Treats amyotrophic lateral sclerosis (ALS). Sold as Radicava, Radicava Ors, Edaravone. Every FDA application for this active ingredient: 3 branded and 7 generic.
As of Nov 14, 2026, FDA lists 10 applications for Edaravone (sold as Radicava, Radicava Ors, Edaravone), first approved May 5, 2017, with 0 new uses approved and 0 published complete response letters.
| Radicava Ors | Part D | $426M | +13% | 3,720 |
| Radicava | Part D | $1.6M | -68% | 19 |
| Radicava | Part B | $1.1M | -59% | 16 |
| Edaravone | Part D | $881K | New | 13 |
| Edaravone Dexborneol for Blood-Brain Barrier Repair in Acute Anterior Circulation StrokeAcute Ischemic Stroke · Shandong Provincial Hospital | Phase 4 | Recruiting | Nov 12, 2026 |
| Positron Emission Tomography (PET) Imaging of Reactive Oxygen and Nitrogen Species: Human Observation of Retention and Safety of [18F]-FluoroedaravoneHealthy Volunteer · St. Jude Children's Research Hospital | Early phase 1 | Not yet recruiting | Sep 3, 2026 |
| Safety and Efficacy of Edaravone Dexborneol Sublingual Tablets for Blood-Brain Barrier Dysfunction in CADASILCADASIL · Huashan Hospital | Phase 2 | Not yet recruiting | Jul 9, 2026 |
| Sublingual Edaravone Dexborneol for Inter-hospital Transfer Acute Ischemic Stroke (SLEDAIS)Acute Ischemic Stroke · Xinqiao Hospital of Chongqing | Phase 4 | Not yet recruiting | Jul 6, 2026 |
| Edaravone Dexborneol for Post-Stroke EpilepsyPost-stroke Epilepsy, Post-stroke Seizure · First Affiliated Hospital of Wenzhou Medical University | Phase 3 | Not yet recruiting | May 22, 2026 |
| Research of Traditional Chinese Medicine Oral Preparation of C. Cicadae in the Treatment of ALS Patients With Elevated Plasma SphingolipidsAmyotrophic Lateral Sclerosis · The Third Xiangya Hospital of Central South University | Phase 2 | Not yet recruiting | Mar 12, 2026 |
| Edaravone and Dexborneol Sublingual Tablet for Treating Chemotherapy- Induced Cognitive Impairment StudyChemo Brain · Chuansheng Zhao | Phase 4 | Recruiting | Mar 6, 2026 |
| FHND1002 for ALS Treatment: Phase 2Amyotrophic Lateral Sclerosis (ALS) · Jiangsu Chia Tai Fenghai Pharmaceutical Co., Ltd. | Phase 2 | Not yet recruiting | Aug 22, 2025 |
| May 5, 2017 | RadicavaNDA 209176 · New molecular entity | Shionogi | 5 | Discontinued |
| May 12, 2022 | Radicava OrsNDA 215446 · New dosage form | Shionogi | 0 | Marketed |
| May 6, 2024 | EdaravoneANDA 215508 | Hikma | 0 | Marketed |
| May 6, 2024 | EdaravoneANDA 215917 | Dr Reddys | 0 | Discontinued |
| May 6, 2024 | EdaravoneANDA 216199 | Gland | 0 | Marketed |
| May 6, 2024 | EdaravoneANDA 218354 | Long Grove Pharms | 0 | Discontinued |
| Oct 31, 2024 | EdaravoneANDA 217565 | Pharmobedient | 0 | Discontinued |
| Dec 23, 2024 | EdaravoneANDA 216902 | Sandoz | 0 | Marketed |
| Jul 22, 2026 | EdaravoneANDA 218349 | Zydus Pharms | 0 | Marketed |
| — | EdaravoneNDA 221059 | Azurity Pharmaceuticals Inc | 0 | 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
Shionogi
Hikma
Sandoz
Zydus Pharms