Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
MDCO-2010 · 1 trial · 2 indications
Number of patients experiencing Adverse Events
Number of patients experiencing Serious Adverse Events
| Arm | Type | Description |
|---|---|---|
| Cohort 1 | EXPERIMENTAL | 3 patients: loading dose 0.005 mg/kg; infusion 0.0125 mg/kg/h; pump prime 0.02 mg |
| Cohort 2 | EXPERIMENTAL | 3 pts: loading dose 0.011 mg/kg; infusion 0.0250 mg/kg/h; pump prime 0.04 mg |
| Cohort 3 | EXPERIMENTAL | 6 patients: loading dose 0.027 mg/kg; infusion 0.0625 mg/kg/h; pump prime 0.09 mg |
| Cohort 4 | EXPERIMENTAL | 6 patients: loading dose 0.054 mg/kg; infusion 0.1250 mg/kg/h; pump prime 0.18mg |
| Cohort 5 | EXPERIMENTAL | 6 patients: loading dose 0.108 mg/kg; infusion 0.2500 mg/kg/h; pump prime 0.35 mg |
| Placebo | PLACEBO_COMPARATOR | 8 patients: commercially available NaCl as matching placebo to MDCO-2010 administered as IV infusion |
| Name | Type | Description |
|---|---|---|
| MDCO-2010 | DRUG | MDCO-2010 solution for infusion. Dosage: Pump priming dose; Loading dose infusion over 6 minutes; Maintenance infusion for duration of surgery |
| Placebo | DRUG | Commercially available NaCl |
Inclusion Criteria * Men, aged 18 to 80 years or * Post-menopausal women, aged up to 80 years. Postmenopausal status defined as ≥ 1 year since last menstruation in women with no medical history of hysterectomy or women with a medical history of bilateral oophorectomy * Planned elective, isolated pr...
MDCO-2010 is an investigational small molecule being studied for use in patients undergoing elective coronary artery bypass graft surgery. It is being evaluated for its safety, tolerability, pharmacokinetics, and pharmacodynamics in this setting. The drug is in Phase 2 clinical development and is not yet approved by regulatory authorities.
MDCO-2010 is being developed by Novartis AG, a multinational pharmaceutical company listed on the stock exchange under the ticker symbol NVS. The drug is currently in Phase 2 clinical development for use in coronary artery bypass graft surgery patients.
MDCO-2010 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. A Phase 2 clinical trial has been completed to evaluate the drug's safety, tolerability, pharmacokinetics, and pharmacodynamics in patients undergoing elective coronary artery bypass graft surgery.
MDCO-2010 has been studied in one completed Phase 2 clinical trial, identified as NCT01535222. This trial evaluated the safety, tolerability, pharmacokinetics, and pharmacodynamics of MDCO-2010 in patients undergoing elective coronary artery bypass graft surgery. The trial enrolled 32 participants and was randomized, double-blind, and placebo-controlled.
MDCO-2010 is not FDA approved. It is an investigational drug currently in Phase 2 clinical development. A Phase 2 clinical trial has been completed, but the drug has not yet received regulatory approval for use in coronary artery bypass graft surgery or any other indication.