Drugs / Probenecid
Probenecid
also known as
Benemid · Benuryl · HC 5006 · NSC-18786 · p-(di-n-propylsulfamyl)-benzoic acid · P-(dipropylsulfamoyl)benzoic acid · PanCytoVir · Probalan · +10 more
Small molecule targets PANX1, SLC22A11, SLC22A6, SLC22A8, TRPV2 via inhibition / activation
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed urinary tract infection 3 milestones | |||||
| Filed | US (FDA) | — | urinary tract infection | 2024-04-29 | “today announced that it has resubmitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for sulopenem etzadroxil/probenecid” iterumtx.com ↗ |
| Rejected (CRL) | US (FDA) | — | urinary tract infection | 2021-07-23 | “received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for sulopenem etzadroxil/probenecid” iterumtx.com ↗ |
| Filed | US (FDA) | — | urinary tract infection | 2020-11-30 | “submitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for sulopenem etzadroxil/probenecid (oral sulopenem) for the treatment of uncomplicated...” iterumtx.com ↗ |
| Approved Indication not stated 1 milestone | |||||
| Approved | US (FDA) | BENEMID | — | 1951-04-26 | fda.gov ↗ |
Trials 53
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 03 trials · 1 missed | ||||||
| Phase 0 | NCT05365451 | Apr 2022 → Jul 2023 | — | Washington State University | Completed | No outcome recorded |
| Phase 0 | NCT03202511 | Jun 2017 → Jul 2018 | — | Indiana University | Completed | Missed primary |
| Phase 0 | NCT02243631 | Oct 2014 → Apr 2021 | chondrocalcinosis | VA Office of Research and Development | Completed | No outcome recorded |
| Phase 130 trials | ||||||
| Phase 1 | NCT07840612 | Sep → Nov 2026 expected | — | Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | Recruiting | No outcome recorded |
| Phase 1 | NCT07796191 | Sep → Nov 2026 expected | — | Jiangsu vcare pharmaceutical technology co., LTD | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT07661108 | Jun → Oct 2026 expected | — | Merck Sharp & Dohme LLC | Active not recruiting | No outcome recorded |
| Phase 1 | NCT07092813 | Apr → Oct 2026 expected | — | Iterum Therapeutics, International Limited | Recruiting | No outcome recorded |
| Phase 1 | NCT07160738 | Sep → Nov 2025 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT06647810 | Nov → Dec 2024 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT06025344 | Sep 2024 | — | TrippBio, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT06025318 | Sep 2024 | — | TrippBio, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT06416800 | Jun 2024 → Jan 2025 | — | Incyte Corporation | Completed | No outcome recorded |
| Phase 1 | NCT05954624 | Jul → Nov 2023 | — | Guangdong Raynovent Biotech Co., Ltd | Completed | No outcome recorded |
| Phase 1 | NCT05881811 | Mar → Apr 2023 | postherpetic neuralgia | Haisco Pharmaceutical Group Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT05618314 | Oct 2022 → Jun 2024 | impaired renal function disease | Atea Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT05497674 | Feb → Jul 2022 | type 2 diabetes mellitus | Sunshine Lake Pharma Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT05280054 | Dec 2021 → Sep 2022 | — | VistaGen Therapeutics, Inc. | Unknown | No outcome recorded |
| Phase 1 | NCT05045313 | Oct → Dec 2021 | — | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT04700787 | Apr 2021 → Mar 2022 | acute pyelonephritis, infectious peritonitis | Iterum Therapeutics, International Limited | Withdrawn | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT04218357 | Dec 2020 → May 2023 | alcohol-related disorders | Brown University | Completed | No outcome recorded |
| Phase 1 | NCT03937258 | May → Jul 2019 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT03801746 | Jul → Aug 2018 | — | Akebia Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT03466567 | Mar → Jul 2018 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT03307252 | Oct 2017 → May 2018 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT03296800 | Sep → Dec 2017 | type 2 diabetes mellitus | Theracos | Completed | No outcome recorded |
| Phase 1 | NCT03105986 | Apr → Jun 2017 | — | Janssen-Cilag International NV | Completed | No outcome recorded |
| Phase 1 | NCT03138759 | Feb → Mar 2017 | — | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 1 | NCT01937026 | Sep → Nov 2013 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT01634100 | Jun → Aug 2012 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT01428284 | Aug → Oct 2011 | — | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Completed | No outcome recorded |
| Phase 1 | NCT00842400 | Feb → Mar 2009 | obesity disorder | VIVUS LLC | Completed | No outcome recorded |
| Phase 1 | NCT00439530 | Nov 2006 → Apr 2007 | avian influenza | Mahidol University | Completed | No outcome recorded |
| Phase 1 | NCT00024245 | May 2001 → Apr 2003 | cancer of unknown primary site | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 1/22 trials | ||||||
| Phase 1/2 | NCT05082909 | Dec 2021 → Jul 2022 | bacterial infectious disease | Imperial College London | Completed | No outcome recorded |
| Phase 1/2 | NCT01322009 | Mar 2011 → Dec 2013 | traumatic brain injury | University of Pittsburgh | Completed | No outcome recorded |
| Phase 26 trials | ||||||
| Phase 2 | NCT07318870 | Aug 2026 → Sep 2029 expected | focal epilepsy | Fondation Ophtalmologique Adolphe de Rothschild | Recruiting | No outcome recorded |
| Phase 2 | NCT07118618 | Mar 2026 → Dec 2030 expected | alcohol-related disorders | Brown University | Recruiting | No outcome recorded |
| Phase 2 | NCT05190744 | Sep 2022 → Dec 2025 | autosomal dominant polycystic kidney disease, nephrogenic diabetes insipidus | Mayo Clinic | Completed | No outcome recorded |
| Phase 2 | NCT05442983 | Jul → Sep 2022 | COVID-19 | TrippBio, Inc. | Completed | Mixed |
| Phase 2 | NCT01814319 | Mar 2013 → Jun 2015 | systolic heart failure | University of Cincinnati | Completed | No outcome recorded |
| Phase 2 | NCT00288158 | Sep 2008 → Jan 2011 | hypertensive disorder, obesity disorder | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Completed | No outcome recorded |
| Phase 34 trials · 1 met primary · 1 missed | ||||||
| Phase 3 | NCT05903859 | Jan 2024 → May 2027 expected | male infertility | University of Miami | Recruiting | No outcome recorded |
| Phase 3 | NCT05584657 | Oct 2022 → Nov 2023 | cystitis, urinary tract infection | Iterum Therapeutics, International Limited | Completed | Met primary |
| Phase 3 | NCT01320722 | Mar 2011 → May 2015 | hypertensive disorder, impaired renal function disease, obesity disorder | Brigham and Women's Hospital | Completed | Missed primary |
| Phase 3 | NCT00323219 | Jan 2004 → Dec 2012 | cellulitis | University of British Columbia | Completed | No outcome recorded |
| Phase 44 trials | ||||||
| Phase 4 | NCT03965351 | Mar 2017 → Jun 2020 | Fontan-associated liver disease | Children's Hospital Medical Center, Cincinnati | Completed | No outcome recorded |
| Phase 4 | NCT01907373 | Aug → Sep 2009 | — | Central South University | Completed | No outcome recorded |
| Phase 4 | NCT00610532 | Mar 2006 → Jun 2011 | epilepsy | Jim McAuley | Terminated | No outcome recorded |
| Phase 4 | NCT00304434 | Feb 2005 → Feb 2007 | influenza | US Department of Veterans Affairs | Completed | No outcome recorded |
| Phase not applicable3 trials | ||||||
| — | NCT00690014 | Aug 2006 → Apr 2007 | kidney disorder | University of Maryland, Baltimore | Completed | No outcome recorded |
| — | NCT00000706 | ? → Dec 1988 | HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| — | NCT00000670 | ? → Jul 1989 | HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT04682834 | — | acute pyelonephritis | Iterum Therapeutics, International Limited | No longer available | No outcome recorded |
| Comparator or background therapy13 trials | ||||||
| Phase 1 | NCT01816646 Background | Sep 2013 → Dec 2016 | disease related to hematopoietic stem cell transplant | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT00000881 Background | — | HIV infectious disease, cytomegalovirus retinitis | National Institute of Allergy and Infectious Diseases (NIAID) | Withdrawn | No outcome recorded |
| Phase 2 | NCT04939623 Comparator | Oct 2023 → Dec 2026 expected | chronic pain syndrome, opiate dependence, substance withdrawal syndrome | University of Calgary | Recruiting | No outcome recorded |
| Phase 2 | NCT01029782 Comparator | May 2010 → Oct 2014 | cellulitis | Kelowna General Hospital | Completed | No outcome recorded |
| Phase 2 | NCT00002437 Background | — | HIV infectious disease, cytomegalovirus retinitis | Gilead Sciences | Completed | No outcome recorded |
| Phase 2/3 | NCT04551222 Comparator | Jun 2021 → Dec 2025 | heart failure | VA Office of Research and Development | Completed | No outcome recorded |
| Phase 3 | NCT03358576 Background | Sep 2018 → Oct 2019 | intestinal infectious disease | Iterum Therapeutics, International Limited | Completed | Missed primary |
| Phase 3 | NCT03354598 Background | Aug 2018 → Jan 2020 | urinary tract infection | Iterum Therapeutics, International Limited | Completed | No outcome recorded |
| Phase 4 | NCT00000894 Background | ? → Jun 2000 | HIV infectious disease, cytomegalovirus retinitis | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| — | NCT04998513 Comparator | Jan 2022 | peritonsillar abscess | Nova Scotia Health Authority | Withdrawn | No outcome recorded |
| — | NCT00000799 Background | ? → Apr 1996 | HIV infectious disease, cytomegalovirus retinitis | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| — | NCT00000945 Background | ? → Mar 2001 | HIV infectious disease, progressive multifocal leukoencephalopathy | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| — | NCT00002142 Background | — | HIV infectious disease, cytomegalovirus retinitis | Gilead Sciences | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 16
| Date | Issuer | Release |
|---|---|---|
| 2025-06-25 | Iterum Therapeutics, International Limited | Results Iterum Therapeutics Announces Publication of REASSURE Trial in NEJM Evidence iterumtx.com ↗
“We are very pleased that NEJM Evidence have published the results from the REASSURE trial,” said Corey Fishman, Iterum’s Chief Executive Officer. |
| 2024-10-25 | Iterum Therapeutics, International Limited | Regulatory Iterum Therapeutics Receives U.S. FDA Approval of ORLYNVAH™ (Oral Sulopenem) for the Treatment of Uncomplicated Urinary Tract Infections iterumtx.com ↗
Iterum Therapeutics plc (Nasdaq: ITRM) (Iterum), today announced that the U.S. Food and Drug Administration (FDA) has approved Iterum’s new drug application for ORLYNVAH™ (sulopenem etzadroxil and probenecid) for the treatment of uncomplicated urinary tract infections (uUTIs) caused by the designated microorganisms Escherichia coli , Klebsiella pneumoniae , or Proteus mirabilis in adult women who have limited or no alternative oral antibacterial treatment options. |
| 2024-06-21 | Iterum Therapeutics, International Limited | Regulatory Iterum Therapeutics Announces FDA Advisory Committee Meeting to discuss NDA for Oral Sulopenem for the treatment of Uncomplicated Urinary Tract Infections iterumtx.com ↗
The proposed date for the Advisory Committee meeting is September 9, 2024. |
| 2024-05-31 | Iterum Therapeutics, International Limited | Regulatory Iterum Therapeutics Receives FDA Acceptance of Resubmission of NDA for Oral Sulopenem for the treatment of Uncomplicated Urinary Tract Infections iterumtx.com ↗
As a result, the FDA has assigned a PDUFA action date of October 25, 2024. |
| 2024-04-29 | Iterum Therapeutics, International Limited | Regulatory Iterum Therapeutics Resubmits New Drug Application to U.S. Food and Drug Administration for Oral Sulopenem iterumtx.com ↗
today announced that it has resubmitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for sulopenem etzadroxil/probenecid (oral sulopenem) for the treatment of uncomplicated urinary tract infections (uUTIs) in adult women. |
| 2024-01-30 | Iterum Therapeutics, International Limited | Results Iterum Therapeutics Announces Positive Topline Results from its Phase 3 REASSURE Clinical Trial of Oral Sulopenem in Uncomplicated Urinary Tract Infections iterumtx.com ↗
With the positive data from this trial, we plan to resubmit our New Drug Application (NDA) for oral sulopenem for the treatment of uUTI in the second quarter of 2024. |
| 2023-08-03 | TrippBio, Inc. | Results TrippBio Announces Results of a Phase 2 Study of PanCytoVir™ in Patients with Mild-toModerate COVID-19 trippbio.com ↗
The median time to virologic clearance was significantly shorter for the PanCytoVir™ 1000 mg group than for placebo (7 days vs. 11 days, respectively; P<0.0001), and for the PanCytoVir™ 500 mg group versus placebo (9 days vs. 11 days, respectively; P<0.0001). |
| 2022-07-11 | Iterum Therapeutics, International Limited | Regulatory Iterum Therapeutics Announces Special Protocol Assessment (SPA) Agreement With the FDA iterumtx.com ↗ |
| 2021-07-26 | Iterum Therapeutics, International Limited | Regulatory Iterum Therapeutics Receives Complete Response Letter from U.S. Food and Drug Administration for Oral Sulopenem iterumtx.com ↗
today announced that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for its New Drug Application (NDA) for sulopenem etzadroxil/probenecid (oral sulopenem) on July 23, 2021. |
| 2021-07-01 | Iterum Therapeutics, International Limited | Regulatory Iterum Therapeutics Provides Regulatory Update iterumtx.com ↗
Iterum Therapeutics plc (Nasdaq: ITRM) (the “Company”), a clinical-stage pharmaceutical company focused on developing next generation oral and IV antibiotics to treat infections caused by multi-drug resistant pathogens in both community and hospital settings, today announced that the Company received a letter from the U.S. Food and Drug Administration (“FDA”) stating that, as part of their ongoing review of the Company’s New Drug Application (“NDA”) for sulopenem etzadroxil/probenecid, the agency has identified deficiencies that preclude the continuation of the discussion of labeling and post marketing requirements/commitments at this time. |
| 2021-01-25 | Iterum Therapeutics, International Limited | Regulatory Iterum Therapeutics Announces U.S. FDA Filing Acceptance of New Drug Application for Oral Sulopenem iterumtx.com ↗
today announced that the U.S. Food and Drug Administration (FDA) accepted for review the New Drug Application (NDA) for sulopenem etzadroxil/probenecid (oral sulopenem) for the treatment of uncomplicated urinary tract infections (uUTIs) in patients with a quinolone non-susceptible pathogen. |
| 2020-11-30 | Iterum Therapeutics, International Limited | Regulatory Iterum Therapeutics Submits New Drug Application to U.S. Food and Drug Administration for Oral Sulopenem iterumtx.com ↗
today announced that it has submitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for sulopenem etzadroxil/probenecid (oral sulopenem) |
| 2020-09-03 | VistaGen Therapeutics, Inc. | Results VistaGen Reports Positive New Data from Second Preclinical Study of AV-101 in Combination with Probenecid vistagen.com ↗
"These new positive results amplify our message that AV-101, when administered in combination with probenecid, has exciting therapeutic potential across a wide range of CNS indications," said Shawn Singh, Chief Executive Officer of VistaGen . |
| 2020-02-11 | VistaGen Therapeutics, Inc. | Results VistaGen Therapeutics Announces Positive Preclinical Data of AV-101 Combined with Probenecid Suggesting Substantially Increased Brain Concentration Effects vistagen.com ↗
The remarkable preclinical data announced today demonstrate a 7-fold concentration increase in the brain of AV-101 prodrug, and, more importantly, a 35-fold increase of 7-Cl-KYNA, AV-101's active metabolite, when AV-101 is administered adjunctively with probenecid. |
| 2018-10-05 | Iterum Therapeutics, International Limited | Results Iterum Therapeutics Presents Data Highlighting Antibiotic Sulopenem at IDWeek 2018 iterumtx.com ↗
Probenecid was found to increase the area under the curve (AUC) of sulopenem by 28 percent |
| 2017-10-04 | Iterum Therapeutics, International Limited | Results Iterum Therapeutics reveals new US maps highlighting antibiotic resistance ‘hotspots’ iterumtx.com ↗
Data also indicate that serum levels of the antibiotic can be significantly raised with co-administration of probenecid, and that patients are free to take their dose with food with the additional benefit of further increasing serum exposures. |
All press releases naming this drug 22 releases
Evidence & citations 26 cited values
Every value below carries the sentence it was read from. 69 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Probenecid | “The medical intervention consists of intravenous dexamethasone (10 mg if bodyweight \< 70 kilograms, 20 mg if bodyweight \> 70 kilograms), intravenous cefazolin 2 grams,...” NCT04998513 ↗65“Objective: To compare 400 mg of oral moxifloxacin (Oral Group) once daily to 2 grams of IV cefazolin and 1 gram of oral probenecid once daily (IV group) for the treatment of...” NCT00323219 ↗ “The following day, patients will receive a single dose of 500 mg of sulopenem etzadroxil and 500 mg of probenecid given orally as a bilayer tablet.” NCT04700787 ↗ “Subjects will receive a single oral dose of probenecid oral suspension (100 mg/mL) under fed and fasted conditions.” NCT06025318 ↗ “Probenecid (PB)” NCT05190744 ↗ |
| Known as | Benemid | ChEMBL registry synonym — accepted as the source's own label CHEMBL897 ↗ |
| Known as | Benuryl | ChEMBL registry synonym — accepted as the source's own label CHEMBL897 ↗ |
| Known as | HC 5006 | ChEMBL registry synonym — accepted as the source's own label CHEMBL897 ↗ |
| Known as | NSC-18786 | ChEMBL registry synonym — accepted as the source's own label CHEMBL897 ↗ |
| Known as | p-(di-n-propylsulfamyl)-benzoic acid | “Probenecid, p-(di-n-propylsulfamyl)-benzoic acid, is a drug used clinically to treat hyperuricemia and gout due to its activity as an inhibitor of the kidneys' organic anion...” PMID 31535696 ↗ Jan 2019 |
| Known as | P-(dipropylsulfamoyl)benzoic acid | ChEMBL registry synonym — accepted as the source's own label CHEMBL897 ↗ |
| Known as | PanCytoVir | “PanCytoVir™ (probenecid)” NCT05442983 ↗ |
| Known as | Probalan | ChEMBL registry synonym — accepted as the source's own label CHEMBL897 ↗ |
| Known as | Probampicin | ChEMBL registry synonym — accepted as the source's own label CHEMBL897 ↗ |
| Known as | Probecid | ChEMBL registry synonym — accepted as the source's own label CHEMBL897 ↗ |
| Known as | Probenate | ChEMBL registry synonym — accepted as the source's own label CHEMBL897 ↗ |
| Known as | Probenecid component of col- | ChEMBL registry synonym — accepted as the source's own label CHEMBL897 ↗ |
| Known as | Probenecid component of colbenemid | ChEMBL registry synonym — accepted as the source's own label CHEMBL897 ↗ |
| Known as | Probenecid component of orlynvah | ChEMBL registry synonym — accepted as the source's own label CHEMBL897 ↗ |
| Known as | Probenecid component of probampacin | ChEMBL registry synonym — accepted as the source's own label CHEMBL897 ↗ |
| Known as | Probenecid component of proben-c | ChEMBL registry synonym — accepted as the source's own label CHEMBL897 ↗ |
| Known as | Probenecide | ChEMBL registry synonym — accepted as the source's own label CHEMBL897 ↗ |
| Known as | Probenecidum | ChEMBL registry synonym — accepted as the source's own label CHEMBL897 ↗ |
| Action | Inhibit | “probenecid effectively inhibited the transport of PAH, Ro 64-0802, and amoxicillin via hOAT1.” PMID 11744606 ↗ Jan 20023“Solute carrier family 22 member 11 inhibitor” CHEMBL897 ↗ “Solute carrier family 22 member 6 inhibitor” CHEMBL897 ↗ “Solute carrier family 22 member 8 inhibitor” CHEMBL897 ↗ |
| Modality | Small molecule | — CHEMBL897 ↗ |
| Route | Oral | “patient starts taking probenecid by mouth every 8 hours” NCT00000670 ↗ |
| Target | PANX1 | “Probenecid also inhibits pannexin1 channels that are involved in purinergic neurotransmission and inflammation” PMID 31535696 ↗ Jan 2019 |
| Target | SLC22A11 | “Solute carrier family 22 member 11 inhibitor” CHEMBL897 ↗ |
| Target | SLC22A6 | “Solute carrier family 22 member 6 inhibitor” CHEMBL897 ↗ |
| Target | SLC22A8 | “Solute carrier family 22 member 8 inhibitor” CHEMBL897 ↗ |