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sulopenem etzadroxil 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | PK/Tox | Related Drugs | BioActivity |
| Stem definition | Drug id | CAS RN |
|---|---|---|
| analogues of penicillanic acid antibiotics modified in the five-membered ring | 5838 | None |
Description:
| Molecule | Description |
|---|---|
|
Synonyms:
|
ORLYNVAH is a combination of sulopenem etzadroxil, is a prodrug that is hydrolyzed to the active drug sulopenem after oral administration and probenecid, a renal tubular inhibitor. Probenecid inhibits OAT3-mediated renal clearance of sulopenem, resulting in increased plasma concentrations of sulopenem. Sulopenem has in vitro activity against gram-positive and gram-negative aerobic and anaerobic bacteria. The bactericidal activity of sulopenem results from the inhibition of cell wall synthesis and is mediated through sulopenem binding to penicillin binding proteins (PBPs). In Escherichia coli, sulopenem demonstrated binding affinity for PBPs in the following order: PBP2 > PBP1A > PBP1B > PBP4 > PBP3 > PBP5/6.
Legend: OFP - off patent OFM - off market ONP - on patent |
Drug dosage:
None
ADMET properties:
None
Predicted pharmacokinetic/toxicological properties (PK-AZ):
None
Approvals:
| Date | Agency | Company | Orphan |
|---|---|---|---|
| Oct. 25, 2024 | FDA | Iterum Therapeutics |
FDA Adverse Event Reporting System (Female)
None
FDA Adverse Event Reporting System (Male)
None
FDA Adverse Event Reporting System (Geriatric)
None
FDA Adverse Event Reporting System (Pediatric)
None
Pharmacologic Action:
| Source | Code | Description |
|---|---|---|
| CHEBI has role | CHEBI:33281 | antimicrobial agent |
| CHEBI has role | CHEBI:35441 | antiinfective agent |
Drug Use | Suggest Off label Use Form| |View source of the data|
| Disease | Relation | SNOMED_ID | DOID |
|---|---|---|---|
| Urinary tract infections | indication | 68566005 |
🐶 Veterinary Drug Use
None
🐶 Veterinary products
None
Acid dissociation constants calculated using MoKa v3.0.0
None
Orange Book patent data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Patent number | Patent expiration date | Patent use |
|---|---|---|---|---|---|---|---|---|---|---|
| 500MG;500MG | ORLYNVAH | ITERUM THERAP | N213972 | Oct. 25, 2024 | RX | TABLET | ORAL | 7795243 | June 3, 2029 | USE IN TREATING UNCOMPLICATED URINARY TRACT INFECTIONS CAUSED BY ESCHERICHIA COLI, KLEBSIELLA PNEUMONIAE, OR PROTEUS MIRABILIS |
| 500MG;500MG | ORLYNVAH | ITERUM THERAP | N213972 | Oct. 25, 2024 | RX | TABLET | ORAL | 11554112 | April 1, 2039 | USE IN TREATING UNCOMPLICATED URINARY TRACT INFECTIONS CAUSED BY ESCHERICHIA COLI, KLEBSIELLA PNEUMONIAE, OR PROTEUS MIRABILIS |
| 500MG;500MG | ORLYNVAH | ITERUM THERAP | N213972 | Oct. 25, 2024 | RX | TABLET | ORAL | 12109197 | April 1, 2039 | USE IN TREATING UNCOMPLICATED URINARY TRACT INFECTIONS CAUSED BY ESCHERICHIA COLI, KLEBSIELLA PNEUMONIAE, OR PROTEUS MIRABILIS |
| 500MG;500MG | ORLYNVAH | ITERUM THERAP | N213972 | Oct. 25, 2024 | RX | TABLET | ORAL | 11478428 | Dec. 23, 2039 | USE IN TREATING UNCOMPLICATED URINARY TRACT INFECTIONS CAUSED BY ESCHERICHIA COLI, KLEBSIELLA PNEUMONIAE, OR PROTEUS MIRABILIS |
| 500MG;500MG | ORLYNVAH | ITERUM THERAP | N213972 | Oct. 25, 2024 | RX | TABLET | ORAL | 12544337 | Dec. 23, 2039 | USE IN TREATING UNCOMPLICATED URINARY TRACT INFECTIONS CAUSED BY ESCHERICHIA COLI, KLEBSIELLA PNEUMONIAE, OR PROTEUS MIRABILIS |
Orange Book exclusivity data (new drug applications)
| Formulation strength | Trade name | Applicant | Application number | Approval date | Type | Dose form | Route | Exclusivity date | Description |
|---|---|---|---|---|---|---|---|---|---|
| 500MG;500MG | ORLYNVAH | ITERUM THERAP | N213972 | Oct. 25, 2024 | RX | TABLET | ORAL | Oct. 25, 2029 | NEW CHEMICAL ENTITY |
| 500MG;500MG | ORLYNVAH | ITERUM THERAP | N213972 | Oct. 25, 2024 | RX | TABLET | ORAL | Oct. 25, 2034 | GENERATING ANTIBIOTIC INCENTIVES NOW |
Bioactivity Summary:
| Target | Class | Pharos | UniProt | Action | Type | Activity value (-log[M]) | Mechanism action | Bioact source | MoA source |
|---|---|---|---|---|---|---|---|---|---|
| Peptidoglycan synthase FtsI | Enzyme | INHIBITOR | UNKNOWN | DRUG LABEL | |||||
| D-alanyl-D-alanine carboxypeptidase DacB | Enzyme | INHIBITOR | UNKNOWN | DRUG LABEL | |||||
| Penicillin-binding protein 1A | Enzyme | INHIBITOR | UNKNOWN | DRUG LABEL | |||||
| Penicillin-binding protein 1B | Enzyme | INHIBITOR | UNKNOWN | DRUG LABEL | |||||
| Penicillin-binding protein 2 | Enzyme | INHIBITOR | UNKNOWN | DRUG LABEL |
External reference:
| ID | Source |
|---|---|
| 1000296-70-7 | SECONDARY_CAS_RN |
| CHEMBL4594246 | ChEMBL_ID |
| DB16335 | DRUGBANK_ID |
| 4044173 | VANDF |
| C2981328 | UMLSCUI |
| CHEBI:757755 | CHEBI |
| 23642298 | PUBCHEM_CID |
| 44540 | MMSL |
| d10343 | MMSL |
| 492M3I304T | UNII |
| 2717834 | RXNORM |
| D05969 | KEGG_DRUG |
| 019904 | NDDF |
Pharmaceutical products:
| Product | Category | Ingredients | NDC | Form | Quantity | Route | Marketing | Label |
|---|---|---|---|---|---|---|---|---|
| ORLYNVAH | HUMAN PRESCRIPTION DRUG LABEL | 2 | 81153-100 | TABLET, FILM COATED | 500 mg | ORAL | NDA | 31 sections |