Drugs / letibotulinumtoxinA

Trials 5 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 34 trials
Phase 3 NCT03985982 Apr → Dec 2019 Croma-Pharma GmbH Completed No outcome recorded
Phase 3 NCT05380154 May 2017 → Jan 2018 Hugel Completed No outcome recorded
Phase 3 NCT02677805 Mar → Sep 2016 Croma-Pharma GmbH Completed No outcome recorded
Phase 3 NCT02677298 Mar → Nov 2016 Croma-Pharma GmbH Completed No outcome recorded
Phase 41 trial
Phase 4 NCT07668375 Jan → Apr 2026 temporomandibular joint dysfunction syndrome PAEC General Hospital, Islamabad Completed No outcome recorded
Also used as a comparator or background therapy in 3 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 32 trials
Phase 3 NCT03408236 Comparator Jan → Dec 2018 Hugel Completed No outcome recorded
Phase 3 NCT01791920 Comparator Aug → Dec 2011 skin atrophy Hugel Completed No outcome recorded
Phase 41 trial
Phase 4 NCT07072806 Comparator Jun → Aug 2022 Yonsei University Completed No outcome recorded

Press releases naming this drug 1 release

DateIssuerRelease
2020-05-23 Ipsen New surveys show over 80% of patients with spasticity and cervical dystonia treated with botulinum toxin-A experience debilitating symptom recurrence ipsen.com

Evidence & citations 7 cited values

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

FieldValueCited text
Known as LetibotulinumtoxinA “BACKGROUND: Letibotulinum toxin A (LeBA) was approved by the Ministry of Food and Drug Safety (known as the Korea Food & Drug Administration) for cosmetic indications in 2012.” PMID 33721365 Apr 2021
3

LetibotulinumtoxinA Attenuates the Psychological Burden of Glabellar Lines and Is Associated With High Subject Satisfaction in Phase 3 Clinical Trials.” PMID 38470985 Mar 2024

NCT07072806

NCT07668375

Known as Botulax “Botulinum Toxin-A (Botulax - letibotulinumtoxinA)” NCT07668375
2

NCT05380154

NCT01791920

Known as Botulinum toxin type A Botulinum toxin type A(Botulax®)” NCT01791920
Known as Botulinum Toxin-A Botulinum Toxin-A (Botulax - letibotulinumtoxinA)” NCT07668375
Known as LeBA “BACKGROUND: Letibotulinum toxin A (LeBA) was approved by the Ministry of Food and Drug Safety (known as the Korea Food & Drug Administration) for cosmetic indications in 2012.” PMID 33721365 Apr 2021
Modality Protein / enzyme biologic “Botulinum toxin type A” NCT01791920
Route Intramuscular “20 Units will be administered (divided in five 0.1 mL i.m. injections) into the glabellar area.” NCT02677298