Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Oritavancin · 1 trial · 1 indication
A composite measure of the number and types of AE/SAEs encountered and relationship to time of dosing
A composite measure of multiple laboratory results assessing the clinical significance of any changes from baseline
A composite of multiple vital sign measurements, assessing the clinical significance of any changes from baseline
A composite of multiple ECG measurements, assessing the clinical significance of any changes from baseline
A composite of multiple physical examination findings, assessing the clinical significance of any changes from baseline
| Arm | Type | Description |
|---|---|---|
| Oritavancin | ACTIVE_COMPARATOR | IV -Single Dose - 1200 mg Oritavancin |
| Placebo | PLACEBO_COMPARATOR | 250 mL Dextrose 5% in Water |
| Name | Type | Description |
|---|---|---|
| Oritavancin | DRUG | IV - Single dose 1200 mg Oritavancin |
| Dextrose | DRUG | D5W 5% in Water |
Inclusion Criteria: 1. Able to provide written informed consent before initiation of any study related procedures. 2. Healthy male or female between the ages of 18 and 65 years, inclusive. 3. Body mass index (BMI) \< 45 kg/m\^2. 4. Subject is in good health based on medical history and physical exa...
Oritavancin is a small molecule being studied in healthy volunteers. It is currently in Phase 1 clinical development, with a completed trial evaluating its safety, tolerability, and pharmacokinetics in healthy subjects. The drug is not approved for any indication and remains investigational.
Oritavancin is being developed by Novartis AG, which is listed on the stock exchange under the ticker NVS. The company is conducting clinical research on this small molecule drug candidate.
Oritavancin is in Phase 1 clinical development. It has completed one Phase 1 trial, and there are no active trials currently ongoing. The drug is investigational and has not been approved by regulatory authorities.
Oritavancin has one completed clinical trial registered under NCT02471690. This Phase 1 study evaluated the safety, tolerability, and pharmacokinetics of a new formulation of Oritavancin in healthy volunteers in the United States, enrolling 56 participants.
Oritavancin is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed trial focused on healthy volunteers to assess safety and pharmacokinetics, and further clinical studies would be needed before any approval could be considered.