Repaglinide
As of the edition of 20 October 2026, Repaglinide is a small molecule: marketed, first approved in 1997 (US); acts on ABCC8 and KCNJ11; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2011
- Kind
- Small molecule
- Brand name
- Prandin
- First approved
- 22 December 1997 (US)
- Approvals on record
- 10 in 3 regions
- Holder of the most recent approval
- Dainippon Sumitomo Pharma; 5 holders in all
- Withdrawn from market
- 29 July 2026 (in some regions)
- Registered trials
- 57, 2 stopped early
- Disease areas
- Nutrition and metabolism; Hormones; Cancer; Inherited and neonatal; Digestive system; Lungs and airways
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
4 company-target rows on route B because of this drug.
Companies on route B for this drug
In the product4 company-target rows are on route B because of Repaglinide.
See the 4 company-target rows on route B for this drug, with the facts behind eachRequest access. Nothing is shown until you do.
Targets
Registered trials
| Phase | Trials | Completed | Active | Stopped early |
|---|---|---|---|---|
| Phase not stated | 8 | 7 | 0 | 1 |
| Phase 1 | 31 | 27 | 3 | 0 |
| Phase 2 | 1 | 0 | 1 | 0 |
| Phase 3 | 2 | 2 | 0 | 0 |
| Phase 4 | 15 | 13 | 0 | 1 |
| All trials | 57 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Novo Nordisk | Applicant, Earlier holder and Lead sponsor of trials | 1997 to now |
| Dainippon Sumitomo Pharma | Applicant | 2011 to now |
| Gemini Therapeutics | Acquired holder | 2017 to now |