Aliskiren
As of the edition of 20 October 2026, Aliskiren is a small molecule: marketed, first approved in 2007 (US); acts on REN; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2009
- Kind
- Small molecule
- Brand name
- Tekturna
- First approved
- 5 March 2007 (US)
- Approvals on record
- 22 in 4 regions
- Holder of the most recent approval
- Noden Pharma Dac; 4 holders in all
- Withdrawn from market
- 25 June 2015 (in some regions)
- Registered trials
- 120, 17 stopped early
- Disease areas
- Heart and blood vessels; Nutrition and metabolism; Hormones; Pregnancy and women's health; Urinary and reproductive; Immune system
US protection
No US protection is listed.
The FDA registers list no drug-substance patent or exclusivity that counts for this drug.
This is the US only.
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 Aliskiren.
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 |
|---|---|---|
| REN | Renin | P00797 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 10 | 4 | 0 | 4 |
| Phase 1 | 5 | 5 | 0 | 0 |
| Phase 2 | 18 | 12 | 1 | 5 |
| Phase 3 | 48 | 46 | 0 | 2 |
| Phase 4 | 39 | 25 | 0 | 6 |
| All trials | 120 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Novartis | Earlier holder and Lead sponsor of trials | 2004 to now |
| Noden Pharma Dac | Later holder | 2017 to now |
| Lxo Ireland Designated Activity | Acquired holder | 2026 to now |