Drugs / Nitrofurantoin
Nitrofurantoin
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | FURADANTIN | — | 1993-05-18 | fda.gov ↗ |
| Approved | US (FDA) | FURADANTIN | — | 1953-02-06 | fda.gov ↗ |
Trials 31 · a red edge is where a trial was stopped
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 04 trials | ||||||
| Phase 0 | NCT07603934 | Dec 2025 → Aug 2026 overdue | dental pulp necrosis | Cairo University | Recruiting | No outcome recorded |
| Phase 0 | NCT06190197 | May 2024 → Oct 2027 expected | infiltrating bladder urothelial carcinoma | University of Minnesota | Recruiting | No outcome recorded |
| Phase 0 | NCT05074628 | Dec 2021 → Jan 2023 | — | Cairo University | Unknown | No outcome recorded |
| Phase 0 | NCT02789579 | Sep 2016 → Dec 2019 | — | Xinhua Hospital, Shanghai Jiao Tong University School of Medicine | Unknown | No outcome recorded |
| Phase 14 trials | ||||||
| Phase 1 | NCT06907199 | Apr 2026 → Jul 2028 expected | chronic cystitis | University of Texas Southwestern Medical Center | Recruiting | No outcome recorded |
| Phase 1 | NCT00649506 | Sep 2003 | — | Mylan Pharmaceuticals Inc | Completed | No outcome recorded |
| Phase 1 | NCT00649285 | Oct → Nov 2002 | — | Mylan Pharmaceuticals Inc | Completed | No outcome recorded |
| Phase 1 | NCT01018342 | Jul → Aug 2002 | — | Mylan Pharmaceuticals Inc | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT07202949 | Feb 2026 → Oct 2027 expected | urinary tract infection | University College, London | Recruiting | No outcome recorded |
| Phase 34 trials | ||||||
| Phase 3 | NCT07686055 | Jul 2026 → Feb 2027 expected | urinary tract infection | Megan Bradley | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT07209150 | Jan 2026 → Dec 2027 expected | benign prostatic hyperplasia | Ohio State University | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06723392 | Dec 2025 → Sep 2028 expected | bacteriuria, fetal growth restriction, pregnancy disorder with abortive outcome | NICHD Global Network for Women's and Children's Health | Recruiting | No outcome recorded |
| Phase 3 | NCT04020341 | Oct 2019 → Nov 2022 | urinary tract infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 416 trials | ||||||
| Phase 4 | NCT07501065 | Jun 2026 → Jun 2028 expected | female stress incontinence, urinary tract infection | University of Miami | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06709196 | Jan 2025 → Jan 2027 expected | urinary bladder cancer | Rigshospitalet, Denmark | Recruiting | No outcome recorded |
| Phase 4 | NCT06387329 | Apr 2024 → Jun 2025 overdue | interstitial cystitis, overactive bladder | Walter Reed National Military Medical Center | Recruiting | No outcome recorded |
| Phase 4 | NCT05652374 | Oct 2022 → Oct 2027 expected | urinary tract infection | Radboud University Medical Center | Recruiting | No outcome recorded |
| Phase 4 | NCT05519072 | Aug 2022 → Aug 2024 overdue | — | Atlantic Health System | Recruiting | No outcome recorded |
| Phase 4 | NCT05600023 | Aug → Oct 2022 | pulpitis | Altamash Institute of Dental Medicine | Completed | No outcome recorded |
| Phase 4 | NCT04900571 | Jan → May 2021 | neuropathy, painful, pulpitis | Altamash Institute of Dental Medicine | Completed | No outcome recorded |
| Phase 4 | NCT04502095 | Sep 2020 → Mar 2025 | urinary bladder carcinoma, urinary tract infection | Roswell Park Cancer Institute | Completed | No outcome recorded |
| Phase 4 | NCT03716804 | Jun → Dec 2018 | bacterial infectious disease, urinary tract infection | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh | Completed | No outcome recorded |
| Phase 4 | NCT02384200 | Mar 2015 → Feb 2017 | nephrolithiasis, urinary tract infection | University of California, San Diego | Completed | No outcome recorded |
| Phase 4 | NCT02375295 | Mar 2015 → Dec 2023 | urolithiasis | University of British Columbia | Unknown | No outcome recorded |
| Phase 4 | NCT02145338 | Sep 2013 → Feb 2017 | urinary tract infection | Newcastle-upon-Tyne Hospitals NHS Trust | Completed | No outcome recorded |
| Phase 4 | NCT00826670 | Jun 2009 → Aug 2012 | bacterial infectious disease | University Hospital, Geneva | Completed | No outcome recorded |
| Phase 4 | NCT00734968 | May 2008 → May 2010 | female stress incontinence | University of Missouri-Columbia | Completed | No outcome recorded |
| Phase 4 | NCT01092351 | Jan 2007 → Sep 2008 | urinary tract infection | Mepha Ltd. | Completed | No outcome recorded |
| Phase 4 | NCT00382343 | Nov 1999 → Mar 2003 | pyelonephritis, renal fibrosis | IRCCS Burlo Garofolo | Completed | No outcome recorded |
| Phase not applicable2 trials | ||||||
| — | NCT02911662 | Sep 2016 → Jan 2018 | bacteriuria | Trinity Health Michigan | Terminated | No outcome recorded |
| — | NCT00678041 | May 2008 → May 2009 | urinary tract infection | University of Pittsburgh | Terminated | No outcome recorded |
Also used as a comparator or background therapy in 39 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 02 trials | ||||||
| Phase 0 | NCT07648290 Comparator | Jul 2026 → Mar 2028 expected | overactive bladder | The Cleveland Clinic | Not yet recruiting | No outcome recorded |
| Phase 0 | NCT02099240 Comparator | Mar 2014 → Nov 2018 | osteomyelitis | University of Louisville | Terminated | No outcome recorded |
| Phase 11 trial | ||||||
| Phase 1 | NCT05138822 Comparator | May 2022 → Dec 2024 | urinary tract infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT07198919 Comparator | May → Oct 2025 overdue | — | Altamash Institute of Dental Medicine | Enrolling by invitation | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT05702762 Comparator | Oct 2022 → Jun 2023 | cystitis | Mercy Health Ohio | Unknown | No outcome recorded |
| Phase 2 | NCT03425396 Comparator | Jan 2018 → May 2019 | cystitis, urinary tract infection | Paratek Pharmaceuticals Inc | Completed | No outcome recorded |
| Phase 2 | NCT00391651 Comparator | Jan 2002 → Jul 2005 | urinary tract infection | University of Washington | Completed | No outcome recorded |
| Phase 36 trials | ||||||
| Phase 3 | NCT06815549 Comparator | Feb → Dec 2025 overdue | Enterococcus faecalis infection, Klebsiella pneumonia, Pseudomonas aeruginosa infectious disease, chronic cystitis +1 | Gamaleya Research Institute of Epidemiology and Microbiology, Health Ministry of the Russian Federation | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT05630833 Comparator | Jan 2023 → Feb 2024 | urinary tract infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 3 | NCT05384197 Comparator | May 2022 → May 2023 | nephrolithiasis | Mansoura University | Unknown | No outcome recorded |
| Phase 3 | NCT05254808 Comparator | Sep 2021 → Feb 2022 | urinary tract infection | MJM Bonten | Terminated | No outcome recorded |
| Phase 3 | NCT04187144 Comparator | Apr 2020 → Dec 2022 | urinary tract infection | GlaxoSmithKline | 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 421 trials | ||||||
| Phase 4 | NCT06706362 Comparator | Sep 2025 → Apr 2027 expected | female stress incontinence | Ohio State University | Recruiting | No outcome recorded |
| Phase 4 | NCT07186465 Comparator | Sep 2025 → Jun 2026 overdue | cystitis, urinary tract infection | Mahidol University | Recruiting | No outcome recorded |
| Phase 4 | NCT06953271 Comparator | May 2025 → May 2026 overdue | overactive bladder, urinary tract infection | Women and Infants Hospital of Rhode Island | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06332781 Comparator | Apr → Sep 2025 | urinary tract infection | Women and Infants Hospital of Rhode Island | Completed | No outcome recorded |
| Phase 4 | NCT06518291 Comparator | Jan → Jun 2025 overdue | urinary tract infection | Shalamar Institute of Health Sciences | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT05274672 Comparator | Mar 2023 → Feb 2025 | benign prostatic hyperplasia, urinary tract infection | Baylor Research Institute | Withdrawn | No outcome recorded |
| Phase 4 | NCT05726318 Background | Feb 2023 → Aug 2024 | urinary tract infection | Megan Bradley | Completed | No outcome recorded |
| Phase 4 | NCT05719285 Comparator | Dec 2022 → Jun 2023 | overactive bladder | The Cleveland Clinic | Completed | No outcome recorded |
| Phase 4 | NCT05206500 Background | May 2022 → Dec 2028 expected | urinary tract infection | Wake Forest University Health Sciences | Recruiting | No outcome recorded |
| Phase 4 | NCT04959331 Comparator | Nov 2021 → Dec 2024 | urinary tract infection | Jordi Gol Institute for Primary Care Research | Completed | No outcome recorded |
| Phase 4 | NCT04285320 Comparator | Mar 2021 → Apr 2023 | urinary tract infection | Atlantic Health System | Unknown | No outcome recorded |
| Phase 4 | NCT03508921 Background | Jul 2018 → Jun 2022 | overactive bladder, urinary tract infection | Vanderbilt University Medical Center | Terminated | No outcome recorded |
| Phase 4 | NCT03287089 Comparator | Sep 2017 → May 2019 | bacterial urinary tract infection | Wake Forest University Health Sciences | Completed | No outcome recorded |
| Phase 4 | NCT03275623 Comparator | Sep 2017 → Mar 2019 | cystitis, pyelonephritis | The University of Texas Health Science Center, Houston | Completed | No outcome recorded |
| Phase 4 | NCT03299387 Comparator | Jun 2017 → Jul 2018 | urinary tract infection | Mayo Clinic | Withdrawn | No outcome recorded |
| Phase 4 | NCT02727322 Comparator | Aug 2016 → Mar 2018 | pelvic organ prolapse | Halina M Zyczynski, MD | Completed | No outcome recorded |
| Phase 4 | NCT01966653 Comparator | Oct 2013 → May 2017 | cystitis, urinary tract infection | University Hospital, Geneva | Unknown | No outcome recorded |
| Phase 4 | NCT02357758 Comparator | Sep 2012 → Jan 2016 | urinary tract infection | London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's | Completed | No outcome recorded |
| Phase 4 | NCT01450800 Comparator | Aug 2011 → Mar 2013 | urinary tract infection | Duke University | Completed | No outcome recorded |
| Phase 4 | NCT01749605 Comparator | Oct 2010 → Jan 2012 | cystitis | University of Iowa | Completed | No outcome recorded |
| Phase 4 | NCT03877289 Background | Oct 2008 → Jul 2014 | cystitis | University of Calgary | Completed | No outcome recorded |
| Phase not applicable5 trials | ||||||
| — | NCT07202832 Comparator | Oct 2025 → Aug 2026 overdue | urinary tract infection | Assiut University | Not yet recruiting | No outcome recorded |
| — | NCT03522961 Comparator | Aug 2018 → Sep 2023 overdue | pelvic organ prolapse, urinary tract infection | Brigham and Women's Hospital | Active not recruiting | No outcome recorded |
| — | NCT03362697 Comparator | Dec 2017 → Dec 2018 | bacterial urinary tract infection | Innovacion y Desarrollo de Estrategias en Salud | Completed | No outcome recorded |
| — | NCT02829060 Comparator | Jan 2016 → Jan 2025 | infectious disease with sepsis, nephrolithiasis, urinary tract infection | 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 |
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 70 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Nitrofurantoin | “Possible prescribed antibiotics include: trimethoprim and sulfamethoxazole (Septra), Cefalotin, Cephalexin, Cefapirin, Cefdroxil, Cefazolin, Cefradine, Cefacetrile,...” NCT03877289 ↗66“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 ↗ “Amoxicillin + clavulanic acid (500 mg twice daily) for seven days in patients with negative nitrites in dipstick or oral nitrofurantoin (200mg twice per day) for patients with...” NCT03362697 ↗ “Oral dose regimen for simple urinary tract infection: Including cephalexin, cefdinir, sulfamethoxazole/trimethoprim, and nitrofurantoin at appropriate dose, frequency, and duration” NCT05702762 ↗ “Oral antibiotics will include trimethoprim/sulfamethoxazole (Bactrim, first line) or nitrofurantoin (Macrobid, second line), determined by patient allergies.” NCT06706362 ↗ “This includes, but is not limited to, antibiotic medications such as nitrofurantoin, amoxicillin/clavulanic acid, and trimethoprim/sulfamethoxazole.” NCT06953271 ↗ “in case of intolerance (leucopoenia) and for children younger than 6 months: nitrofurantoin [2 mg/kg once daily]” NCT00382343 ↗ “We then assessed the response of uropathogenic E. faecalis to nitrofurantoin and trimethoprim-sulfamethoxazole.” PMID 30132694 ↗ Aug 2018 “All participants in this arm will receive nitrofurantoin 100 milligrams by mouth daily for either 10 or 21 days” NCT06190197 ↗ “If allergic to both of the above antibiotics, patients will receive 100mg nitrofurantoin BID for three days.” NCT03508921 ↗ “Participants will be provided either nitrofurantoin 100 mg oral twice a day for 5 days” NCT07686055 ↗ “Participants will be provided either nitrofurantoin 100 mg oral twice a day for 5 days” NCT05726318 ↗ “Nitrofurantoin (100mg 3x/day PO) or Norfloxacin (400mg 2x/day PO) for 5 days” NCT00826670 ↗ “Subjects will receive Nitrofurantoin (MACROBID) 100mg BID for 5 days” NCT07648290 ↗ “This includes: Nitrofurantoin, Cephalexin, and Amoxicillin.” NCT03275623 ↗ “Nitrofurantoin monohydrate/macrocrystals daily (50 mg)” NCT04285320 ↗ “Arm 1: nitrofurantoin 100 mg once pre-procedure” NCT05719285 ↗ “Nitrofurantoin (100mg twice daily)” NCT07202949 ↗ “100 mg Nitrofurantoin twice daily” NCT05384197 ↗ “Nitrofurantoin” NCT05206500 ↗ “Nitrofurantoin” NCT02099240 ↗ |
| Known as | Macrobid | “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 ↗3“Oral antibiotics will include trimethoprim/sulfamethoxazole (Bactrim, first line) or nitrofurantoin (Macrobid, second line), determined by patient allergies.” NCT06706362 ↗ “Subjects will receive Nitrofurantoin (MACROBID) 100mg BID for 5 days” NCT07648290 ↗ “macrobid if preoperative culture is negative” NCT07209150 ↗ |
| Known as | macrodantin | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02375295 ↗ |
| Known as | nitrofurantoin monohydrate/macrocrystalline | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02384200 ↗ |
| Action | Inhibit | “These metabolites inhibit bacterial enzymes that are essential for energy metabolism and inhibit bacterial protein synthesis by binding to ribosomes.” NCT05254808 ↗ |
| Route | Oral | “following a single, oral 100 mg (1 x 100 mg) dose under fed conditions” NCT00649285 ↗ |