Drugs / Acarbose
Acarbose
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | PRECOSE | — | 1998-09-29 – 1999-08-16 | fda.gov ↗ |
| Approved | US (FDA) | PRECOSE | — | 1995-09-06 | fda.gov ↗ |
Trials 43
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT07436585 | Sep → Dec 2025 | diabetes mellitus, diabetic neuropathy | Shifa International Hospital | Completed | No outcome recorded |
| Phase 1 | NCT02211950 | Oct → Dec 2008 | — | Boehringer Ingelheim | Completed | No outcome recorded |
| Phase 1 | NCT00223691 | Mar 2002 → Jan 2017 | autonomic nervous system disorder, orthostatic hypotension | Vanderbilt University | Completed | Mixed |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT04521751 | May 2020 → Aug 2021 | obesity disorder | Empros Pharma AB | Completed | No outcome recorded |
| Phase 26 trials | ||||||
| Phase 2 | NCT05487859 | Dec 2025 → Oct 2026 | renal cell carcinoma | University of Alabama at Birmingham | Withdrawn | No outcome recorded |
| Phase 2 | NCT06993428 | May → Jul 2025 overdue | obesity disorder | Empros Pharma AB | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT05934110 | Apr → Nov 2023 | obesity disorder | Empros Pharma AB | Unknown | No outcome recorded |
| Phase 2 | NCT02953093 | Aug 2017 → Apr 2019 | premature aging syndrome | Montefiore Medical Center | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT02865499 | Jun 2016 → Oct 2017 | premature aging syndrome | The University of Texas Health Science Center at San Antonio | Completed | No outcome recorded |
| Phase 2 | NCT00677521 | Jan 2007 → Aug 2008 | NAFLD1 | The Hospital for Sick Children | Terminated | No outcome recorded Stop: Enrollment |
| Phase 38 trials | ||||||
| Phase 3 | NCT03380546 | Jul 2018 → Aug 2023 | gestational diabetes | Assistance Publique - Hôpitaux de Paris | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT03349684 | Mar 2018 → Aug 2019 | type 2 diabetes mellitus | Bayer | Completed | No outcome recorded |
| Phase 3 | NCT02315495 | Apr 2015 → Aug 2016 | type 2 diabetes mellitus | Zilin Sun | Completed | No outcome recorded |
| Phase 3 | NCT01316861 | Sep 2012 → Mar 2013 | type 2 diabetes mellitus | EMS | Completed | No outcome recorded |
| Phase 3 | NCT01000688 | Jan → Aug 2010 | type 2 diabetes mellitus | Radboud University Medical Center | Completed | No outcome recorded |
| Phase 3 | NCT00551954 | Jul 2006 → Jul 2007 | type 2 diabetes mellitus | Technical University Dresden | Completed | No outcome recorded |
| Phase 3 | NCT00221156 | May 2005 → Apr 2009 | coronary artery disorder, glucose metabolism disease | Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan | Completed | No outcome recorded |
| Phase 3 | NCT01010100 | Aug 2000 → May 2007 | diabetes mellitus | Bayer | Completed | No outcome recorded |
| Phase 421 trials · 2 met primary · 1 missed | ||||||
| Phase 4 | NCT05542849 | Aug → Oct 2022 | — | AgelessRx | Completed | No outcome recorded |
| Phase 4 | NCT04287387 | Mar 2020 → Mar 2021 | type 2 diabetes mellitus | Peking Union Medical College Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT03359837 | Jan 2018 → Jun 2020 | type 2 diabetes mellitus | Sanofi | Completed | No outcome recorded |
| Phase 4 | NCT03383068 | Jan → Dec 2018 | glucose intolerance, polycystic ovary syndrome | RenJi Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT02589353 | Apr 2017 → Dec 2022 | — | Oregon State University | Completed | No outcome recorded |
| Phase 4 | NCT02999841 | Mar 2016 → Dec 2017 | obesity disorder, type 2 diabetes mellitus | Peking University | Unknown | No outcome recorded |
| Phase 4 | NCT02605772 | Dec 2015 → Nov 2016 | type 2 diabetes mellitus | Fifth Affiliated Hospital, Sun Yat-Sen University | Unknown | No outcome recorded |
| Phase 4 | NCT02527993 | Oct 2015 → Apr 2017 | hypoglycemia, obesity disorder | Zealand University Hospital | Completed | No outcome recorded |
| Phase 4 | NCT02438397 | Dec 2014 → Oct 2016 | type 2 diabetes mellitus | Shanghai 6th People's Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT01863147 | Jul 2013 → Jul 2015 | coronary artery disorder | Wuhan General Hospital of Guangzhou Military Command | Completed | No outcome recorded |
| Phase 4 | NCT01758471 | Dec 2012 → Dec 2013 | type 2 diabetes mellitus | Shanghai Jiao Tong University School of Medicine | Unknown | No outcome recorded |
| Phase 4 | NCT01709305 | Nov 2012 → Apr 2015 | type 2 diabetes mellitus | Merck Sharp & Dohme LLC | Completed | Mixed |
| Phase 4 | NCT01490918 | Apr 2012 → Sep 2014 | type 2 diabetes mellitus | The Catholic University of Korea | Completed | Met primary |
| Phase 4 | NCT01181674 | Jan 2011 → Feb 2015 | type 2 diabetes mellitus | Population Health Research Institute | Completed | Met primary |
| Phase 4 | NCT02355509 | Jan 2010 → Jul 2014 | glucose intolerance, hyperglycemia | National Institute of Medical Sciences and Nutrition Salvador Zubiran | Completed | No outcome recorded |
| Phase 4 | NCT00970528 | Nov 2009 → Mar 2012 | type 2 diabetes mellitus | Bayer | Completed | No outcome recorded |
| Phase 4 | NCT01025765 | Nov 2009 → Dec 2012 | chronic hepatitis C virus infection | National Taiwan University Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT00437918 | Jan 2007 → Mar 2008 | type 2 diabetes mellitus | Inje University | Completed | No outcome recorded |
| Phase 4 | NCT01279512 | Dec 2006 → Dec 2008 | — | Royan Institute | Completed | No outcome recorded |
| Phase 4 | NCT00846521 | Sep 2006 → Sep 2008 | cardiovascular disorder, glucose intolerance | Yale University | Terminated | No outcome recorded |
| Phase 4 | NCT01470937 | Feb 1998 → Sep 2004 | type 2 diabetes mellitus | Indiana University | Completed | Missed primary |
| Phase not applicable4 trials | ||||||
| — | NCT03241303 | Aug 2017 → Jan 2018 | glucose metabolism disease | University Hospital, Gentofte, Copenhagen | Completed | No outcome recorded |
| — | NCT02446834 | Apr 2015 → Dec 2017 | polycystic ovary syndrome | RenJi Hospital | Completed | No outcome recorded |
| — | NCT00464594 | Apr 2007 → ? | diabetes mellitus | Japan Early Diabetes Intervention Study Group | Unknown | No outcome recorded |
| — | NCT00417950 | Jan 2007 → ? | diabetes mellitus, glucose intolerance | Taichung Veterans General Hospital | Unknown | No outcome recorded |
| Comparator or background therapy40 trials | ||||||
| Phase 0 | NCT02587741 Background | Jul 2015 → Jul 2023 | diabetic retinopathy | Third Affiliated Hospital, Sun Yat-Sen University | Unknown | No outcome recorded |
| Phase 1 | NCT06013163 Comparator | Sep 2023 → Dec 2024 | obesity disorder | Empros Pharma AB | Unknown | No outcome recorded |
| Phase 1 | NCT02685852 Comparator | Feb 2016 → Jul 2019 | hyperinsulinemic hypoglycemia | University of Minnesota | Completed | No outcome recorded |
| Phase 2 | NCT01914133 Comparator | Jan 2014 → May 2021 | hypotensive disorder | Kenneth Madden | Completed | No outcome recorded |
| Phase 2 | NCT01839344 Comparator | May 2013 → Mar 2014 | type 2 diabetes mellitus | Bastyr University | Completed | No outcome recorded |
| Phase 2 | NCT02043886 Comparator | Jun 2007 → Jan 2013 | postprandial hypotension, type 2 diabetes mellitus | University of British Columbia | Completed | No outcome recorded |
| Phase 3 | NCT05629806 Comparator | Apr 2022 → May 2023 | type 2 diabetes mellitus | Nanjing First Hospital, Nanjing Medical University | Unknown | No outcome recorded |
| Phase 3 | NCT01514838 Comparator | Apr → Oct 2012 | type 2 diabetes mellitus | Astellas Pharma Inc | Terminated | No outcome recorded Stop: Business |
| Phase 3 | NCT01177384 Background | Jan 2011 → Mar 2013 | type 2 diabetes mellitus | Merck Sharp & Dohme LLC | Completed | Met primary |
| Phase 3 | NCT01245166 Comparator | Nov 2010 → Jun 2011 | type 2 diabetes mellitus | Lotus Pharmaceutical | Unknown | No outcome recorded |
| Phase 3 | NCT01242202 Background | Oct 2010 → May 2012 | type 2 diabetes mellitus | Astellas Pharma Inc | Completed | No outcome recorded |
| Phase 3 | NCT00558883 Comparator | Jan 2005 → May 2007 | type 2 diabetes mellitus | GWT-TUD GmbH | 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 3 | NCT00629213 Comparator | — | metabolic syndrome X | GWT-TUD GmbH | Completed | No outcome recorded |
| 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 4 | NCT07711171 Comparator | Aug 2024 → Oct 2026 expected | cognitive impairment with or without cerebellar ataxia, type 2 diabetes mellitus | Fudan University | Recruiting | No outcome recorded |
| Phase 4 | NCT03794336 Comparator | Jun 2019 → Dec 2020 | type 2 diabetes mellitus | Sanofi | Completed | No outcome recorded |
| Phase 4 | NCT03602638 Comparator | Oct 2018 → May 2019 | type 2 diabetes mellitus | Chinese PLA General Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT03344341 Comparator | Dec 2017 → May 2019 | type 2 diabetes mellitus | AstraZeneca | Terminated | No outcome recorded |
| Phase 4 | NCT02836704 Background | Sep 2016 → Apr 2018 | type 2 diabetes mellitus | Sanofi | Completed | No outcome recorded |
| Phase 4 | NCT02243176 Comparator | Sep 2014 → Sep 2015 | type 2 diabetes mellitus | AstraZeneca | Completed | Met primary |
| Phase 4 | NCT02500329 Comparator | Sep 2014 → Dec 2015 | type 2 diabetes mellitus | Seoul National University Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT02049814 Comparator | May 2014 → Jun 2016 | type 2 diabetes mellitus | Takeda | Completed | No outcome recorded |
| Phase 4 | NCT02143765 Comparator | May 2014 → Dec 2015 | type 2 diabetes mellitus | Zhongda Hospital | Completed | No outcome recorded |
| Phase 4 | NCT02072096 Background | Feb 2014 → Oct 2015 | type 2 diabetes mellitus | Eli Lilly and Company | Terminated | Missed primary |
| Phase 4 | NCT01175486 Comparator | Jul 2010 → Dec 2012 | type 2 diabetes mellitus | Taipei Veterans General Hospital, Taiwan | Unknown | Missed primary |
| Phase 4 | NCT01030952 Comparator | Dec 2009 → Feb 2011 | type 2 diabetes mellitus | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT00928889 Comparator | Jul 2009 → Jun 2010 | type 2 diabetes mellitus | Novartis Pharmaceuticals | Completed | No outcome recorded |
| Phase 4 | NCT00858676 Comparator | Apr 2009 → Mar 2012 | coronary artery disorder, diabetes mellitus, glucose intolerance | Aichi Gakuin University | Unknown | No outcome recorded |
| Phase 4 | NCT00829660 Comparator | Feb 2009 → Apr 2017 | acute coronary syndrome, coronary artery disorder, glucose intolerance, type 2 diabetes mellitus | University of Oxford | Completed | No outcome recorded |
| Phase 4 | NCT00417729 Comparator | Jan 2007 → Jan 2009 | type 2 diabetes mellitus | Taichung Veterans General Hospital | Completed | No outcome recorded |
| Phase 4 | NCT01244971 Comparator | Jan → Jun 2004 | type 2 diabetes mellitus | Karolinska Institutet | Completed | No outcome recorded |
| — | NCT07122102 Comparator | Oct 2025 → Jun 2027 expected | type 2 diabetes mellitus | Haisco Pharmaceutical Group Co., Ltd. | Not yet recruiting | No outcome recorded |
| — | NCT05261997 Background | Mar 2022 → Nov 2023 | chronic pancreatitis, exocrine pancreatic insufficiency | Changhai Hospital | Unknown | No outcome recorded |
| — | NCT05035849 Comparator | Jan 2020 → Apr 2021 | type 2 diabetes mellitus | Nanjing First Hospital, Nanjing Medical University | Completed | No outcome recorded |
| — | NCT03961659 Comparator | May 2019 → Aug 2020 | cognitive impairment with or without cerebellar ataxia, obesity disorder, type 2 diabetes mellitus | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Unknown | No outcome recorded |
| — | NCT01624116 Comparator | Aug → Sep 2011 | type 2 diabetes mellitus | Services Hospital, Lahore | Completed | No outcome recorded |
| — | NCT00691314 Comparator | Jun 2008 → Sep 2010 | atherosclerosis, transient ischemic attack | Peking Union Medical College Hospital | Completed | No outcome recorded |
| — | NCT00664846 Background | Apr 2008 → Dec 2010 | ischemic stroke | Peking Union Medical College Hospital | Completed | No outcome recorded |
| — | NCT01019356 Comparator | Aug 2006 → Jul 2021 | polycystic ovary syndrome | Jean-Patrice Baillargeon | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 4
| Date | Issuer | Release |
|---|---|---|
| 2025-11-03 | Empros Pharma AB | Results Topline POEM Study Results Position EMP16 as a Promising Oral Weight-Loss Maintenance Therapy emprospharma.com ↗
Empros Pharma AB, a Stockholm-based biopharmaceutical company developing EMP16, an investigational oral fixed dose combination of orlistat and acarbose for obesity and long-term weight-loss maintenance, is pleased to announce positive topline results from its Phase 2 POEM study. |
| 2017-09-11 | Empros Pharma AB | Results Pressrelease phase 2A trial emprospharma.com ↗
The trials show best-in class safety and indicates stronger appetite suppressing effect and improved glycaemic control compared to existing alternatives like Xenical ® . |
| 2017-08-13 | Empros Pharma AB | Results Phase 2A trial concluded emprospharma.com ↗
The results clearly indicate that EMP16-01 has a stronger appetite suppressing effect as compared to Xenical®, see figure, which is expected reduce the BMI more than Xenical®. |
| 2009-05-19 | Impax Laboratories, LLC | Regulatory Impax Receives FDA Approval for Generic Precose(R) Tablets, 25 mg, 50 mg and 100 mg amneal.com ↗
Impax Laboratories, Inc. (NASDAQ: IPXL) today confirmed that the U.S. Food and Drug Administration ( FDA ) has granted approval of the Company’s Abbreviated New Drug Application (ANDA) for generic versions of Precose® Tablets (acarbose), 25 mg, 50 mg and 100 mg strengths. |
All press releases naming this drug 4 releases
| Date | Issuer | Release |
|---|---|---|
| 2025-11-03 | Empros Pharma AB | Topline POEM Study Results Position EMP16 as a Promising Oral Weight-Loss Maintenance Therapy emprospharma.com ↗ |
| 2017-09-11 | Empros Pharma AB | Pressrelease phase 2A trial emprospharma.com ↗ |
| 2017-08-13 | Empros Pharma AB | Phase 2A trial concluded emprospharma.com ↗ |
| 2009-05-19 | Impax Laboratories, LLC | Impax Receives FDA Approval for Generic Precose(R) Tablets, 25 mg, 50 mg and 100 mg amneal.com ↗ |
Evidence & citations 9 cited values
Every value below carries the sentence it was read from. 86 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Acarbose | “Single dose of EMP16 (120 mg orlistat/40 mg acarbose) will be taken together with breakfast during one PK study day.” NCT06013163 ↗83“Chemical Name: Alpha-Glucosidase Inhibitors (e.g., Acarbose, Miglitol) Class: Alpha-Glucosidase Inhibitors” NCT06449235 ↗ “EMP16 is supplied as oral MR capsules with the strength of 60 mg orlistat/20 mg acarbose.” NCT05934110 ↗ “antidiabetic agents: Metformin 0.5 tid or Glipizide 5mg tid or Acarbose 50mg tid” NCT00691314 ↗ “if still not reach the target，add acarbose 50mg tid” NCT02587741 ↗ “Glipizide 5mg tid or Acarbose 50mg tid” NCT00664846 ↗ “Acarbose” NCT00000620 ↗ “Acarbose” NCT01242202 ↗ “Acarbose” NCT00000620 ↗ |
| Known as | ACA | “The participants were randomly assigned to 12 weeks of metformin (MET) or acarbose (ACA) treatment combined with insulin.” PMID 36273168 ↗ Oct 2022 |
| Known as | BAYG5421 | “Acarbose (Glucobay, BAYG5421)” NCT00970528 ↗1“Acarbose (Glucobay, BAYG5421)” NCT01010100 ↗ |
| Known as | Glucobay | “Acarbose is an Alpha-glucosidase inhibitor. It is a compound also known under the names Glucobay, Precose, and Prandase.” NCT05542849 ↗3“Acarbose (Glucobay, BAYG5421)” NCT00970528 ↗ “Acarbose (Glucobay, BAYG5421)” NCT01010100 ↗ “Glucobay” NCT02243176 ↗ |
| Known as | Glucobay (Acarbose Tablets) | “Glucobay (Acarbose Tablets)” NCT02999841 ↗ |
| Known as | Prandase | “Acarbose is an Alpha-glucosidase inhibitor. It is a compound also known under the names Glucobay, Precose, and Prandase.” NCT05542849 ↗ |
| Known as | Precose | “Acarbose is an Alpha-glucosidase inhibitor. It is a compound also known under the names Glucobay, Precose, and Prandase.” NCT05542849 ↗ |
| Action | Inhibit | “Acarbose, an alpha-glucosidase inhibitor” PMID 17515447 ↗ May 2007 |
| Route | Oral | “oral anti-diabetic agent with glibenclamide or acarbose” PMID 24932223 ↗ May 2014 |