Tygacil

(Tigecycline)

ApprovedSmall molecule

Tigecycline is an antibiotic used to treat serious bacterial infections in the skin, stomach area, and bloodstream when other antibiotics don't work or can't be used.[2] Tygacil is currently approved and in use across 29 indications[4].[1]

Tygacil is one of 419 small molecule programs targeting Bacterial Disease. It is currently in Approved.

Indications

Total Trials

Active Trials

418

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Bacterial DiseaseActive, not recruiting

AbscessActive, not recruiting

PyodermaActive, not recruiting

Skin Disorder Caused by InfectionActive, not recruiting

Skin Disease Caused by Bacterial InfectionActive, not recruiting

Bacterial PneumoniaApproved

Gram-Positive Bacterial InfectionsApproved

AppendicitisActive, not recruiting

Abdominal AbscessApproved

Skin InfectionActive, not recruiting

Bacterial DiseaseApproved

Active, not recruiting

AbscessPhase 2/Phase 3

Active, not recruiting

PyodermaApproved

Active, not recruiting

Skin Disorder Caused by InfectionApproved

Active, not recruiting

Skin Disease Caused by Bacterial InfectionApproved

Active, not recruiting

Bacterial PneumoniaApproved

Approved

Gram-Positive Bacterial InfectionsApproved

Approved

AppendicitisPreclinical

Active, not recruiting

Abdominal AbscessApproved

Approved

Skin InfectionApproved

Active, not recruiting

Showing 10 of 27 indications

Competition

Competitive Landscape

804 competitors in Acute Myeloid Leukemia

#DrugCompanyPhaseTrials

Tygacil

PPrism Pharmaceuticals

Approved

1 2

Xpovio

KKaryopharm Therapeutics Inc

Phase 3

12 3

Decadron

AAspen Global Incorporated

Phase 3

5 4

Lenograstim

Sanofi

Phase 3

1 5

AG-120

Institut de Recherches Internationales Servier

Phase 3

4 6

ALL-Trans Retinoid Acid

UUniversity of Ulm

Phase 3

1 7

PR1 Leukemia Peptide Vaccine

TThe Vaccine Company

Phase 3

1 8

Leukine

Sanofi

Preclinical

7 9

Sprycel

KKaruna Therapeutics, Inc., a Bristol Myers Squibb company

Preclinical

8 10

Antibiotic

Pfizer

Preclinical

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q2 2027

N/ARecruiting

Treatment

NCT03962920

Not yet recruiting

Infections

NCT06702943

Q2 2030

Phase 2/3Recruiting

Abscess

NCT04310930

Q3 2031

Phase 2Not yet recruiting

Cystic Fibrosis

NCT07485010

Clinical

Trials by Indication[1]

Pneumonia8 trials

The Combined Antibiotic Therapy for Carbapenem Resistant Klebsiella Pneumoniae

Unknown status·SShanghai 10th People's Hospital·Phase 1·NCT03950544·80 enrolled

Study Comparing Tigecycline vs. Levofloxacin in Subjects Hospitalized With Community-Acquired Pneumonia

Completed· Pfizer logo

Pfizer·Phase 3·NCT00081575·434 enrolled

Study Evaluating Tigecycline vs Levofloxacin in Hospitalized With Community-Acquired Pneumonia

Completed· Pfizer logo

Pfizer·Phase 3·NCT00079885·430 enrolled

Show 5 more trials

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

Withdrawn· Pfizer logo

Pfizer·Phase 3·NCT01602874

Study Evaluating Tigecycline Versus Imipenem/Cilastatin in Hospital-Acquired Pneumonia

Completed· Pfizer logo

Pfizer·Phase 3·NCT00080496·430 enrolled

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

Unknown status·—·Phase 4·NCT04489459·60 enrolled

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

Withdrawn· Pfizer logo

Pfizer·Phase 3·NCT00914888

Study Evaluating Safety and Efficacy of Tigecycline Versus Imipenem/Cilastatin Subjects With Hospital-Acquired Pneumonia

Terminated· Pfizer logo

Pfizer·Phase 2·NCT00707239·108 enrolled

Intra-abdominal Infection3 trials

Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection

Completed· Pfizer logo

Pfizer·Phase 4·NCT00195351·467 enrolled

A Study To Determine The Efficacy And Safety Of Tigecycline Compared With Imipenem/Cliastatin to Treat Complicated Intra-Abdominal Infection

Completed· Pfizer logo

Pfizer·Phase 4·NCT01721408·470 enrolled

Study Comparing Tigecycline Versus Ceftriaxone Sodium Plus Metronidazole in Complicated Intra-abdominal Infection (cIAI)

Completed· Pfizer logo

Pfizer·Phase 4·NCT00230971·473 enrolled

Infections3 trials

Study Comparing Tigecycline and Vancomycin With Aztreonam in Complicated Skin and Skin Structure Infections

Completed· Pfizer logo

Pfizer·Phase 3·NCT00228410·503 enrolled

Study Evaluating Tigecycline in Selected Serious Infections Due to Resistant Gram-Negative Organisms

Completed· Pfizer logo

Pfizer·Phase 3·NCT00079989·115 enrolled

Comparing Tigecycline Vs. Colistimethate in CNS Infections

Not yet recruiting·—··NCT06702943·70 enrolled

Treatment2 trials

Tigecycline for Treatment of Rapidly Growing Mycobacteria

Completed·TThe University of Texas Health Science Center at Tyler·Phase 2·NCT00600600·8 enrolled

Personalized Treatment of Urogenital Cancers Depends on the Microbiome

Recruiting·ZZealand University Hospital·N/A·NCT03962920·28 enrolled

Complicated Intra-abdominal Infections2 trials

Study Comparing Tigecycline and Imipenem/Cilastatin in Chinese Subjects With Complicated Intra-Abdominal Infections

Completed· Pfizer logo

Pfizer·Phase 3·NCT00136201·200 enrolled

Study Comparing Tigecycline to Imipenem/Cilastatin in Complicated Intra-Abdominal Infections in Hospitalized Subjects

Completed· Pfizer logo

Pfizer·Phase 3·NCT00081744·850 enrolled

27 more indications

Methicillin-resistant Staphylococcus Aureus2 trials

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

Withdrawn· Pfizer logo

Pfizer·Phase 3·NCT00911573

Study Evaluating Tigecycline in Selected Serious Infections Caused by Vancomycin-Resistant Enterococcus (VRE) or Methicillin-Resistant Staphylococcus Aureus (MRSA)

Completed· Pfizer logo

Pfizer·Phase 3·NCT00079976·174 enrolled

Hospitalized Patients2 trials

Study Evaluating the Safety and Efficacy of Tigecycline in Hospitalized Patients With cIAI

Completed· Pfizer logo

Pfizer·Phase 4·NCT00488306·50 enrolled

Study Evaluating the Safety and Efficacy of Tigecycline in Hospitalized Patients With cSSSI

Completed· Pfizer logo

Pfizer·Phase 4·NCT00488761·50 enrolled

Skin Infection2 trials

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

Completed·MMelinta Therapeutics, Inc.·Phase 2·NCT00719810·150 enrolled

Study Comparing the Safety and Efficacy of Tigecycline With Ampicillin-Sulbactam or Amoxicillin-Clavulanate to Treat Skin Infections

Completed· Pfizer logo

Pfizer·Phase 4·NCT00368537·550 enrolled

Renal Replacement Therapy1 trial

Study of Tigecycline Pharmacokinetics in Patients Undergoing Continuous Renal Replacement Therapy(CRRT)

Unknown status·ZZhujiang Hospital··NCT02931526·20 enrolled

Infection1 trial

A Study of Plazomicin Compared With Colistin in Patients With Infection Due to Carbapenem-Resistant Enterobacteriaceae (CRE)

Completed·AAchaogen, Inc.·Phase 3·NCT01970371·69 enrolled

Infectious Disease1 trial

Antibiotic Therapy for Infectious Diseases

Unknown status·SShandong University··NCT04937894·300 enrolled

Obese1 trial

Pharmacokinetics Of Tigecycline In Morbidly Obese Subjects

Completed·MManjunath Prakash Pai·Phase 4·NCT01560143·12 enrolled

Septic Shock1 trial

A Randomized Controlled Trial Comparing Imipenem and Tigecycline Versus Imipenem and Tigecycline With GM-CSF for the Management of Spontaneous Bacterial Peritonitis Presenting With Septic Shock.

Unknown status·IInstitute of Liver and Biliary Sciences, India·N/A·NCT04208763·90 enrolled

Outcome1 trial

Comparative Study of Clinical Outcomes and Safety Between Colistin and Tigecycline

Active, not recruiting·—·Phase 4·NCT06893835·132 enrolled

Diabetic Foot1 trial

Study Evaluating the Safety and Efficacy of a Once-daily Dose of Tigecycline vs Ertapenem in Diabetic Foot Infections (DFI) With a Substudy in Patients With Diabetic Foot Infections Complicated by Osteomyelitis.

Completed· Pfizer logo

Pfizer·Phase 3·NCT00366249·1,061 enrolled

Acute Myeloid Leukemia1 trial

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

Completed·UUniversity Health Network, Toronto·Phase 1·NCT01332786·27 enrolled

Tics1 trial

Study Evaluating the Pharmacokinetics of Tigecycline in Human Bone

Completed· Pfizer logo

Pfizer·Phase 1·NCT00376324·36 enrolled

Acinetobacter Baumannii1 trial

Effectiveness and Safety of Tigecycline for Therapy of Infections Caused by Multi-Drug Resistant Acinetobacter Baumannii

Unknown status·MMahidol University·Phase 4·NCT01342731·30 enrolled

Abscess1 trial

Finding the Optimal Regimen for Mycobacterium Abscessus Treatment

Recruiting·TThe University of Queensland·Phase 2/3·NCT04310930·300 enrolled

Intravenous1 trial

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

Completed· Pfizer logo

Pfizer·Phase 1·NCT01287793·48 enrolled

Mortality1 trial

Impact of Treatment With Colistin on Mortality Bacteremia Multiresistant Acinetobacter Baumannii Sensitive Colistin in Patients Critical

Completed·MMaimónides Biomedical Research Institute of Córdoba··NCT02573064·113 enrolled

Surgical Site Infections1 trial

Delafloxacin IV and OS Administration Compared to Best Available Therapy in Patients With Surgical Site Infections

Terminated· Menarini logo

Menarini·Phase 3·NCT04042077·268 enrolled

Effectiveness1 trial

Study Evaluating The Safety And Effectiveness In Subjects With Tigecycline Treatment

Completed· Pfizer logo

Pfizer··NCT01072539·3,172 enrolled

Diarrhea1 trial

Pharmacokinetics and Safety of Tigecycline in the Treatment of Clostridium Difficile Associated Diarrhea (CDAD)

Completed·—·N/A·NCT01401023·10 enrolled

CAR1 trial

A Pharmacovigilance Evaluation And Assessment Of The Prescribing Practice For Tygacil In Usual Health Care Setting

Completed· Pfizer logo

Pfizer··NCT00488488·1,028 enrolled

Safety and Efficacy1 trial

Study Evaluating the Safety and Efficacy of Intravenous Tigecycline to Treat Hospitalized Japanese Subjects

Completed· Pfizer logo

Pfizer·Phase 3·NCT00575094·9 enrolled

Catheter Infection1 trial

Open Label Non-comparative Clinical Trial of Tigecycline in Patients With Catheter Infection

Completed·CCPL Associates·Phase 4·NCT00419991·10 enrolled

Primary Biliary Cirrhosis1 trial

Pharmacokinetic Study Of Tigecycline In Adult Subjects With Primary Biliary Cirrhosis

Completed· Pfizer logo

Pfizer·Phase 1·NCT00406237·8 enrolled

Cystic Fibrosis1 trial

Testing a Novel Combination Treatment (Arm D) Versus Standard of Care for Intensive Phase 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

Not yet recruiting·TThe University of Queensland·Phase 2·NCT07485010·300 enrolled

Intensive Care Unit1 trial

Predictors of Antimicrobial Resistance in the Respiratory Intensive Care Unit of Alexandria Main University Hospital

Completed·MMohamed Sabry··NCT06750744·50 enrolled

Drug1 trial

Tygacil Drug Use Investigation

Completed· Pfizer logo

Pfizer··NCT01789905·116 enrolled

Unspecified3 trials

Study Evaluating Emergency-use Tigecycline in Subjects With Resistant Pathogens.

Completed· Pfizer logo

Pfizer·Phase 3·NCT00205816·26 enrolled

Post-Authorization Study Evaluating Safety Of Tigecycline

Completed· Pfizer logo

Pfizer··NCT00827541·115 enrolled

Post-Marketing Study Of The Safety Of Tygacil (Tigecycline)

Completed· Pfizer logo

Pfizer··NCT00683332·621 enrolled

Regulatory

FDA Approval Timeline[5]

Jun 15, 2005

TYGACIL

NDA NDA021821

Dec 1, 2016

TIGECYCLINE

NDA NDA205645

Jan 18, 2018

TIGECYCLINE

NDA NDA208744

Aug 2, 2018

TIGECYCLINE

NDA NDA211158

Sources

References

[1]
ClinicalTrials.gov — 50 trial records for Tigecycline. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Tygacil drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Tigecycline compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Tigecycline. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA211158). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Tygacil. U.S. Food & Drug Administration.
[7]
SEC EDGAR — Prism Pharmaceuticals company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: Bacterial 70s Ribosome Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: PPrism Pharmaceuticals

Patent Landscape[6]

Patent Cliff

Oct 24, 2028

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9694078Mar 13, 2026

9254328Mar 13, 2026

10588975Mar 13, 2026

8975242Oct 24, 2028

7879828Feb 5, 2029

2 more patents

8372995Oct 8, 2030

9855335Apr 7, 2033

Tygacil

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q2 2027

Q2 2030

Q3 2031

Trials by Indication[1]

Pneumonia8 trials

Intra-abdominal Infection3 trials

Infections3 trials

Treatment2 trials

Complicated Intra-abdominal Infections2 trials

Methicillin-resistant Staphylococcus Aureus2 trials

Hospitalized Patients2 trials

Skin Infection2 trials

Renal Replacement Therapy1 trial

Infection1 trial

Infectious Disease1 trial

Obese1 trial

Septic Shock1 trial

Outcome1 trial

Diabetic Foot1 trial

Acute Myeloid Leukemia1 trial

Tics1 trial

Acinetobacter Baumannii1 trial

Abscess1 trial

Intravenous1 trial

Mortality1 trial

Surgical Site Infections1 trial

Effectiveness1 trial

Diarrhea1 trial

CAR1 trial

Safety and Efficacy1 trial

Catheter Infection1 trial

Primary Biliary Cirrhosis1 trial

Cystic Fibrosis1 trial

Intensive Care Unit1 trial

Drug1 trial

Unspecified3 trials

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

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