NDAORALTABLETPriority Review
Approved
Oct 2024
Lifecycle
Growth
Competitive Pressure
0/100
Data completeness
3/8 — Basic
Priority Review
ORLYNVAH (sulopenem etzadroxil and probenecid) by Iterum Therapeutics is etzadroxil, a penem antibacterial drug [see microbiology ] and probenecid, a renal tubular transport inhibitor. First approved in 2024.
Drug data last refreshed 15h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ORLYNVAH is an oral combination of sulopenem etzadroxil (a penem antibiotic) and probenecid (a renal transport inhibitor) approved in October 2024. Probenecid enhances sulopenem plasma concentrations by blocking OAT3-mediated renal clearance, improving oral bioavailability of this broad-spectrum antibacterial. Indicated for oral treatment of bacterial infections in patients who previously required intravenous therapy.
Growth13.5 years to LOE
Early-stage growth product with minimal competitive pressure creates opportunity for field-building roles, though team scaling depends on payer/prescriber adoption rates in Q1–Q2 2025.
Mechanism of Action
etzadroxil, a penem antibacterial drug [see Microbiology ] and probenecid, a renal tubular transport inhibitor. Probenecid inhibits OAT3-mediated renal clearance of sulopenem, resulting in increased plasma concentrations of sulopenem .
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Career Relevance
ORLYNVAH is a newly launched product at Iterum Therapeutics with no current linked vacancies, indicating small initial team size typical of biotech launches. Career growth will correlate with commercial uptake and franchise expansion; roles will concentrate in field sales, payer management, and MSL medical support as the product scales.
Brand Manager
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.