Sold as Retavase. Every FDA application for this active ingredient.
As of Nov 13, 2026, FDA lists 1 application for Reteplase (sold as Retavase), first approved May 6, 1998, with 0 new uses approved and 0 published complete response letters.
| Tenecteplase or Reteplase as Bridging Thrombolysis Before Thrombectomy in Acute Ischemic Cerebrovascular EventsAcute Ischemic Stroke, Large Vessel Occlusion · Yongjun Wang | Phase 3 | Recruiting | Aug 5, 2026 |
| Efficacy and Safety of Human Urinary Kallidinogenase Combined With Reteplase Intravenous Thrombolysis in the Treatment of Acute Ischemic StrokeAcute Ischemic Stroke · China-Japan Union Hospital | Not applicable | Not yet recruiting | Mar 19, 2026 |
| Intravenous Thrombolysis in Acute Ischemic Stroke with Active CancerStroke, Acute Ischemic Stroke · Second Affiliated Hospital, Zhejiang University, School of Medicine | Phase 3 | Not yet recruiting | Feb 24, 2025 |
| Intravenous Thrombosis and Patients with Prior Ischemic Stroke Within 3 MonthsStroke, Acute Ischemic Stroke · Second Affiliated Hospital, Zhejiang University, School of Medicine | Phase 3 | Not yet recruiting | Feb 24, 2025 |
| Intravenous Thrombolysis and NOACAcute Ischemic Stroke · Second Affiliated Hospital, Zhejiang University, School of Medicine | Phase 3 | Recruiting | Dec 27, 2024 |
| Intravenous Thrombolytic Therapy for Acute Ischemic Stroke Patients with Low NIHSS and Non-disabling DeficitsThrombosis, Acute Ischemic Stroke (AIS) · Second Affiliated Hospital, Zhejiang University, School of Medicine | Phase 4 | Not yet recruiting | Nov 2, 2023 |
| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| May 6, 1998 | RetavaseBLA 103786 · New molecular entity | Ekr Therap | 0 | Marketed |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
