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ABT-335 plus rosuvastatin
ABT-335 (fenofibrate analog) combined with rosuvastatin reduces triglycerides and LDL cholesterol through dual lipid-lowering pathways.
ABT-335 (fenofibrate analog) combined with rosuvastatin reduces 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 plus rosuvastatin |
|---|---|
| Also known as | fenofibric acid and rosuvastatin |
| Sponsor | AstraZeneca |
| Drug class | Fibrate + statin combination |
| Target | PPARα (ABT-335); HMG-CoA reductase (rosuvastatin) |
| 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 rosuvastatin is an HMG-CoA reductase inhibitor (statin) that reduces LDL cholesterol. Together, they provide complementary lipid management in patients with dyslipidemia and cardiovascular risk.
Approved indications
- Dyslipidemia with elevated triglycerides and LDL cholesterol
Common side effects
- Myalgia or muscle pain
- Elevated liver enzymes
- Gastrointestinal disturbances
- Elevated creatinine/renal effects
Key clinical trials
- 30 Week Study of the Combination of ABT-335 and Rosuvastatin Compared to Rosuvastatin Monotherapy for Subjects With Dyslipidemia and Stage 3 Chronic Kidney Disease (PHASE3)
- A Multicenter Study Comparing the Safety and Efficacy of ABT-335 and Rosuvastatin Calcium Combination Therapy to Monotherapy in Subjects With Dyslipidemia (PHASE3)
- Safety Study to Evaluate the Effects of Mild and Moderate Renal Impairment on the Pharmacokinetics of ABT-335 and Rosuvastatin When Administered Concomitantly (PHASE1)
- Interaction Between ABT-335, Rosuvastatin and Warfarin (PHASE1)
- 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 Rosuvastatin Calcium 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 plus rosuvastatin CI brief — competitive landscape report
- ABT-335 plus rosuvastatin updates RSS · CI watch RSS
- AstraZeneca portfolio CI