Tigecycline

Overview

Tigecycline is a glycylcycline antibiotic developed and marketed by Wyeth under the brand name Tygacil. It was developed in response to the growing prevalence of antibiotic resistance in bacteria such as Staphylococcus aureus. It was granted fast-track approval by the U.S. Food and Drug Administration (FDA) on June 17, 2005.

Indication

For the treatment of infections caused by susceptible strains of the designated microorganisms in the following conditions: Complicated skin and skin structure infections caused by Escherichia coli, Enterococcus faecalis (vancomycin-susceptible isolates only), Staphylococcus aureus (methicillin-susceptible and -resistant isolates), Streptococcus agalactiae, Streptococcus anginosus grp. (includes S. anginosus, S. intermedius, and S. constellatus), Streptococcus pyogenes and Bacteroides fragilis. Complicated intra-abdominal infections caused by Citrobacter freundii, Enterobacter cloacae, Escherichia coli, Klebsiella oxytoca, Klebsiella pneumoniae, Enterococcus faecalis (vancomycin-susceptible isolates only), Staphylococcus aureus (methicillin-susceptible isolates only), Streptococcus anginosus grp. (includes S. anginosus, S. intermedius, and S. constellatus), Bacteroides fragilis, Bacteroides thetaiotaomicron, Bacteroides uniformis, Bacteroides vulgatus, Clostridium perfringens, and Peptostreptococcus micros.

Associated Conditions

Bacterial Infections
Community Acquired Pneumonia (CAP)
Complicated Intra-Abdominal Infections (cIAIs)
Complicated Skin and Skin Structure Infection

Clinical Trials

Title	Posted	Study ID	Phase	Status	Sponsor
Comparative Study of Clinical Outcomes and Safety Between Colistin and Tigecycline	2025/03/25	NCT06893835	Phase 4	Active, not recruiting	Beni-Suef University
Predictors of Antimicrobial Resistance in the Respiratory Intensive Care Unit of Alexandria Main University Hospital	2024/12/27	NCT06750744	N/A	Completed	Mohamed Sabry
Comparing Tigecycline Vs. Colistimethate in CNS Infections	2024/11/25	NCT06702943	N/A	Not yet recruiting	Ain Shams University
Antibiotic Therapy for Infectious Diseases	2021/06/24	NCT04937894	N/A	Recruiting	Shandong University
Comparative Clinical Study Between Colistin-Tigecycline Combined Therapy Versus Colistin-Meropenem Combined Therapy in Treatment of Blood Stream Infections With Multidrug-Resistant Klebsiella Pneumoniae	2020/07/28	NCT04489459	Phase 4	UNKNOWN	Al-Azhar University
Finding the Optimal Regimen for Mycobacterium Abscessus Treatment	2020/03/17	NCT04310930	Phase 2	Recruiting	The University of Queensland
A Randomized Controlled Trial Comparing Imipenem and Tigecycline Versus Imipenem and Tigecycline With GM-CSF for the Management of Spontaneous Bacterial Peritonitis Presenting With Septic Shock.	2019/12/23	NCT04208763	Not Applicable	UNKNOWN	Institute of Liver and Biliary Sciences, India
Delafloxacin IV and OS Administration Compared to Best Available Therapy in Patients With Surgical Site Infections	2019/08/01	NCT04042077	Phase 3	Terminated	Menarini Group
Personalized Treatment of Urogenital Cancers Depends on the Microbiome	2019/05/24	NCT03962920	Not Applicable	Recruiting	Zealand University Hospital
The Combined Antibiotic Therapy for Carbapenem Resistant Klebsiella Pneumoniae	2019/05/15	NCT03950544	Early Phase 1	UNKNOWN	Shanghai 10th People's Hospital

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Tigecycline	Meitheal Pharmaceuticals Inc.	71288-019	INTRAVENOUS	50 mg in 5 mL	5/13/2021
Tigecycline	AuroMedics Pharma LLC	55150-228	INTRAVENOUS	50 mg in 1 1	4/13/2022
Tigecycline	Eugia US LLC	55150-228	INTRAVENOUS	50 mg in 1 1	4/13/2022
Tigecycline	Apotex Corp	60505-6098	INTRAVENOUS	50 mg in 5 mL	3/13/2023
Tygacil	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	0008-4990	INTRAVENOUS	50 mg in 5 mL	5/31/2021
TIGECYCLINE	Accord Healthcare Inc.	16729-364	INTRAVENOUS	50 mg in 10 mL	9/16/2021
Tygacil	Wyeth Pharmaceuticals LLC, a subsidiary of Pfizer Inc.	0008-4994	INTRAVENOUS	50 mg in 5 mL	5/31/2021
Tigecycline	Sandoz Inc	0781-3481	INTRAVENOUS, PARENTERAL	50 mg in 10 mL	6/29/2020
Tigecycline	Amneal Pharmaceuticals LLC	70121-1647	INTRAVENOUS	50 mg in 5 mL	12/27/2020

EMA Drug Approvals

Approved Product	Authorization Holder	Status	Issued Date
Tigecycline Accord	Accord Healthcare S.L.U.,Edificio Este Planta 6a,World Trade Center,Moll De Barcelona S/n,08039 Barcelona,SPAIN	Authorised	4/17/2020
Tygacil	Pfizer Europe MA EEIG,Boulevard de la Plaine 17,1050 Bruxelles,Belgium	Authorised	4/24/2006

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
TIGECCORD TIGECYCLINE FOR INJECTION USP 50 MG/VIAL	Intas Pharmaceuticals Limited, INTAS PHARMACEUTICALS LIMITED	SIN16104P	INJECTION, POWDER, FOR SOLUTION	50 mg	2/15/2021
Tygacil(TM) (Tigecycline) Injection 50mg	Wyeth Lederle S.r.l.	SIN13282P	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION	50 mg/ml	5/21/2007

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
TYGACIL FOR INJ 50MG	N/A	Pfizer Corporation Hong Kong Limited	N/A	N/A	10/5/2006

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
TYGACIL tigecycline 50 mg powder for injection	147450	Pfizer Australia Pty Ltd	Medicine	A	5/14/2008
TIGECYCLINE JUNO tigecycline 50 mg Powder for injection Glass vial	275811	Juno Pharmaceuticals Pty Ltd	Medicine	A	4/11/2017
TIGECYCLINE INTAS tigecycline 50 mg powder for injection vial	331681	Accord Healthcare Pty Ltd	Medicine	A	2/11/2021
TYGACYCLINE tigecycline 50 mg Powder for injection Glass vial	275814	MedTAS Pty Ltd	Medicine	A	4/11/2017
TYGALINE tigecycline 50 mg Powder for injection Glass vial	275813	MedTAS Pty Ltd	Medicine	A	4/11/2017
TIGECYCLE tigecycline 50 mg Powder for injection Glass vial	275812	Steriscience Pty Ltd	Medicine	A	4/11/2017
TIGECYCLINE ACCORD tigecycline 50 mg powder for injection vial	331680	Accord Healthcare Pty Ltd	Medicine	A	2/11/2021

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
TIGECYCLINE FOR INJECTION	pharmaris canada inc	02484749	Powder For Solution - Intravenous	50 MG / VIAL	N/A
TIGECYCLINE	Apotex Inc	02409356	Powder For Solution - Intravenous	50 MG / VIAL	10/23/2014
TYGACIL	Pfizer Canada Ulc	02285401	Powder For Solution - Intravenous	50 MG / VIAL	11/30/2006

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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