Tenapanor
As of the edition of 20 October 2026, Tenapanor is a small molecule: marketed, first approved in 2019 (US); acts on SLC9A3; US protection ends in 2033.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2023
- Kind
- Small molecule
- Brand name
- Ibsrela
- First approved
- 12 September 2019 (US)
- Approvals on record
- 5 in 2 regions
- Holder of the most recent approval
- Ardelyx; 2 holders in all
- Registered trials
- 35, 0 stopped early
- Disease areas
- Nutrition and metabolism; Pregnancy and women's health; Urinary and reproductive; Digestive system; Inherited and neonatal; Lungs and airways
US protection
US protection ends in 2033.
The last listed US drug-substance patent ends in 2033. The application that gives this date is held by Ardelyx.
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 product15 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
2 companies on route B because of this drug.
Companies on route B for this drug
In the product2 companies are on route B because of Tenapanor.
See the 2 companies on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Target
| Gene | Protein | UniProt |
|---|---|---|
| SLC9A3 | Sodium/hydrogen exchanger 3 | P48764 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase 1 | 10 | 10 | 0 | 0 |
| Phase 2 | 8 | 7 | 1 | 0 |
| Phase 3 | 13 | 10 | 3 | 0 |
| Phase 4 | 4 | 4 | 0 | 0 |
| All trials | 35 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Ardelyx | Originator and Lead sponsor of trials | 2010 to now |
| Kyowa Kirin | Applicant and Lead sponsor of trials | 2018 to now |