Numerous clinical trials evaluate tigecycline across early Phase 1 through Phase 4 and non-applicable study designs for severe bacterial infections, including complicated intra-abdominal infections, community-acquired bacterial pneumonia, catheter-related bacteremia, and carbapenem-resistant Enterobacteriaceae. These studies are sponsored by academic medical institutions, university hospitals, and major pharmaceutical companies such as Wyeth (Pfizer) and the Menarini Group. The overall clinical landscape encompasses diverse recruitment statuses, including completed, currently recruiting, terminated, withdrawn, and unknown records.
| NCT Number | Recruitment | Conditions | Sponsor/Collaborators | Start Date | Phases |
|---|---|---|---|---|---|
| NCT07485010 | NOT_YET_RECRUITING | Mycobacterium Abscessus Pulmonary Disease; Mycobacterium Abscessus Infection; Non-Tuberculous Mycobacterial (NTM) Infections; Non-Tuberculous Mycobacteria Pulmonary Disease |
The University of Queensland |
2027-04 | PHASE2 |
| NCT04310930 | RECRUITING | Pulmonary Disease Due to Mycobacteria (Diagnosis) |
The University of Queensland |
2020-03-02 | PHASE2; PHASE3 |
| NCT07759453 | NOT_YET_RECRUITING | Liver Transplant; Carbapenem-resistant Enterobacterales; CRE Colonization |
IRCCS Azienda Ospedaliero-Universitaria di Bologna |
2026-10-01 | PHASE3 |
| NCT07004049 | RECRUITING | Bloodstream Infection; Ventilator Associated Bacterial Pneumonia; Hospital Acquired Bacterial Pneumonia; Carbapenem Resistant Bacterial Infection; Multidrug Resistance |
National University of Singapore |
2025-04-21 | PHASE4 |
| NCT07495150 | NOT_YET_RECRUITING | Blood-Brain Barrier; Bacterial Meningitis |
yilong Wang |
2026-04-01 | |
| NCT07524920 | NOT_YET_RECRUITING | MDR Bacteria |
Ain Shams University |
2026-04-01 | PHASE2 |
| NCT07258225 | ACTIVE_NOT_RECRUITING | Multi Drug Resistant Infections |
Air Force Specialized Hospital, Cairo, Egypt |
2024-04-01 | PHASE4 |
| NCT06049771 | UNKNOWN | Carbapenem-resistant Enterobacteriaceae |
Phramongkutklao College of Medicine and Hospital |
2023-09-17 | |
| NCT06893835 | ACTIVE_NOT_RECRUITING | Infection in ICU |
Beni-Suef University |
2024-12-01 | PHASE4 |
| NCT03962920 | RECRUITING | Microbial Disease |
Zealand University Hospital |
2020-05-01 | |
| NCT07513103 | COMPLETED | Scrub Typhus |
Jin Soo Lee |
2022-11-19 | |
| NCT07366372 | COMPLETED | Taurolidine; Lock Solution; Prevention; Central Venous Catheter Infection; Intensive Care Unit |
Tanta University |
2023-05-01 | |
| NCT06049771 | Recruiting | Carbapenem-resistant Enterobacteriaceae |
Phramongkutklao College of Medicine and Hospital|Silpakorn University |
2023-09-17 | Not Applicable |
| NCT05698160 | Not yet recruiting | Blood Coagulation Disorder |
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School |
2023-05-01 | -- |
| NCT04208763 | UNKNOWN | Spontaneous Bacterial Peritonitis |
Institute of Liver and Biliary Sciences, India |
2019-12-20 | |
| NCT06739382 | COMPLETED | Ventilation Acquired Pneumonia |
Beni-Suef University |
2021-01-01 | PHASE3 |
| NCT04937894 | Recruiting | Infectious Disease |
Shandong University|Shandong Provincial Hospital |
2021-06-01 | -- |
| NCT04042077 | TERMINATED | Surgical Site Infection |
Menarini Group |
2019-09-25 | PHASE3 |
| NCT03950544 | UNKNOWN | Antibiotic Resistant Infection |
Shanghai 10th People's Hospital |
2019-01-01 | EARLY_PHASE1 |
| NCT04489459 | UNKNOWN | Treatment of Blood Stream Infections Due to Multidrug-Resistant Klebsiella Pneumoniae |
Al-Azhar University |
2019-09-21 | PHASE4 |
| NCT02800785 | COMPLETED | Appendicitis |
University of Washington |
2016-05 | |
| NCT04724798 | Unknown status | Extracorporeal Membrane Oxygenation|Pharmacokinetics|Tigecycline |
Nanfang Hospital Southern Medical University |
2020-01-20 | -- |
| NCT04489459 | Unknown status | Treatment of Blood Stream Infections Due to Multidrug-Resistant Klebsiella Pneumoniae |
Al-Azhar University |
2019-09-21 | Phase 4 |
| NCT02191475 | UNKNOWN | Abdominal Infection |
Tianjin Medical University Cancer Institute and Hospital |
2014-05 | PHASE2; PHASE3 |
| NCT02040818 | WITHDRAWN | Hemodialysis Catheter-related Bacteremia |
University of California, San Diego |
2013-11 | PHASE2; PHASE3 |
| NCT01970371 | COMPLETED | Bloodstream Infections (BSI) Due to CRE; Hospital-Acquired Bacterial Pneumonia (HABP) Due to CRE; Ventilator-Associated Bacterial Pneumonia (VABP) Due to CRE; Complicated Urinary Tract Infection (cUTI) Due to CRE; Acute Pyelonephritis (AP) Due to CRE |
Achaogen, Inc. |
2014-09-16 | PHASE3 |
| NCT01721408 | COMPLETED | Intra-abdominal Infection |
Pfizer |
2012-11 | PHASE4 |
| NCT01592032 | UNKNOWN | Catheter-Related Infections; Bacteremia. |
Clinica Universidad de Navarra, Universidad de Navarra |
2012-05 | PHASE4 |
| NCT01332786 | COMPLETED | Acute Myeloid Leukemia |
University Health Network, Toronto |
2011-03 | PHASE1 |
| NCT00914888 | WITHDRAWN | Community Acquired Bacterial Pneumonia; Complicated Intra-Abdominal Infection |
Wyeth is now a wholly owned subsidiary of Pfizer |
2011-01 | PHASE3 |
| NCT01602874 | WITHDRAWN | Community Acquired Bacterial Pneumonia; Complicated Intra-Abdominal Infection |
Pfizer |
2011-01 | PHASE3 |
| NCT00911573 | WITHDRAWN | Skin Diseases; Infection |
Wyeth is now a wholly owned subsidiary of Pfizer |
2011-08 | PHASE3 |
| NCT01483872 | TERMINATED | Infection; Dialysis Catheter |
University of California, San Diego |
2012-03 | PHASE3 |
| NCT01401023 | COMPLETED | Diarrhea; Clostridium Difficile |
Gary E. Stein, Pharm.D. |
2011-07 | |
| NCT01342731 | UNKNOWN | Antibiotic Resistant Infection |
Mahidol University |
2011-07 | PHASE4 |
| NCT01560143 | COMPLETED | Obesity |
Manjunath Prakash Pai |
2012-03 | PHASE4 |
| NCT00707239 | TERMINATED | Pneumonia, Bacterial |
Pfizer |
2008-12 | PHASE2 |
| NCT01287793 | COMPLETED | Healthy |
Pfizer |
2011-01 | PHASE1 |
| NCT00600600 | COMPLETED | Mycobacterium Abscessus Lung Disease; Rapidly Growing Mycobacterial Lung Disease |
The University of Texas Health Science Center at Tyler |
2002-04 | PHASE2 |
| NCT00488345 | COMPLETED | Bacterial Infections; Intra-Abdominal Infection; Pneumonia, Bacterial; Skin Diseases, Bacterial; Skin Diseases, Infectious |
Wyeth is now a wholly owned subsidiary of Pfizer |
2007-12 | PHASE2 |
| NCT00366249 | COMPLETED | Bacterial Infections; Diabetic Foot; Osteomyelitis |
Wyeth is now a wholly owned subsidiary of Pfizer |
2007-01 | PHASE3 |
| NCT00406237 | COMPLETED | Liver Cirrhosis, Biliary |
Wyeth is now a wholly owned subsidiary of Pfizer |
2006-12 | PHASE1 |
| NCT00614679 | COMPLETED | End-Stage Renal Disease; Hemodialysis Catheter-associated Infection |
University of California, San Diego |
2006-10 | PHASE1 |
| NCT00376324 | COMPLETED | Healthy Subjects |
Wyeth is now a wholly owned subsidiary of Pfizer |
2006-09 | PHASE1 |
| NCT00719810 | COMPLETED | Skin Structure Infections; Bacterial Skin Diseases; Staphylococcal Skin Infections |
Melinta Therapeutics, Inc. |
2008-06 | PHASE2 |
| NCT00368537 | COMPLETED | Skin Diseases, Bacterial |
Wyeth is now a wholly owned subsidiary of Pfizer |
2006-09 | PHASE4 |
| NCT00230971 | COMPLETED | Appendicitis; Cholecystitis; Diverticulitis; Intra-Abdominal Abscess; Intra-Abdominal Infection; Peritonitis |
Wyeth is now a wholly owned subsidiary of Pfizer |
2005-10 | PHASE4 |
| NCT00419991 | COMPLETED | Staphylococcal Infections |
CPL Associates |
2007-01 | PHASE4 |
| NCT00575094 | COMPLETED | Community-Acquired Infections |
Wyeth is now a wholly owned subsidiary of Pfizer |
2007-11 | PHASE3 |
| NCT00195351 | COMPLETED | Appendicitis; Cholecystitis; Cross Infection; Diverticulitis; Peritonitis |
Wyeth is now a wholly owned subsidiary of Pfizer |
2005-09 | PHASE4 |
| NCT00136201 | COMPLETED | Abdominal Abscess |
Wyeth is now a wholly owned subsidiary of Pfizer |
2005-11 | PHASE3 |
| NCT00079989 | COMPLETED | Gram-Negative Bacterial Infections |
Wyeth is now a wholly owned subsidiary of Pfizer |
2003-12 | PHASE3 |
| NCT00205816 | COMPLETED | Bacterial Infections |
Wyeth is now a wholly owned subsidiary of Pfizer |
2004-01 | PHASE3 |
| NCT00079885 | COMPLETED | Community Acquired Pneumonia; Bacterial Pneumonia; Cross Infection |
Wyeth is now a wholly owned subsidiary of Pfizer |
2003-11 | PHASE3 |
| NCT00079976 | COMPLETED | Gram-Positive Bacterial Infections; Staphylococcus Infections; Vancomycin Resistance; Methicillin Resistance |
Wyeth is now a wholly owned subsidiary of Pfizer |
2003-10 | PHASE3 |
| NCT00081575 | COMPLETED | Community-Acquired Infections; Bacterial Pneumonia; Cross Infection |
Wyeth is now a wholly owned subsidiary of Pfizer |
2004-01 | PHASE3 |
| NCT00081744 | COMPLETED | Gram-Positive Bacterial Infections; Cross Infection |
Wyeth is now a wholly owned subsidiary of Pfizer |
2002-11 | PHASE3 |
| NCT00228410 | COMPLETED | Skin Diseases, Infectious |
Wyeth is now a wholly owned subsidiary of Pfizer |
2002-11 | PHASE3 |
| NCT00080496 | COMPLETED | Bacterial Pneumonia |
Wyeth is now a wholly owned subsidiary of Pfizer |
2003-07 | PHASE3 |
| NCT00488306 | COMPLETED | Abdominal Abscess |
Wyeth is now a wholly owned subsidiary of Pfizer |
2006-08 | PHASE4 |
| NCT00488761 | COMPLETED | Skin Diseases, Infectious |
Wyeth is now a wholly owned subsidiary of Pfizer |
2006-07 | PHASE4 |
(data from https://clinicaltrials.gov, updated on 2026-03-20)
Check the
Tigecycline
product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.
Mechanism and Biochemical Profile
Appendix RUO and cGMP Quality Standards
| Quality Dimension | RUO (Research Use Only) | cGMP (Current Good Manufacturing Practice) |
|---|---|---|
| Clinical Applicability | Prohibited in human clinical trials or medical diagnostics. | Mandatory for human clinical trials (Phase I–III) and therapies. |
| Regulatory Status | Non-regulated grade; exempt from drug manufacturing laws. | Legally enforced by health authorities (e.g., FDA, EMA, NMPA). |
| Facility Environment | Unclassified analytical or research laboratories. | Validated Cleanrooms (ISO Class 5–8) with continuous monitoring. |
| Quality Control | Basic purity and activity testing. | Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma). |
| Process Validation | Basic equipment calibration; no process validation required. | Full qualification (IQ/OQ/PQ) and complete batch records. |
| Quality Assurance | Vendor self-declared without required formal QMS. | Mandatory QA/QC unit, Change Control, CAPA, and vendor audits. |
| Regulatory Impact | High risk of IND rejection if used as a critical raw material. | Required for IND/NDA filings, supported by Drug Master Files (DMF). |
Footnotes
Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).
Note: Technical data last updated: Sep 1, 2026.