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Also known as Phenazopyridine Hydrochloride, Pyridium
Phenazopyridine · 1 trial · 2 indications
| Arm | Type | Description |
|---|---|---|
| Phenazopyridine Hydrochloride Tablets, USP 200 mg | ACTIVE_COMPARATOR | - |
| Placebo | PLACEBO_COMPARATOR | Matching placebo to the phenazopyridine hydrochloride tablets |
| Name | Type | Description |
|---|---|---|
| Phenazopyridine Hydrochloride | DRUG | Tablets, 200 mg, every 8 hours for 48 hours. |
| Placebo | DRUG | Tablets, every 8 hours for 48 hours |
Inclusion Criteria: * Diagnosis of uncomplicated urinary tract infection (uUTI) * Must have one of the following uUTI diagnosis * Cystitis * Urethritis * A Positive urine dipstick test showing nitrate or leukocyte esterase (LE) * Negative pregnancy test (if applicable) * Must have one or both of th...
Phenazopyridine is used to treat pain, specifically pain associated with urinary tract infections. It is an oral small molecule developed by Amneal Pharmaceuticals, Inc. under the ticker AMRX. The drug has been studied in a Phase 3 clinical trial for pain and urinary tract infections.
Phenazopyridine targets sodium channels SCN1A, SCN5A, SCN4A, SCN7A, SCN2A, and SCN9A. It acts as a blocker of these targets. This mechanism is thought to contribute to its analgesic effects in treating pain associated with urinary tract infections.
Phenazopyridine is developed by Amneal Pharmaceuticals, Inc., which trades under the ticker AMRX. The company is responsible for the development and manufacturing of the drug.
Phenazopyridine is in Phase 3 clinical development. A Phase 3 trial has been completed, but the drug is not approved by the FDA and remains investigational. It is being developed for pain associated with urinary tract infections.
Phenazopyridine has been studied in a completed Phase 3 clinical trial, NCT01064024, titled "Evaluate the Safety and Efficacy of Phenazopyridine Hydrochloride Tablets, USP 200 mg vs. Placebo." This randomized, double-blind, placebo-controlled trial enrolled 233 female participants aged 18 years and older in the United States.
Yes, Phenazopyridine is also known as Phenazopyridine Hydrochloride. The hydrochloride salt form is the active ingredient in the tablets studied in clinical trials. Both names refer to the same chemical entity.