Levacetylleucine
As of the edition of 20 October 2026, Levacetylleucine is a small molecule: marketed, first approved in 2024 (US); acts on F9; US protection ends in 2031.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2024
- Kind
- Small molecule
- Brand name
- Aqneursa
- First approved
- 24 September 2024 (US)
- Approvals on record
- 1 in 1 region
- Holder of the most recent approval
- IntraBio
- Registered trials
- 4, 0 stopped early
- Disease areas
- Inherited and neonatal; Nervous system; Nutrition and metabolism; Heart and blood vessels; Immune system; Blood and lymph
US protection
US protection ends in 2031.
The last listed US exclusivity ends in 2031. The application that gives this date is held by IntraBio.
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.
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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 Levacetylleucine.
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 |
|---|---|---|
| F9 | Coagulation factor IX | P00740 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 1 | 0 | 0 | 0 |
| Phase 3 | 3 | 0 | 3 | 0 |
| All trials | 4 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| IntraBio | Originator and Lead sponsor of trials | 2024 to now |