Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as Oritavancin, Current Formulation of Oritavancin
Orbactiv · 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...
Orbactiv is used for the treatment of Acute Bacterial Skin and Skin Structure Infection (ABSSSI). It is a small molecule being developed by CorMedix Inc. for this infectious disease indication. The drug is currently in clinical development and has been studied in pediatric patients with skin infections.
Orbactiv is being developed by CorMedix Inc., a biopharmaceutical company. CorMedix Inc. is publicly traded under the ticker symbol CRMD. The company is conducting clinical trials to evaluate the safety and efficacy of Orbactiv for the treatment of skin infections.
Orbactiv is in Phase 2 clinical development. A Phase 2 clinical trial has been completed to evaluate the safety of intravenous oritavancin for the treatment of children with skin infections. The drug is investigational and has not been approved by regulatory authorities.
Orbactiv has been studied in one clinical trial with the identifier NCT05599295. This Phase 2 study evaluated the safety of intravenous oritavancin for the treatment of children with skin infections. The trial was completed and enrolled 118 participants across multiple countries including the United States, Bulgaria, Greece, Latvia, Lithuania, Portugal, Romania, and Spain.
Orbactiv is the brand name for the drug oritavancin. The clinical trial NCT05599295 specifically evaluated intravenous oritavancin for the treatment of children with skin infections. Oritavancin is the active pharmaceutical ingredient in Orbactiv, which is being developed by CorMedix Inc.
Orbactiv is being developed for the treatment of Acute Bacterial Skin and Skin Structure Infection (ABSSSI). In a completed Phase 2 clinical trial, the drug was evaluated for safety in children aged 3 months and older with skin infections. The study was controlled and enrolled 118 participants.