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Non-statin Lipid-Modifying Therapy
Non-statin lipid-modifying therapies work through alternative pathways to reduce cholesterol and triglycerides without inhibiting HMG-CoA reductase.
Non-statin lipid-modifying therapies work through alternative pathways to reduce cholesterol and triglycerides without inhibiting HMG-CoA reductase. Used for Hyperlipidemia / dyslipidemia management, Cardiovascular risk reduction in statin-intolerant or inadequately controlled patients.
At a glance
| Generic name | Non-statin Lipid-Modifying Therapy |
|---|---|
| Sponsor | Sanofi |
| Drug class | Non-statin lipid-modifying agent (specific class within this category unknown) |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | Phase 3 |
Mechanism of action
This category encompasses multiple drug classes including PCSK9 inhibitors, bempedoic acid, inclisiran, and other agents that target different steps in lipid metabolism. They may work by enhancing LDL receptor expression, inhibiting uric acid production coupled with lipid reduction, or silencing PCSK9 gene expression to lower LDL cholesterol and improve cardiovascular outcomes in patients who cannot tolerate or are inadequately controlled on statins.
Approved indications
- Hyperlipidemia / dyslipidemia management
- Cardiovascular risk reduction in statin-intolerant or inadequately controlled patients
Common side effects
- Elevated uric acid levels
- Gout
- Injection site reactions (if injectable formulation)
- Influenza-like symptoms
Key clinical trials
- Evaluation of Long-Term Safety and Tolerability of ETC-1002 in High-Risk Patients With Hyperlipidemia and High CV Risk (CLEAR Harmony) (PHASE3)
- Evaluation of the Efficacy and Safety of Bempedoic Acid (ETC-1002) in Patients With Hyperlipidemia and Statin Intolerant (PHASE3)
- Effectiveness of Intensive Lipid Modification Medication in Preventing the Progression of Peripheral Arterial Disease (The ELIMIT Study) (PHASE4)
- Evaluation of Alirocumab Versus Ezetimibe on Top of Statin in Asia in High Cardiovascular Risk Patients With Hypercholesterolemia (PHASE3)
- Evaluation of Effect of Alirocumab on Coronary Atheroma Volume in Japanese Patients Hospitalized for Acute Coronary Syndrome With Hypercholesterolemia (PHASE4)
- Efficacy and Safety of Alirocumab in Patients With Hypercholesterolemia Not Adequately Controlled With Non-statin Lipid Modifying Therapy or the Lowest Strength of Statin (PHASE3)
- Phase III Study To Evaluate Alirocumab in Patients With Hypercholesterolemia Not Treated With a Statin (ODYSSEY CHOICE II) (PHASE3)
- Efficacy and Safety of Alirocumab Versus Placebo on Top of Maximally Tolerated Lipid Lowering Therapy in Patients With Hypercholesterolemia Who Have Type 1 or Type 2 Diabetes and Are Treated With Insulin (ODYSSEY DM - Insulin) (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Non-statin Lipid-Modifying Therapy CI brief — competitive landscape report
- Non-statin Lipid-Modifying Therapy updates RSS · CI watch RSS
- Sanofi portfolio CI