Ranolazine
As of the edition of 20 October 2026, Ranolazine is a small molecule: marketed, first approved in 2006 (US); acts on SCN4A and SCN5A; no US protection is listed.
Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.
The drug
- Status
- Marketed; latest approval 2016
- Kind
- Small molecule
- Brand name
- Ranexa
- First approved
- 27 January 2006 (US)
- Approvals on record
- 6 in 3 regions
- Holder of the most recent approval
- SUN Pharmaceutical Industries; 4 holders in all
- Registered trials
- 58, 11 stopped early
- Disease areas
- Heart and blood vessels; Nutrition and metabolism; Hormones; Lungs and airways; Inherited and neonatal; Nervous 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
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 Ranolazine.
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 | 9 | 4 | 0 | 4 |
| Phase 1 | 8 | 6 | 0 | 1 |
| Phase 2 | 16 | 11 | 2 | 2 |
| Phase 3 | 12 | 9 | 1 | 1 |
| Phase 4 | 13 | 8 | 0 | 3 |
| All trials | 58 |
Who has held its approvals
| Company | Role | Years |
|---|---|---|
| Gilead Sciences | Originator and Lead sponsor of trials | 2004 to now |
| Menarini | Applicant | 2008 to now |
| SUN Pharmaceutical Industries | Acquired holder | 2022 to now |
| Menarini | Acquired holder | 2024 to now |