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Drug

Doripenem

Approved medicine
ClassBacterial penicillin-binding protein inhibitorResearchOngoing clinical research

Also known as Doribax.

RxNorm119771ChEMBLCHEMBL491571ATCJ01DH04UNIIBHV525JOBH
7
Protein targets
1
Regulatory events
Latest activity
beta

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

A Prospective Study on the Usage Patterns of Doripenem in the Asia Pacific Region

Clinical trial2024-11-19Results posted · ClinicalTrials.gov

A Randomized, Open-Label, Multicenter Study to Assess the Safety and Tolerability of Doripenem Compared With Imipenem in the Treatment of Subjects With Complicated Intra-Abdominal Infections or Ventilator Associated Pneumonia

Clinical trial2019-03-19Results posted · ClinicalTrials.gov

A Phase III, Randomized, Multicenter, Double-Blind, Double Dummy, Parallel Group, Comparative Study to Determine the Efficacy, Safety, and Tolerability of Ceftazidime Avibactam (CAZ-AVI, Formerly CAZ104) Versus Doripenem Followed by Appropriate Oral Therapy in the Treatment of Complicated Urinary Tract Infections, Including Acute Pyelonephritis, With a Gram Negative Pathogen in Hospitalized Adults

Clinical trial2017-09-06Results posted · ClinicalTrials.gov

A Phase III, Randomized, Multicenter, Double-Blind, Double Dummy, Parallel Group, Comparative Study to Determine the Efficacy, Safety, and Tolerability of Ceftazidime Avibactam (CAZ-AVI, Formerly CAZ104) Versus Doripenem Followed by Appropriate Oral Therapy in the Treatment of Complicated Urinary Tract Infections, Including Acute Pyelonephritis, With a Gram Negative Pathogen in Hospitalized Adults

Clinical trial2017-09-06Results posted · ClinicalTrials.gov

Pharmacokinetic/Pharmacodynamic Study of Doripenem in Febrile Neutropenic Patients With Possible Bacterial Infection

Clinical trial2015-10-14Results posted · ClinicalTrials.gov

Drug Safety Update: Doripenem (Doribax▼): updated dosing recommendations

Regulatory2014-12-11MHRA

Pharmacokinetic and Pharmacodynamic Evaluation of Doripenem in Critically Ill Trauma Patients With Sepsis at Grady Health System

Clinical trial2014-01-27Results posted · ClinicalTrials.gov

A Post Marketing Surveillance Study on the Safety and Effectiveness of Doripenem in the Therapy of Thai Patients With Nosocomial Pneumonia, Complicated Intra-Abdominal Infections and Complicated Urinary Tract Infections

Clinical trial2013-10-30Results posted · ClinicalTrials.gov

A Phase 2 Study of Doripenem In The Treatment of Nosocomial and Ventilator-Associated Pneumonia In Hospitals

Clinical trial2013-09-25Results posted · ClinicalTrials.gov

A Prospective, Randomized, Double-Blind, Multicenter Study to Establish the Safety and Tolerability of Doripenem Compared With Meropenem in Hospitalized Children With Complicated Intra-Abdominal Infections

Clinical trial2013-09-01Terminated · ClinicalTrials.gov

A Prospective, Randomized, Double-Blind, Multicenter Study to Establish the Safety and Tolerability of Doripenem Compared With Cefepime in Hospitalized Children With Complicated Urinary Tract Infections

Clinical trial2013-06-01Terminated · ClinicalTrials.gov

A Phase 2, Multicenter, Randomized, Double-blind, Comparative Study to Evaluate the Efficacy and Safety of Intravenous Coadministered Ceftaroline Fosamil and NXL104 Versus Intravenous Doripenem in Adult Subjects With Complicated Urinary Tract Infection

Clinical trial2012-07-01Completed · ClinicalTrials.gov

Profile

Identifiers & mechanism

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

Canonical name
Doripenem
Aliases & brands
Doribax
RxNorm CUI
119771
ChEMBL ID
CHEMBL491571
ATC codes
J01DH04
UNII
BHV525JOBH
Primary mechanism
Bacterial penicillin-binding protein inhibitor
Regulatory jurisdictions
mhra

Pharmacology & targets

7 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

D-alanyl-D-alanine carboxypeptidase DacB
dacB · P24228
INHIBITORBacterial penicillin-binding protein inhibitor
Peptidoglycan D,D-transpeptidase FtsI
ftsI · P0AD68
INHIBITORBacterial penicillin-binding protein inhibitor
Penicillin-binding protein 1A
mrcA · P02918
INHIBITORBacterial penicillin-binding protein inhibitor
Penicillin-binding protein 1B
mrcB · P02919
INHIBITORBacterial penicillin-binding protein inhibitor
D-alanyl-D-alanine carboxypeptidase DacA
dacA · P0AEB2
INHIBITORBacterial penicillin-binding protein inhibitor
Peptidoglycan D,D-transpeptidase MrdA
mrdA · P0AD65
INHIBITORBacterial penicillin-binding protein inhibitor
D-alanyl-D-alanine carboxypeptidase DacC
dacC · P08506
INHIBITORBacterial penicillin-binding protein inhibitor

Regulatory timeline

1 event

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.

Authorities
MHRA
Total events
1
mhraMedicines and Healthcare products Regulatory Agency· 1 event
2014-12-11Safety communicationSafety
Drug Safety Update: Doripenem (Doribax▼): updated dosing recommendations
Evidence ↗

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

Clinical trials

23 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
23
registered trials across all phases
LATEST COMPLETION 2014
17
Late-stage (III+)
18
Completed
5
Discontinued
PHASE DISTRIBUTIONn = 23
Phase 13Phase 23Phase 311Phase 46

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Pharmacokinetic/Pharmacodynamic Study of Doripenem in Febrile Neutropenic Patients With Possible Bacterial Infection

CompletedPH IVGary E. Stein, Pharm.D.n=122012

Pharmacokinetic and Pharmacodynamic Evaluation of Doripenem in Critically Ill Trauma Patients With Sepsis at Grady Health System

CompletedPH IVEmory Universityn=302011

The Pharmacodynamics of Doripenem Between 4-hour and 1-hour Infusion in Patients With Ventilator-associated Pneumonia

CompletedPH IVSutep Jaruratanasirikuln=122011

A Prospective Study on the Usage Patterns of Doripenem in the Asia Pacific Region

CompletedPH IVJanssen Research & Development, LLCn=2162011

Target Site Pharmacokinetics of Doripenem After a Single Dose of 500mg in Healthy Volunteers - a Pilot Study

CompletedPH IVMedical University of Viennan=62011

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Phase III, Randomized, Multicenter, Double-Blind, Double Dummy, Parallel Group, Comparative Study to Determine the Efficacy, Safety, and Tolerability of Ceftazidime Avibactam (CAZ-AVI, Formerly CAZ104) Versus Doripenem Followed by Appropriate Oral Therapy in the Treatment of Complicated Urinary Tract Infections, Including Acute Pyelonephritis, With a Gram Negative Pathogen in Hospitalized Adults

CompletedPH IIIPfizern=6412014

A Phase III, Randomized, Multicenter, Double-Blind, Double Dummy, Parallel Group, Comparative Study to Determine the Efficacy, Safety, and Tolerability of Ceftazidime Avibactam (CAZ-AVI, Formerly CAZ104) Versus Doripenem Followed by Appropriate Oral Therapy in the Treatment of Complicated Urinary Tract Infections, Including Acute Pyelonephritis, With a Gram Negative Pathogen in Hospitalized Adults

CompletedPH IIIPfizern=5982014

A Phase 2, Multicenter, Randomized, Double-blind, Comparative Study to Evaluate the Efficacy and Safety of Intravenous Coadministered Ceftaroline Fosamil and NXL104 Versus Intravenous Doripenem in Adult Subjects With Complicated Urinary Tract Infection

CompletedPH IIForest Laboratoriesn=2172012

An Open-Label Study to Evaluate the Single-Dose Pharmacokinetics, Safety, and Tolerability of Doripenem in Infants (Term and Preterm), Less Than 12 Weeks Chronological Age

CompletedPH IJanssen Research & Development, LLCn=522012

Pharmacokinetic/Pharmacodynamic Study of Doripenem in Febrile Neutropenic Patients With Possible Bacterial Infection

CompletedPH IVGary E. Stein, Pharm.D.n=122012

Pharmacokinetic and Pharmacodynamic Evaluation of Doripenem in Critically Ill Trauma Patients With Sepsis at Grady Health System

CompletedPH IVEmory Universityn=302011
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.