Sulfamethoxazole
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | GANTANOL | — | 1965-07-01 | fda.gov ↗ |
Trials 35 · a red edge is where a trial was stopped
Also used as a comparator or background therapy in 29 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT02099240 Comparator | Mar 2014 → Nov 2018 | osteomyelitis | University of Louisville | Terminated | No outcome recorded |
| Phase 12 trials | ||||||
| Phase 1 | NCT07228702 Background | Jan 2026 → Oct 2027 expected | pulmonary non-tuberculous mycobacterial infection | Vancouver Coastal Health | Enrolling by invitation | No outcome recorded |
| Phase 1 | NCT01967758 Background | Jan 2014 → Jun 2018 | anaplastic astrocytoma, brain neoplasm, glioblastoma | Providence Health & Services | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT01632891 Background | Jan 2014 → Jun 2016 | HIV infectious disease, parasitemia | Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections | Completed | No outcome recorded |
| Phase 1/2 | NCT00141037 Background | Mar 2004 → Sep 2006 | kidney disorder | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 26 trials | ||||||
| Phase 2 | NCT05835479 Comparator | Nov 2023 → May 2025 overdue | pneumocystosis | Mundipharma Research Limited | Recruiting | No outcome recorded |
| Phase 2 | NCT05702762 Comparator | Oct 2022 → Jun 2023 | cystitis | Mercy Health Ohio | Unknown | No outcome recorded |
| Phase 2 | NCT05488340 Background | Jul 2022 → Jun 2026 overdue | urinary tract infection | Locus Biosciences | Recruiting | No outcome recorded |
| Phase 2 | NCT02734732 Comparator | Apr 2015 → Apr 2020 | prostatitis | Umeå University | Unknown | No outcome recorded |
| Phase 2 | NCT01757236 Comparator | Oct 2012 → Apr 2016 | periprosthetic joint infection | University Hospital, Tours | Unknown | No outcome recorded |
| Phase 2 | NCT00014911 Background | Apr 2001 → Jun 2005 | type 1 diabetes mellitus | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT06341998 Background | Jun 2020 → Jan 2024 | yolk sac tumor | Shandong First Medical University | Completed | No outcome recorded |
| Phase 38 trials | ||||||
| Phase 3 | NCT05224401 Comparator | May 2023 → Sep 2027 expected | bacterial urinary tract infection | Lund University | Recruiting | No outcome recorded |
| Phase 3 | NCT02282293 Comparator | Dec 2014 → May 2016 | HIV infectious disease, malaria | University of California, San Francisco | Completed | No outcome recorded |
| Phase 3 | NCT02021006 Comparator | Dec 2013 → Jan 2020 | chronic kidney disease, renal hypodysplasia/aplasia 1, vesicoureteral reflux | Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico | Unknown | No outcome recorded |
| Phase 3 | NCT01595438 Background | Oct 2012 → Aug 2014 | acute pyelonephritis | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT01599806 Background | Oct 2012 → Aug 2014 | acute pyelonephritis | Pfizer | Completed | No outcome recorded |
| Phase 3 | NCT00933049 Comparator | Jul 2007 → Jan 2008 | pneumonia | Makerere University | Completed | No outcome recorded |
| Phase 3 | NCT00405704 Comparator | May 2007 → Jun 2013 | urinary tract infection, vesicoureteral reflux | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Completed | No outcome recorded |
| Phase 3 | NCT00324922 Comparator | May 2006 → May 2007 | methicillin-resistant staphylococcus aureus infectious disease, osteomyelitis | University of Washington | Completed | No outcome recorded |
| Phase 44 trials | ||||||
| Phase 4 | NCT05719285 Comparator | Dec 2022 → Jun 2023 | overactive bladder | The Cleveland Clinic | Completed | No outcome recorded |
| Phase 4 | NCT03235947 Background | Sep 2016 → Nov 2017 | bacteriuria, urinary tract infection | National Institute of Medical Sciences and Nutrition Salvador Zubiran | Completed | No outcome recorded |
| Phase 4 | NCT01820897 Comparator | Apr 2013 → Mar 2015 | bacteriuria, transplant rejection, urinary tract infection | JOSE MANUEL ARREOLA GUERRA | Completed | No outcome recorded |
| Phase 4 | NCT03877289 Background | Oct 2008 → Jul 2014 | cystitis | University of Calgary | Completed | No outcome recorded |
| Phase not applicable5 trials | ||||||
| — | NCT02944825 Comparator | Jan 2016 → Jan 2025 | urinary tract infection, urolithiasis | University of California, San Diego | Completed | No outcome recorded |
| — | NCT01507974 Comparator | Jan 2012 → Jul 2014 | pregnancy disorder | HaEmek Medical Center, Israel | Completed | No outcome recorded |
| — | NCT00976963 Comparator | Sep 2009 → Dec 2016 | urinary tract infection | University of Washington | Completed | No outcome recorded |
| — | NCT00822692 Comparator | Jul 2008 → Jun 2009 | abscess, methicillin-resistant staphylococcus aureus infectious disease | 59th Medical Wing | Completed | No outcome recorded |
| — | NCT00002002 Background | — | HIV infectious disease, pneumocystosis | Lederle Laboratories | Completed | No outcome recorded |
Evidence & citations 28 cited values
Every value below carries the sentence it was read from. 65 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | SULFAMETHOXAZOLE | “AIDS patients with TE were randomly divided into 3 groups that received a 6-week course of either pyrimethamine (50 mg/day or 100 mg/day) plus sulfadiazine (4 g/day) and...” NCT00367081 ↗62“Possible prescribed antibiotics include: trimethoprim and sulfamethoxazole (Septra), Cefalotin, Cephalexin, Cefapirin, Cefdroxil, Cefazolin, Cefradine, Cefacetrile,...” NCT03877289 ↗ “A 3-day course of oral amoxicillin (500 mg three times per day) or trimethoprim/sulfamethoxazole in penicillin-allergic patients (160 mg trimethoprim / 800mg sulfamethoxazole...” NCT01967758 ↗ “Participants will receive a single oral dose of either Bactrim (800 mg sulfamethoxazole + 160 mg trimethoprim) or if allergic to sulfonamides, a single oral dose of Macrobid...” NCT07501065 ↗ “Daily oral cotrimoxazole suspension from 1 to 6 months of age at the following weight-based doses: * less than 5kg: 100mg sulfamethoxazole, 20mg trimethoprim * greater than...” NCT01086878 ↗ “Patients randomized to the "Procedural Antibiotics Only" arm will receive a single dose of trimethoprim/sulfamethoxazole (800/160mg) peri-procedurally at the time of the first...” NCT03508921 ↗ “Oral dose regimen for simple urinary tract infection: Including cephalexin, cefdinir, sulfamethoxazole/trimethoprim, and nitrofurantoin at appropriate dose, frequency, and duration” NCT05702762 ↗ “Antimicrobials included co-trimoxazole (trimethoprim 160 mg/sulfamethoxazole 800 mg twice daily plus folic acid 5 mg daily, n = 128) or doxycycline” PMID 33974018 ↗ May 2021 “Sulfamethoxazole/trimethoprim (Bactrim): one double strength (DS) tablet (800 mg/160 mg) twice per day for adolescents and adults” NCT06397781 ↗ “sulfamethoxazole were prescribed to prevent hemorrhagic cystitis and Pneumocystis Jirovecii Pneumonia (PJP), respectively” NCT06341998 ↗ “we randomized adults to oral trimethoprim-sulfamethoxazole or placebo after uncomplicated abscess incision and drainage.” PMID 20346539 ↗ Mar 2010 “co-trimoxazole will also be given with trimethoprim 15-20 mg/kg/day and sulfamethoxazole 75-100 mg/kg/day” NCT05835479 ↗ “800 mg sulfamethoxazole and 160 mg trimethoprim daily, from 28 weeks of gestation until delivery” NCT00970879 ↗ “TMP/SMX (160 mg trimethoprim and 800 mg sulfamethoxazole) given orally BID on Days 1 through 3.” NCT05488340 ↗ “Sulfamethoxazole-Trimethoprim 800-160 MG Oral Tab; 800mg/160mg BID x 3 days” NCT00976963 ↗ “4 mg trimethoprim and 20 mg sulfamethoxazole per kg bodyweight once daily” NCT00522821 ↗ “Arm 1: trimethoprim / sulfamethoxazole 800/160 mg once pre-procedure” NCT05719285 ↗ “Sulfamethoxazole” NCT02099240 ↗ |
| Known as | Gantanol | ChEMBL registry synonym — accepted as the source's own label CHEMBL443 ↗ |
| Known as | Gantanol-ds | ChEMBL registry synonym — accepted as the source's own label CHEMBL443 ↗ |
| Known as | NSC-147832 | ChEMBL registry synonym — accepted as the source's own label CHEMBL443 ↗ |
| Known as | RO 4-2130 | ChEMBL registry synonym — accepted as the source's own label CHEMBL443 ↗ |
| Known as | Sinomin | ChEMBL registry synonym — accepted as the source's own label CHEMBL443 ↗ |
| Known as | SMX | “sulfamethoxazole/trimethoprim (SMX/TMP)” NCT00000640 ↗ |
| Known as | STX-608 | ChEMBL registry synonym — accepted as the source's own label CHEMBL443 ↗ |
| Known as | Sulfamethoxazole component of azo gantanol | ChEMBL registry synonym — accepted as the source's own label CHEMBL443 ↗ |
| Known as | Sulfamethoxazole component of bactrim | ChEMBL registry synonym — accepted as the source's own label CHEMBL443 ↗ |
| Known as | Sulfamethoxazole component of bactrim ds | ChEMBL registry synonym — accepted as the source's own label CHEMBL443 ↗ |
| Known as | Sulfamethoxazole component of bactrim pediatric | ChEMBL registry synonym — accepted as the source's own label CHEMBL443 ↗ |
| Known as | Sulfamethoxazole component of co-trimethoxazole | ChEMBL registry synonym — accepted as the source's own label CHEMBL443 ↗ |
| Known as | Sulfamethoxazole component of cotrim | ChEMBL registry synonym — accepted as the source's own label CHEMBL443 ↗ |
| Known as | Sulfamethoxazole component of cotrim d.s. | ChEMBL registry synonym — accepted as the source's own label CHEMBL443 ↗ |
| Known as | Sulfamethoxazole component of septra | ChEMBL registry synonym — accepted as the source's own label CHEMBL443 ↗ |
| Known as | Sulfamethoxazole component of sulfamethoprim | ChEMBL registry synonym — accepted as the source's own label CHEMBL443 ↗ |
| Known as | Sulfamethoxazole component of sulfatrim | ChEMBL registry synonym — accepted as the source's own label CHEMBL443 ↗ |
| Known as | Sulfamethoxazole component of sulmeprim | ChEMBL registry synonym — accepted as the source's own label CHEMBL443 ↗ |
| Known as | Sulfamethoxazole component of uroplus | ChEMBL registry synonym — accepted as the source's own label CHEMBL443 ↗ |
| Known as | Sulfamethoxazole sodium | ChEMBL registry synonym — accepted as the source's own label CHEMBL443 ↗ |
| Known as | Sulfamethoxazolum | ChEMBL registry synonym — accepted as the source's own label CHEMBL443 ↗ |
| Known as | Sulfametoxazol | ChEMBL registry synonym — accepted as the source's own label CHEMBL443 ↗ |
| Known as | sulphamethoxazole | “8 mg/kg/dose trimethoprim + 40 mg/kg/dose sulphamethoxazole” NCT00933049 ↗ |
| Known as | Suphamethoxazole | ChEMBL registry synonym — accepted as the source's own label CHEMBL443 ↗ |
| Known as | Urobak | ChEMBL registry synonym — accepted as the source's own label CHEMBL443 ↗ |
| Modality | Small molecule | — CHEMBL443 ↗ |
| Route | Intravenous | “intravenous SMX/TMP” NCT00000715 ↗ |