Drugs / letibotulinumtoxinA
letibotulinumtoxinA
Trials 5
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| 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 |
| Comparator or background therapy3 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 4 | NCT07072806 Comparator | Jun → Aug 2022 | — | Yonsei University | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2025-06-18 | Croma-Pharma GmbH | Results LetibotulinumtoxinA (Letybo®) demonstrates significantly smaller diffusion characteristics compared to other neuromodulators cromapharma.com ↗
A new study on diffusion characteristics of letibotulinumtoxinA, onabotulinumtoxinA and abobotulinumtoxinA and its impact on muscle relaxation demonstrates significantly smaller diffusion with letibotulinumtoxinA compared to other neuromodulators. |
| 2024-03-04 | Croma-Pharma GmbH | Results Further clinical data confirms the safety and efficacy of letibotulinumtoxinA cromapharma.com ↗
97,7% of females aged between 35-50 presented with a glabellar line severity (GLS ) improvement of >1 at week 4, this is compared to 95,0% among the remaining female population receiving active treatment.+,2 |
| 2024-02-29 | Croma-Pharma GmbH | Regulatory Letybo® receives FDA Approval for the treatment of glabellar lines cromapharma.com ↗
Croma-Pharma announced today that Hugel, Korean toxin manufacturer and partner of Croma, has received approval of the U.S. Food and Drug Administration (FDA) for Letybo® (letibotulinumtoxinA), the company’s botulinum toxin product. |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-06-18 | Croma-Pharma GmbH | LetibotulinumtoxinA (Letybo®) demonstrates significantly smaller diffusion characteristics compared to other neuromodulators cromapharma.com ↗ |
| 2024-03-04 | Croma-Pharma GmbH | Further clinical data confirms the safety and efficacy of letibotulinumtoxinA cromapharma.com ↗ |
| 2024-02-29 | Croma-Pharma GmbH | Letybo® receives FDA Approval for the treatment of glabellar lines cromapharma.com ↗ |
| 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.
| Field | Value | Cited text |
|---|---|---|
| Known as | Letibotulinum toxin A | “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 20213“LetibotulinumtoxinA Attenuates the Psychological Burden of Glabellar Lines and Is Associated With High Subject Satisfaction in Phase 3 Clinical Trials.” PMID 38470985 ↗ Mar 2024 |
| Known as | Botulax | “Botulinum Toxin-A (Botulax - letibotulinumtoxinA)” NCT07668375 ↗ |
| 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 ↗ |