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ABT-335 and rosuvastatin calcium
ABT-335 and rosuvastatin calcium is a Fibrate and statin combination Small molecule drug developed by AstraZeneca. It is currently in Phase 3 development for Dyslipidemia with elevated triglycerides and low HDL cholesterol, Cardiovascular risk reduction in patients with mixed dyslipidemia. Also known as: ABT-335 / Rosuvastatin Combination (ABT-143), ABT-335, TRILIPIX.
ABT-335 (fenofibrate) reduces triglycerides and raises HDL cholesterol by activating peroxisome proliferator-activated receptor alpha (PPARα), while rosuvastatin calcium lowers LDL cholesterol by inhibiting HMG-CoA reductase.
ABT-335 (fenofibrate) reduces triglycerides and raises HDL cholesterol by activating peroxisome proliferator-activated receptor alpha (PPARα), while rosuvastatin calcium lowers LDL cholesterol by inhibiting HMG-CoA reductase. Used for Dyslipidemia with elevated triglycerides and low HDL cholesterol, Cardiovascular risk reduction in patients with mixed dyslipidemia.
At a glance
| Generic name | ABT-335 and rosuvastatin calcium |
|---|---|
| Also known as | ABT-335 / Rosuvastatin Combination (ABT-143), ABT-335, TRILIPIX |
| Sponsor | AstraZeneca |
| Drug class | Fibrate and statin combination |
| Target | PPARα (ABT-335) and HMG-CoA reductase (rosuvastatin) |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | Phase 3 |
Mechanism of action
This combination targets dyslipidemia through dual mechanisms: ABT-335 activates PPARα to increase lipoprotein lipase activity and reduce VLDL production, thereby lowering triglycerides and increasing HDL. Rosuvastatin competitively inhibits HMG-CoA reductase, the rate-limiting enzyme in cholesterol synthesis, effectively reducing LDL cholesterol. Together, they address multiple lipid abnormalities in patients at cardiovascular risk.
Approved indications
- Dyslipidemia with elevated triglycerides and low HDL cholesterol
- Cardiovascular risk reduction in patients with mixed dyslipidemia
Common side effects
- Myalgia or muscle pain
- Elevated liver enzymes
- Gastrointestinal disturbances
- Headache
- Rhabdomyolysis (rare with combination)
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)
- Study to Compare the Bioavailability of ABT-335 and Rosuvastatin From ABT-143 Capsules Relative to That From Co-administration of ABT-335 and Rosuvastatin for the 5/45mg Dosage Form. (PHASE1)
- Study to Compare the Bioavailability of ABT-335 and Rosuvastatin From ABT-143 Relative to That From the Co-administration of ABT-335 and Rosuvastatin Calcium (PHASE1)
- Comparison of the Bioavailability of Fenofibric Acid and Rosuvastatin From ABT-143 Relative to That From the Coadministration of ABT-335 (Fenofibric Acid) and Rosuvastatin Calcium (PHASE1)
- Comparison of the Bioavailability of Fenofibric Acid and Rosuvastatin From 5/45 mg Strength of ABT-143 Relative to That From the Coadministration of ABT-335 (Fenofibric Acid) 45 mg and Rosuvastatin Calcium 5 mg (PHASE1)
- 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)
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 rosuvastatin calcium CI brief — competitive landscape report
- ABT-335 and rosuvastatin calcium updates RSS · CI watch RSS
- AstraZeneca portfolio CI
Frequently asked questions about ABT-335 and rosuvastatin calcium
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Related
- Drug class: All Fibrate and statin combination drugs
- Target: All drugs targeting PPARα (ABT-335) and HMG-CoA reductase (rosuvastatin)
- Manufacturer: AstraZeneca — full pipeline
- Therapeutic area: All drugs in Cardiovascular
- Indication: Drugs for Dyslipidemia with elevated triglycerides and low HDL cholesterol
- Indication: Drugs for Cardiovascular risk reduction in patients with mixed dyslipidemia
- Also known as: ABT-335 / Rosuvastatin Combination (ABT-143), ABT-335, TRILIPIX
- Compare: ABT-335 and rosuvastatin calcium vs similar drugs
- Pricing: ABT-335 and rosuvastatin calcium cost, discount & access