Oritavancin

Overview

Oritavancin is a glycopeptide antibiotic used for the treatment of skin infections. It was developed by The Medicines Company (acquired by Novartis). Oritavancin was initially approved by the FDA in 2014 and formulated to combat susceptible gram-positive bacteria that cause skin and skin structure infections. It boasts the option of single-dose administration and has been proven as non-inferior to a full course of vancomycin therapy. On March 12, 2021 the FDA approved Kimyrsa, a complete course of therapy in a single, 1 hour 1200 mg infusion. Orbactiv, the other FDA approved oritavancin product, is administered over a 3 hour infusion and contains a lower dose of 400 mg. Marketed by Melinta Therapeutics, Kimyrsa offers effective and time-efficient treatment for skin and skin structure infections.

Indication

用于治疗由下列易感分离株革兰氏阳性微生物所致急性细菌皮肤和皮肤结构感染(ABSSSI)成年患者的治疗。如金黄色葡萄球菌(包括甲氧西林-易感和甲氧西林–耐药分离株)，化脓性链球菌，无乳链球菌，停乳链球菌，咽峡炎链球菌群(包括咽颊炎链球菌，中间型链球菌,和星座链球菌)，和粪肠球菌(万古霉素-仅易感分离株)。

Associated Conditions

Skin and skin structure infections

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Study to Evaluate the Safety and Tolerability of Single-Dose Intravenous (IV) Oritavancin	2022/10/31	NCT05599295	Phase 2	Recruiting	Melinta Therapeutics, LLC
Anchoring Sequential Intermittent Long Acting Antimicrobials With Medication for Opioid Use Disorder (MOUD) for Invasive Infections Related to Opioid Use	2022/08/30	NCT05521880	Phase 4	Terminated	University of Maryland, Baltimore
Relative Exposure and Safety Study of Kimyrsa in ABSSSI Patients	2019/03/14	NCT03873987	Phase 1	Completed	Melinta Therapeutics, Inc.
Oritavancin for Staphylococcus Aureus Infections in Opioid Users	2018/12/03	NCT03761953	Phase 4	Withdrawn	University of Pennsylvania
A Retrospective Observational Study to Evaluate the Utilization, Outcomes, and Adverse Events in Participants Treated With Orbactiv® (Oritavancin) for Infections Caused by Gram Positive Bacteria in a Real World Setting	2017/05/18	NCT03159403	N/A	Completed	Melinta Therapeutics, Inc.
Safety of Either a Single or Two Intravenous Doses of Orbactiv in Participants With Acute Bacterial Skin and Skin Structure Infection	2016/10/05	NCT02925416	Phase 4	Completed	The Medicines Company
Study to Evaluate the Safety, Tolerability and Pharmacokinetics of a New Formulation of Oritavancin in Healthy Volunteers	2015/06/15	NCT02471690	Phase 1	Completed	The Medicines Company
Multiple Oritavancin Doses on Safety, Tolerability, and Pharmacokinetics in Healthy Subjects	2015/06/12	NCT02470702	Phase 1	Completed	Melinta Therapeutics, Inc.
A Study to Evaluate the Safety of a Single Intravenous (IV) Dose of Orbactiv (Oritavancin) in Participants on Chronic Warfarin Therapy Being Treated For Acute Bacterial Skin and Skin Structure Infection (ABSSSI)	2015/05/25	NCT02452918	Phase 4	Completed	The Medicines Company
Oritavancin on the Results of Multiple Coagulation Tests in Healthy Volunteers	2015/02/06	NCT02357524	Phase 1	Completed	Melinta Therapeutics, Inc.

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Kimyrsa	Melinta Therapeutics, LLC	70842-225	INTRAVENOUS	1200 mg in 40 mL	7/30/2021
Orbactiv	Melinta Therapeutics, LLC	70842-140	INTRAVENOUS	400 mg in 1 1	2/25/2022

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
No HSA approvals found for this drug.

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
No TGA approvals found for this drug.

AI-Powered Research

Premium Access