Lomitapide
As of the edition of 20 October 2026, Lomitapide is a small molecule: marketed, first approved in 2012 (US); acts on MTTP; US protection ends in 2029.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2016
- Kind
- Small molecule
- Brand name
- Juxtapid
- First approved
- 21 December 2012 (US)
- Approvals on record
- 12 in 4 regions
- Holder of the most recent approval
- Chiesi Farmaceutici; 2 holders in all
- Registered trials
- 16, 3 stopped early
- Disease areas
- Nutrition and metabolism; Inherited and neonatal
US protection
US protection ends in 2029.
The last listed US exclusivity ends in 2029. The application that gives this date is held by Chiesi Farmaceutici.
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 product6 listings count towards this date. The exact date and each listing are in the product.
See the exact date and the 6 listings behind itRequest access. Nothing is shown until you do.
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 Lomitapide.
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 |
|---|---|---|
| MTTP | Microsomal triglyceride transfer protein large subunit | P55157 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 3 | 1 | 0 | 2 |
| Phase 1 | 5 | 5 | 0 | 0 |
| Phase 2 | 3 | 3 | 0 | 0 |
| Phase 3 | 5 | 4 | 0 | 1 |
| All trials | 16 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Qlt | Originator and Lead sponsor of trials | 2003 to now |
| Chiesi Farmaceutici | Acquired holder | 2024 to now |