Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Apabetalone · 1 trial · 2 indications
Incidence of first occurrence of MACE narrowly defined as a single composite endpoint of Cardiovascular (CV) Death (including undetermined cause of death) or Non-fatal Myocardial Infarction (MI) or Stroke. If a subject has multiple events, only the first event contributing to the composite endpoint is counted.
| Arm | Type | Description |
|---|---|---|
| High-Intensity statin therapy+RVX000222 | EXPERIMENTAL | Daily dose 100 mg capsule b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin) |
| High-Intensity statin therapy+Placebo | ACTIVE_COMPARATOR | Placebo (for RVX000222 100 mg capsule) b.i.d. with high-intensity statin therapy (atorvastatin or rosuvastatin) |
| Name | Type | Description |
|---|---|---|
| Apabetalone | DRUG | 100 mg capsule |
| Placebo | DRUG | Capsule manufactured to mimic RVX000222 100 mg capsule |
| Atorvastatin | DRUG | High-Intensity Statin |
| Rosuvastatin | DRUG | High-Intensity Statin |
Inclusion Criteria: • ACS event of either unstable angina or myocardial infarction 7-90 days prior Visit 1: Unstable angina: for a qualifying unstable angina event, each of components (a), (b), and (c) must be satisfied: a.) Characteristic ischemic pain or discomfort in chest/associated referral a...
Apabetalone is an investigational small molecule being studied for the treatment of Type 2 Diabetes Mellitus in patients with Coronary Artery Disease. It is in Phase 3 clinical development and has not been approved by regulatory authorities.
Apabetalone is a small molecule that targets BET proteins, which are involved in gene regulation. By inhibiting these proteins, it may affect pathways related to cardiovascular disease and diabetes. The drug is being evaluated for its effects on major adverse cardiovascular events.
Apabetalone is being developed by Icon Plc, a company listed on the stock exchange under the ticker ICLR. The drug is currently in Phase 3 clinical trials for Type 2 Diabetes Mellitus and Coronary Artery Disease.
Apabetalone is in Phase 3 clinical development. It is an investigational drug, meaning it has not yet been approved by the FDA or other regulatory agencies. The Phase 3 trial has been completed, and the drug is not currently in active trials.
Apabetalone has one completed Phase 3 trial with the identifier NCT02586155. This trial studied the effect of the drug on time to major adverse cardiovascular events in high-risk Type 2 Diabetes patients with Coronary Artery Disease, enrolling 2425 participants across multiple countries.
Yes, Apabetalone is also known as RVX000222. The Phase 3 clinical trial NCT02586155 used the name RVX000222 in its title, confirming that both names refer to the same investigational drug.