Last reviewed · How we verify
Rosuvastatin-omeprazole
Rosuvastatin-omeprazole is a Statin + proton pump inhibitor combination Small molecule drug developed by Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec. It is currently FDA-approved for Hypercholesterolemia with elevated cardiovascular risk in patients requiring gastric acid suppression.
This combination drug reduces cholesterol via HMG-CoA reductase inhibition (rosuvastatin) while simultaneously reducing gastric acid secretion (omeprazole) to protect the gastrointestinal tract.
This combination drug reduces cholesterol via HMG-CoA reductase inhibition (rosuvastatin) while simultaneously reducing gastric acid secretion (omeprazole) to protect the gastrointestinal tract. Used for Hypercholesterolemia with elevated cardiovascular risk in patients requiring gastric acid suppression.
At a glance
| Generic name | Rosuvastatin-omeprazole |
|---|---|
| Sponsor | Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec |
| Drug class | Statin + proton pump inhibitor combination |
| Target | HMG-CoA reductase (rosuvastatin); H+/K+-ATPase (omeprazole) |
| Modality | Small molecule |
| Therapeutic area | Cardiovascular |
| Phase | FDA-approved |
Mechanism of action
Rosuvastatin is a statin that inhibits HMG-CoA reductase, the rate-limiting enzyme in cholesterol synthesis, thereby lowering LDL cholesterol and reducing cardiovascular risk. Omeprazole is a proton pump inhibitor that suppresses gastric acid production, protecting against acid-related GI injury that may occur with statin therapy or in patients at risk for ulcers. The combination addresses both lipid management and GI protection in a single formulation.
Approved indications
- Hypercholesterolemia with elevated cardiovascular risk in patients requiring gastric acid suppression
Common side effects
- Headache
- Myalgia
- Nausea
- Diarrhea
- Abdominal pain
Key clinical trials
- Study to Evaluate the Effect of Repotrectinib on the Drug Levels of Transporter and CYP P450 Probe Substrates in Healthy Adult Participants (PHASE1)
- A Study to Evaluate the Effect of Multiple Doses of JNJ-56021927 on the Pharmacokinetics of Multiple Cytochrome P450 and Transporter Substrates in Participants With Castration-Resistant Prostate Cancer (PHASE1)
- Drug-drug Interaction Study of Vorasidenib With Bupropion, Repaglinide, Flurbiprofen, Omeprazole, Midazolam, and Rosuvastatin in Healthy Adult Participants (PHASE1)
- A Study to Evaluate the Drug Interactions of HRS-7535 With Acetaminophen, Digoxin, Rosuvastatin, and Omeprazole in Obese or Overweight Subjects (PHASE1)
- A Study of Imlunestrant (LY3484356) in Female Healthy Participants (PHASE1)
- Phase 1, Open-label, Drug-drug Interaction Study to Assess Effect Between Radiprodil and the Co-administered Drugs. (PHASE1)
- A Phase 1 Clinical Study to Evaluate the Effects of SHR7280 on the Pharmacokinetics of Midazolam, S-warfarin, Omeprazole, Digoxin, and Rosuvastatin in Healthy Subjects (PHASE1)
- A Study to Learn How Different Amounts of PF-06954522 Are Tolerated and Act in Adults With Type 2 Diabetes Mellitus (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:
- Rosuvastatin-omeprazole CI brief — competitive landscape report
- Rosuvastatin-omeprazole updates RSS · CI watch RSS
- Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec portfolio CI
Frequently asked questions about Rosuvastatin-omeprazole
What is Rosuvastatin-omeprazole?
How does Rosuvastatin-omeprazole work?
What is Rosuvastatin-omeprazole used for?
Who makes Rosuvastatin-omeprazole?
What drug class is Rosuvastatin-omeprazole in?
What development phase is Rosuvastatin-omeprazole in?
What are the side effects of Rosuvastatin-omeprazole?
What does Rosuvastatin-omeprazole target?
Related
- Drug class: All Statin + proton pump inhibitor combination drugs
- Target: All drugs targeting HMG-CoA reductase (rosuvastatin); H+/K+-ATPase (omeprazole)
- Manufacturer: Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec — full pipeline
- Therapeutic area: All drugs in Cardiovascular
- Indication: Drugs for Hypercholesterolemia with elevated cardiovascular risk in patients requiring gastric acid suppression
- Compare: Rosuvastatin-omeprazole vs similar drugs
- Pricing: Rosuvastatin-omeprazole cost, discount & access