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ABT-335 and simvastatin
ABT-335 and simvastatin is a Fibrate + statin combination Small molecule drug developed by Abbott. It is currently in Phase 3 development for Dyslipidemia with elevated triglycerides and LDL cholesterol. Also known as: ABT-335, TRILIPIX.
ABT-335 (fenofibrate) combined with simvastatin works by reducing triglycerides and LDL cholesterol through dual lipid-lowering pathways.
ABT-335 (fenofibrate) combined with simvastatin works by reducing triglycerides and LDL cholesterol through dual lipid-lowering pathways. Used for Dyslipidemia with elevated triglycerides and LDL cholesterol.
At a glance
| Generic name | ABT-335 and simvastatin |
|---|---|
| Also known as | ABT-335, TRILIPIX |
| Sponsor | Abbott |
| Drug class | Fibrate + statin combination |
| Target | PPARα (ABT-335); HMG-CoA reductase (simvastatin) |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | Phase 3 |
Mechanism of action
ABT-335 is a peroxisome proliferator-activated receptor alpha (PPARα) agonist that lowers triglycerides and raises HDL cholesterol, while simvastatin is an HMG-CoA reductase inhibitor that reduces LDL cholesterol. Together, they provide complementary lipid management in patients with dyslipidemia who require both triglyceride and cholesterol reduction.
Approved indications
- Dyslipidemia with elevated triglycerides and LDL cholesterol
Common side effects
- Myalgia
- Elevated liver enzymes
- Gastrointestinal disturbances
- Rhabdomyolysis (rare with fibrate-statin combination)
Key clinical trials
- A Year 2, Safety Extension Study of the Combination of ABT-335 and Statin Therapy for Subjects With Mixed Dyslipidemia (PHASE3)
- Study to Evaluate the Long-Term Safety and Efficacy of ABT-335, in Combination With Three Different Statins in Subjects With Mixed Dyslipidemia. (PHASE3)
- Evaluate Safety and Efficacy of ABT-335 in Combination With Simvastatin in Subjects With Multiple Abnormal Lipid Levels in the Blood (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:
- ABT-335 and simvastatin CI brief — competitive landscape report
- ABT-335 and simvastatin updates RSS · CI watch RSS
- Abbott portfolio CI
Frequently asked questions about ABT-335 and simvastatin
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Related
- Drug class: All Fibrate + statin combination drugs
- Target: All drugs targeting PPARα (ABT-335); HMG-CoA reductase (simvastatin)
- Manufacturer: Abbott — full pipeline
- Therapeutic area: All drugs in Cardiovascular
- Indication: Drugs for Dyslipidemia with elevated triglycerides and LDL cholesterol
- Also known as: ABT-335, TRILIPIX
- Compare: ABT-335 and simvastatin vs similar drugs
- Pricing: ABT-335 and simvastatin cost, discount & access