Drugs / Repaglinide
Repaglinide
also known as
A10BX02 · AG-EE 388 ZW · AG-EE 623 ZW · CHEMBL1272 · ENYGLID · NOVONORM · NSC-759893 · PRANDIN · +6 more
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | PRANDIN | — | 2002-01-18 – 2002-10-21 | fda.gov ↗ |
| Approved | EU (EMA) | NovoNorm | — | 1998-08-16 | europa.eu ↗ |
| Approved | US (FDA) | PRANDIN | — | 1997-12-22 | fda.gov ↗ |
Trials 62 · started per year
today
US approved 1997
EU approved 1998
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 139 trials · 1 met primary | ||||||
| Phase 1 | NCT07340190 | Jun 2026 → Mar 2028 expected | cancer | Novartis Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 1 | NCT07372625 | Feb 2026 → Mar 2027 expected | cancer | PMV Pharmaceuticals, Inc | Recruiting | No outcome recorded |
| Phase 1 | NCT07259330 | Oct 2025 → Mar 2026 | — | SpringWorks Therapeutics, Inc., a healthcare company of Merck KGaA, Darmstadt, Germany | Completed | No outcome recorded |
| Phase 1 | NCT07235748 | Oct → Dec 2025 | — | Servier | Completed | No outcome recorded |
| Phase 1 | NCT07065058 | Jul 2025 | obesity disorder | Vincentage Pharma Co., Ltd | Completed | No outcome recorded |
| Phase 1 | NCT06930872 | Jun → Oct 2025 | — | Harmony Biosciences Management, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT07068841 | May → Jun 2025 | — | Neurodawn Pharmaceutical Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT06948747 | May → Oct 2025 | — | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT06601517 | Oct 2024 → Feb 2025 overdue | — | Hangzhou Zhongmei Huadong Pharmaceutical Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT06494761 | Jul → Oct 2024 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT06503679 | Jul → Dec 2024 | — | DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT06367153 | May → Aug 2024 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT06290050 | Mar → May 2024 | — | Takeda | Completed | No outcome recorded |
| Phase 1 | NCT06196580 | Jan → Feb 2024 | gout | Jiangsu HengRui Medicine Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT06092931 | Oct → Nov 2023 | — | DICE Therapeutics, Inc., a wholly owned subsidiary of Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT05981365 | Apr → Oct 2023 | sickle cell disease | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT05602675 | Nov 2022 → Mar 2023 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT05392127 | Jul → Aug 2022 | rheumatoid arthritis | Jiangsu HengRui Medicine Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT05444556 | Jul → Nov 2022 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT05236530 | Mar → Oct 2022 | malaria | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 1 | NCT04530981 | Sep 2021 → Nov 2023 | gastrointestinal stromal tumor | Deciphera Pharmaceuticals, LLC | Completed | No outcome recorded |
| Phase 1 | NCT04457180 | Nov 2020 → May 2021 | — | Jiangsu HengRui Medicine Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT04643249 | Nov → Dec 2020 | mitochondrial disease | Abliva AB | Completed | No outcome recorded |
| Phase 1 | NCT06165146 | Nov → Dec 2020 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT04664725 | Jun 2020 → Jan 2021 | prostate cancer | Jiangsu HengRui Medicine Co., Ltd. | Unknown | No outcome recorded |
| Phase 1 | NCT04233437 | Feb → May 2020 | stroke disorder | Moleac Pte Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT04008186 | Jun → Aug 2019 | — | Biogen | Completed | No outcome recorded |
| Phase 1 | NCT05469113 | Jan → Mar 2019 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT03723395 | Sep → Dec 2018 | — | Seagen Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03028103 | Mar 2017 → Oct 2019 | diffuse large B-cell lymphoma, mantle cell lymphoma, marginal zone lymphoma, mediastinal malignant lymphoma | Epizyme, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02305901 | Dec 2014 → Mar 2015 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT02128321 | Jan → Feb 2014 | — | Astellas Pharma Global Development, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT01780051 | Mar → Apr 2013 | type 2 diabetes mellitus | Dalim BioTech Co., Ltd. | Completed | No outcome recorded |
| Phase 1 | NCT01797198 | Apr → Jun 2012 | — | Astellas Pharma Europe B.V. | 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 | NCT00959101 | Aug → Oct 2009 | diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT01536366 | Jun → Jul 2009 | Parkinson disease | Bial - Portela C S.A. | Completed | No outcome recorded |
| Phase 1 | NCT01489644 | Jun → Jul 2006 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT01490658 | Jun → Aug 2006 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | Met primary |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT05384626 | Jun 2022 → Dec 2027 expected | metastatic neoplasm | Nuvalent Inc. | Recruiting | No outcome recorded |
| Phase 33 trials · 1 met primary · 1 missed | ||||||
| Phase 3 | NCT00399711 | Nov 2006 → Nov 2007 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | Met primary |
| Phase 3 | NCT00662714 | Sep 2001 → Dec 2011 | cystic fibrosis, diabetes mellitus | Mukoviszidose Institut gGmbH | Completed | Missed primary |
| Phase 3 | NCT01562561 | Jun 2001 → Dec 2002 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 415 trials · 1 missed | ||||||
| Phase 4 | NCT07704658 | Jun 2026 → Jul 2027 expected | non-small cell lung carcinoma, thyroid cancer | Rigel Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 4 | NCT03359837 | Jan 2018 → Jun 2020 | type 2 diabetes mellitus | Sanofi | Completed | No outcome recorded |
| Phase 4 | NCT01709305 | Nov 2012 → Apr 2015 | type 2 diabetes mellitus | Merck Sharp & Dohme LLC | Completed | Mixed |
| Phase 4 | NCT02040246 | Feb 2009 → Dec 2013 | type 2 diabetes mellitus | RenJi Hospital | Completed | No outcome recorded |
| Phase 4 | NCT00336310 | Jul 2006 → ? | type 2 diabetes mellitus | National Cheng-Kung University Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT00491725 | Sep 2005 → Jun 2006 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 4 | NCT00568074 | Dec 2003 → Sep 2004 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 4 | NCT00799448 | Sep 2003 → Sep 2004 | type 2 diabetes mellitus | Novo Nordisk A/S | Terminated | No outcome recorded Stop: Enrollment |
| Phase 4 | NCT00118963 | Jan 2003 → Feb 2006 | type 2 diabetes mellitus | Steno Diabetes Center Copenhagen | Completed | Missed primary |
| Phase 4 | NCT00568984 | Nov 2002 → Nov 2003 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 4 | NCT01720303 | Sep 2002 → Apr 2003 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 4 | NCT01720290 | Jul 2002 → Feb 2003 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 4 | NCT01698931 | Apr 2002 → Mar 2003 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 4 | NCT00133718 | Jan 2002 → Apr 2006 | type 2 diabetes mellitus | Asker & Baerum Hospital | Completed | Mixed |
| Phase 4 | NCT01605773 | Nov 2001 → Mar 2003 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase not applicable4 trials | ||||||
| — | NCT01974544 | May 2013 → Dec 2015 | type 2 diabetes mellitus | Pontificia Universidad Catolica de Chile | Unknown | No outcome recorded |
| — | NCT03563287 | Jan 2012 → Dec 2014 | morbid obesity | University of Eastern Finland | Completed | No outcome recorded |
| — | NCT00763412 | Nov 2006 → Jan 2013 | cystic fibrosis-related diabetes, exocrine pancreatic insufficiency | Arbelaez, Ana Maria | Completed | No outcome recorded |
| — | NCT00231192 | Oct 2005 → Aug 2007 | diabetes mellitus | Children's Hospital of Philadelphia | Withdrawn | No outcome recorded Stop: Enrollment |
| Comparator or background therapy15 trials | ||||||
| Phase 0 | NCT06796660 Background | Sep 2025 → Dec 2027 expected | chronic kidney disease | Liu Zhanghong | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT05555823 Comparator | Jun 2022 → Jul 2023 | — | Atriva Therapeutics GmbH | Completed | No outcome recorded |
| Phase 3 | NCT00072904 Comparator | Jun 2001 → Dec 2007 | cystic fibrosis, diabetes mellitus | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Completed | No outcome recorded |
| Phase 3 | NCT00000620 Background | Sep 1999 → Jun 2009 | atherosclerosis, coronary artery disorder, hyperlipoproteinemia, hypertensive disorder +1 | National Heart, Lung, and Blood Institute (NHLBI) | Completed | Missed primary |
| Phase 4 | NCT03824002 Background | Apr → Oct 2017 | type 2 diabetes mellitus | University of Palermo | Completed | No outcome recorded |
| Phase 4 | NCT02616666 Comparator | Aug 2016 → Dec 2025 | type 2 diabetes mellitus | University of Liverpool | Completed | No outcome recorded |
| Phase 4 | NCT02694263 Comparator | Jul 2016 → Sep 2018 | type 2 diabetes mellitus | University of Leicester | Completed | No outcome recorded |
| Phase 4 | NCT01919489 Comparator | Mar 2014 → Aug 2020 | type 2 diabetes mellitus | Emory University | Completed | No outcome recorded |
| Phase 4 | NCT01022762 Comparator | Nov 2009 → Nov 2010 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 4 | NCT00819741 Comparator | Feb → Nov 2009 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | Met primary |
| Phase 4 | NCT01465152 Comparator | Mar 2002 → Oct 2004 | type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 4 | NCT00118950 Comparator | Mar 2001 → Mar 2003 | type 2 diabetes mellitus | Steno Diabetes Center Copenhagen | Completed | No outcome recorded |
| — | NCT06566794 Comparator | Aug 2024 → Jan 2025 | — | Helsinki University Central Hospital | Completed | No outcome recorded |
| — | NCT01140438 Comparator | Mar 2009 → Nov 2018 | diabetes mellitus | Norwegian University of Science and Technology | Completed | No outcome recorded |
| — | NCT00832481 Comparator | Jan → Oct 2009 | type 2 diabetes mellitus | Chinese PLA General Hospital | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2008-06-24 | Novo Nordisk A/S | Regulatory Novo Nordisk opnår godkendelse for PrandiMet® i USA novonordisk.com ↗
Novo Nordisk meddelte i dag, at de amerikanske sundhedsmyndigheder (FDA) har godkendt PrandiMet®, som er en kombinationstablet til behandling af type 2-diabetes. |
| 2008-06-24 | Novo Nordisk A/S | Regulatory Novo Nordisk receives approval in the US for PrandiMet(TM) novonordisk.com ↗
Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved PrandiMet(TM), a fixed-dose combination of the fast-acting insulin secretagogue repaglinide and metformin for the treatment of type 2 diabetes. |
All press releases naming this drug 12 releases
Evidence & citations 17 cited values
Every value below carries the sentence it was read from. 78 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Repaglinide | “Ten healthy Caucasian subjects were orally dosed with the CIME combination (caffeine-CYP1A2, repaglinide-CYP2C8, tolbutamide-CYP2C9, omeprazole-CYP2C19,...” PMID 25465228 ↗ Dec 201476“Nirogacestat 100 mg BID will be administered orally from Day 1 through Day 17 and an oral dose of CYP cocktail (CYP2B6 [bupropion 20 mg], CYP2C8 [repaglinide 0.05 mg], CYP2C9...” NCT07259330 ↗ “Two equally loaded capsules containing: Melatonin (2.0 mg) Nicotine (1.0 mg) Bupropion (37.5 mg) Repaglinide (0.25 mg) Losartan (12.5 mg) Omeprazole (10 mg) Chlorzoxazone...” NCT03563287 ↗ “Midazolam, repaglinide, and losartan (CYP probe substrates) and, for female participants, estradiol/norethisterone acetate (hormonal probe substrate), administered orally (PO)...” NCT07704658 ↗ “ZYN002 (transdermal), midazolam (oral), omeprazole (oral), losartan (oral), dextromethorphan (oral), caffeine (oral), repaglinide (oral), bupropion (oral)” NCT06930872 ↗ “SU treatments will include any SU and the related insulin secretagogues repaglinide or nateglinide, each of them in combination with metformin.” NCT02616666 ↗ “Blood Sugar Control: Medications such as repaglinide tablets (1.0 mg qd) or gliclazide modified-release tablets (30 mg qd) can be used.” NCT06796660 ↗ “Repaglinide 0.25 mg, caffeine 100 mg, warfarin 10 mg (with vitamin K), omeprazole 40 mg, dextromethorphan 30 mg, midazolam 2 mg” NCT04233437 ↗ “Repaglinide can be considered in patients with significant renal impairment and in patients who refused insulin treatment.” NCT01974544 ↗ “oral anti-diabetic agents (OADs: metformin, sulfonylureas, nateglinide, repaglinide or pioglitazone)” NCT01919489 ↗ “polypharmacy for glucose control (metformin, repaglinide/glimepiride, pioglitazone or insulin)” NCT00133718 ↗ |
| Known as | A10BX02 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1272 ↗ |
| Known as | AG-EE 388 ZW | ChEMBL registry synonym — accepted as the source's own label CHEMBL1272 ↗ |
| Known as | AG-EE 623 ZW | ChEMBL registry synonym — accepted as the source's own label CHEMBL1272 ↗ |
| Known as | CHEMBL1272 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1272 ↗ |
| Known as | ENYGLID | ChEMBL registry synonym — accepted as the source's own label CHEMBL1272 ↗ |
| Known as | NOVONORM | ChEMBL registry synonym — accepted as the source's own label CHEMBL1272 ↗ |
| Known as | NSC-759893 | ChEMBL registry synonym — accepted as the source's own label CHEMBL1272 ↗ |
| Known as | PRANDIN | ChEMBL registry synonym — accepted as the source's own label CHEMBL1272 ↗ |
| Known as | REPAGLINIDA | ChEMBL registry synonym — accepted as the source's own label CHEMBL1272 ↗ |
| Known as | repaglinide (Gluconorm, Prandin) | “repaglinide (Gluconorm, Prandin)” NCT00000620 ↗ |
| Known as | REPAGLINIDE ACCORD | ChEMBL registry synonym — accepted as the source's own label CHEMBL1272 ↗ |
| Known as | REPAGLINIDE COMPONENT OF PRANDIMET | ChEMBL registry synonym — accepted as the source's own label CHEMBL1272 ↗ |
| Known as | REPAGLINIDE KRKA | ChEMBL registry synonym — accepted as the source's own label CHEMBL1272 ↗ |
| Known as | REPAGLINIDE TEVA | ChEMBL registry synonym — accepted as the source's own label CHEMBL1272 ↗ |
| Modality | Small molecule | — CHEMBL1272 ↗ |
| Route | Oral | “0.5mg tab with meals tid” NCT00072904 ↗ |