Sotagliflozin
As of the edition of 20 October 2026, Sotagliflozin is a small molecule: marketed, first approved in 2023 (US); acts on SLC5A2; US protection ends in 2030.
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
- Inpefa
- First approved
- 26 May 2023 (US)
- Approvals on record
- 2 in 1 region
- Holder of the most recent approval
- Lexicon Pharmaceuticals
- Withdrawn from market
- 22 March 2022 (in some regions)
- Registered trials
- 57, 6 stopped early
- Disease areas
- Hormones; Nutrition and metabolism; Immune system; Heart and blood vessels; Pregnancy and women's health; Urinary and reproductive
US protection
US protection ends in 2030.
The last listed US drug-substance patent ends in 2030. The application that gives this date is held by Lexicon Pharmaceuticals.
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 product8 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 Sotagliflozin.
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 |
|---|---|---|
| SLC5A2 | Sodium/glucose cotransporter 2 | P31639 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 1 | 0 | 1 | 0 |
| Phase 1 | 25 | 24 | 0 | 0 |
| Phase 2 | 11 | 6 | 4 | 1 |
| Phase 3 | 18 | 11 | 2 | 5 |
| Phase 4 | 2 | 2 | 0 | 0 |
| All trials | 57 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Lexicon Pharmaceuticals | Originator and Lead sponsor of trials | 2009 to now |