Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
ABT-335 plus rosuvastatin · 1 trial · 2 indications
Triglycerides were measured in milligrams/deciliter.
| Arm | Type | Description |
|---|---|---|
| ABT-335 plus rosuvastatin | EXPERIMENTAL | ABT-335 45 mg plus rosuvastatin 5 mg for 8 weeks, then ABT-335 45 mg plus rosuvastatin 10 mg for 8 weeks |
| Rosuvastatin | ACTIVE_COMPARATOR | Rosuvastatin 5 mg for 8 weeks then rosuvastatin 10 mg for 8 weeks |
| Name | Type | Description |
|---|---|---|
| ABT-335 plus rosuvastatin | DRUG | ABT-335 45 mg plus rosuvastatin 5 mg for 8 weeks, then ABT-335 45 mg plus rosuvastatin 10 mg for 8 weeks |
| Rosuvastatin | DRUG | Rosuvastatin 5 mg for 8 weeks then rosuvastatin 10 mg for 8 weeks |
Inclusion Criteria * Dyslipidemic participants with Chronic Kidney Disease Stage 3 * For entry into the Treatment Phase (Visit 3), the participant satisfied the following laboratory criteria (measured at the Screening Visit\[s\]): * Estimated glomerular filtration rate between 30 and 59 mL/min/1...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Eli Lilly and Company | LLY | 2 | PHASE3 | Lepodisiran |
| Merck & Co., Inc. | MRK | 1 | PHASE3 | Enlicitide, Rosuvastatin |
| NewAmsterdam Pharma Company N.V. | NAMS | 3 | PHASE3 | obicetrapib, ezetimibe daily |
| AstraZeneca PLC | AZN | 3 | PHASE2 | AZD0780, Rosuvastatin |
| Arrowhead Pharmaceuticals, Inc. | ARWR | 1 | PHASE1 | ARO-DIMERPA |
| Novartis AG Sponsored ADR | NVS | 1 | - | Undisclosed |
| CRISPR Therapeutics AG | CRSP | 1 | PHASE1 | CTX310 |
| HeartFlow, Inc. | HTFL | 1 | N/A | Rosuvastatin |
ABT-335 is an investigational small molecule being developed for cardiovascular conditions including dyslipidemia, hypercholesterolemia, and renal insufficiency. It has been studied in clinical trials for these indications, though it remains in clinical development and is not approved.
ABT-335 is being developed by AstraZeneca PLC, a biopharmaceutical company traded on the stock exchange under the ticker symbol AZN. The company has sponsored clinical trials evaluating the drug for dyslipidemia and related conditions.
ABT-335 is in Phase 1 clinical development. While some completed trials were Phase 3, the drug's current development stage is Phase 1, meaning it is still investigational and has not received regulatory approval.
ABT-335 has been studied in completed clinical trials including NCT00463606, a Phase 3 study comparing combination therapy with rosuvastatin to monotherapy in dyslipidemia, and NCT00585143, a Phase 1 pharmacokinetic study in renal impairment. Another Phase 3 trial, NCT00680017, evaluated the drug in chronic kidney disease.
ABT-335 has been studied as part of combination therapy with rosuvastatin calcium in clinical trials for dyslipidemia. The trials evaluated the safety and efficacy of ABT-335 and rosuvastatin together compared to rosuvastatin alone, but ABT-335 itself is a distinct investigational drug.