Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Current Formulation of Oritavancin · 1 trial · 1 indication
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)
| Arm | Type | Description |
|---|---|---|
| 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. |
| Kimyrsa | EXPERIMENTAL | A single vial containing 1200 mg of oritavancin, HPβCD, and mannitol. Kimyrsa vials will be reconstituted with SWFI and further diluted with 0.9% sodium chloride for a total volume of 250 mL and infused intravenously over 1 hour. |
| Name | Type | Description |
|---|---|---|
| Current Formulation of Oritavancin | DRUG | Current formulation of oritavancin (3 hour infusion of 1200 mg in 1000 ml of D5W) |
| Kimyrsa | DRUG | New formulation of oritavancin (1 hour infusion of 1200 mg in 250 ml of saline) |
Inclusion Criteria: Subjects may be included in the study if they meet all of the following criteria: 1. Subject must be 18 years of age or older, male or female, and of any race. 2. Subject must give written informed consent before initiation of any study-related procedures. 3. Diagnosis of ABSSS...
Current Formulation of Oritavancin is an investigational small molecule being studied for gram-positive bacterial infections, acute bacterial skin and skin structure infection (ABSSSI), and in healthy volunteers. It is in Phase 1 clinical development and is not yet approved by the FDA.
Current Formulation of Oritavancin is being developed by CorMedix Inc., a biopharmaceutical company traded on the NYSE American under the ticker symbol CRMD. The company is conducting Phase 1 clinical trials to evaluate the drug's safety, tolerability, and pharmacokinetics.
Current Formulation of Oritavancin is in Phase 1 clinical development. All four clinical trials listed for this drug have been completed, with a total enrollment of 102 participants. The drug remains investigational and has not received FDA approval.
Current Formulation of Oritavancin has completed four Phase 1 trials: NCT02134301 in pediatric participants with gram-positive bacterial infections, NCT02357524 in healthy volunteers in New Zealand, NCT02470702 in healthy subjects in the US, and NCT03873987 in ABSSSI patients. All trials are completed.
Current Formulation of Oritavancin is the drug being studied in the clinical trial NCT03873987, which is titled 'Relative Exposure and Safety Study of Kimyrsa in ABSSSI Patients.' This indicates that Kimyrsa is the brand name or alternative name for the formulation being tested in that trial.