Saxagliptin anhydrous
As of the edition of 20 October 2026, Saxagliptin anhydrous is a small molecule: marketed, first approved in 2009 (US); acts on DPP4; US protection ends in 2027.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2017
- Kind
- Small molecule
- Brand name
- Onglyza
- First approved
- 31 July 2009 (US)
- Approvals on record
- 21 in 6 regions
- Holder of the most recent approval
- AstraZeneca; 3 holders in all
- Registered trials
- 96, 4 stopped early
- Disease areas
- Nutrition and metabolism; Hormones; Pregnancy and women's health; Urinary and reproductive; Digestive system; Heart and blood vessels
US protection
US protection ends in 2027.
The last listed US exclusivity ends in 2027. The application that gives this date is held by AstraZeneca.
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
2 companies on route B and 1 company on route A because of this drug.
Companies on route B for this drug
In the product2 companies are on route B because of Saxagliptin anhydrous.
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Companies on route A for this drug
In the product1 company is on route A because of Saxagliptin anhydrous.
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Target
| Gene | Protein | UniProt |
|---|---|---|
| DPP4 | Dipeptidyl peptidase 4 | P27487 |
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 12 | 8 | 0 | 0 |
| Phase 1 | 20 | 18 | 0 | 2 |
| Phase 2 | 4 | 4 | 0 | 0 |
| Phase 3 | 34 | 33 | 0 | 1 |
| Phase 4 | 26 | 14 | 0 | 1 |
| All trials | 96 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| AstraZeneca | Applicant, Acquired holder and Lead sponsor of trials | 2003 to now |
| Otsuka | Applicant | 2013 to now |
| Bristol Myers Squibb | Originator | 2009 to 2014 |