Rimabotulinumtoxinb
As of the edition of 20 October 2026, Rimabotulinumtoxinb is a protein: marketed, first approved in 2000 (US); acts on VAMP2; US protection ended in 2012.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2011
- Kind
- Protein
- Brand name
- Myobloc
- First approved
- 8 December 2000 (US)
- Approvals on record
- 4 in 2 regions
- Holder of the most recent approval
- Eisai; 2 holders in all
- Registered trials
- 15, 4 stopped early
- Disease areas
- Nervous system; Mouth and teeth; Heart and blood vessels; Bones, joints and muscles; Injuries; Skin and connective tissue
US protection
US protection ended in 2012.
US protection ended in 2012, 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 Solstice NeuroSciences. 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 product2 listings count 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 Rimabotulinumtoxinb.
Target
| Gene | Protein | UniProt |
|---|---|---|
| VAMP2 | Vesicle-associated membrane protein 2 | P63027 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 1 | 1 | 0 | 0 |
| Phase 1 | 2 | 1 | 0 | 0 |
| Phase 2 | 4 | 4 | 0 | 0 |
| Phase 3 | 5 | 2 | 0 | 3 |
| Phase 4 | 3 | 2 | 0 | 1 |
| All trials | 15 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Solstice NeuroSciences | Applicant | 2000 to now |
| Eisai | Applicant and Lead sponsor of trials | 2004 to now |