Drugs / Phenazopyridine
Phenazopyridine
also known as
Phenazopyridine Hydrochloride · Pyridium · phenazopyridine HCl · Azo-Gesic · Baridium · Fenazopiridina · NC 150 · NSC-145895 · +6 more
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | AZO GANTRISIN | — | 1990-08-31 | fda.gov ↗ |
Trials 10 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT03432572 | Jun 2018 → Jun 2020 | — | Texas Tech University Health Sciences Center | Completed | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT03065075 | Feb 2017 → Aug 2018 | urinary tract obstruction | University of Massachusetts, Worcester | Completed | No outcome recorded |
| 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 | ||||||
| — | NCT02715648 | Apr 2016 → Jun 2021 | — | Boston Urogynecology Associates | Unknown | No outcome recorded |
| — | NCT02424149 | Apr 2015 → Jan 2016 | — | Hartford Hospital | Completed | No outcome recorded |
| — | NCT02476448 | Feb 2015 → Feb 2016 | ureteral disorder | Cecilia Calvo | Completed | No outcome recorded |
Also used as a comparator or background therapy in 10 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT07016451 Background | Apr 2024 → Sep 2025 | radiation cystitis | Ramathibodi Hospital | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| 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 33 trials | ||||||
| Phase 3 | NCT01657448 Comparator | Jun → Nov 2016 | urethral syndrome | EMS | Completed | No outcome recorded |
| Phase 3 | NCT00969254 Comparator | Dec 2009 → Feb 2010 | urethral syndrome | Laboratorios Osorio de Moraes Ltda. | Unknown | No outcome recorded |
| Phase 3 | NCT01064024 Comparator | Dec 2009 → Dec 2010 | urinary tract infection | Amneal Pharmaceuticals, LLC | Completed | No outcome recorded |
| Phase 43 trials | ||||||
| Phase 4 | NCT06514430 Comparator | Jul 2025 → Feb 2026 | overactive bladder | Montefiore Medical Center | Withdrawn | No outcome recorded |
| Phase 4 | NCT03755089 Comparator | Nov 2018 → Mar 2021 | overactive bladder | Women and Infants Hospital of Rhode Island | Unknown | No outcome recorded |
| Phase 4 | NCT00771173 Comparator | Aug 2008 → Jan 2010 | interstitial cystitis | Loyola University | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT02757417 Comparator | Jul 2016 → Jan 2018 | — | University Hospitals Cleveland Medical Center | Withdrawn | No outcome recorded |
| — | NCT02703558 Comparator | Mar 2016 → Jan 2018 | — | Johns Hopkins University | Withdrawn | No outcome recorded |
Evidence & citations 17 cited values
Every value below carries the sentence it was read from. 22 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Phenazopyridine | “* Phenazopyridine” NCT07016451 ↗ |
| 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 ↗ |
| 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 ↗ |
| 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 ↗ |