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 12h ago · AI intelligence enriched 6d ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
ORLYNVAH is an oral combination tablet containing sulopenem etzadroxil (a penem antibacterial) and probenecid (a renal tubular transport inhibitor). Probenecid enhances sulopenem plasma concentrations by inhibiting OAT3-mediated renal clearance, enabling oral administration of a beta-lactam antibiotic. The product addresses the need for oral carbapenem-class alternatives in bacterial infections.
Growth13.3 years to LOE
Early-stage product in growth phase with opportunity to build market presence and team infrastructure in an emerging oral carbapenem category.
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 represents a rare opportunity to join the commercial launch of a novel oral beta-lactam in an underserved market with minimal competition and strong patent protection. Roles will focus on establishing the product category, educating prescribers, and building market infrastructure during the critical growth phase.
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.