Drugs / Tolbutamide
Tolbutamide
also known as
1-butyl-3-(p-tolylsulfonyl)urea · Arkozal · Butamide · Diabetamid · Glyconon · Ipoglicone · NSC-23813 · NSC-87833 · +12 more
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | US (FDA) | ORINASE | — | 1957-05-31 | fda.gov ↗ |
Trials 24 · a red edge is where a trial was stopped
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 122 trials | ||||||
| Phase 1 | NCT05830799 | Mar → May 2023 | — | Vicore Pharma AB | Completed | No outcome recorded |
| Phase 1 | NCT05097716 | Nov 2021 → Jan 2022 | — | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT04525235 | Jan → Aug 2021 | tuberculosis | Radboud University Medical Center | Completed | No outcome recorded |
| Phase 1 | NCT03948243 | Apr 2019 → Jul 2020 | — | University of Illinois at Chicago | Completed | No outcome recorded |
| Phase 1 | NCT03723395 | Sep → Dec 2018 | — | Seagen Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03457597 | Mar → Apr 2018 | — | Corcept Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT03291288 | Feb → Sep 2018 | — | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 1 | NCT03103568 | Mar → Jun 2017 | — | Swedish Orphan Biovitrum | Completed | No outcome recorded |
| Phase 1 | NCT03716427 | Nov → Dec 2016 | — | Cognition Therapeutics | Completed | No outcome recorded |
| Phase 1 | NCT02819102 | Mar → Jun 2016 | hereditary angioedema | BioCryst Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT02473627 | May → Jul 2015 | — | Daiichi Sankyo | Completed | No outcome recorded |
| Phase 1 | NCT02211079 | Sep → Nov 2014 | — | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT01525628 | Apr 2012 → Dec 2013 | chronic hepatitis C virus infection | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT01218620 | Sep 2010 → Jul 2012 | neoplasm | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 1 | NCT01188525 | Aug 2010 → Jul 2011 | — | French National Institute of Health and Medical Research | Completed | No outcome recorded |
| Phase 1 | NCT01185548 | Jul → Dec 2010 | lymphoma | Eli Lilly and Company | Terminated | No outcome recorded |
| Phase 1 | NCT01147887 | Jun → Aug 2010 | — | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Completed | No outcome recorded |
| Phase 1 | NCT02182401 | Jul → Aug 2009 | — | Boehringer Ingelheim | Terminated | No outcome recorded |
| Phase 1 | NCT00930306 | Jun → Sep 2009 | chronic pain syndrome | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT00741468 | Jul → Sep 2008 | — | Repros Therapeutics Inc. | Completed | No outcome recorded |
| Phase 1 | NCT00369304 | Jul → Aug 2006 | — | Wyeth is now a wholly owned subsidiary of Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT00185003 | Jan 2003 → Jun 2005 | — | Radboud University Medical Center | Completed | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT04044001 | Nov 2019 → Mar 2022 | pulmonary tuberculosis | Michael Hoelscher | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT02291666 | Apr 2015 → Jul 2019 | type 2 diabetes mellitus | University of Montreal Hospital Centre (CHUM) | Completed | No outcome recorded |
Also used as a comparator or background therapy in 2 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 41 trial | ||||||
| Phase 4 | NCT06449235 Comparator | Sep 2024 → Apr 2025 overdue | type 2 diabetes mellitus | Bangladesh Institute of Research and Rehabilitation in Diabetes, Endocrine and Metabolic Disorders | Not yet recruiting | No outcome recorded |
| Phase not applicable1 trial | ||||||
| — | NCT02515526 Comparator | Jun → Aug 2015 | — | University of Cologne | Completed | No outcome recorded |
Evidence & citations 24 cited values
Every value below carries the sentence it was read from. 28 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Tolbutamide | “Ten healthy Caucasian subjects were orally dosed with the CIME combination (caffeine-CYP1A2, repaglinide-CYP2C8, tolbutamide-CYP2C9, omeprazole-CYP2C19,...” PMID 25465228 ↗ Dec 201425“The BTZ-043 groups also received oral dolutegravir (a third of participants) or a probe drug cocktail (caffeine [probe for CYP1A2], tolbutamide [CYP2C9], dextromethorphan...” PMID 39793592 ↗ Jan 2025 “A single dose of selective substrates (probe drugs) was administered orally on days 15 and 30: caffeine (CYP1A2), tolbutamide (CYP2C9), omeprazole (CYP2C19), dextromethorphan...” PMID 37768317 ↗ Sep 2023 “Participants will take a combination of 3 drugs (omeprazole 20 mg capsule, tolbutamide 500 mg tablet, and midazolam 2mg/mL liquid) orally (by mouth) or 2 tablets of study drug...” NCT01147887 ↗ “There will be 2 parallel cohorts of 12 subjects each who will be enrolled to receive single doses of tolbutamide or AGG-523 plus tolbutamide in periods 1 and 2 in a crossover design.” NCT00369304 ↗ “This Arm will include patients receiving Sulphonylureas (Gliclazide/ Glipizide/ Glimepiride/ Tolbutamide) according to the physician's choice.” NCT06449235 ↗ “500 mg tolbutamide, 40 mg omeprazole, and 30 mg dextromethorphan orally.” NCT02819102 ↗ “250 mg tolbutamide (CYP2C9)” PMID 31099895 ↗ Jul 2019 “Tolbutamide, Tolbutamide CF” NCT05830799 ↗ “Tolbutamide (250 mg)” NCT00741468 ↗ |
| Known as | 1-butyl-3-(p-tolylsulfonyl)urea | ChEMBL registry synonym — accepted as the source's own label CHEMBL782 ↗ |
| Known as | Arkozal | ChEMBL registry synonym — accepted as the source's own label CHEMBL782 ↗ |
| Known as | Butamide | ChEMBL registry synonym — accepted as the source's own label CHEMBL782 ↗ |
| Known as | Diabetamid | ChEMBL registry synonym — accepted as the source's own label CHEMBL782 ↗ |
| Known as | Glyconon | ChEMBL registry synonym — accepted as the source's own label CHEMBL782 ↗ |
| Known as | Ipoglicone | ChEMBL registry synonym — accepted as the source's own label CHEMBL782 ↗ |
| Known as | NSC-23813 | ChEMBL registry synonym — accepted as the source's own label CHEMBL782 ↗ |
| Known as | NSC-87833 | ChEMBL registry synonym — accepted as the source's own label CHEMBL782 ↗ |
| Known as | Orinase | ChEMBL registry synonym — accepted as the source's own label CHEMBL782 ↗ |
| Known as | Orinase diagnostic | ChEMBL registry synonym — accepted as the source's own label CHEMBL782 ↗ |
| Known as | Pramidex | ChEMBL registry synonym — accepted as the source's own label CHEMBL782 ↗ |
| Known as | Rastinon | ChEMBL registry synonym — accepted as the source's own label CHEMBL782 ↗ |
| Known as | Sodium tolbutamide | ChEMBL registry synonym — accepted as the source's own label CHEMBL782 ↗ |
| Known as | Tolbutamida | ChEMBL registry synonym — accepted as the source's own label CHEMBL782 ↗ |
| Known as | TOLBUTAMIDE SODIUM | ChEMBL registry synonym — accepted as the source's own label CHEMBL782 ↗ |
| Known as | Tolbutamide sodium salt | ChEMBL registry synonym — accepted as the source's own label CHEMBL782 ↗ |
| Known as | Tolbutamide sodium, sterile | ChEMBL registry synonym — accepted as the source's own label CHEMBL782 ↗ |
| Known as | Tolbutamide, Tolbutamide CF | “Tolbutamide, Tolbutamide CF” NCT05830799 ↗ |
| Known as | Tolbutamidum | ChEMBL registry synonym — accepted as the source's own label CHEMBL782 ↗ |
| Known as | Willbutamide | ChEMBL registry synonym — accepted as the source's own label CHEMBL782 ↗ |
| Action | Inhibit | “In the absence of an effect of the selective adenosine triphosphate-dependent K-channel blocker tolbutamide” PMID 16864730 ↗ Jul 2006 |
| Modality | Small molecule | — CHEMBL782 ↗ |
| Route | Oral | “Given as Tablet” NCT00930306 ↗ |