Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Orbactiv
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 drug being developed by Novartis AG under the ticker NVS. It is in Phase 1 clinical development. The specific therapeutic indication for this asset has not been disclosed. It is an investigational product and has not been approved by the FDA.
Oritavancin is being developed by Novartis AG, which trades under the ticker NVS. Novartis is the sponsor responsible for the clinical program, including the completed Phase 1 trial NCT02471690 that evaluated a new formulation of the drug in healthy volunteers.
Oritavancin is in Phase 1 clinical development. One Phase 1 trial has been completed, and there are no active trials at this time. The drug remains investigational and has not been approved by the FDA for any indication.
Oritavancin has been studied in one completed Phase 1 trial, NCT02471690, titled "Study to Evaluate the Safety, Tolerability and Pharmacokinetics of a New Formulation of Oritavancin in Healthy Volunteers." The trial enrolled 56 healthy adult volunteers in the United States and was randomized, double-blind, and placebo-controlled.
The intended use of Oritavancin has not been disclosed. The only completed clinical trial evaluated the safety, tolerability, and pharmacokinetics of a new formulation in healthy volunteers, not in patients with a specific disease. It is an investigational drug and is not approved for any indication.