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Iterum Therapeutics Plc (ITRM)
NASDAQ:ITRM
Sulopenem Etzadroxil And Probenecid
Pharmacokinetics After Oral Intake
Phase I
Not Yet Recruiting
Pharmacokinetics of Sulopenem Etzadroxil Plus Probenecid in Adolescents
Jul 22, 2025
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Amoxicillin/Clavulanate, Sulopenem Etzadroxil/Probenecid
Urinary Tract Infections, Cystitis
Phase III
Completed
Oral Sulopenem Versus Amoxicillin/Clavulanate for Uncomplicated Urinary Tract Infection in Adult Women
Oct 14, 2022
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Iterum Therapeutics Plc (ITRM) have in its pipeline
ITRM is currently developing the following drugs: Sulopenem Etzadroxil And Probenecid, Amoxicillin/Clavulanate, Sulopenem Etzadroxil/Probenecid. These drug candidates are in various stages of clinical development as the company works toward FDA approval.