Sold as Kinlytic. Every FDA application for this active ingredient.
As of Nov 14, 2026, FDA lists 1 application for Urokinase (sold as Kinlytic), first approved Jan 16, 1978, with 2 new uses approved and 0 published complete response letters.
| Intravenous Thrombolysis, Endovascular Treatment, or Bridging Therapy for Medium Vessel Occlusion Stroke Within 24 HoursMedium Vessel Occlusion Stroke (MeVO), Acute Ischemic Stroke · The First Affiliated Hospital of University of Science and Technology of China | Phase 3 | Not yet recruiting | Nov 12, 2026 |
| Evaluation of [⁶⁸Ga/¹⁷⁷Lu]HT547: Safety, Biodistribution, and Dosimetry in Solid TumorsBreast Cancer, Head and Neck Cancer (H&N) · Hua Pang | Early phase 1 | Not yet recruiting | Jun 10, 2026 |
| Early Lumbar Drainage for Intraventricular HemorrhageIntraventricular Hemorrhage, Cerebral Hemorrhage · Second Affiliated Hospital of Nanchang University | Not applicable | Not yet recruiting | Jun 4, 2026 |
| Pro-urokinase for Extended-Window Posterior Circulation StrokeAcute Ischemic Stroke · The First Affiliated Hospital of Zhengzhou University | Phase 3 | Not yet recruiting | Jun 1, 2026 |
| STRATEGY-PE: Real-World Treatment Strategies for Intermediate-High Risk Pulmonary EmbolismPulmonary Embolism, Venous Thromboembolism · Nanjing First Hospital, Nanjing Medical University | — | Not yet recruiting | May 22, 2026 |
| Role of Medical Thoracoscopy in Pleural Infection (PROMPT Trial)Pleural Infection, Pleural Infections · Università Politecnica delle Marche | Not applicable | Not yet recruiting | Apr 24, 2026 |
| TrIal of Early Minimally Invasive Catheter Evacuation With Thrombolysis in IntraCerebral HemorrhageIntracerebral Hemorrhage · Xuanwu Hospital, Beijing | Not applicable | Recruiting | Sep 23, 2025 |
| Timing and Outcomes of Recovery After intraCerebral HemorrhageIntracerebral Haemorrhage, Intracerebral Hemorrhage · Xuanwu Hospital, Beijing | — | Recruiting | Sep 10, 2025 |
| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| Jan 16, 1978 | KinlyticBLA 21846 | Microbix Biosystems | 8 | Discontinued |
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
