Drug

Tigecycline

Approved · EMA

Late-stage development

Also known as Tygacil, Tigeciclina, (4S,4aS,5aR,12aS)-9-(2-(tert-butylamino)acetamido)-4,7-bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamide, Tigecyclinum.

RxNorm384455 ChEMBLCHEMBL376140UNII70JE2N95KR

Active clinical trials

Regulatory events

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

Finding the Optimal Regimen for Mycobacterium Abscessus Treatment (FORMaT)

Clinical trial2026-05-11Results expected Q2 2029 · ClinicalTrials.gov

A Multi-centre, Randomised Trial Comparing a Novel Combination Treatment (Arm D - Intravenous Sulbactam-durlobactam in Combination With Intravenous Ceftriaxone, Oral Amoxicillin, Oral Azithromycin and Oral Clofazimine) Versus Standard of Care Treatments for the Intensive Phase of Treatment for Mycobacterium Abscessus Pulmonary Disease in People With or Without Cystic Fibrosis in the Finding the Optimal Regimen for Mycobacterium Abscessus Treatment (FORMaT) Adaptive Platform Trial

Clinical trial2026-03-20Results expected Q2 2031 · ClinicalTrials.gov

Comparative Study of Clinical Outcomes and Safety Between Colistin and Tigecycline for Multi-Drug Resistant Gram Negative Bacteria

Clinical trial2025-05-30Primary completion · ClinicalTrials.gov

Personalized Treatment of Urogenital Cancers Depends on the Microbiome

Clinical trial2025-05-01Primary completion · ClinicalTrials.gov

Clinical Efficacy Analysis of Drug Use Tigecycline for Re-creation of Antimicrobial Agents for Treatment of Scrub Typhus.

Clinical trial2024-06-11Completed · ClinicalTrials.gov

Imipenem and Tigecycline Versus Imipenem and Tigecycline With GM-CSF for the Management of Spontaneous Bacterial Peritonitis Presenting With Septic Shock.

Clinical trial2021-12-31Primary completion · ClinicalTrials.gov

A Randomized, Observer-blinded, Active-controlled, Phase Illb Study to Compare IV / Oral Delafloxacin Fixed-dose Monotherapy With Best Available Treatments in a Microbiologically Enriched Population With Surgical Site Infections

Clinical trial2020-10-28Terminated · ClinicalTrials.gov

How to Optimize the Combined Antibiotic Therapy for Carbapenem Resistant Klebsiella Pneumoniae

Clinical trial2020-08-31Primary completion · ClinicalTrials.gov

Comparative Clinical Study Between Colistin-Tigecycline Combined Therapy Versus Colistin-Meropenem Combined Therapy in Treatment of Blood Stream Infections With Multidrug-Resistant Klebsiella Pneumoniae

Clinical trial2020-07-01Primary completion · ClinicalTrials.gov

Approval: Tigecycline Accord (EMA)

Regulatory2020-04-17EMA

Drug Safety Update: Tigecycline (Tygacil▼): increased mortality in clinical trials

Regulatory2014-12-11MHRA

Approval: Tygacil (EMA)

Regulatory2006-04-24EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Tigecycline

Aliases & brands

TygacilTigeciclina(4S,4aS,5aR,12aS)-9-(2-(tert-butylamino)acetamido)-4,7-bis(dimethylamino)-1,4,4a,5,5a,6,11,12a-octahydro-3,10,12,12a-tetrahydroxy-1,11-dioxo-2-naphthacenecarboxamideTigecyclinum

RxNorm CUI

384455

ChEMBL ID

CHEMBL376140

UNII

70JE2N95KR

Regulatory jurisdictions

mhraema

Regulatory timeline

3 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval

2006-04-24

Latest approval

2020-04-17

Authorities

EMA · MHRA

Total events

emaEuropean Medicines Agency· 2 events

2020-04-17Approval

Approval: Tigecycline Accord (EMA)

Indication: Tygecycline Accord is indicated in adults and in children from the age of eight years for the treatment of the following infections (see sections 4.4 and 5.1): Complicated skin… Show full indication

Tygecycline Accord is indicated in adults and in children from the age of eight years for the treatment of the following infections (see sections 4.4 and 5.1): Complicated skin and soft tissue infections (cSSTI), excluding diabetic foot infections (see section 4.4) Complicated intra-abdominal infections (cIAI) Tygecycline Accord should be used only in situations where other alternative antibiotics are not suitable (see sections 4.4, 4.8 and 5.1). Consideration should be given to official guidance on the appropriate use of antibacterial agents.

Evidence ↗

2006-04-24Approval

Approval: Tygacil (EMA)

Indication: Tygacil is indicated in adults and in children from the age of eight years for the treatment of the following infections: Complicated skin and soft tissue infections (cSSTI),… Show full indication

Tygacil is indicated in adults and in children from the age of eight years for the treatment of the following infections: Complicated skin and soft tissue infections (cSSTI), excluding diabetic foot infections Complicated intra-abdominal infections (cIAI) Tygacil should be used only in situations where other alternative antibiotics are not suitable. Consideration should be given to official guidance on the appropriate use of antibacterial agents. appropriate use of antibacterial agents.

Evidence ↗

mhraMedicines and Healthcare products Regulatory Agency· 1 event

2014-12-11Safety communicationSafety

Drug Safety Update: Tigecycline (Tygacil▼): increased mortality in clinical trials

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Contains public sector information from the Medicines and Healthcare products Regulatory Agency (MHRA) licensed under the Open Government Licence (OGL v3).