Lowers the risk of major adverse cardiovascular (CV) events (CV death, myocardial…. Sold as Repatha. Every FDA application for this active ingredient.
As of Nov 14, 2026, FDA lists 1 application for Evolocumab (sold as Repatha), first approved Feb 26, 2021, with 5 new uses approved and 1 published complete response letter.
| Repatha Sureclick | Part D | $2.63B | +54% | 539,135 |
| Repatha Syringe | Part D | $235M | +20% | 67,619 |
| Repatha Pushtronex | Part D | $3.9M | -93% | 2,290 |
| RESCUE: PCSK9 Inhibitors for Carotid Vulnerable Plaque RemodelingAtherosclerosis Cerebral, Carotid Plaque · Keqiang Zhao | Phase 4 | Not yet recruiting | Sep 15, 2026 |
| A Trial Assessing the Effectiveness of Evolocumab in Reducing the Plaque Burden in Participants With Subclinical AtheromaCoronary Artery Disease, Hypercholesterolemia · Amgen | Phase 4 | Not yet recruiting | Sep 4, 2026 |
| Aggressive Lipid Lowering Therapy in ICI-Treated MelanomaMelanoma · University of Colorado, Denver | Not applicable | Recruiting | Jul 15, 2026 |
| Management Strategy of 1L Lorlatinib With Hyperlipidemia in Stage IIIB-IV ALK Positive NSCLCNon-Small Cell Lung Cancer (NSCLC), Hyperlipidemia · Sun Yat-sen University | — | Not yet recruiting | Jun 29, 2026 |
| CAPRA-EVO: a Randomized Serial PCCT Trial of Early Evolocumab After ACSCoronary, Coronary Artery Disease · West China Hospital | Phase 4 | Recruiting | May 29, 2026 |
| A Real-World Study of Long-Term Adherence and Persistence to Inclisiran, Evolocumab, and AlirocumabCardiovascular Diseases, Atherosclerotic Cardiovascular Disease · Novartis Pharmaceuticals | — | Recruiting | Apr 22, 2026 |
| Efficacy and Safety of PCSK9 Inhibitors in Patients With Large-Artery Atherosclerosis (LAA) Ischemic StrokeAcute Ischemic Stroke · First Affiliated Hospital of Harbin Medical University | — | Recruiting | Apr 20, 2026 |
| Real World Adherence of PCSK9 Targeted TherapyDyslipidemia, Hypercholesterolemia · Novartis Pharmaceuticals | — | Not yet recruiting | Mar 12, 2026 |
| Letter | Product | Now |
|---|---|---|
| Aug 27, 2015 | Repatha (evolocumab)Clinical, Labeling | Approved |
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
