Approval Probability
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Adjusted LOA
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Also known as ABT-335, ABT-335 and rosuvastatin calcium
ABT-335 and rosuvastatin · 3 trials · 4 indications
Triglycerides were measured in milligrams/deciliter.
The mean percent change from baseline to the final visit in High-density lipoprotein cholesterol (HDL-C), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy.
The mean percent change from baseline to the final visit in triglycerides, with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy.
The mean percent change from baseline to the final visit in low-density lipoprotein cholesterol (LDL-C), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus ABT-335 135 mg monotherapy.
| 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 |
| ABT-335 and Rosuvastatin Calcium | EXPERIMENTAL | ABT-335 135mg in combination with rosuvastatin calcium 5mg administered orally, once daily for 12 weeks |
| ABT-335 | ACTIVE_COMPARATOR | ABT-335 135mg monotherapy administered orally, once daily for 12 weeks |
| Rosuvastatin Calcium | ACTIVE_COMPARATOR | Rosuvastatin calcium 5mg monotherapy administered orally, once daily for 12 weeks |
| 1 | EXPERIMENTAL | - |
| 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 |
| ABT-335 and rosuvastatin calcium | DRUG | ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks |
| ABT-335 | DRUG | ABT-335 135 mg monotherapy administered orally, once daily for 12 weeks |
| rosuvastatin calcium | DRUG | Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 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 and hypercholesterolemia. It has been studied in patients with dyslipidemia, including those with renal insufficiency or stage 3 chronic kidney disease. The drug is not approved and remains in clinical development.
ABT-335 is being developed by AstraZeneca PLC, a biopharmaceutical company traded on the NASDAQ under the ticker symbol AZN. The company has sponsored clinical trials evaluating the drug for the treatment of dyslipidemia and related cardiovascular conditions.
ABT-335 is an investigational drug that has completed Phase 1 and Phase 3 clinical trials. It is not FDA approved and remains in clinical development. The most advanced completed studies were Phase 3 trials evaluating the drug in combination with rosuvastatin for dyslipidemia.
ABT-335 has been studied in three completed clinical trials. NCT00463606 was a Phase 3 study comparing ABT-335 and rosuvastatin combination therapy to monotherapy in 760 subjects with dyslipidemia. NCT00585143 was a Phase 1 pharmacokinetic study in 37 subjects with renal impairment. NCT00680017 was a Phase 3 study in 280 subjects with dyslipidemia and stage 3 chronic kidney disease.
ABT-335 has been studied as a combination therapy with rosuvastatin calcium in clinical trials for dyslipidemia. The trials compared the safety and efficacy of the combination to rosuvastatin monotherapy. ABT-335 itself is the investigational drug being evaluated in these combination regimens.