Last reviewed 2026-04-22 · How we verify

ABT-335 and atorvastatin calcium

ABT-335 and atorvastatin calcium is a Fibrate + HMG-CoA reductase inhibitor (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 is a fibrate that reduces triglycerides and raises HDL cholesterol, combined with atorvastatin calcium which inhibits HMG-CoA reductase to lower LDL cholesterol.

ABT-335 is a fibrate that reduces triglycerides and raises HDL cholesterol, combined with atorvastatin calcium which inhibits HMG-CoA reductase to lower LDL cholesterol. Used for Dyslipidemia with elevated triglycerides and LDL cholesterol.

At a glance

Mechanism of action

ABT-335 (fenofibrate derivative) activates peroxisome proliferator-activated receptor alpha (PPARα) to increase lipolysis and reduce hepatic triglyceride production. Atorvastatin calcium is a statin that competitively inhibits HMG-CoA reductase, the rate-limiting enzyme in cholesterol synthesis, thereby lowering LDL cholesterol. Together, this combination addresses multiple lipid abnormalities in dyslipidemia.

Approved indications

• Dyslipidemia with elevated triglycerides and LDL cholesterol

Common side effects

• Myalgia or muscle pain
• Elevated liver enzymes
• Gastrointestinal upset
• Rhabdomyolysis (rare)

Key clinical trials

• Safety and Efficacy Study Using ABT-335 (Investigational Drug) in Combination With Atorvastatin, to Study the Effects on Thickening of the Blood Vessel Wall in Patients With Abnormal Lipid (Fat) Levels in the Blood (PHASE3)
• Combined Effects of Non-statin Treatments on Apolipoprotein A-I Up-Regulation (CENTAUR): A Feasibility Study (PHASE2)
• A Year 2, Safety Extension Study of the Combination of ABT-335 and Statin Therapy for Subjects With Mixed Dyslipidemia (PHASE3)
• Safety and Efficacy Study Comparing ABT-335 Coadministered With Atorvastatin and Ezetimibe to Atorvastatin Coadministered With Ezetimibe in Subjects With Multiple Abnormal Lipid (Fat) Levels in the Blood (PHASE3)
• A Multiple-Dose Pharmacokinetic Interaction Study Between ABT-335, Atorvastatin and Ezetimibe (PHASE1)
• 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 Atorvastatin in Subjects With Multiple Abnormal Lipid Levels in the Blood (PHASE3)

Primary sources

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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 atorvastatin calcium CI brief — competitive landscape report
• ABT-335 and atorvastatin calcium updates RSS · CI watch RSS
• Abbott portfolio CI

Frequently asked questions about ABT-335 and atorvastatin calcium

Related

• Drug class: All Fibrate + HMG-CoA reductase inhibitor (statin combination) drugs
• Target: All drugs targeting PPARα (ABT-335); HMG-CoA reductase (atorvastatin)
• 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 atorvastatin calcium vs similar drugs
• Pricing: ABT-335 and atorvastatin calcium cost, discount & access