Primaxin, Recarbrio(cilastatin)
Cilastatin / Imipenem, Primaxin, Recarbrio (cilastatin) is a small molecule pharmaceutical. Cilastatin was first approved as Primaxin on 1985-11-26. It is used to treat bacterial endocarditis, infectious arthritis, infectious bone diseases, infectious skin diseases, and intraabdominal infections amongst others in the USA. It has been approved in Europe to treat gram-negative bacterial infections. The pharmaceutical is active against dipeptidase 1.
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FDA approval date
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Commercial
Trade Name
FDA
EMA
Combinations
Primaxin, Recarbrio (generic drugs available since 2011-12-21)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Cilastatin sodium
+
Imipenem
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| PRIMAXIN | Merck KGaA | N-050587 RX | 1985-11-26 | 1 products, RLD, RS |
Show 2 discontinued
Cilastatin sodium
+
Imipenem
+
Relebactam
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| RECARBRIO | Merck & Co | N-212819 RX | 2019-07-16 | 1 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| imipenem and cilastatin | ANDA | 2022-10-06 |
| imipenem and cilastatin imipenem and cilastatin | ANDA | 2022-10-11 |
| primaxin | ANDA, New Drug Application | 2023-12-01 |
| recarbrio | New Drug Application | 2023-07-26 |
Indications
FDA
EMA
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
CILASTATIN SODIUM / IMIPENEM / RELEBACTAM, RECARBRIO, MSD MERCK CO | |||
| 2029-07-16 | GAIN | ||
| 2024-07-16 | NCE | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Cilastatin Sodium / Imipenem / Relebactam, Recarbrio, Msd Merck Co | |||
| 8487093 | 2029-11-19 | DS, DP | U-2586, U-2587, U-2840 |
Clinical
Clinical Trials
58 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Urinary tract infections | D014552 | EFO_0003103 | N39.0 | — | 5 | 2 | 1 | — | 8 |
| Ventilator-associated pneumonia | D053717 | EFO_1001865 | J95.851 | — | 1 | 4 | 1 | — | 6 |
| Bacterial pneumonia | D018410 | EFO_1001272 | J15.9 | — | 2 | 2 | 1 | — | 5 |
| Sepsis | D018805 | HP_0100806 | A41.9 | 2 | 1 | — | 1 | 1 | 4 |
| Critical illness | D016638 | — | — | — | — | 1 | 1 | 2 | 4 |
| Infections | D007239 | EFO_0000544 | — | 1 | — | 1 | 2 | — | 4 |
| Pneumonia | D011014 | EFO_0003106 | — | 1 | 1 | — | 1 | — | 3 |
| Intraabdominal infections | D059413 | — | — | — | 1 | 1 | 1 | — | 3 |
| Hematologic neoplasms | D019337 | — | — | — | 1 | 1 | 1 | — | 2 |
| Multidrug-resistant tuberculosis | D018088 | EFO_0007381 | — | — | — | — | 1 | — | 1 |
Show 6 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Bacterial infections | D001424 | — | A49 | 6 | 3 | 2 | — | 2 | 11 |
| Iatrogenic disease | D007049 | — | — | — | — | 2 | — | — | 2 |
| Abdominal abscess | D018784 | EFO_1001753 | — | — | 1 | 1 | — | — | 2 |
| Bacteremia | D016470 | EFO_0003033 | R78.81 | — | — | 1 | — | — | 1 |
| Cross infection | D003428 | — | — | — | — | 1 | — | — | 1 |
| Gram-positive bacterial infections | D016908 | — | — | — | — | 1 | — | — | 1 |
| Sinusitis | D012852 | EFO_0007486 | J32 | — | — | 1 | — | — | 1 |
| Abscess | D000038 | EFO_0003030 | — | — | — | 1 | — | — | 1 |
| Cellulitis | D002481 | EFO_0003035 | L03.90 | — | — | 1 | — | — | 1 |
| Healthcare-associated pneumonia | D000077299 | — | — | — | — | 1 | — | — | 1 |
Show 1 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pyelonephritis | D011704 | EFO_1001141 | N10-N16 | — | 2 | — | — | — | 2 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Osteomyelitis | D010019 | EFO_0003102 | M86 | 1 | — | — | — | — | 1 |
| Communicable diseases | D003141 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Acute kidney injury | D058186 | HP_0001919 | N17 | — | — | — | — | 2 | 2 |
| Neutropenia | D009503 | — | D70 | — | — | — | — | 1 | 1 |
| Hematopoietic stem cell transplantation | D018380 | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Cilastatin |
| INN | cilastatin |
| Description | Cilastatin inhibits the human enzyme dehydropeptidase.
|
| Classification | Small molecule |
| Drug class | enzyme inhibitors: antihyperlipidemics (HMG-CoA inhibitors) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CC1(C)C[C@@H]1C(=O)N/C(=C\CCCCSC[C@H](N)C(=O)O)C(=O)O |
Identifiers
| PDB | — |
| CAS-ID | 82009-34-5 |
| RxCUI | — |
| ChEMBL ID | CHEMBL766 |
| ChEBI ID | 3697 |
| PubChem CID | 5280454 |
| DrugBank | DB01597 |
| UNII ID | 141A6AMN38 (ChemIDplus, GSRS) |
Target
Agency Approved
DPEP1
DPEP1
Organism
Homo sapiens
Gene name
DPEP1
Gene synonyms
MDP, RDP
NCBI Gene ID
Protein name
dipeptidase 1
Protein synonyms
Beta-lactamase, Dehydropeptidase-I, dipeptidase 1 (renal), hRDP, Microsomal dipeptidase, Renal dipeptidase, testicular tissue protein Li 57
Uniprot ID
Mouse ortholog
Dpep1 (13479)
dipeptidase 1 (P31428)
Alternate
No data
Variants
No data
Financial
Revenue by drug
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Primaxin – Merck & Co
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Estimated US medical usage
Cilastatin
+
Imipenem
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Refill frequency
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Price per prescription (USD)
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Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 5,429 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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5,006 adverse events reported
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