meropenem
Trade name: merrem
Approved
Jun 21, 1996
Meropenem (generic name: meropenem hydrate) is a carbapenem antibiotic for injection showing a strong antibacterial activity to a wide range of bacteria strains from Gram-positive bacteria, Gram-negative bacteria to anaerobic bacteria. It is used as single agent therapy for the treatment of the following infections: complicated skin and skin structure infections due to Staphylococcus aureus (b-lactamase and non-b-lactamase producing, methicillin-susceptible isolates only), Streptococcus pyogenes, Streptococcus agalactiae, viridans group streptococci. This drug also used in case of Intra-abdominal Infections for the treatment complicated appendicitis and peritonitis caused by viridans group streptococci, Escherichia coli, Klebsiella pneumoniae, Pseudomonas aeruginosa, Bacteroides fragilis, B. thetaiotaomicron, and Peptostreptococcus species. In addition is used the treatment of bacterial meningitis caused by Streptococcus pneumoniae, Haemophilus influenzae (b-lactamase and non-b-lactamase-producing isolates), and Neisseria meningitides. The bactericidal activity of meropenem results from the inhibition of cell wall synthesis. Meropenem readily penetrates the cell wall of most Gram-positive and Gram-negative bacteria to reach penicillin-binding-protein (PBP) targets. Its strongest affinities are toward PBPs 2, 3 and 4 of Escherichia coli and Pseudomonas aeruginosa; and PBPs 1, 2 and 4 of Staphylococcus aureus. Meropenem has significant stability to hydrolysis by β-lactamases, both penicillinases and cephalosporinases produced by Gram-positive and Gram-negative bacteria. Meropenem should not be used to treat methicillin-resistant Staphylococcus aureus (MRSA) or methicillin-resistant Staphylococcus epidermidis (MRSE). Meropenem product with such superior effectiveness and safety has been approved for marketing by 100 countries or more in the world (as of March 2004) since its first launch in Italy in 1994. — NCATS
Clinical trial activity
148 trials · 172 clinical orgs · 17 marketing orgs
Earliest trial started Feb 1, 2001 (NCT00619710)
Timeline
1990s
2000s
2010s
- Jun 22, 2010
Hospira — Marketing Organization
- Mar 29, 2011
Sandoz — Marketing Organization
- Mar 29, 2011
Novartis — Marketing Organization
- Apr 30, 2015
B. Braun — NDA Secondary Org
- Apr 30, 2015
B. Braun — Marketing Organization
- Dec 18, 2015
Daewoong Pharmaceutical Co. LTD. — Marketing Organization
- Apr 12, 2016
Amneal Pharmaceuticals — Marketing Organization
- Apr 19, 2016
Savior Lifetec Corp — Marketing Organization
- Jun 8, 2016
Gland Pharma Ltd — Marketing Organization
- Jun 9, 2016
ACS Dobfar — Marketing Organization
- Mar 27, 2017
Aurobindo Pharma — Marketing Organization
- Mar 27, 2017
Eugia Pharma — Marketing Organization
- Aug 29, 2017
Rempex Pharmaceuticals — Marketing Organization
- Aug 29, 2017
Rempex Pharmaceuticals — NDA Secondary Org
- Aug 29, 2017
The Medicines Company — NDA Secondary Org
- Aug 16, 2019
Hq Speciality Pharma — Marketing Organization
2020s
- Aug 18, 2022
STERISCIENCE — Marketing Organization
- Jul 26, 2023
Hq Speciality Pharma — NDA Secondary Org
- Jul 22, 2024
Qilu Pharmaceutical Co., Ltd. — Marketing Organization
Indications
Approved for
Studied for
- Abdomen, Acute · Phase 3
- Abdominal Abscess · Phase 3
- Abdominal Injuries · Phase 3
- Abdominal Pain · Phase 3
- Abscess · Phase 3
- Administration, Intravenous · Phase 2/Phase 3
- Ampicillin · Phase 2/Phase 3
- Anti-Bacterial Agents · Phase 2/Phase 3
- Appendicitis · Phase 3
- Ascites · Phase 2/Phase 3
- Aztreonam · Phase 2/Phase 3
- Bacteremia · Phase 4
- Bacterial Infections · Phase 4
- Blood-Borne Infections · Phase 3
- Bronchiectasis · Phase 4
- Carbapenems · Phase 4
- Cellulitis · Phase 3
- Central Nervous System Infections · Phase 4
- Ciprofloxacin · Phase 2/Phase 3
- Clinical Trial · Phase 4
- Critical Illness · Phase 4
- Cross Infection · Phase 2
- Cystic Fibrosis · Phase 4
- Diabetes Mellitus · Early Phase 1
- Dialysis · Phase 2/Phase 3
- Drug-Related Side Effects and Adverse Reactions · Phase 4
- Drug Resistance, Bacterial · Phase 4
- Drug Therapy · Phase 2/Phase 3
- Enterobacteriaceae Infections · Phase 4
- Enterocolitis, Necrotizing · Phase 1/Phase 2
- Escherichia coli Infections · Phase 4
- Febrile Neutropenia · Phase 4
- Fever · Phase 4
- Fibrosis · Phase 2/Phase 3
- Gram-Negative Bacterial Infections · Phase 4
- Hamartoma · Phase 2/Phase 3
- Healthcare-Associated Pneumonia · Phase 3
- Healthy Volunteers · Phase 4
- Hematologic Neoplasms · Phase 4
- Ileus · Phase 3
- Inflammation · Early Phase 1
- Intestinal Neoplasms · Phase 2
- Intestinal Perforation · Phase 3
- Intraabdominal Infections · Phase 3
- Kidney Diseases · Phase 1
- Kidney Failure, Chronic · Phase 2/Phase 3
- Klebsiella pneumoniae · Phase 4
- Liver Cirrhosis, Biliary · Phase 4
- Lung Diseases · Phase 3
- Lymphoma · Phase 2
- Melioidosis · Phase 2
- Meningitis · Phase 1/Phase 2
- Meropenem · Phase 2/Phase 3
- Neonatal Sepsis · Phase 3
- Neoplasms · Phase 2
- Obesity · Early Phase 1
- Osteomyelitis · Phase 2
- Osteoporosis · Early Phase 1
- Pancreatitis · Phase 4
- Pancreatitis, Acute Necrotizing · Phase 4
- Patient Compliance · Phase 4
- Peritoneal Dialysis · Phase 2/Phase 3
- Peritoneal Dialysis, Continuous Ambulatory · Phase 2/Phase 3
- Peritonitis · Phase 3
- Pharmacokinetics · Phase 2/Phase 3
- Pharmacological and Toxicological Phenomena · Phase 4
- Pharmacology · Phase 4
- Pneumonia · Phase 4
- Pneumonia, Bacterial · Phase 2
- Pneumonia, Ventilator-Associated · Phase 4
- Pseudomonas Infections · Phase 4
- Pyelonephritis · Phase 3
- Respiratory Tract Infections · Phase 4
- Rupture · Phase 3
- Sepsis · Phase 4
- Severe Acute Respiratory Syndrome · Phase 1/Phase 2
- Shock, Septic · Phase 4
- Systemic Inflammatory Response Syndrome · Phase 2
- Tuberculosis · Phase 2
- Tuberculosis, Pulmonary · Phase 2
- Typhoid Fever · Phase 4
- Urinary Bladder Neoplasms · Phase 3
- Venous Cutdown · Phase 2/Phase 3
Mechanism of action
- Bacterial penicillin-binding proteinINHIBITOR
Bacterial penicillin-binding protein inhibitor
- D-alanyl-D-alanine carboxypeptidase DacB (dacB) ↗
- Peptidoglycan D,D-transpeptidase FtsI (ftsI) ↗
- Penicillin-binding protein 1A (mrcA) ↗
- Penicillin-binding protein 1B (mrcB) ↗
- D-alanyl-D-alanine carboxypeptidase DacA (dacA) ↗
- Peptidoglycan D,D-transpeptidase MrdA (mrdA) ↗
- D-alanyl-D-alanine carboxypeptidase DacC (dacC) ↗
Combination products
vabomere
with vaborbactam
Also known as meropenem and vaborbactam
Approval history
- approvedJun 21, 1996
Chemistry & pharmacology
SMILES
C[C@@H](O)[C@@H]1[C@H]2[C@@H](C)C(S[C@@H]3CN[C@@H](C3)C(=O)N(C)C)=C(N2C1=O)C(O)=O- Mol. weight
- 383.463 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
Oral
No
Parenteral
Yes
Topical
No
Sources
- WikipediaMeropenem ↗
- NCATSYOP6PX0BAO ↗
- ChEMBLCHEMBL127 ↗
Also known as
- 1-azabicyclo(3.2.0)hept-2-ene-2-carboxylic acid, 3-((5-((dimethylamino)carbonyl)-3-pyrrolidinyl)thio)-6-(1-hydroxyethyl)-4-methyl-7-oxo-, (4r-(3(3s*,5s*),4alpha,5beta,6beta(r*)))-
- (1r,5s,6s)-2-[(3s,5s)-5-dimethylaminocarbonylpyrrolidin-3-ylthio]-6-[(r)-1-hydroxyethyl]-1-methylcarbapen-2-em-3-carboxylic acid
- (1r,5s,6s)-2-[(3s,5s)-5-dimethylaminocarbonylpyrrolidin-3-ylthio]-6-[(r)-1-hydroxyethyl]-1-methylcarbapen-2-em-3-carboxylic acid
- 3-(5-dimethylcarbamoylpyrrolidin-3-ylthio)-6-(1-hydroxyethyl)-4-methyl-7-oxo-1-azabicyclo(3.2.0)hept-2-ene-2-carboxylic acid
- (4r,5s,6s)-3-{[(3s,5s)-5-(dimethylcarbamoyl)pyrrolidin-3-yl]thio}-6-[(1r)-1-hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid
- (4r,5s,6s)-3-{[(3s,5s)-5-(dimethylcarbamoyl)pyrrolidin-3-yl]thio}-6-[(1r)-1-hydroxyethyl]-4-methyl-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid
- antibiotic sm 7338
- antibiotic sm 7338
- combination rpx7009
- ici-194660
- ici-194660
- meropenem
- meropenem
- meropenem
- meropenem
- meropenem
- meropenem
- meropenem
- meropenem
- meropenem
- meropenem
- meropenem anhydrous
- meropenem anhydrous
- meropenem hydrate
- meropenem hydrate
- meropenem hydrate
- meropenem hydrate
- meropenem hydrate
- meropenem trihydrate
- meropenem trihydrate
- meropenem trihydrate
- meropenemum
- meropenemum
- meropenemum trihydricum
- meropenemum trihydricum
- merrem
- merrem
- merrem
- merrem
- merrem
- merrem iv
- merrem iv
- penem
- ronem
- rpx2014
- rpx7009
- rpx7009
- sm 7338
- sm-7338
- sm-7338
- sm-7338
- vabomere
- vabomere
- vaborbactam
- vaborbactam
- vaborbactam
- vaborbactam
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT07124468 | Phase 1 | Sep 13, 2025 | Qilu Pharmaceutical Co., Ltd. |
| NCT06916156 | Phase 1 | Apr 28, 2025 | Antabio, Clinartis |
| NCT07089186 | Phase 3 | Apr 12, 2025 | Qilu Pharmaceutical Co., Ltd. |
| NCT06841731 | Phase 2 | Mar 31, 2025 | Hengrui Therapeutics, Inc. |
| NCT06818565 | N/A | Feb 10, 2025 | Institute of Liver and Biliary Sciences, India |
| NCT06672978 | Phase 2 | Jan 31, 2025 | Department of Health and Human Services, Melinta Therapeutics |
| NCT06342115 | Phase 4 | Oct 31, 2024 | Beneficência Portuguesa de Sao Paulo, Merck |
| NCT06633718 | Phase 3 | Oct 31, 2024 | Qilu Pharmaceutical Co., Ltd. |
| NCT06527677 | Phase 1 | Jul 19, 2024 | Antabio, University of Kiel |
| NCT06787885 | N/A | May 1, 2024 | Fayoum University |
| NCT07122596 | Phase 4 | Apr 1, 2024 | Government of Pakistan |
| NCT06293677 | Phase 4 | Mar 1, 2024 | University of Lausanne |
| NCT06184659 | Phase 4 | Mar 1, 2024 | Scandinavian Critical Care Trials Group |
| NCT05922124 | Phase 4 | Jan 31, 2024 | Hebrew University, Monaldi Hospital, Rutgers University, Technion University, Tel Aviv University |
| NCT05784844 | Phase 4 | Jan 31, 2024 | Wake Forest University |
| NCT06087536 | Phase 2 | Jan 31, 2024 | Omnix Medical |
| NCT07096310 | Phase 1/Phase 2 (Phase 2) | Jan 1, 2024 | Ain Shams University |
| NCT06168734 | Phase 3 | Dec 31, 2023 | Department of Health and Human Services, VenatoRx Pharmaceuticals, Inc. |
| NCT05925309 | N/A | Jul 1, 2023 | Fudan University |
| NCT05905913 | Phase 1 | Apr 12, 2023 | Antabio, Biotrial |
Organizations
Research & Development (172)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| AstraZeneca | For profit | 10 | 9 | 3 | 2001 |
| Merck | For profit | 8 | 4 | 3 | 2008 |
| The Medicines Company | For profit | 6 | 6 | 2 | 2012 |
| Department of Health and Human Services | Government | 5 | 0 | 3 | 2014 |
| Qilu Pharmaceutical Co., Ltd. | For profit | 5 | 5 | 3 | 2020 |
| Tel Aviv University | Academic/Hospital | 5 | 1 | 1 | 2013 |
| Fundación Pública Andaluza | Academic/Hospital | 4 | 4 | 1 | 2012 |
| King Abdul-Aziz University | Academic/Hospital | 4 | 3 | 1 | 2020 |
| Technion University | Academic/Hospital | 4 | 3 | 1 | 2013 |
| Antabio | For profit | 3 | 3 | 1 | 2023 |
| Cubist | For profit | 3 | 3 | 2 | 2010 |
| European Commission | Government | 3 | 0 | 2 | 2012 |
| Fudan University | Academic/Hospital | 3 | 2 | 3 | 2008 |
| Jiao Tong University | Academic/Hospital | 3 | 1 | 1 | 2012 |
| Mahidol University | Academic/Hospital | 3 | 2 | 2 | 2007 |
| Prince of Songkla University | Academic/Hospital | 3 | 3 | 1 | 2004 |
| Spanish Network for Research in Infectious Diseases | Academic/Hospital | 3 | 0 | 1 | 2014 |
| Sponsor GmbH | Academic/Hospital | 3 | 0 | 1 | 2012 |
| University of Queensland | Academic/Hospital | 3 | 3 | 2 | 2014 |
| Achaogen, Inc. | For profit | 2 | 2 | 1 | 2014 |
Marketing (23)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| ACS Dobfar | For profit | SYN | Oct 26, 2011 |
| ACS Dobfar | For profit | MKTG | Jun 9, 2016 |
| Amneal Pharmaceuticals | For profit | MKTG | Apr 12, 2016 |
| Aurobindo Pharma | For profit | MKTG | Mar 27, 2017 |
| B. Braun | For profit | NDA2 | Apr 30, 2015 |
| B. Braun | For profit | MKTG | Apr 30, 2015 |
| Daewoong Pharmaceutical Co. LTD. | For profit | MKTG | Dec 18, 2015 |
| Eugia Pharma | For profit | MKTG | Mar 27, 2017 |
| Gland Pharma Ltd | For profit | MKTG | Jun 8, 2016 |
| Gland Pharma Ltd | For profit | MKTG | Jun 8, 2016 |
| Hospira | For profit | MKTG | Jun 22, 2010 |
| Hq Speciality Pharma | For profit | MKTG | Aug 16, 2019 |
| Hq Speciality Pharma | For profit | NDA2 | Jul 26, 2023 |
| Novartis | For profit | MKTG | Mar 29, 2011 |
| Pfizer | For profit | NDA2 | Jun 21, 1996 |
| Pfizer | For profit | NDA | Jun 21, 1996 |
| Qilu Pharmaceutical Co., Ltd. | For profit | MKTG | Jul 22, 2024 |
| Rempex Pharmaceuticals | For profit | MKTG | Aug 29, 2017 |
| Rempex Pharmaceuticals | For profit | NDA2 | Aug 29, 2017 |
| STERISCIENCE | For profit | MKTG | Aug 18, 2022 |
| Sandoz | For profit | MKTG | Mar 29, 2011 |
| Savior Lifetec Corp | For profit | MKTG | Apr 19, 2016 |
| The Medicines Company | For profit | NDA2 | Aug 29, 2017 |