3 NCT01128738 Comparator Apr 2010 → Aug 2011 isolated hyperchlorhidrosis GlaxoSmithKline Completed No outcome recorded
Phase 3 NCT00460655 Comparator May 2007 → Dec 2008 stroke disorder GlaxoSmithKline Completed No outcome recorded
Phase 3 NCT00460564 Comparator May 2007 → Dec 2008 stroke disorder GlaxoSmithKline Completed No outcome recorded

News releases announcing trial results or a regulatory action · 2

DateIssuerRelease
2022-03-29 AbbVie Results AbbVie to Showcase Breadth of Neuroscience Portfolio and Pipeline at American Academy of Neurology (AAN) 2022 Annual Meeting abbvie.com ↗
Neutralizing Antibody Conversion with OnabotulinumtoxinA from Global Studies Across Multiple Indications in nearly 30,000 Patient Records: A Meta-Analysis
2021-02-10 AbbVie Regulatory BOTOX® (onabotulinumtoxinA) Receives FDA Approval for Pediatric Detrusor Overactivity Associated with a Neurologic Condition abbvie.com ↗

All press releases naming this drug 13 releases

DateIssuerRelease

Evidence & citations 5 cited values

Every value below carries the sentence it was read from. 7 sources stand behind the page.

FieldValueCited text
Known as GSK1358820 ClinicalTrials.gov intervention name — accepted as the source's own label NCT01584843 ↗
6

NCT01153815 ↗

NCT00460655 ↗

NCT01128738 ↗

NCT02820844 ↗

NCT00460564 ↗

NCT02849418 ↗

Known as BOTOX “GSK1358820 (hereinafter, referred to as BOTOX®)” NCT01128738 ↗
Known as Botulinum Toxin Type A “A Phase III Study to Evaluate the Efficacy and Safety of GSK1358820 (Botulinum Toxin Type A) in Patients With Overactive Bladder” NCT02820844 ↗
Modality Protein / enzyme biologic “Botulinum Toxin Type A” NCT01153815 ↗
Route Other “as intradermal injections” NCT01128738 ↗