Tigecycline

also known as TGC · Tygacil · Haizheng Li Xing · tegecycline · Tigeciclina · Tigecycline accord · tigecycline: tygacil 50 mg vial. · WAY-GAR-936

Small molecule

Developed for: bacterial pneumonia · bacterial infectious disease · pulmonary non-tuberculous mycobacterial infection · abscess · gram-positive bacterial infections · infectious disease · nosocomial infection · skin infection
+24 more
· acute myeloid leukemia · acute pyelonephritis · bacterial meningitis · Clostridium difficile colitis · diarrheal disease · digestive system infectious disorder · gram-negative bacterial infections · intestinal infectious disease · Klebsiella pneumonia · methicillin-resistant staphylococcus aureus infectious disease · peritonitis · scrub typhus · skin disease caused by bacterial infection · skin disorder · ventilation pneumonitis · appendicitis · cholecystitis · diverticulitis · infectious disease with sepsis · infectious peritonitis · osteomyelitis · primary bacterial infectious disease · staphylococcal infection · urinary tract infection
Investigated by: Wyeth is now a wholly owned subsidiary of Pfizer · Pfizer · University of California, San Diego · The University of Queensland · Achaogen, Inc. · Ain Shams University
+37 more
· Air Force Specialized Hospital, Cairo, Egypt · Australian Government Department of Health and Ageing · Beni-Suef University · Cairo University · Children's Hospital Foundation · Clinica Universidad de Navarra, Universidad de Navarra · Cystic Fibrosis Foundation · Department of Health and Human Services · Erasmus Medical Center · Gary E. Stein, Pharm.D. · Griffith University · Innoviva Specialty Therapeutics · Jin Soo Lee · Korean Center for Disease Control and Prevention · Mahidol University · Manjunath Prakash Pai · Memorial Sloan Kettering Cancer Center · Monash University · Murdoch Childrens Research Institute · National Institutes of Health (NIH) · Newcastle University · Phramongkutklao College of Medicine and Hospital · QIMR Berghofer Medical Research Institute · Shanghai 10th People's Hospital · Silpakorn University · South Australian Health and Medical Research Institute · Tanta University · The University of Texas Health Science Center at Tyler · Tianjin Medical University Cancer Institute and Hospital · University Health Network, Toronto · University of California, Los Angeles · University of Copenhagen · University of Kansas · University of Melbourne · University of Navarrra Hospital (Clinica Universitaria) · Zhejiang Hisun Pharmaceutical Co. Ltd. · yilong Wang

Regulatory milestones approvals, filings & regulatory actions · 3 recorded

Milestone	Jurisdiction	Brand	Indication	Date	Sentence it was read from
Label expansion	US (FDA)	TYGACIL	—	2009-03-20	fda.gov ↗
Approved	EU (EMA)	Tygacil	—	2006-04-24	europa.eu ↗
Approved	US (FDA)	TYGACIL	—	2005-06-15	fda.gov ↗

Trials 42

today

US approved 2005

EU approved 2006

NCT07485010 · Ph 2 NCT07826351 · not/applicable NCT07524920 · Ph 2 NCT07258225 · Ph 4 NCT05862402 · Ph 4 NCT07366372 · not/applicable NCT07513103 · not/applicable NCT06739382 · Ph 3 NCT04310930 · Ph 2/3 NCT03950544 · Ph 0 NCT01970371 · Ph 3 NCT02191475 · Ph 2/3 NCT02040818 · Ph 2/3 NCT01721408 · Ph 4 NCT01592032 · Ph 4 NCT01560143 · Ph 4 NCT01483872 · Ph 3 NCT00911573 · Ph 3 NCT01401023 · not/applicable NCT01342731 · Ph 4 NCT01332786 · Ph 1 NCT01602874 · Ph 3 NCT01287793 · Ph 1 NCT00914888 · Ph 3 NCT00707239 · Ph 2 NCT00488345 · Ph 2 NCT00575094 · Ph 3 NCT00406237 · Ph 1 NCT00614679 · Ph 1 NCT00376324 · Ph 1 NCT00488306 · Ph 4 NCT00488761 · Ph 4 NCT00136201 · Ph 3 NCT00205816 · Ph 3 NCT00081575 · Ph 3 NCT00079989 · Ph 3 NCT00079885 · Ph 3 NCT00079976 · Ph 3 NCT00080496 · Ph 3 NCT00081744 · Ph 3 NCT00228410 · Ph 3 NCT00600600 · Ph 2

2002200320042005200620072008200920102011201220132014201520162017201820192020202120222023202420252026202720282029203020312032

Phase	Registry id	Dates	Indication	Sponsor	Status	Outcome
Phase 01 trial
Phase 0	NCT03950544	Jan 2019 → Aug 2020	bacterial infectious disease	Shanghai 10th People's Hospital	Unknown	No outcome recorded
Phase 15 trials · 1 met primary
Phase 1	NCT01332786	Mar 2011 → Oct 2014	acute myeloid leukemia	University Health Network, Toronto	Completed	No outcome recorded
Phase 1	NCT01287793	Jan → May 2011	—	Pfizer	Completed	Met primary
Phase 1	NCT00406237	Dec 2006 → Mar 2009	cirrhosis of liver	Wyeth is now a wholly owned subsidiary of Pfizer	Completed	No outcome recorded
Phase 1	NCT00614679	Oct 2006 → Dec 2008	end stage renal failure	University of California, San Diego	Completed	No outcome recorded
Phase 1	NCT00376324	Sep 2006 → Oct 2008	—	Wyeth is now a wholly owned subsidiary of Pfizer	Completed	No outcome recorded
Phase 25 trials · 1 missed
Phase 2	NCT07485010	Apr 2027 → Apr 2031 expected	pulmonary non-tuberculous mycobacterial infection	The University of Queensland	Not yet recruiting	No outcome recorded
Phase 2	NCT07524920	Apr → Aug 2026 overdue	bacterial infectious disease	Ain Shams University	Not yet recruiting	No outcome recorded
Phase 2	NCT00707239	Dec 2008 → Jun 2011	bacterial pneumonia	Pfizer	Terminated	Missed primary
Phase 2	NCT00488345	Dec 2007 → Sep 2009	bacterial pneumonia, peritonitis, skin disease caused by bacterial infection	Wyeth is now a wholly owned subsidiary of Pfizer	Completed	No outcome recorded
Phase 2	NCT00600600	Apr 2002 → Apr 2010	pulmonary non-tuberculous mycobacterial infection	The University of Texas Health Science Center at Tyler	Completed	No outcome recorded
Phase 2/33 trials
Phase 2/3	NCT04310930	Mar 2020 → Jun 2029 expected	pulmonary non-tuberculous mycobacterial infection	The University of Queensland	Recruiting	No outcome recorded
Phase 2/3	NCT02191475	May 2014 → May 2017	digestive system infectious disorder	Tianjin Medical University Cancer Institute and Hospital	Unknown	No outcome recorded
Phase 2/3	NCT02040818	Nov 2013 → Jan 2017	—	University of California, San Diego	Withdrawn	No outcome recorded Stop: Enrollment
Phase 316 trials · 3 met primary · 1 missed
Phase 3	NCT06739382	Jan → Dec 2021	ventilation pneumonitis	Beni-Suef University	Completed	No outcome recorded
Phase 3	NCT01970371	Sep 2014 → Aug 2016	acute pyelonephritis, bacterial pneumonia	Achaogen, Inc.	Completed	Missed primary
Phase 3	NCT01483872	Mar 2012 → Sep 2013	—	University of California, San Diego	Terminated	No outcome recorded Stop: Enrollment
Phase 3	NCT00911573	Aug 2011 → May 2014	infectious disease, skin disorder	Wyeth is now a wholly owned subsidiary of Pfizer	Withdrawn	No outcome recorded
Phase 3	NCT01602874	Jan 2011 → May 2014	bacterial pneumonia	Pfizer	Withdrawn	No outcome recorded
Phase 3	NCT00914888	Jan 2011 → May 2014	bacterial pneumonia	Wyeth is now a wholly owned subsidiary of Pfizer	Withdrawn	No outcome recorded
Phase 3	NCT00575094	Nov 2007 → Mar 2008	bacterial infectious disease	Wyeth is now a wholly owned subsidiary of Pfizer	Completed	No outcome recorded
Phase 3	NCT00136201	Nov 2005 → Dec 2006	abscess	Wyeth is now a wholly owned subsidiary of Pfizer	Completed	No outcome recorded
Phase 3	NCT00205816	Jan 2004 → Nov 2005	bacterial infectious disease	Wyeth is now a wholly owned subsidiary of Pfizer	Completed	No outcome recorded
Phase 3	NCT00081575	Jan 2004 → Mar 2005	bacterial pneumonia, nosocomial infection	Wyeth is now a wholly owned subsidiary of Pfizer	Completed	Met primary
Phase 3	NCT00079989	Dec 2003 → Nov 2005	gram-negative bacterial infections	Wyeth is now a wholly owned subsidiary of Pfizer	Completed	No outcome recorded
Phase 3	NCT00079885	Nov 2003 → Jul 2005	bacterial pneumonia	Wyeth is now a wholly owned subsidiary of Pfizer	Completed	Met primary
Phase 3	NCT00079976	Oct 2003 → Jun 2005	gram-positive bacterial infections, methicillin-resistant staphylococcus aureus infectious disease	Wyeth is now a wholly owned subsidiary of Pfizer	Completed	No outcome recorded
Phase 3	NCT00080496	Jul 2003 → Dec 2006	bacterial pneumonia	Wyeth is now a wholly owned subsidiary of Pfizer	Completed	No outcome recorded
Phase 3	NCT00081744	Nov 2002 → Aug 2004	gram-positive bacterial infections, nosocomial infection	Wyeth is now a wholly owned subsidiary of Pfizer	Completed	Met primary
Phase 3	NCT00228410	Nov 2002 → Dec 2003	skin infection	Wyeth is now a wholly owned subsidiary of Pfizer	Completed	No outcome recorded

Phase 48 trials · 1 met primary
Phase 4	NCT07258225	Apr 2024 → Feb 2026 overdue	—	Air Force Specialized Hospital, Cairo, Egypt	Active not recruiting	No outcome recorded
Phase 4	NCT05862402	May 2023 → May 2024	Klebsiella pneumonia	Phramongkutklao College of Medicine and Hospital	Unknown	No outcome recorded
Phase 4	NCT01721408	Nov 2012 → Oct 2015	intestinal infectious disease	Pfizer	Completed	Met primary
Phase 4	NCT01592032	May 2012 → Jan 2015	bacterial infectious disease, prosthesis-related infectious disease	Clinica Universidad de Navarra, Universidad de Navarra	Unknown	No outcome recorded
Phase 4	NCT01560143	Mar → May 2012	obesity disorder	Manjunath Prakash Pai	Completed	No outcome recorded
Phase 4	NCT01342731	Jul 2011 → Jun 2012	infectious disease	Mahidol University	Unknown	No outcome recorded
Phase 4	NCT00488306	Aug 2006 → Aug 2007	abscess	Wyeth is now a wholly owned subsidiary of Pfizer	Completed	No outcome recorded
Phase 4	NCT00488761	Jul 2006 → Aug 2007	skin infection	Wyeth is now a wholly owned subsidiary of Pfizer	Completed	No outcome recorded
Phase not applicable4 trials
—	NCT07826351	Sep 2026 → Jan 2027 expected	bacterial meningitis	yilong Wang	Not yet recruiting	No outcome recorded
—	NCT07366372	May 2023 → Nov 2024	—	Tanta University	Completed	No outcome recorded
—	NCT07513103	Sep 2022 → Jun 2024	scrub typhus	Jin Soo Lee	Completed	No outcome recorded
—	NCT01401023	Jul 2011 → Jul 2013	Clostridium difficile colitis, diarrheal disease	Gary E. Stein, Pharm.D.	Completed	No outcome recorded
Comparator or background therapy19 trials
Phase 2	NCT00719810 Comparator	Jun → Oct 2008	skin disease caused by bacterial infection, skin infection, staphylococcal infection	Melinta Therapeutics, Inc.	Completed	No outcome recorded
Phase 3	NCT07089186 Comparator	Apr 2025 → Dec 2026 expected	bacterial pneumonia, urinary tract infection	Qilu Pharmaceutical Co., Ltd.	Recruiting	No outcome recorded
Phase 3	NCT04042077 Comparator	Sep 2019 → Oct 2020	—	Menarini Group	Terminated	Met primary
Phase 3	NCT00366249 Comparator	Jan 2007 → Mar 2009	bacterial infectious disease, osteomyelitis	Wyeth is now a wholly owned subsidiary of Pfizer	Completed	No outcome recorded
Phase 4	NCT07004049 Comparator	Apr 2025 → Dec 2028 expected	bacterial pneumonia, infectious disease with sepsis	National University of Singapore	Recruiting	No outcome recorded
Phase 4	NCT06893835 Comparator	Dec 2024 → May 2025 overdue	primary bacterial infectious disease	Beni-Suef University	Active not recruiting	No outcome recorded
Phase 4	NCT05977868 Comparator	Aug 2023 → Feb 2025	digestive system infectious disorder	West Virginia University	Terminated	No outcome recorded
Phase 4	NCT05494957 Background	Aug 2022 → Aug 2024	pulmonary non-tuberculous mycobacterial infection	Shanghai Pulmonary Hospital, Shanghai, China	Unknown	No outcome recorded
Phase 4	NCT04882085 Comparator	Aug 2021 → Aug 2023	acute pyelonephritis, bacterial pneumonia, infectious peritonitis	Pfizer	Completed	No outcome recorded
Phase 4	NCT04489459 Comparator	Sep 2019 → Jul 2020	—	Al-Azhar University	Unknown	No outcome recorded
Phase 4	NCT00419991 Comparator	Jan 2007 → May 2008	staphylococcal infection	CPL Associates	Completed	No outcome recorded
Phase 4	NCT00368537 Comparator	Sep 2006 → Sep 2008	skin disease caused by bacterial infection	Wyeth is now a wholly owned subsidiary of Pfizer	Completed	No outcome recorded
Phase 4	NCT00230971 Comparator	Oct 2005 → Sep 2008	abscess, appendicitis, cholecystitis, diverticulitis +2	Wyeth is now a wholly owned subsidiary of Pfizer	Completed	No outcome recorded
Phase 4	NCT00195351 Comparator	Sep 2005 → Feb 2008	appendicitis, cholecystitis, diverticulitis, nosocomial infection +1	Wyeth is now a wholly owned subsidiary of Pfizer	Completed	No outcome recorded
—	NCT07495150 Background	Apr 2026 → Apr 2027 expected	bacterial meningitis	yilong Wang	Not yet recruiting	No outcome recorded
—	NCT06051513 Background	Nov 2023 → Dec 2025 overdue	—	Southeast University, China	Recruiting	No outcome recorded
—	NCT03962920 Comparator	May 2020 → May 2025 overdue	infectious disease	Zealand University Hospital	Recruiting	No outcome recorded
—	NCT04208763 Background	Dec 2019 → Dec 2021	infectious peritonitis	Institute of Liver and Biliary Sciences, India	Unknown	No outcome recorded
—	NCT02800785 Comparator	May 2016 → Mar 2020	appendicitis	University of Washington	Completed	No outcome recorded

Evidence & citations 12 cited values

Every value below carries the sentence it was read from. 65 sources stand behind the page.

Field	Value	Cited text
Known as	Tigecycline	“Antibiotics: Ceftazidime-Avibactam or Combination antibiotics (eg. Meropenem-Colistin, Imipenem-Colistin, Tigecycline-Amikacin, Tigecycline-Gentamicin, Tigecycline-Meropenem or...” NCT05862402 ↗ 59 “The main therapeutic agents anticipated for use, either in combination or as monotherapy, commonly include colistin, meropenem, tigecycline, amikacin, and ceftazidime-avibactam.” NCT07089186 ↗ “The basic regimen consists of bedaquiline, clofazimine, linezolid, and 2-3 drugs such as amikacin and tigecycline are selected according to the drug use history” NCT05494957 ↗ “main treatment expected to be used as either monotherapy or in combination are colistin, tigecycline, fosfomycin, amikacin, and meropenem” NCT04882085 ↗ “Tigecycline (Haizheng Li Xing ®) combined with piperacillin / tazobactam (tazocin ®), with or without antifungal therapy” NCT02191475 ↗ “meropenem, oritavancin, oxacillin, penicillin, piperacillin-tazobactam, tigecycline, vancomycin” NCT05977868 ↗ “colistin combined with tigecycline” NCT06051513 ↗ NCT00366249 ↗ NCT01401023 ↗ NCT00205816 ↗ NCT01592032 ↗ Show 49 more sources
Known as	Haizheng Li Xing	“Tigecycline (Haizheng Li Xing ®) combined with piperacillin / tazobactam (tazocin ®), with or without antifungal therapy” NCT02191475 ↗
Known as	tegecycline	“Best Available Therapy (e.g., colistin, meropenem, tegecycline, amikacinceftezidime-avibatam)” NCT07089186 ↗
Known as	TGC	“This randomized, open-label, multi-center trial compared tigecycline (TGC), a broad-spectrum glycylcycline, with ceftriaxone-metronidazole (CTX/MET) for the treatment of...” PMID 22439781 ↗ Mar 2012 2 “Tigecycline (TGC) has demonstrated clinical efficacy and safety, in comparison with imipenem/cilastatin in phase 3 clinical trials, for complicated intra-abdominal infection (cIAI).” PMID 20670293 ↗ Aug 2010 “Tigecycline (TGC), a glycylcycline, has expanded activity against Gram-positive and Gram-negative, anaerobic, and atypical bacteria.” PMID 18508226 ↗ May 2008
Known as	Tigeciclina	ChEMBL registry synonym — accepted as the source's own label CHEMBL376140 ↗
Known as	Tigecycline accord	ChEMBL registry synonym — accepted as the source's own label CHEMBL376140 ↗
Known as	tigecycline: tygacil 50 mg vial.	“tigecycline: tygacil 50 mg vial.” NCT01592032 ↗
Known as	Tygacil	“Tigecycline (Tygacil)” NCT07513103 ↗ 1 NCT00488345 ↗
Known as	WAY-GAR-936	ChEMBL registry synonym — accepted as the source's own label CHEMBL376140 ↗
Action	Inhibit	“demonstrates a broad spectrum of antibacterial activity by inhibiting multiply resistant gram-positive, gram-negative, anaerobic, and "atypical" bacteria” NCT00419991 ↗
Modality	Small molecule	“Tigecycline, a glycylcycline antibiotic and an analog of the tetracycline minocycline” NCT00419991 ↗
Route	Intravenous	“Hospitalized patients with community-acquired pneumonia (CAP) were randomized to intravenous (IV) TGC (100 mg followed by 50 mg bid) or IV levofloxacin (LEV) (500 mg bid).” PMID 18508226 ↗ May 2008