phenazopyridine
Trade name: gantanol
Small moleculeapproved
Approved
Jun 1, 1914
Phenazopyridine hydrochloride, an azo dye marketed in the US in 1914, became widely prescribed for the treatment of urinary tract infections (UTIs). With the assumption that the drug possessed antiseptic properties, phenazopyridine was recommended for UTIs caused by Staphylococcus, Streptococcus, and Escherichia coli. Although in the early 1930s the medical and scientific communities rescinded the claim that phenazopyridine is bactericidal, a specific mechanism of action has not been identified subsequently. Currently, phenazopyridine is classified as a urinary analgesic that relieves burning, urgency, frequency, and pain associated with UTI, trauma, or surgery. — NCATS
Clinical trial activity
21 trials · 25 clinical orgs · 2 marketing orgs
Phase 1
1
Phase 2
7
Phase 3
6
Phase 4
7
Earliest trial started Aug 1, 2008 (NCT00743977)
Timeline
1910s
- Jun 1, 1914
Earliest FDA Approval
1990s
- Aug 31, 1990
Roche — NDA Secondary Org
2000s
- Jun 26, 2001
Able Laboratories — NDA Secondary Org
- Jan 1, 2009
Earliest Phase 3 Sponsor(trial)
Indications
Approved for
Studied for
- Aging · Phase 2
- Alzheimer Disease · Phase 2
- Catheters · Phase 4
- Cognition Disorders · Phase 2
- Cognitive Dysfunction · Phase 2
- Dysuria · Phase 3
- Gastritis · Phase 4
- Pain · Phase 4
- Postoperative Complications · Phase 3
- Postoperative Pain · Phase 3
- Ureteral Diseases · Phase 4
- Urinary Bladder · Phase 4
- Urinary Bladder, Overactive · Phase 4
- Urinary Incontinence · Phase 4
- Urinary Incontinence, Urge · Phase 4
- Urinary Retention · Phase 4
- Urinary Tract Infections · Phase 3
- Urination Disorders · Phase 3
Mechanism of action
- Sodium channel alpha subunitBLOCKER
Sodium channel alpha subunit blocker
- Sodium channel protein type 1 subunit alpha (SCN1A) ↗
- Sodium channel protein type 5 subunit alpha (SCN5A) ↗
- Sodium channel protein type 4 subunit alpha (SCN4A) ↗
- Sodium channel protein type 7 subunit alpha (SCN7A) ↗
- Sodium channel protein type 2 subunit alpha (SCN2A) ↗
- Sodium channel protein type 9 subunit alpha (SCN9A) ↗
- Sodium channel protein type 3 subunit alpha (SCN3A) ↗
- Sodium channel protein type 11 subunit alpha (SCN11A) ↗
- Sodium channel protein type 8 subunit alpha (SCN8A) ↗
- Sodium channel protein type 10 subunit alpha (SCN10A) ↗
- Sodium channel protein type I alpha subunit
- Sodium channel protein type V alpha subunit
- Sodium channel protein type IV alpha subunit
- Sodium channel protein type VII alpha subunit
- Sodium channel protein type IX alpha subunit
- Sodium channel protein type II alpha subunit
- Sodium channel protein type III alpha subunit
- Sodium channel protein type XI alpha subunit
- Sodium channel protein type VIII alpha subunit
- Sodium channel protein type X alpha subunit
- Sodium channel alpha subunits; brain (Types I, II, III)
Combination products
azo gantanol
with sulfamethoxazole
azo gantrisin
with sulfisoxazole
Approval history
- approvedJun 1, 1914
Chemistry & pharmacology
Loading structure…
SMILES
Nc1ccc(/N=N/c2ccccc2)c(N)n1- Mol. weight
- 213.24 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Achiral Molecule
- Inorganic
- No
- Polymer
- No
- Delivery
- Oral
- Availability
- Discontinued
Oral
Yes
Parenteral
No
Topical
No
Sources
- ChEMBLCHEMBL1242 ↗
- WikipediaPhenazopyridine ↗
- NCATS0EWG668W17 ↗
- ChEMBLCHEMBL139877 ↗
- ChEMBLCHEMBL1201022 ↗
Also known as
- 3-(phenylazo)-2,6-pyridinediamine
- 3-(phenylazo)-2,6-pyridinediamine
- eupasidin
- fenazopiridina
- fenazopiridina
- gastracid
- nc-150
- nc-150
- phenazopyridine
- phenazopyridine
- phenazopyridine
- phenazopyridine
- phenazopyridine
- phenazopyridine
- phenazopyridine
- phenazopyridine
- phenazopyridine
- phenazopyridine
- phenazopyridine
- phenazopyridine hcl
- phenazopyridine hcl
- phenazopyridine hcl
- phenazopyridine hydrochloride
- phenazopyridine hydrochloride
- phenazopyridine hydrochloride
- phenazopyridine hydrochloride
- phenylazo-diaminopyridine
- pyridium
- pyridium
- pyridium
- pyridium
- pyridium
- uromide
- uromide
- uropyrine
- uropyrine
- w-1655
- w-1655
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT06514430 | Phase 4 | Dec 31, 2024 | Yeshiva University |
| NCT06577493 | Phase 4 | Sep 15, 2024 | University of South Florida |
| NCT03755089 | Phase 4 | Nov 1, 2018 | Brown University |
| NCT03432572 | Early Phase 1 (Phase 1) | Oct 1, 2018 | Texas Tech University |
| NCT03302936 | Phase 4 | Oct 24, 2017 | Icahn School of Medicine at Mount Sinai |
| NCT03065075 | Phase 3 | Feb 1, 2017 | University of Massachusetts |
| NCT02757417 | N/A | Jul 1, 2016 | Case Western Reserve University |
| NCT02715648 | N/A | Apr 1, 2016 | Boston Urogynecology Associates |
| NCT02703558 | N/A | Mar 1, 2016 | Johns Hopkins University |
| NCT02806713 | Phase 3 | Feb 1, 2016 | University of Massachusetts |
| NCT01657448 | Phase 3 | Jan 1, 2016 | EMS S/A |
| NCT02380573 | Phase 2 | Jul 1, 2015 | University of Texas, San Antonio |
| NCT02424149 | N/A | Apr 1, 2015 | University of Connecticut |
| NCT02677623 | Phase 4 | Mar 1, 2015 | Columbia University |
| NCT02476448 | N/A | Feb 1, 2015 | University of Rochester |
| NCT02356679 | Phase 4 | Aug 1, 2014 | Chong Kun Dang Pharmaceutical, Inje University |
| NCT01650051 | Phase 3 | Feb 1, 2012 | Amneal Pharmaceuticals, Symbio |
| NCT01064024 | Phase 3 | Dec 1, 2009 | Amneal Pharmaceuticals, Biostudy Solutions, LLC, Oxford Pharmaceutical Resources, Inc., Sristek Clinical Research |
| NCT00969254 | Phase 3 | Dec 1, 2009 | Laboratorios Osorio de Moraes Ltda., Universidade de Santo Amaro |
| NCT00743977 | N/A | Aug 1, 2008 | Universal Enterprises |
Showing 20 of 21 trials
Page 1 / 2
Organizations
Research & Development (25)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Amneal Pharmaceuticals | For profit | 2 | 2 | 1 | 2009 |
| University of Massachusetts | Academic/Hospital | 2 | 2 | 1 | 2016 |
| Biostudy Solutions, LLC | For profit | 1 | 0 | 1 | 2009 |
| Boston Urogynecology Associates | Academic/Hospital | 1 | 1 | 1 | 2016 |
| Brown University | Academic/Hospital | 1 | 1 | 1 | 2018 |
| Case Western Reserve University | Academic/Hospital | 1 | 1 | 1 | 2016 |
| Chong Kun Dang Pharmaceutical | For profit | 1 | 1 | 1 | 2014 |
| Columbia University | Academic/Hospital | 1 | 1 | 1 | 2015 |
| EMS S/A | For profit | 1 | 1 | 1 | 2016 |
| Icahn School of Medicine at Mount Sinai | Academic/Hospital | 1 | 1 | 1 | 2017 |
| Inje University | Academic/Hospital | 1 | 0 | 1 | 2014 |
| Johns Hopkins University | Academic/Hospital | 1 | 1 | 1 | 2016 |
| Laboratorios Osorio de Moraes Ltda. | For profit | 1 | 1 | 1 | 2009 |
| Loyola University | Academic/Hospital | 1 | 1 | 1 | 2008 |
| Oxford Pharmaceutical Resources, Inc. | For profit | 1 | 0 | 1 | 2009 |
| Sristek Clinical Research | Academic/Hospital | 1 | 0 | 1 | 2009 |
| Symbio | For profit | 1 | 0 | 1 | 2012 |
| Texas Tech University | Academic/Hospital | 1 | 1 | 1 | 2018 |
| Universal Enterprises | For profit | 1 | 1 | 1 | 2008 |
| Universidade de Santo Amaro | Academic/Hospital | 1 | 0 | 1 | 2009 |
25 organizations
Page 1 / 2
Marketing (3)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Able Laboratories | For profit | NDA2 | Jun 26, 2001 |
| Roche | For profit | NDA | Jun 1, 1987 |
| Roche | For profit | NDA2 | Aug 31, 1990 |