Tigecycline

Generic Name: Tigecycline

Brand Names: Tygacil, Tigecycline Accord

Drug Type: Small Molecule

Chemical Formula: C_₂₉H_₃₉N_₅O_₈

CAS Number: 220620-09-7

Unique Ingredient Identifier: 70JE2N95KR

Background: 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

Safety Study Evaluating Intravenous Infusions of Tigecycline to Treat Acute Myeloid Leukemia

Phase 1

Completed

Conditions: Acute Myeloid Leukemia

Interventions: Drug: Tigecycline

First Posted Date: 2011-04-11

Last Posted Date: 2015-04-15

Lead Sponsor: University Health Network, Toronto

Target Recruit Count: 27

Registration Number: NCT01332786

Locations: 🇺🇸
University of California, Los Angeles, Los Angeles, California, United States
🇨🇦
Princess Margaret Hospital, Toronto, Ontario, Canada
🇺🇸
The University of Kansas Medical Center, Kansas City, Kansas, United States

Study To Evaluate The Effect Of Single Intravenous Doses Of Tigecycline On QTc Intervals In Healthy Subjects

Phase 1

Completed

Conditions: Healthy

Interventions: Drug: tigecycline
Drug: placebo
Drug: moxifloxacin
Drug: 100 mL 0.9% Sodium Chloride intravenous

First Posted Date: 2011-02-01

Last Posted Date: 2011-05-24

Lead Sponsor: Pfizer

Target Recruit Count: 48

Registration Number: NCT01287793

Locations: 🇺🇸
Pfizer Investigational Site, New Haven, Connecticut, United States

Study Evaluating The Safety And Effectiveness In Subjects With Tigecycline Treatment

Completed

Conditions: Community-Acquired Bacterial Pneumonia
Complicated Skin and Skin Structure Infections
Complicated Intra-abdominal Infections

Interventions: Drug: tigecycline

First Posted Date: 2010-02-22

Last Posted Date: 2023-12-29

Lead Sponsor: Pfizer

Target Recruit Count: 3172

Registration Number: NCT01072539

Locations: 🇰🇷
Hanil Medical Center, Dobong-Gu, Seoul, Korea, Republic of
🇰🇷
Dong-A University Medical Center (Dong-A University Hospital), Busan, Korea, Republic of
🇰🇷
Korea University Ansan Hospital, Gyeonggi-do, Korea, Republic of

and more 30 locations

Study Evaluating Tigecycline Versus Ceftriaxone In Complicated Intra-Abdominal Infections & Community Acquired Pneumonia

Phase 3

Withdrawn

Conditions: Community Acquired Bacterial Pneumonia
Complicated Intra-Abdominal Infection

Interventions: Drug: Tigecycline

First Posted Date: 2009-06-05

Last Posted Date: 2012-06-07

Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Registration Number: NCT00914888

Study Evaluating Tigecycline Versus Clindamycin Or Vancomycin On Complicated Skin And Skin Structure Infections Including Those Due To Methicillin-Resistant Staphylococcus Aureus (MRSA) In Pediatric Subjects

Phase 3

Withdrawn

Conditions: Skin Diseases
Infection

Interventions: Drug: Clindamycin (or Vancomycin if needed)
Drug: Tigecycline

First Posted Date: 2009-06-02

Last Posted Date: 2012-06-07

Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Registration Number: NCT00911573

Post-Authorization Study Evaluating Safety Of Tigecycline

Completed

Conditions: Intra-Abdominal Infections
Skin Disease, Infectious
Soft Tissues Infections

Interventions: Drug: Tigecycline

First Posted Date: 2009-01-22

Last Posted Date: 2012-02-01

Lead Sponsor: Pfizer

Target Recruit Count: 115

Registration Number: NCT00827541

Safety and Efficacy Study of a Fluoroquinolone to Treat Complicated Skin Infections

Phase 2

Completed

Conditions: Skin Structure Infections
Bacterial Skin Diseases
Staphylococcal Skin Infections

Interventions: Drug: delafloxacin
Drug: tigecycline

First Posted Date: 2008-07-22

Last Posted Date: 2014-07-14

Lead Sponsor: Melinta Therapeutics, Inc.

Target Recruit Count: 150

Registration Number: NCT00719810

Locations: 🇺🇸
Riverside Methodist Hospital, Columbus, Ohio, United States
🇺🇸
Physician Alliance Research Center, Anaheim, California, United States
🇺🇸
Tri City Medical Center, Oceanside, California, United States

and more 9 locations