Mipomersen
As of the edition of 20 October 2026, Mipomersen is an oligonucleotide: marketed, first approved in 2013 (US); acts on APOB; US protection ends in 2027.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2013
- Kind
- Oligonucleotide
- Brand name
- Kynamro
- First approved
- 29 January 2013 (US)
- Approvals on record
- 1 in 1 region
- Holder of the most recent approval
- Kastle Therapeutics
- Registered trials
- 19, 0 stopped early
- Disease areas
- Nutrition and metabolism; Inherited and neonatal; Heart and blood vessels; Nervous system
US protection
US protection ends in 2027.
The last listed US drug-substance patent ends in 2027. The application that gives this date is held by Kastle Therapeutics.
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 Mipomersen.
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 |
|---|---|---|
| APOB | Apolipoprotein B-100 | P04114 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase 1 | 5 | 5 | 0 | 0 |
| Phase 2 | 7 | 7 | 0 | 0 |
| Phase 3 | 7 | 7 | 0 | 0 |
| All trials | 19 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Kastle Therapeutics | Acquired holder and Lead sponsor of trials | 2005 to now |
| Sanofi | Originator | 2013 to 2016 |