Incobotulinumtoxina
As of the edition of 20 October 2026, Incobotulinumtoxina is a drug: marketed, first approved in 2009 (CA); acts on SNAP25; US protection ended in 2022.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2010
- Kind
- Unknown
- Brand name
- Xeomin
- First approved
- 13 March 2009 (CA)
- Approvals on record
- 7 in 2 regions
- Holder of the most recent approval
- Merz Pharma GmbH & Co. KGaA; 2 holders in all
- Registered trials
- 72, 5 stopped early
- Disease areas
- Nervous system; Bones, joints and muscles; Heart and blood vessels; Injuries; Skin and connective tissue; Urinary and reproductive
US protection
US protection ended in 2022.
US protection ended in 2022, 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 Merz Pharmaceuticals GmbH c/o Merz Pharmaceuticals. 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.
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 Incobotulinumtoxina.
Target
| Gene | Protein | UniProt |
|---|---|---|
| SNAP25 | Synaptosomal-associated protein 25 | P60880 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 9 | 6 | 1 | 1 |
| Phase 1 | 4 | 2 | 1 | 0 |
| Phase 2 | 23 | 11 | 5 | 4 |
| Phase 3 | 32 | 22 | 8 | 0 |
| Phase 4 | 4 | 2 | 2 | 0 |
| All trials | 72 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Merz Pharma GmbH & Co. KGaA | Applicant and Lead sponsor of trials | 2006 to now |
| Merz Pharmaceuticals GmbH c/o Merz Pharmaceuticals | Acquired holder | 2021 to now |