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Also known as Atorvastatin injection
Atorvastatin · 1 trial · 2 indications
LDL-C levels were measured prior to and at the end of the 15 day treatment period to quantify the percent baseline LDL-C at 15 days. Efficacy is defined as eleven or more subjects in a dosing cohort with a Day 15 LDL-C not more than 125% of their baseline.
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | Cohort 1 = Baseline daily dose of 10 mg oral atorvastatin during lead-in, then IV study drug for up to 15 days |
| Cohort 2 | EXPERIMENTAL | Cohort 2 = Baseline daily dose of 20 mg oral atorvastatin during lead-in, then IV study drug for up to 15 days |
| Cohort 3 | EXPERIMENTAL | Cohort 3 = Baseline daily dose of 40 mg oral atorvastatin during lead-in, then IV study drug for up to 15 days |
| Cohort 4 | EXPERIMENTAL | Cohort 4 = Baseline daily dose of 20 mg oral atorvastatin during lead-in, then SC study drug for up to 15 days |
| Name | Type | Description |
|---|---|---|
| Atorvastatin injection | DRUG | statin (i.e., 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase inhibitor) for injection |
Inclusion Criteria: * On stable dose of daily oral atorvastatin for \>= 5 weeks (oral atorvastatin may be provided during a lead-in period for subjects not previously taking atorvastatin) * Stable LDL-C confirmed in the previous 7 to 10 days prior to enrollment into the treatment phase. Exclusion ...
Top 12 of 15 competitors
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 4 | PHASE3 | Enlicitide |
| Novartis AG Sponsored ADR | NVS | 14 | PHASE3 | Inclisiran, Pelacarsen, DII235, QCZ484 |
| AstraZeneca PLC | AZN | 3 | PHASE3 | AZD0780, Laroprovstat, Rosuvastatin |
| Arrowhead Pharmaceuticals, Inc. | ARWR | 5 | PHASE3 | Plozasiran, zodasiran, VSA003 |
| Ionis Pharmaceuticals, Inc. | IONS | 2 | PHASE3 | Olezarsen, ION775 |
| Regeneron Pharmaceuticals, Inc. | REGN | 2 | PHASE2 | Alirocumab |
| Eli Lilly and Company | LLY | 1 | PHASE2 | Solbinsiran |
| MediciNova, Inc. | MNOV | 1 | PHASE2 | MN-001 |
| Verve Therapeutics, Inc. | VERV | 4 | PHASE2 | VERVE-102, VERVE-201 |
| NewAmsterdam Pharma Company N.V. | NAMS | 1 | PHASE1 | Obicetrapib |
| CRISPR Therapeutics AG | CRSP | 1 | PHASE1 | CTX310 |
| Esperion Therapeutics, Inc. | ESPR | 1 | - | Bempedoic acid+ Ezetimibe |
Atorvastatin is used to treat hypercholesterolemia, a condition of elevated cholesterol in the blood. Cumberland Pharmaceuticals Inc. is developing an intravenous formulation of atorvastatin for this indication. The drug is a small molecule HMGCR inhibitor. It is currently in Phase 2 clinical development.
Atorvastatin targets HMGCR, also known as HMG-CoA reductase. It acts as an inhibitor of this enzyme, which is a key target in cholesterol regulation. By inhibiting HMGCR, atorvastatin reduces cholesterol synthesis. This mechanism underlies its use in managing hypercholesterolemia.
Cumberland Pharmaceuticals Inc. (ticker: CPIX) is developing Atorvastatin. The company is responsible for the clinical development of this intravenous formulation. Cumberland Pharmaceuticals is a specialty pharmaceutical company. The drug is being studied for hypercholesterolemia.
Atorvastatin is in Phase 2 clinical development. It is investigational and has not been approved by the FDA for the studied indication. The Phase 2 trial has been completed. Cumberland Pharmaceuticals Inc. is the developer.
Atorvastatin has been studied in one completed Phase 2 clinical trial, NCT03611010. The trial was titled 'Dose-ranging Efficacy and Pharmacokinetics Study of Intravenous Atorvastatin in Hypercholesterolemic Patients.' It enrolled 40 participants in the United States and included patients with hypercholesterolemia and dyslipidemias.
Yes, Atorvastatin injection is another name for Atorvastatin in this context. The drug is being developed as an intravenous formulation by Cumberland Pharmaceuticals Inc. It is intended for the treatment of hypercholesterolemia. The injectable form is in Phase 2 development.