Drugs / Phenazopyridine

Regulatory milestones approvals, filings & regulatory actions · 1 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Approved US (FDA) AZO GANTRISIN — 1990-08-31 fda.gov ↗

Trials 10

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PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 01 trial
Phase 0 NCT03432572 Jun 2018 → Jun 2020 — Texas Tech University Health Sciences Center Completed No outcome recorded
Phase 33 trials · 1 missed
Phase 3 NCT03065075 Feb 2017 → Aug 2018 urinary tract obstruction University of Massachusetts, Worcester Completed Missed primary
Phase 3 NCT02806713 Feb 2016 → Aug 2017 — University of Massachusetts, Worcester Completed No outcome recorded
Phase 3 NCT01650051 Feb 2012 → Feb 2013 urinary tract infection Amneal Pharmaceuticals, LLC Completed No outcome recorded
Phase 43 trials
Phase 4 NCT06577493 Dec 2024 → Nov 2025 overdue — University of South Florida Active not recruiting No outcome recorded
Phase 4 NCT03302936 Oct 2017 → Jul 2019 urinary tract obstruction Icahn School of Medicine at Mount Sinai Completed No outcome recorded
Phase 4 NCT02677623 Mar 2015 → Aug 2016 — Columbia University Completed No outcome recorded
Phase not applicable3 trials · 1 met primary · 1 missed
— NCT02715648 Apr 2016 → Jun 2021 — Boston Urogynecology Associates Unknown No outcome recorded
— NCT02424149 Apr 2015 → Jan 2016 — Hartford Hospital Completed Missed primary
— NCT02476448 Feb 2015 → Feb 2016 ureteral disorder Cecilia Calvo Completed Met primary
Comparator or background therapy10 trials
Phase 0 NCT07016451 Background Apr 2024 → Sep 2025 radiation cystitis Ramathibodi Hospital Completed No outcome recorded
Phase 2 NCT02380573 Background Jul 2015 → Apr 2022 Alzheimer disease, cognitive impairment with or without cerebellar ataxia The University of Texas Health Science Center at San Antonio Completed No outcome recorded
Phase 3 NCT01657448 Comparator Jun → Nov 2016 urethral syndrome EMS Completed No outcome recorded
Phase 3 NCT01064024 Comparator Dec 2009 → Dec 2010 urinary tract infection Amneal Pharmaceuticals, LLC Completed No outcome recorded
Phase 3 NCT00969254 Comparator Dec 2009 → Feb 2010 urethral syndrome Laboratorios Osorio de Moraes Ltda. Unknown No outcome recorded

Evidence & citations 17 cited values

Every value below carries the sentence it was read from. 22 sources stand behind the page.

FieldValueCited text
Known as Phenazopyridine “* Phenazopyridine” NCT07016451 ↗
15

NCT01650051 ↗

NCT02424149 ↗

NCT01064024 ↗

NCT06514430 ↗

NCT02703558 ↗

NCT03755089 ↗

NCT02715648 ↗

NCT06577493 ↗

NCT02476448 ↗

NCT01657448 ↗

Show 5 more sources

Known as Azo-Gesic “Phenazopyridine is an over-the-counter medication (Azo-Gesic, Baridium, Urinary Pain Relief) that has been used safely for decades as a bladder analgesic and taints the urine orange.” NCT03065075 ↗
Known as Baridium “Phenazopyridine is an over-the-counter medication (Azo-Gesic, Baridium, Urinary Pain Relief) that has been used safely for decades as a bladder analgesic and taints the urine orange.” NCT03065075 ↗
Known as Fenazopiridina ChEMBL registry synonym — accepted as the source's own label CHEMBL1242 ↗
Known as NC 150 ChEMBL registry synonym — accepted as the source's own label CHEMBL1242 ↗
Known as NSC-145895 ChEMBL registry synonym — accepted as the source's own label CHEMBL1242 ↗
Known as NSC-1879 ChEMBL registry synonym — accepted as the source's own label CHEMBL1242 ↗
Known as Phenazopyridine HCl “compare the utility of phenazopyridine HCl vs. placebo in reducing catheter-associated discomfort during the post-operative period in the gynecologic patient using mean VAS...” NCT00771173 ↗
1

“Phenazopyridine HCl Tablets, USP 200 mg” NCT01650051 ↗

Known as Phenazopyridine Hydrochloride “Phenazopyridine Hydrochloride Tables, USP 200 mg” NCT01650051 ↗
4

“to placebo or phenazopyridine hydrochloride.” PMID 21376167 ↗ Mar 2011

“pyridium (Phenazopyridine Hydrochloride)” NCT03432572 ↗

“Phenazopyridine Hydrochloride 99.5 MG” NCT06577493 ↗

NCT02380573 ↗

Known as Phenazopyridine hydrochloride component of azo gantanol ChEMBL registry synonym — accepted as the source's own label CHEMBL1242 ↗
Known as Phenazopyridine hydrochloride component of azo gantrisin ChEMBL registry synonym — accepted as the source's own label CHEMBL1242 ↗
Known as Pyridium ClinicalTrials.gov intervention name — accepted as the source's own label NCT00969254 ↗
2

NCT02677623 ↗

NCT03432572 ↗

Known as Urinary Pain Relief “Phenazopyridine is an over-the-counter medication (Azo-Gesic, Baridium, Urinary Pain Relief) that has been used safely for decades as a bladder analgesic and taints the urine orange.” NCT03065075 ↗
Known as Uropyrine ChEMBL registry synonym — accepted as the source's own label CHEMBL1242 ↗
Known as W 1655 ChEMBL registry synonym — accepted as the source's own label CHEMBL1242 ↗
Modality Small molecule — CHEMBL1242 ↗
Route Oral “200 mg of phenzopyridine HCl orally” NCT00771173 ↗