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CLINICAL TRIALS PROFILE FOR KIMYRSA

505(b)(2) Clinical Trials for KIMYRSA

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Formulation	NCT03873987 ↗	Relative Exposure and Safety Study of Kimyrsa in ABSSSI Patients	Completed	Melinta Therapeutics, Inc.	Phase 1	2019-07-16	This study is being conducted to evaluate the pharmacokinetic (PK) and safety of Kimyrsa versus the approved oritavancin formulation in subjects with acute bacterial skin and skin structure infection (ABSSSI). Kimyrsa adjusts the infusion time, concentration and reconstitution/administration solutions of a single 1200 mg intravenous (IV) infusion of oritavancin

All Clinical Trials for KIMYRSA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03873987 ↗	Relative Exposure and Safety Study of Kimyrsa in ABSSSI Patients	Completed	Melinta Therapeutics, Inc.	Phase 1	2019-07-16	This study is being conducted to evaluate the pharmacokinetic (PK) and safety of Kimyrsa versus the approved oritavancin formulation in subjects with acute bacterial skin and skin structure infection (ABSSSI). Kimyrsa adjusts the infusion time, concentration and reconstitution/administration solutions of a single 1200 mg intravenous (IV) infusion of oritavancin
NCT05599295 ↗	Study to Evaluate the Safety and Tolerability of Single-Dose Intravenous (IV) Oritavancin	Not yet recruiting	Melinta Therapeutics, Inc.	Phase 2	2022-10-31	This protocol describes a randomized, open-label study to evaluate the safety and tolerability of single-dose intravenous (IV) oritavancin diphosphate (oritavancin) versus standard of care (SoC) antibiotics for the treatment of pediatric subjects with acute bacterial skin and skin structure infections (ABSSSIs). This study involves two oritavancin products, ORBACTIV® and KIMYRSATM. Oritavancin is the active drug substance in both ORBACTIV and KIMYRSA. This study protocol distinguishes the differences between ORBACTIV and KIMYRSA by providing product-specific data, and information and guidance for Investigators. "Oritavancin" is used to describe drug product data, and information and guidance that is not specific to ORBACTIV or KIMYRSA (i.e., applies to both). The study involves pharmacokinetic (PK) sampling and will evaluate clinical outcome assessments. The study was designed to capture adequate data while minimizing the impact to subjects and their caregivers.

Clinical Trial Conditions for KIMYRSA

Condition Name

Condition Name for KIMYRSA
Intervention	Trials
Acute Bacterial Skin and Skin Structure Infection	2

Condition MeSH

Condition MeSH for KIMYRSA
Intervention	Trials
Skin Diseases, Bacterial	2
Infections	1

Clinical Trial Locations for KIMYRSA

Trials by Country

Trials by Country for KIMYRSA
Location	Trials
United States	4

Trials by US State

Trials by US State for KIMYRSA
Location	Trials
Georgia	1
New Jersey	1
Illinois	1
California	1

Clinical Trial Progress for KIMYRSA

Clinical Trial Phase

Clinical Trial Phase for KIMYRSA
Clinical Trial Phase	Trials
Phase 2	1
Phase 1	1

Clinical Trial Status

Clinical Trial Status for KIMYRSA
Clinical Trial Phase	Trials
Completed	1
Not yet recruiting	1

Clinical Trial Sponsors for KIMYRSA

Sponsor Name

Sponsor Name for KIMYRSA
Sponsor	Trials
Melinta Therapeutics, Inc.	2

Sponsor Type

Sponsor Type for KIMYRSA
Sponsor	Trials
Industry	2