REPATHA (evolocumab)
Repatha (evolocumab) is a PCSK9 inhibitor indicated to reduce the risk of major adverse cardiovascular events, such as myocardial infarction and stroke, in adults at increased risk. It is also used as an adjunct to diet and exercise to lower low-density lipoprotein cholesterol (LDL-C) in adults with hypercholesterolemia. Additionally, the medication is approved for adults and pediatric patients aged 10 years and older with heterozygous or homozygous familial hypercholesterolemia.
How REPATHA Works
Evolocumab is a human monoclonal antibody that targets the proprotein convertase subtilisin kexin type 9 (PCSK9) protein. Normally, PCSK9 binds to low-density lipoprotein receptors (LDLR) on the surface of liver cells to promote their degradation. By inhibiting PCSK9, evolocumab increases the number of available LDLRs to clear LDL from the blood, which results in lower circulating LDL-C levels.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2015-08-27
- Patent Cliff
- 2027
- Revenue
- $870M (Q4-2025)
- Routes
- INJECTION
- Dosage Forms
- INJECTABLE
REPATHA Approval History
What REPATHA Treats
4 indicationsREPATHA is approved for 4 conditions since its original approval in 2015. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Major adverse cardiovascular events in adults at increased risk
- Hypercholesterolemia in adults
- Heterozygous familial hypercholesterolemia (HeFH) in adults and pediatric patients aged 10 years and older
- Homozygous familial hypercholesterolemia (HoFH) in adults and pediatric patients aged 10 years and older
REPATHA Target & Pathway
ProTarget
A protein that promotes degradation of LDL receptors, reducing the liver's ability to clear LDL cholesterol. Blocking PCSK9 increases LDL receptor availability, dramatically lowering LDL cholesterol levels beyond what statins achieve.
REPATHA Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
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Clinical Trial Registry
71 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03337698 Morpheus Lung results posted | BO39610 2017-001267-21 | Ph 1, Ph 2 | terminated | A Study Of Multiple Immunotherapy-Based Treatment Combinations In Participants With Metastatic Non-Small Cell Lung Cancer (Morpheus- Non-Small Cell Lung Cancer) |
| NCT05144529 TOP2101 results posted | Pro00109594 W81XWH-21-1-0532 | Ph 2 | terminated | A Randomized Pilot Study of Evolocumab Plus Nivolumab/Ipilimumab in Treatment-Naïve Patients With Metastatic NSCLC |
| NCT03515304 EVACS results posted | IRB00156313 | Ph 2 | completed | Evolocumab in Acute Coronary Syndrome |
| NCT03829046 results posted | GCO 18-1412 20167719 | Ph 4 | completed | The Effects of Evolocumab in Patients With Diabetes and Atherosclerotic Vascular Disease |
| NCT06284564 | 2023-0538 NCI-2024-03604 | Ph 2 | active not recruiting | A Phase II Study Bolstering Outcomes by Optimizing Immunotherapy Strategies With Evolocumab and Nivolumab in Patients With Metastatic Renal Cell Carcinoma (BOOST-RCC) |
| NCT04608474 results posted | 2020P000437 | Ph 4 | completed | Lipid Management in Renal Transplant Recipients Using Evolocumab. |
| NCT06700720 | YN001-004 | Ph 2 | recruiting | YN001-004 in Patients With Coronary Atherosclerosis in Australia |
| NCT03872401 VESALIUS-CV | 20170625 2023-503673-38-00, 2018-004565-14 | Ph 3 | completed | Effect of Evolocumab in Patients at High Cardiovascular Risk Without Prior Myocardial Infarction or Stroke |
| NCT05152888 EMPOWER | 2021P003360 | Ph 4 | recruiting | The Impact of Pcsk-9 Inhibition on PET CFR in Patients at High CV Risk |
| NCT04082442 EVACS II results posted | IRB00206305 | Ph 2 | completed | Evolocumab in Patients With Acute MI |
| NCT05284747 EVOLVE-MI | 20190184 2021-005272-19 | Ph 4 | active not recruiting | EVOLVE-MI: EVOLocumab Very Early After Myocardial Infarction |
| NCT03900026 NEWTON-CABG | NEWTON CABG (CardioLink-5) | Ph 4 | completed | Effect of Evolocumab on Saphenous Vein Graft Patency Following Coronary Artery Bypass Surgery |
| NCT04303377 ExOTIC | EXO_01 2018-001065-17 | Ph 2 | withdrawn | Early Treatment With Evolocumab in Patients With ST-elevation Myocardial Infarction |
| NCT04073134 CHORAL | 18HH4626 2018-002483-11 | Ph 4 | terminated | The CHORAL Flow Study |
| NCT03689946 results posted | 54274 | Ph 3 | completed | Effect of Evolocumab on Coronary Atherosclerosis |
| NCT03944577 results posted | 0104-19-FB | Ph 2 | completed | Impact of Evolocumab in Cardiac Transplant Patients With CAV |
| NCT03403374 RAMAN results posted | 20170199 2020-005111-51 | Ph 4 | completed | Safety and Tolerability of Repatha® (Evolocumab) in Indian Participants With Homozygous Familial Hypercholesterolemia |
| NCT02624869 HAUSER-OLE results posted | 20120124 2015-002276-25 | Ph 3 | completed | Safety, Tolerability and Efficacy of Evolocumab (AMG 145) in Children With Inherited Elevated Low-density Lipoprotein Cholesterol (Familial Hypercholesterolemia) |
| NCT03080935 results posted | 20160250 2016-004066-26 | Ph 3 | terminated | Fourier Open-label Extension Study in Subjects With Clinically Evident Cardiovascular Disease in Selected European Countries |
| NCT01764633 FOURIER results posted | 20110118 2014/01/004324, 2012-001398-97 | Ph 3 | completed | Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk |
| NCT01624142 TAUSSIG results posted | 20110271 2011-005400-15 | Ph 2, Ph 3 | completed | Trial Assessing Long Term USe of PCSK9 Inhibition in Subjects With Genetic LDL Disorders |
| NCT04189484 results posted | SCR-007 | Ph 1 | completed | Pharmacodynamic Biomarkers to Support Biosimilar Development: PCSK9 Inhibitors |
| NCT06231459 CytoEx-PCSK9 | 061.2019 | Ph 4 | completed | Expression of Pro- and Anti-inflammatory Cytokines During Anti-PCSK9 in Familial Hypercholesterolemia |
| NCT03734211 EVOLVD | 2017-005097-19 | Ph 3 | completed | Cholesterol Lowering With EVOLocumab to Prevent Cardiac Allograft Vasculopathy in De-novo Heart Transplant Recipients |
| NCT04941105 IMPACT-SIRIO 5 | IMPACT-SIRIO 5 | Ph 3 | completed | Impact of PCSK9 Inhibition on Clinical Outcome in Patients During the Inflammatory Stage of the COVID-19 |
| NCT02867813 FOURIER OLE results posted | 20130295 2015-004780-36 | Ph 3 | completed | Further Cardiovascular Outcomes Research With PCSK9 Inhibition in Subjects With Elevated Risk Open-label Extension |
| NCT04790513 LIBerate-H2H | LIB003-011 | Ph 3 | completed | Trial to Evaluate Efficacy and Safety of LIB003, Evolocumab and Alirocumab in High-risk CVD Patients |
| NCT04034485 | LIB003-003 | Ph 3 | completed | Phase 3 Study to Evaluate the Efficacy and Safety of LIB003 With Evolocumab in HoFH |
| NCT03433755 results posted | 20150172 | Ph 3 | terminated | Safety and Efficacy of Evolocumab in Addition to Optimal Stable Background Statin Therapy in Chinese Participants With Primary Hypercholesterolemia and Mixed Dyslipidemia |
| NCT03060577 ORION-3 results posted | MDCO-PCS-16-01 2016-003815-37 | Ph 2 | completed | An Extension Trial of Inclisiran in Participants With Cardiovascular Disease and High Cholesterol |
| NCT04573777 RISER results posted | 00121763 | Ph 4 | terminated | Reducing Intracranial atheroSclErosis With Repatha |
| NCT03791593 EVO-HF | ICOR-2016-05 2017-004656-30 | Ph 2 | completed | EVOlocumab in Stable Heart Failure With Reduced Ejection Fraction of Ischemic Etiology: EVO-HF Pilot |
| NCT03258281 ISS-DMII results posted | 17-2639 | Ph 4 | terminated | Effects of Evolocumab on Platelet Reactivity in Patients With Diabetes Mellitus |
| NCT02585895 results posted | 20140316 2015-001343-37 | Ph 3 | completed | Evolocumab Compared to LDL-C Apheresis in Patients Receiving LDL-C Apheresis Prior to Study Enrollment |
| NCT01380730 LAPLACE results posted | 20101155 | Ph 2 | completed | LAPLACE-TIMI 57: Low-density Lipoprotein Cholesterol (LDL-C) Assessment With PCSK9 monoclonaL Antibody Inhibition Combined With Statin thErapy |
| NCT01375751 RUTHERFORD results posted | 20090158 | Ph 2 | completed | Reduction of Low-Density Lipoprotein Cholesterol (LDL-C) With PCSK9 Inhibition in Heterozygous Familial Hypercholesterolemia Disorder Study |
| NCT01763866 LAPLACE-2 results posted | 20110115 2012-001363-70 | Ph 3 | completed | LDL-C Assessment With PCSK9 Monoclonal Antibody Inhibition Combined With Statin Therapy-2 |
| NCT01763827 MENDEL-2 results posted | 20110114 | Ph 3 | completed | Monoclonal Antibody Against PCSK9 to Reduce Elevated LDL-C in Subjects Currently Not Receiving Drug Therapy for Easing Lipid Levels-2 |
| NCT01375777 MENDEL results posted | 20101154 | Ph 2 | completed | Monoclonal Antibody Against PCSK9 to Reduce Elevated Low-density Lipoprotein Cholesterol (LDL-C) in Adults Currently Not Receiving Drug Therapy for Easing Lipid Levels |
| NCT02392559 HAUSER-RCT results posted | 20120123 2014-002277-11 | Ph 3 | completed | Trial Assessing Efficacy, Safety and Tolerability of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibition in Paediatric Subjects With Genetic Low-Density Lipoprotein (LDL) Disorders |
| NCT01375764 GAUSS results posted | 20090159 | Ph 2 | completed | Goal Achievement After Utilizing an Anti-PCSK9 Antibody in Statin Intolerant Subjects |
| NCT02275156 results posted | 20140213 | Ph 1 | completed | Estimation Study to Assess the Effect of Severe Renal Impairment and End-stage Renal Disease Hemodialysis on the Pharmacokinetics of Evolocumab |
| NCT02729025 ANITSCHKOW results posted | 20130293 2015-003731-35 | Ph 3 | completed | Effects of Proprotein Convertase Subtilisin/Kexin Type 9 (PCSK9) Inhibition on Arterial Wall Inflammation in Patients With Elevated Lipoprotein(a) (Lp(a)) |
| NCT01439880 OSLER results posted | 20110110 2011-001915-29 | Ph 2 | completed | Open Label Study of Long Term Evaluation Against LDL-C Trial |
| NCT04510844 EVO-CKD | 20-00405 21-00455 | Ph 4 | withdrawn | Evolocumab In Advanced Chronic Kidney Disease Trial |
| NCT01516879 DESCARTES results posted | 20110109 | Ph 3 | completed | Durable Effect of PCSK9 Antibody CompARed wiTh placEbo Study |
| NCT02833844 results posted | 20130286 2015-004735-12 | Ph 3 | completed | Safety, Tolerability and Efficacy on Low Density Lipoprotein Cholesterol (LDL-C) of Evolocumab in Participants With Human Immunodeficiency Virus (HIV) and Hyperlipidemia/Mixed Dyslipidemia |
| NCT03570697 results posted | 20160184 2017-003236-37 | Ph 3 | completed | Imaging of Coronary Plaques in Participants Treated With Evolocumab |
| NCT03096288 results posted | IIS AMG001 | Ph 4 | completed | Impact of Evolocumab on the Effects of Clopidogrel in Patients With High On-Treatment Platelet Reactivity |
| NCT02948777 results posted | EVOLKIN | Ph 4 | completed | Effects of PCSK9 Inhibition by Evolocumab on Postprandial Lipid Metabolism in Type 2 Diabetes |
Showing 50 of 71 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
REPATHA FDA Label Details
Indications & Usage
FDA Label (PDF)REPATHA is indicated for the treatment of Major adverse cardiovascular events in adults at increased risk; Hypercholesterolemia in adults; Heterozygous familial hypercholesterolemia (HeFH) in adults and pediatric patients aged 10 years and older; Homozygous familial hypercholesterolemia (HoFH) in adults and pediatric patients aged 10 years and older.
Pro Intelligence Preview
Deep insights for REPATHA
Revenue Insights
- • Q4-2025: $870M
- • Historical trend analysis
Patent Timeline
- • Cliff: 2027
- • Generic/biosimilar risk
Trial Analysis
- • 75 total trials
- • Stage: Declining
Competitive Landscape
- • 1 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment