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orlynvah

Generic: sulopenem etzadroxil-probenecid

orlynvah: developed by 1 company · 1 FDA decision.

orlynvah evidence translation

What we can confirm

What it means

Source-backed records connect orlynvah to ITRMF; that link alone does not prove the drug works.

What to watch

Watch for new trials or company disclosures after the FDA record.
BioSniper AIPage evidence connected

Prepared research question

How could orlynvah → ITRMF affect its developer, and what evidence supports the link?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence1 indications · 0 study sponsors

Related indications

uncomplicated urinary tract infections (uUTI) in adult women caused by the designated microorganisms Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis in adult women with limited or no alternative oral antibacterial treatment options

Study sponsors

No additional listed-company sponsor is linked.

Development Pipeline (1)
CompanyPhase
Iterum Therapeutics plc (ITRMF)
uncomplicated urinary tract infections (uUTI) in adult women…
Approved
FDA Decisions1 records
Approval1 INDICATIONS AND USAGE ORLYNVAH, a combination of sulopenem etzadroxil, a penem antibacterial, and probenecid, a renal tubular transport inhibitor, is indicated for the treatment of uncomplicated urinary tract infections (uUTI) caused by the designated microorganisms Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis in adult women who have limited or no alternative oral antibacterial treatment options. ( 1.1 ) Limitations of Use ORLYNVAH is not indicated for the treatment of: Compli(ITRMF)FDA ↗
NDA213972Type 1 - New Molecular Entity and Type 4 - New CombinationPriorityOralTablet

Frequently asked questions

Who is developing orlynvah?

orlynvah is being developed by Iterum Therapeutics plc.

What is orlynvah's latest FDA decision?

The most recent tracked FDA decision for orlynvah is Approval for 1 INDICATIONS AND USAGE ORLYNVAH, a combination of sulopenem etzadroxil, a penem antibacterial, and probenecid, a renal tubular transport inhibitor, is indicated for the treatment of uncomplicated urinary tract infections (uUTI) caused by the designated microorganisms Escherichia coli, Klebsiella pneumoniae, or Proteus mirabilis in adult women who have limited or no alternative oral antibacterial treatment options. ( 1.1 ) Limitations of Use ORLYNVAH is not indicated for the treatment of: Compli, dated October 25, 2024.