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

Research Report

Published: Aug 3, 2025

Tigecycline (DB00560): A Comprehensive Monograph on a Last-Resort Glycylcycline Antibiotic

Section 1: Introduction to Tigecycline

1.1 A First-in-Class Agent for a Resistant Era

Tigecycline represents the first clinically available member of the glycylcycline class of antibiotics, a novel therapeutic category derived from the well-established tetracyclines.[1] Developed by Wyeth Pharmaceuticals (now part of Pfizer) and marketed under the brand name Tygacil, its creation was a direct and necessary response to the escalating global public health crisis of antimicrobial resistance (AMR).[3] The primary impetus for its development was the urgent need for new agents with activity against a growing list of multidrug-resistant (MDR) pathogens, most notably methicillin-resistant

Staphylococcus aureus (MRSA), vancomycin-resistant enterococci (VRE), and Gram-negative organisms producing extended-spectrum β-lactamases (ESBLs).[5] Its expedited approval by the U.S. Food and Drug Administration (FDA) underscored the critical gap in the therapeutic armamentarium that Tigecycline was designed to fill.[3]

1.2 The Central Paradox: Potency vs. Peril

Continue reading the full research report

Clinical Trials

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Title	Posted	Study ID	Phase	Status	Sponsor
Study Evaluating the Safety and Efficacy of Intravenous Tigecycline to Treat Hospitalized Japanese Subjects	2007/12/17	NCT00575094	Phase 3	Completed	Wyeth is now a wholly owned subsidiary of Pfizer
Study Evaluating the Pharmacokinetics (PK), Safety, and Tolerability of Tigecycline in Patients 8 to 11 Years of Age	2007/06/20	NCT00488345	Phase 2	Completed	Wyeth is now a wholly owned subsidiary of Pfizer
A Pharmacovigilance Evaluation And Assessment Of The Prescribing Practice For Tygacil In Usual Health Care Setting	2007/06/20	NCT00488488	N/A	Completed	Pfizer
Study Evaluating the Safety and Efficacy of Tigecycline in Hospitalized Patients With cSSSI	2007/06/20	NCT00488761	Phase 4	Completed	Wyeth is now a wholly owned subsidiary of Pfizer
Study Evaluating the Safety and Efficacy of Tigecycline in Hospitalized Patients With cIAI	2007/06/20	NCT00488306	Phase 4	Completed	Wyeth is now a wholly owned subsidiary of Pfizer
Health Economic Assessment of Tygacil® in the Treatment of Secondary Peritonitis in Intensive Care Units (ICUs)	2007/06/04	NCT00481962	N/A	Completed	Wyeth is now a wholly owned subsidiary of Pfizer
Open Label Non-comparative Clinical Trial of Tigecycline in Patients With Catheter Infection	2007/01/09	NCT00419991	Phase 4	Completed	CPL Associates
Pharmacokinetic Study Of Tigecycline In Adult Subjects With Primary Biliary Cirrhosis	2006/12/04	NCT00406237	Phase 1	Completed	Wyeth is now a wholly owned subsidiary of Pfizer
Study Evaluating the Pharmacokinetics of Tigecycline in Human Bone	2006/09/14	NCT00376324	Phase 1	Completed	Wyeth is now a wholly owned subsidiary of Pfizer
Study Comparing the Safety and Efficacy of Tigecycline With Ampicillin-Sulbactam or Amoxicillin-Clavulanate to Treat Skin Infections	2006/08/24	NCT00368537	Phase 4	Completed	Wyeth is now a wholly owned subsidiary of Pfizer

FDA Drug Approvals

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EMA Drug Approvals

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HSA Drug Approvals

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NMPA Drug Approvals

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PPB Drug Approvals

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TGA Drug Approvals

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Health Canada Drug Approvals

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CIMA AEMPS Drug Approvals

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Philippines FDA Drug Approvals

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Saudi SFDA Drug Approvals

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Malaysia NPRA Drug Approvals

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UK EMC Drug Information

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