Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Current Formulation of Oritavancin, Orbactiv, Kimyrsa
Oritavancin · 3 trials · 2 indications
Relative exposure of AUC of the new formulation to the approved formulation of oritavancin based on area under the plasma concentration-time curve from time zero to 72 hr (AUC0-72)
PK parameters (AUC)
| Arm | Type | Description |
|---|---|---|
| Orbactiv | EXPERIMENTAL | Orbactiv will be infused at 15 milligrams/kilogram (mg/kg) over 3 hours for all participants and will not exceed a dose of 1200 mg. |
| Kimyrsa | EXPERIMENTAL | Kimyrsa will be infused at 15 mg/kg over 3 hours for all participants and will not exceed a dose of 1200 mg. |
| Current Formulation of Oritavancin | ACTIVE_COMPARATOR | Three single-use vials, each containing 400 mg (1200 mg total) of oritavancin diphosphate (as the free base) and the inactive component mannitol. Oritavancin vials will be reconstituted with SWFI and further diluted in D5W for a total volume of 1000 mL and infused intravenously over 3 hours. |
| Oritavancin | EXPERIMENTAL | Single-dose IV Oritavancin Diphosphate |
| Name | Type | Description |
|---|---|---|
| Orbactiv | DRUG | Solution for IV infusion |
| Kimyrsa | DRUG | Solution for IV infusion |
| Current Formulation of Oritavancin | DRUG | Current formulation of oritavancin (3 hour infusion of 1200 mg in 1000 ml of D5W) |
| Oritavancin | DRUG | - |
Inclusion Criteria: 1. Male or female, 3 months to \<12 years of age at randomization 2. Diagnosis of at least 1 of the following ABSSSI infections (known or suspected to be caused by a gram-positive pathogen): 1. Wound infection: that is either traumatic or surgical in origin, defined as an in...
Oritavancin is being studied for the treatment of acute bacterial skin and skin structure infections and other Gram-positive bacterial infections. It is an infectious disease therapy developed by CorMedix Inc. under the ticker CRMD. The drug is currently in Phase 1 clinical development.
Oritavancin is being developed by CorMedix Inc., which trades on the Nasdaq under the ticker CRMD. The company is advancing the drug for acute bacterial skin and skin structure infections and Gram-positive bacterial infections.
Oritavancin is in Phase 1 clinical development. It has completed one Phase 1 trial and has no active trials at this time. The drug is investigational and has not been approved by the FDA for any indication.
Oritavancin has been evaluated in two completed Phase 1 trials. NCT03873987 was a relative exposure and safety study in patients with acute bacterial skin and skin structure infection, enrolling 102 participants. NCT02134301 was an open-label, dose-finding pharmacokinetics, safety, and tolerability study in pediatric participants with suspected or confirmed bacterial infections, enrolling 41 participants.
Yes, Oritavancin is also known as the Current Formulation of Oritavancin. Both names refer to the same investigational drug being developed by CorMedix Inc. for acute bacterial skin and skin structure infections and Gram-positive bacterial infections.