Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MDCO-216 · 1 trial · 1 indication
Change from Baseline to Day 36 post-randomization in PAV in a targeted (imaged) coronary artery for all anatomically comparable slices, as determined by IVUS. The change is calculated by subtracting the value at Baseline from the value at Day 36, with positive numbers to represent increases and negative numbers to represent decreases. Change in PAV was analyzed using an analysis of covariance (ANCOVA) model that included Baseline PAV as a covariate and treatment group as factor. Least Squares (LS) mean was adjusted for stratification factors of country and prior statin use.
| Arm | Type | Description |
|---|---|---|
| MDCO-216 | EXPERIMENTAL | 20 mg/kg of MDCO-216 administered intravenously (IV) as a 360 milliliter (mL) infusion over 2 hours on Days 1, 8, 15, 22, and 29 |
| Placebo | PLACEBO_COMPARATOR | 360 mL of placebo (0.9% sodium chloride \[NaCl\] solution) infusion, IV, over 2 hours on Days 1, 8, 15, 22, and 29 |
| Name | Type | Description |
|---|---|---|
| MDCO-216 | DRUG | - |
| Placebo | DRUG | - |
Inclusion Criteria: * Have experienced a recent ACS event within 14 days of screening that requires a clinically indicated coronary angiogram. * A qualifying ACS event will be defined as follows: a diagnosis of a qualifying myocardial infarction (MI) event will be defined by abnormal levels of card...
MDCO-216 is an investigational small molecule being developed for the treatment of Acute Coronary Syndrome. It is currently in Phase 1 clinical development, meaning it has not yet been approved by regulatory authorities and remains under investigation for safety and efficacy in this cardiovascular condition.
MDCO-216 is being developed by Novartis AG, a global pharmaceutical company listed on the New York Stock Exchange under the ticker symbol NVS. The company is conducting clinical research to evaluate the drug's potential in treating Acute Coronary Syndrome.
MDCO-216 is currently in Phase 1 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The drug is being studied for its potential use in patients with Acute Coronary Syndrome, but further clinical trials are needed before it can be considered for approval.
MDCO-216 has one completed clinical trial registered under NCT02678923. This Phase 1 study, titled 'MDCO-216 Infusions Leading to Changes in Atherosclerosis: A Novel Therapy in Development to Improve Cardiovascular Outcomes - Proof of Concept Intravascular Ultrasound (IVUS), Lipids, and Other Surrogate Biomarkers Trial,' enrolled 126 participants with Acute Coronary Syndrome across Canada, Czechia, Hungary, Netherlands, and Poland.
No, MDCO-216 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for Acute Coronary Syndrome. The drug has completed one clinical trial, but it remains under investigation and has not received regulatory approval for any use.
No alternative names for MDCO-216 have been identified. The drug is known by its development code MDCO-216 and is being studied by Novartis AG for the treatment of Acute Coronary Syndrome. No other names or aliases are currently associated with this investigational compound.