Product Description
Simvastatin is an oral HMG-CoA reductase inhibitor indicated as an adjunct to diet. It is a semi-synthetic derivative of lovastatin, the first FDA-approved statin. Simvastatin helps lower cholesterol production and reduce dyslipidemia-associated complications. (Sourced from: https://pubmed.ncbi.nlm.nih.gov/30422514/)
Mechanisms of Action: HMG-CoA Inhibitor
Novel Mechanism: No
Modality: Small Molecule
Route of Administration: Oral
FDA Designation: None *
Approval Status: Approved
Approved Countries: Algeria | Argentina | Australia | Austria | Bangladesh | Belgium | Bosnia | Brazil | Bulgaria | Canada | Chile | China | Colombia | Croatia | Cyprus | Czech | Denmark | Dominican Republic | Ecuador | Egypt | Estonia | European Medicines Agency | Finland | France | Germany | Greece | Hong Kong | Hungary | Iceland | India | Indonesia | Ireland | Israel | Italy | Jordan | Korea | Latvia | Lebanon | Lithuania | Luxembourg | Malaysia | Malta | Mexico | Morocco | Netherlands | New Zealand | Norway | Pakistan | Peru | Philippines | Poland | Portugal | Romania | Russia | Saudi Arabia | Serbia | Singapore | Slovakia | Slovenia | South Africa | Spain | Sri Lanka | Sweden | Switzerland | Taiwan | Thailand | Tunisia | Turkey | Ukraine | United Arab Emirates | United Kingdom | United States | Uruguay | Venezuela | Vietnam
Approved Indications: Coronary Disease | Myocardial Infarction | Hyperlipidemia | Stroke | General Diabetes | Hypercholesterolemia | Hypertriglyceridemia | Dyslipidemia | Myocardial Infarction | Hyperlipidemia | Stroke | Pancreatitis | Dyslipidemia | General Diabetes | Hypercholesterolemia | Hypertriglyceridemia | Type 2 Diabetes
Known Adverse Events: Abdominal Pain | Headache | Pain Unspecified | Constipation | Nasopharyngitis | Pharyngitis | Respiratory Tract Infections | Hypoglycemia
Company: Organon
Company Location: JERSEY CITY NJ 07302
Company CEO:
Additonal Commercial Interests: None
Clinical Description
Countries in Clinic: China, United States
Active Clinical Trial Count: 7
Highest Development Phases
Phase 3: Dyslipidemia|Hypercholesterolemia|Hypertriglyceridemia|Liver Cirrhosis|Pancreatitis, Acute
Phase 2: Smoking Cessation|Tobacco Use Disorder
Phase 1: Coronary Disease|Healthy Volunteers|Hyperlipidemia|Stroke
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
|---|---|---|---|---|---|
| ADDICTSTATINE | P2 |
Completed |
Smoking Cessation|Tobacco Use Disorder |
2038-12-17 |
|
| CL020_168 | P1 |
Completed |
Healthy Volunteers |
2022-08-11 |
28% |
| CL020_168 | P1 |
Completed |
Healthy Volunteers |
2022-08-11 |
28% |
| Statin-DDI | P1 |
Completed |
Healthy Volunteers |
2022-04-05 |
28% |
| 2018-001698-25 | P3 |
Active, not recruiting |
Liver Cirrhosis |
2021-03-19 |