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 30
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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 33 trials · 1 met primary | ||||||
| Phase 3 | NCT07686055 | Jul 2026 → Feb 2027 expected | urinary tract infection | Megan Bradley | 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 | Met primary |
| Phase 416 trials · 2 met primary · 2 missed | ||||||
| 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 | Met primary |
| 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 | NCT02375295 | Mar 2015 → Dec 2023 | urolithiasis | University of British Columbia | Unknown | 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 | 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 | Missed primary |
| Phase 4 | NCT00734968 | May 2008 → May 2010 | female stress incontinence | University of Missouri-Columbia | Completed | Met primary |
| 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 | Missed primary |
| Phase not applicable2 trials | ||||||
| — | NCT02911662 | Sep 2016 → Jan 2018 | bacteriuria | Trinity Health Michigan | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT00678041 | May 2008 → May 2009 | urinary tract infection | University of Pittsburgh | Terminated | No outcome recorded Stop: Enrollment |
| Comparator or background therapy39 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 Stop: Enrollment |
| Phase 1 | NCT05138822 Comparator | May 2022 → Dec 2024 | urinary tract infection | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1/2 | NCT07198919 Comparator | May → Oct 2025 overdue | — | Altamash Institute of Dental Medicine | Enrolling by invitation | No outcome recorded |
| 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 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 | Met primary |
| 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 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 Stop: Enrollment |
| 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 Stop: Enrollment |
| 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 Stop: Enrollment |
| 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 |
| — | 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 |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2021-07-01 | Alembic Pharmaceuticals Ltd. | Regulatory A lem bic~ - Touching U- s OWi' 1c;J>Y alembicpharmaceuticals.com ↗
Alembic Pharmaceuticals Limited (Alembic) today announced that it has received final approval from the US Food & Drug Administration (US FDA) for .its Abbreviated New Drug Application (ANDA) for Nitrofurantoin Capsules, USP (Macrocrystals), 25 mg, 50 mg and 100 mg. |
| 2018-07-12 | Lupin Limited | Regulatory Lupin receives FDA approval for generic Nitrofurantoin Capsules USP (Macrocrystals), 50 mg and 100 mg lupin.com ↗
Mumbai, Baltimore: Pharma major Lupin announced that it has received final approval for its Nitrofurantoin Capsules USP (Macrocrystals), 50 mg and 100 mg from the United States Food and Drug Administration (FDA) to market a generic version of Alvogen Malta Operations Ltd.’s Macrodantin® Capsules, 50 mg and 100 mg. |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2021-07-01 | Alembic Pharmaceuticals Ltd. | A lem bic~ - Touching U- s OWi' 1c;J>Y alembicpharmaceuticals.com ↗ |
| 2018-07-12 | Lupin Limited | Lupin receives FDA approval for generic Nitrofurantoin Capsules USP (Macrocrystals), 50 mg and 100 mg lupin.com ↗ |
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 69 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 ↗ “All participants in this arm will receive nitrofurantoin 100 milligrams by mouth daily for either 10 or 21 days” NCT06190197 ↗ “We then assessed the response of uropathogenic E. faecalis to nitrofurantoin and trimethoprim-sulfamethoxazole.” PMID 30132694 ↗ Aug 2018 “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 ↗ |
| 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 ↗2“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 ↗ |
| 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 ↗ |