Lowers the risk of major adverse cardiovascular (CV) events (coronary heart disease…. Sold as Praluent. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for Alirocumab (sold as Praluent), first approved Jul 24, 2015, with 8 new uses approved and 0 published complete response letters.
| Product | Part | Spending, 2025 | Change | Beneficiaries |
|---|---|---|---|---|
| Praluent Pen | Part D | $336M | -1% | 84,102 |
| RESCUE: PCSK9 Inhibitors for Carotid Vulnerable Plaque RemodelingAtherosclerosis Cerebral, Carotid Plaque · Keqiang Zhao | Phase 4 | Not yet recruiting | Sep 15, 2026 |
| Aggressive Lipid Lowering Therapy in ICI-Treated MelanomaMelanoma · University of Colorado, Denver | Not applicable | Recruiting | Jul 15, 2026 |
| Alirocumab for Stabilisation of Symptomatic Vulnerable Carotid PlaqueCarotid Stenosis · Middle East North Africa Stroke and Interventional Neurotherapies Organization | Phase 3 | Recruiting | May 14, 2026 |
| Dual PCSK9 Inhibition With Inclisiran and Alirocumab in Secondary PreventionHypercholesterolemia, Atherosclerotic Cardiovascular Disease (ASCVD) · University Medical Centre Ljubljana | Phase 4 | Recruiting | May 12, 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 |
| A Study to See How Safe and Effective Alirocumab is When Given Weekly to Adult Participants Who Have HypercholesterolemiaHypercholesterolemia · Regeneron Pharmaceuticals | Phase 2 | Active, not recruiting | Mar 17, 2026 |
| Evaluation of Adherence, Persistence and Efficacy of Treatment With Alirocumab 300mg in ItalyHypercholesterolaemia · Federico II University | — | Recruiting | Jan 29, 2026 |
| PCSK9 Inhibitors in Acute Ischemic Stroke Patients Undergoing Endovascular TherapyAcute Ischemic Stroke · Nanfang Hospital, Southern Medical University | Phase 2 / Phase 3 | Not yet recruiting | Sep 15, 2025 |
| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| Jul 24, 2015 | PraluentBLA 125559 · New molecular entity | Regeneron Pharmaceuticals | 13 | 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
Regeneron Pharmaceuticals