Letibotulinumtoxina
As of the edition of 20 October 2026, Letibotulinumtoxina is a drug: marketed, first approved in 2022 (CA); acts on SNAP25; US protection ends in 2036.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2024
- Kind
- Unknown
- Brand name
- Letybo
- First approved
- 14 June 2022 (CA)
- Approvals on record
- 4 in 2 regions
- Holder of the most recent approval
- Hugel
- Registered trials
- 6, 0 stopped early
- Disease areas
- Bones, joints and muscles; Heart and blood vessels; Nervous system
US protection
US protection ends in 2036.
US protection ends in 2036, computed as 12 years from the first US licence because FDA publishes no date for this product. The application that gives this date is held by Hugel. The date is computed, not published.
This is the US only, and it is not the date generics or biosimilars can enter.
The exact date and the listings behind it
In the product1 listing counts towards this date. The exact date and each listing are in the product.
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Companies that need a new molecule because of this drug
1 company on route B because of this drug.
Companies on route B for this drug
In the product1 company is on route B because of Letibotulinumtoxina.
See the 1 company on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| SNAP25 | Synaptosomal-associated protein 25 | P60880 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 2 | 2 | 0 | 0 |
| Phase 2 | 1 | 1 | 0 | 0 |
| Phase 3 | 3 | 3 | 0 | 0 |
| All trials | 6 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Hugel | Applicant and Lead sponsor of trials | 2012 to now |