Sulopenem etzadroxil
Orlynvah (sulopenem etzadroxil) is a small molecule pharmaceutical. Sulopenem etzadroxil was first approved as Orlynvah on 2024-10-25.
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New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Probenecid
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Sulopenem etzadroxil
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ORLYNVAH | Iterum Therapeutics | N-213972 DISCN | 2024-10-25 | 1 products, RLD |
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FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| orlynvah | New Drug Application | 2025-03-20 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| gonorrhea | DOID_7551 | D006069 | A54 |
| neurosyphilis | EFO_0007339 | D009494 | A50.40 |
| gout | EFO_0004274 | D006073 | M10 |
Agency Specific
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Clinical
Clinical Trials
8 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Infections | D007239 | EFO_0000544 | — | 1 | — | 3 | — | 1 | 5 |
| Urinary tract infections | D014552 | EFO_0003103 | N39.0 | 1 | — | 3 | — | 1 | 5 |
| Communicable diseases | D003141 | — | — | 1 | — | 2 | — | 1 | 4 |
| Intraabdominal infections | D059413 | — | — | 1 | — | 1 | — | — | 2 |
| Cystitis | D003556 | EFO_1000025 | N30 | — | — | 1 | — | — | 1 |
Indications Phases 2
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pyelonephritis | D011704 | EFO_1001141 | N10-N16 | 1 | — | — | — | 1 | 2 |
Indications Without Phase
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Sulopenem etzadroxil |
| INN | _ |
| Description | Sulopenem/probenecid, sold under the brand name Orlynvah, is a fixed-dose combination medication used for the treatment of urinary tract infections. It contains sulopenem, a penem antibacterial, as the prodrug sulopenem etzadroxil; and probenecid, a renal tubular transport inhibitor.
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| Classification | Small molecule |
| Drug class | antibacterial antibiotics, carbapenem derivatives |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CCC(CC)C(=O)OCOC(=O)C1=C(S[C@H]2CC[S+]([O-])C2)S[C@@H]2[C@@H]([C@@H](C)O)C(=O)N12 |
Identifiers
| PDB | — |
| CAS-ID | 1000296-70-7 |
| RxCUI | — |
| ChEMBL ID | CHEMBL4594246 |
| ChEBI ID | — |
| PubChem CID | — |
| DrugBank | — |
| UNII ID | 492M3I304T (ChemIDplus, GSRS) |
Target
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Variants
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Financial
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Trends
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Safety
Black-box Warning
No Black-box warning
Adverse Events
0 adverse events reported
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