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ABT-335
ABT-335 is a PPARδ agonist Small molecule drug developed by AstraZeneca. It is currently in Phase 3 development for Dyslipidemia with low HDL cholesterol, Hypertriglyceridemia. Also known as: fenofibric acid, Choline fenofibrate, Fenofibric acid, Trilipix.
ABT-335 is a selective peroxisome proliferator-activated receptor delta (PPARδ) agonist that modulates lipid and glucose metabolism.
ABT-335 is a selective peroxisome proliferator-activated receptor delta (PPARδ) agonist that modulates lipid and glucose metabolism. Used for Dyslipidemia with low HDL cholesterol, Hypertriglyceridemia.
At a glance
| Generic name | ABT-335 |
|---|---|
| Also known as | fenofibric acid, Choline fenofibrate, Fenofibric acid, Trilipix, TriLipix |
| Sponsor | AstraZeneca |
| Drug class | PPARδ agonist |
| Target | PPARδ (peroxisome proliferator-activated receptor delta) |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | Phase 3 |
Mechanism of action
PPARδ agonists enhance fatty acid oxidation and improve insulin sensitivity by activating nuclear receptors involved in metabolic regulation. ABT-335 was developed to improve lipid profiles and reduce cardiovascular risk in dyslipidemic patients, particularly those with low HDL cholesterol or elevated triglycerides.
Approved indications
- Dyslipidemia with low HDL cholesterol
- Hypertriglyceridemia
Common side effects
- Muscle pain or myalgia
- Elevated liver enzymes
- Gastrointestinal disturbances
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)
- Study of Trilipix Effects on Lipids and Arteries (PHASE4)
- Combined Effects of Non-statin Treatments on Apolipoprotein A-I Up-Regulation (CENTAUR): A Feasibility Study (PHASE2)
- 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)
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 CI brief — competitive landscape report
- ABT-335 updates RSS · CI watch RSS
- AstraZeneca portfolio CI
Frequently asked questions about ABT-335
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Related
- Drug class: All PPARδ agonist drugs
- Target: All drugs targeting PPARδ (peroxisome proliferator-activated receptor delta)
- Manufacturer: AstraZeneca — full pipeline
- Therapeutic area: All drugs in Cardiovascular
- Indication: Drugs for Dyslipidemia with low HDL cholesterol
- Indication: Drugs for Hypertriglyceridemia
- Also known as: fenofibric acid, Choline fenofibrate, Fenofibric acid, Trilipix, TriLipix
- Compare: ABT-335 vs similar drugs
- Pricing: ABT-335 cost, discount & access