EMA · European Union
ranolazine — EMA regulatory status
ranolazine (RANEXA (PREVIOUSLY LATIXA)) regulatory status in the European Union is tracked from public EMA records and cross-linked clinical and patent datasets on NovaPharmaNews. Current status: EMA approved.
Status snapshot
- Status
- EMA approved
- Brand
- RANEXA (PREVIOUSLY LATIXA)
- Originator
- Amneal Pharma Europe Ltd
- Mechanism
- Sodium channel protein type IV alpha subunit blocker
- Target
- Sodium channel protein type 4 subunit alpha
- Structured fields
- 7
Sponsor / originator context: Amneal Pharma Europe Ltd. Pipeline programs and exclusivity signals below are joined from ClinicalTrials.gov-linked projects and USPTO/EPO patent rows associated with this INN.
Pharmacology context used for competitive intelligence: Sodium channel protein type IV alpha subunit blocker. Target: Sodium channel protein type 4 subunit alpha. This page is a status aggregation for professional reference — not prescribing advice.
Regional decision snapshot — EMA: approved.
Linked evidence on this spoke: 20 published clinical programs and 0 related patent records. Use the tables below for NCT identifiers, phases, and exclusivity dates; verify against primary sources before BD or medical decisions.
Regulatory timeline
| Regulator | Region | Status | Date | Source |
|---|---|---|---|---|
| EMA | European Union | approved | — | Evidence |
Linked clinical programs
| Program | Phase | Sponsor | NCT |
|---|---|---|---|
| APHP200043 | Phase 3 | PARItec | 2024-515010-40-00 |
| D9604C00001 | Phase 3 | AstraZeneca | 2022-501353-37-00 |
| RANOLAZINE, FLECARDIA Διάλυμα για ένεση/έχχυση | Phase 3 | Anaxis Pharma | 2024-514677-22-00 |
| Tranexamic Acid | Phase 3 | Arrowhead Pharmaceuticals Ireland | NCT03469947 |
| Tranexamic Acid | Phase 3 | United Therapeutics Europe | NCT02314988 |
| Tranexamic acid | Phase 3 | First People's Hospital | NCT05811676 |
| pad-gauze with tranexamic acid (Hemostopan™) | Phase 3 | Sionna Therapeutics | NCT01854476 |
| Tranexamic Acid | Phase 2 | Neuroscience Trials Australia | NCT03385928 |
| Tranexamic Acid | Phase 2 | United Therapeutics Europe | NCT03552705 |
| Tranexamic Acid | Phase 2 | United Therapeutics Europe | NCT02535949 |
| Ranolazine | Phase 1 | BRIGHT MINDS BIOSCIENCES | NCT03070470 |
| Tranexamic Acid； | Phase 1 | Chinese Academy of | NCT06149091 |
Related hubs
FAQ
What is the EMA approval status of ranolazine?
ranolazine currently shows EMA approved in our European Union regulatory index. Confirm on the official EMA label or EPAR before clinical or commercial use.
Where does NovaPharmaNews get ranolazine regulatory data?
Status fields are joined from public sources (openFDA / EMA / regional agencies), ClinicalTrials.gov-linked programs, and patent registries. See /about/data-sources for attribution.
How many clinical programs are linked to ranolazine?
This spoke lists 20 published programs associated with ranolazine in our pipeline index.