Drugs / Glucagon
Glucagon
also known as
GlucaGen · G-Pen Mini · G-Pen · G-Pen (glucagon injection) · Lilly Glucagon · XeriSol glucagon · Baqsimi · BC Glucagon · +16 more
Regulatory milestones approvals, filings & regulatory actions · 9 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed severe nonproliferative diabetic retinopathy 2 milestones | |||||
| Filed | EU (EMA) | — | severe nonproliferative diabetic retinopathy | 2019-11-21 | “Xeris recently submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for its liquid stable glucagon for the treatment of severe hypoglycemia” xerispharma.com ↗ |
| Filed | US (FDA) | — | severe nonproliferative diabetic retinopathy | 2018-08-13 | “Xeris submitted the NDA for its lead product candidate, Glucagon Rescue Pen, for the treatment of severe hypoglycemia” xerispharma.com ↗ “Submitted NDA to US Food and Drug Administration ( FDA ) for Glucagon Rescue Pen” xerispharma.com ↗ |
| Approved Indication not stated 4 milestones | |||||
| Label expansion | US (FDA) | GVOKE KIT | — | 2025-03-14 | fda.gov ↗ |
| Approved | EU (EMA) | Baqsimi | — | 2019-12-16 | europa.eu ↗ |
| Label expansions (4) | US (FDA) | GLUCAGON | — | 1979-11-27 – 2019-09-09 | fda.gov ↗ |
| Approved | US (FDA) | GLUCAGON | — | 1960-11-14 | fda.gov ↗ |
Trials 74 · started per year
today
US approved 1960
EU approved 2019
1
1
1
1
2
2
3
3
7
5
5
7
7
6
6
2
3
4
1
3
1
3
19591960196119621963196419651966196719681969197019711972197319741975197619771978197919801981198219831984198519861987198819891990199119921993199419951996199719981999200020012002200320042005200620072008200920102011201220132014201520162017201820192020202120222023202420252026202720282029
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 02 trials | ||||||
| Phase 0 | NCT04712266 | Sep → Dec 2020 | type 1 diabetes mellitus | Abvance Therapeutics | Completed | No outcome recorded |
| Phase 0 | NCT04300049 | Feb 2018 → Nov 2023 | — | The University of Texas Health Science Center at San Antonio | Completed | No outcome recorded |
| Phase 115 trials · 2 met primary | ||||||
| Phase 1 | NCT06588504 | Sep 2024 → Jul 2025 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT04992312 | Mar 2022 → Nov 2023 | type 1 diabetes mellitus | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT04347252 | Sep 2019 → Apr 2021 | — | David D'Alessio, M.D. | Completed | No outcome recorded |
| Phase 1 | NCT03965130 | Jun 2019 → Jul 2022 | — | Yale University | Completed | No outcome recorded |
| Phase 1 | NCT03424044 | Mar 2018 → May 2019 | type 1 diabetes mellitus | Oregon Health and Science University | Completed | Met primary |
| Phase 1 | NCT03339453 | Nov → Dec 2017 | hypoglycemia, type 1 diabetes mellitus | Eli Lilly and Company | Completed | Met primary |
| Phase 1 | NCT03176524 | Jun → Sep 2017 | type 1 diabetes mellitus | Adocia | Completed | No outcome recorded |
| Phase 1 | NCT02817659 | Nov 2016 → Jan 2017 overdue | obesity disorder | AdventHealth Translational Research Institute | Active not recruiting | No outcome recorded |
| Phase 1 | NCT02740829 | Mar 2015 → Jan 2016 | diabetes mellitus | University Health Network, Toronto | Completed | No outcome recorded |
| Phase 1 | NCT02403648 | Nov 2014 → Mar 2015 | hypoglycemia | Biodel | Completed | No outcome recorded |
| Phase 1 | NCT01916265 | Aug → Nov 2013 | type 1 diabetes mellitus | Profil Institute for Metabolic Research GmbH | Completed | No outcome recorded |
| Phase 1 | NCT02778100 | Mar → Apr 2013 | common cold | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT02778113 | Oct 2011 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT00817271 | Feb → Apr 2009 | type 2 diabetes mellitus | AstraZeneca | Completed | No outcome recorded |
| Phase 1 | NCT00304538 | Mar → Jul 2006 | type 1 diabetes mellitus | DiObex | Completed | No outcome recorded |
| Phase 1/24 trials · 1 missed | ||||||
| Phase 1/2 | NCT07300982 | Apr 2026 → Dec 2029 expected | diabetes mellitus | Duke University | Not yet recruiting | No outcome recorded |
| Phase 1/2 | NCT06854861 | Apr → Nov 2025 | type 1 diabetes mellitus | St. Olavs Hospital | Suspended | No outcome recorded |
| Phase 1/2 | NCT05500586 | Oct 2022 → Sep 2025 | metabolic dysfunction-associated steatotic liver disease, obesity disorder, type 2 diabetes mellitus | Adrian Vella | Completed | No outcome recorded |
| Phase 1/2 | NCT03255629 | Sep 2017 → Aug 2018 | postgastrectomy syndrome | Joslin Diabetes Center | Completed | Missed primary |
| Phase 215 trials · 1 met primary · 3 missed | ||||||
| Phase 2 | NCT05960565 | Dec 2023 | type 1 diabetes mellitus | St. Olavs Hospital | Terminated | No outcome recorded |
| Phase 2 | NCT03841526 | Aug 2019 → Apr 2020 | hypoglycemia | Xeris Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT03770637 | May 2019 → Feb 2020 | hyperinsulinemic hypoglycemia | Xeris Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT03490942 | Mar 2018 → Nov 2019 | type 1 diabetes mellitus | Xeris Pharmaceuticals | Terminated | Missed primary |
| Phase 2 | NCT02971228 | Nov 2016 → May 2017 | type 1 diabetes mellitus | Zealand Pharma | Completed | No outcome recorded |
| Phase 2 | NCT02937558 | Oct 2016 → Sep 2018 | congenital isolated hyperinsulinism | Xeris Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT02733588 | Mar 2016 → Apr 2017 | hypoglycemia | Xeris Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT02660242 | Jan 2016 → Feb 2017 | type 1 diabetes mellitus | Jaeb Center for Health Research | Completed | Met primary |
| Phase 2 | NCT02411578 | Sep 2015 → Apr 2016 | type 1 diabetes mellitus | Jaeb Center for Health Research | Completed | Missed primary |
| Phase 2 | NCT02423980 | Apr → May 2015 | hypoglycemia | Xeris Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT02081001 | Mar → Aug 2014 | hypoglycemia | Xeris Pharmaceuticals | Completed | Missed primary |
| Phase 2 | NCT02081014 | Mar → Nov 2014 | hypoglycemia | Xeris Pharmaceuticals | Completed | No outcome recorded |
| Phase 2 | NCT01556594 | Mar → Jul 2012 | hypoglycemia | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 2 | NCT00797823 | Nov 2008 → Sep 2009 | type 1 diabetes mellitus | Legacy Health System | Completed | No outcome recorded |
| Phase 2 | NCT00434772 | Dec 2007 → May 2009 | hypoglycemia | Shaare Zedek Medical Center | Completed | No outcome recorded |
| Phase 2/32 trials | ||||||
| Phase 2/3 | NCT03650582 | Jun 2017 → Sep 2018 | obesity disorder | University Health Network, Toronto | Unknown | No outcome recorded |
| Phase 2/3 | NCT01997411 | Nov 2013 → Jan 2015 | type 1 diabetes mellitus | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 311 trials · 2 met primary | ||||||
| Phase 3 | NCT03738865 | Sep 2018 → Mar 2019 | hypoglycemia, type 1 diabetes mellitus | Xeris Pharmaceuticals | Completed | No outcome recorded |
| Phase 3 | NCT03421379 | Feb → Aug 2018 | diabetes mellitus | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT03216226 | Jun 2017 → Feb 2018 | hypoglycemia, type 1 diabetes mellitus | Zealand Pharma | Completed | No outcome recorded |
| Phase 3 | NCT03091673 | Mar → Sep 2017 | type 1 diabetes mellitus | Xeris Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT02656069 | Mar → Aug 2017 | hypoglycemia, type 1 diabetes mellitus | Xeris Pharmaceuticals | Completed | Met primary |
| Phase 3 | NCT02402933 | Mar → Aug 2015 | diabetes mellitus, hypoglycemia | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT02171130 | May 2014 → Aug 2015 | diabetes mellitus, hypoglycemia | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT01994746 | Nov 2013 → Jan 2015 | type 1 diabetes mellitus | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT01959334 | Sep → Dec 2013 | diabetes mellitus | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 3 | NCT00740324 | Aug 2008 → Mar 2009 | — | Nihon Pharmaceutical Co., Ltd | Completed | No outcome recorded |
| Phase 3 | NCT00206258 | Jul 2002 → Aug 2005 | type 1 diabetes mellitus | Baylor College of Medicine | Completed | No outcome recorded |
| Phase 410 trials | ||||||
| Phase 4 | NCT07818707 | Jan 2026 → Jan 2027 expected | hypoglycemia | Joslin Diabetes Center | Recruiting | No outcome recorded |
| Phase 4 | NCT06986603 | Nov 2024 → Jun 2026 overdue | hypoglycemia | Joslin Diabetes Center | Active not recruiting | No outcome recorded |
| Phase 4 | NCT04307797 | Jan → Oct 2022 | obesity disorder, type 2 diabetes mellitus | Cambridge University Hospitals NHS Foundation Trust | Completed | No outcome recorded |
| Phase 4 | NCT05206149 | Oct → Dec 2021 | hypopituitarism | A.O.U. Città della Salute e della Scienza | Completed | No outcome recorded |
| Phase 4 | NCT03533179 | Jun 2018 → Oct 2019 | — | University Hospital Bispebjerg and Frederiksberg | Completed | No outcome recorded |
| Phase 4 | NCT02516150 | Mar 2016 → May 2017 | type 1 diabetes mellitus | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 4 | NCT02232971 | Sep 2014 → Jan 2015 | type 1 diabetes mellitus | Hvidovre University Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT01674283 | Oct 2013 | female infertility | Clinique Ovo | Withdrawn | No outcome recorded |
| Phase 4 | NCT01155206 | Jun 2009 → Jan 2010 | diabetes mellitus | University Health Network, Toronto | Completed | No outcome recorded |
| Phase 4 | NCT00155376 | Sep 2005 | liver disorder | National Taiwan University Hospital | Unknown | No outcome recorded |
| Phase not applicable15 trials · 1 missed | ||||||
| — | NCT06872060 | Jun 2026 → Nov 2027 expected | kidney disorder | Bispebjerg Hospital | Not yet recruiting | No outcome recorded |
| — | NCT07366710 | Nov 2024 → Oct 2027 expected | NAFLD1, glucose metabolism disease | Rigshospitalet, Denmark | Active not recruiting | No outcome recorded |
| — | NCT05379686 | Sep 2022 → May 2024 | hypoglycemia, type 1 diabetes mellitus | Steno Diabetes Center Copenhagen | Completed | No outcome recorded |
| — | NCT05076292 | Nov 2021 → Aug 2023 | hypoglycemia, type 1 diabetes mellitus | Steno Diabetes Center Copenhagen | Completed | No outcome recorded |
| — | NCT04859322 | Feb → Dec 2021 | NAFLD1 | Malte Palm Suppli, MD | Completed | No outcome recorded |
| — | NCT05056584 | Aug 2020 → Mar 2023 | abnormality of glucagon secretion, chronic kidney disease, cirrhosis of liver | University Hospital, Gentofte, Copenhagen | Completed | No outcome recorded |
| — | NCT05095259 | Dec 2019 → Dec 2023 | type 1 diabetes mellitus | Nordsjaellands Hospital | Unknown | No outcome recorded |
| — | NCT03970772 | Apr → Jun 2019 | hypoglycemia, type 1 diabetes mellitus | Qassim University | Completed | No outcome recorded |
| — | NCT02882737 | Sep 2016 → Jul 2017 | type 1 diabetes mellitus | Hvidovre University Hospital | Completed | No outcome recorded |
| — | NCT02475421 | May 2015 → Dec 2016 | diabetes mellitus | University Hospital, Gentofte, Copenhagen | Completed | No outcome recorded |
| — | NCT01935791 | Jul 2013 → Nov 2018 | metabolic disease | Imperial College London | Completed | No outcome recorded |
| — | NCT01795235 | Dec 2012 → Jul 2014 | — | University of Virginia | Unknown | No outcome recorded |
| — | NCT01680653 | May → Sep 2012 | type 1 diabetes mellitus | Stanford University | Completed | Missed primary |
| — | NCT01483651 | Nov 2011 → Mar 2013 | type 1 diabetes mellitus | Legacy Health System | Completed | No outcome recorded |
| — | NCT01986231 | Jan 2011 → Dec 2012 | type 1 diabetes mellitus | Legacy Health System | Completed | No outcome recorded |
| Comparator or background therapy39 trials | ||||||
| Phase 1 | NCT06558422 Background | Jan 2027 → Dec 2028 expected | hyperinsulinism, metabolic dysfunction-associated steatotic liver disease, obesity disorder, prediabetes syndrome | Columbia University | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT06592261 Background | Sep 2024 → Sep 2026 overdue | hyperinsulinism, obesity disorder | Columbia University | Recruiting | No outcome recorded |
| Phase 1 | NCT06126354 Background | Jul 2024 → Nov 2025 | NAFLD1, prediabetes syndrome | Columbia University | Withdrawn | No outcome recorded |
| Phase 1 | NCT05724134 Background | Aug 2023 → Sep 2025 | NAFLD1, hyperinsulinism, obesity disorder, prediabetes syndrome | Columbia University | Completed | No outcome recorded |
| Phase 1 | NCT03765502 Comparator | Nov 2018 → Jan 2019 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT03241706 Comparator | Aug 2018 → May 2028 expected | hypoglycemia | Jason Winnick | Active not recruiting | No outcome recorded |
| Phase 1 | NCT03444467 Comparator | Feb → May 2018 | type 1 diabetes mellitus, type 2 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT03139305 Comparator | Oct 2017 → Feb 2018 overdue | obesity disorder | AdventHealth Translational Research Institute | Active not recruiting | No outcome recorded |
| Phase 1 | NCT02748369 Comparator | Jul 2016 → Mar 2017 | hypermetabolism due to uncoupled mitochondrial oxidative phosphorylation 2 | K. Sreekumaran Nair | Completed | No outcome recorded |
| Phase 1 | NCT02459938 Comparator | Jan → Aug 2015 | hypoglycemia | Zosano Pharma Corporation | Completed | No outcome recorded |
| Phase 1 | NCT02367053 Comparator | Dec 2014 → Apr 2015 | hypoglycemia | Zealand Pharma | Completed | No outcome recorded |
| Phase 1 | NCT02237053 Comparator | Sep 2014 → Jun 2015 | abnormality of glucagon secretion, obesity disorder | AdventHealth Translational Research Institute | Completed | No outcome recorded |
| Phase 1 | NCT01640834 Background | Jul → Sep 2012 | type 1 diabetes mellitus | Eli Lilly and Company | Completed | Missed primary |
| Phase 1 | NCT01300260 Background | Feb → Aug 2011 | type 2 diabetes mellitus | Eli Lilly and Company | Completed | Met primary |
| Phase 1 | NCT00823940 Background | Jan → Apr 2009 | type 2 diabetes mellitus | GlaxoSmithKline | Completed | No outcome recorded |
| Phase 1 | NCT00745186 Comparator | Aug → Oct 2007 | hypoglycemia | Pfizer | Completed | No outcome recorded |
| Phase 1 | NCT02012166 Background | Jul → Dec 2005 | type 2 diabetes mellitus | Merck Sharp & Dohme LLC | Completed | No outcome recorded |
| Phase 2 | NCT05454709 Comparator | Dec 2023 | type 1 diabetes mellitus | Inreda Diabetic B.V. | Withdrawn | No outcome recorded |
| Phase 2 | NCT02490098 Comparator | Jan → Jul 2018 | type 1 diabetes mellitus | Montreal Clinical Research Institute | Withdrawn | No outcome recorded Stop: Business |
| Phase 2 | NCT02916251 Comparator | Dec 2016 → Apr 2017 | type 1 diabetes mellitus | Zealand Pharma | Completed | No outcome recorded |
| Phase 2 | NCT02798250 Comparator | Jun 2016 → Mar 2017 | type 1 diabetes mellitus | Montreal Clinical Research Institute | Completed | No outcome recorded |
| Phase 2 | NCT02626936 Comparator | Jan → Jun 2016 | type 1 diabetes mellitus | Montreal Clinical Research Institute | Completed | No outcome recorded |
| Phase 2 | NCT02660008 Comparator | Jan → Jun 2016 | hypoglycemia | Zealand Pharma | Completed | No outcome recorded |
| Phase 2 | NCT02416765 Comparator | May → Oct 2015 | type 1 diabetes mellitus | Montreal Clinical Research Institute | Completed | No outcome recorded |
| Phase 2 | NCT01828125 Comparator | Apr → Dec 2013 | type 1 diabetes mellitus | Montreal Clinical Research Institute | Withdrawn | No outcome recorded |
| Phase 2 | NCT02846857 Comparator | ? → Jul 2019 | type 1 diabetes mellitus | Montreal Clinical Research Institute | Withdrawn | No outcome recorded |
| Phase 2/3 | NCT02018627 Comparator | Apr 2014 → Aug 2018 | type 1 diabetes mellitus | Steven J. Russell, MD, PhD | Completed | No outcome recorded |
| Phase 3 | NCT03667053 Comparator | Sep 2018 → Jun 2019 | hypoglycemia | Zealand Pharma | Completed | Met primary |
| Phase 3 | NCT03378635 Comparator | Dec 2017 → Apr 2018 | hypoglycemia, type 1 diabetes mellitus | Zealand Pharma | Completed | Met primary |
| Phase 3 | NCT00929812 Comparator | Jun 2006 → Jan 2008 | obesity disorder, type 1 diabetes mellitus | Charite University, Berlin, Germany | Unknown | No outcome recorded |
| Phase 4 | NCT07427251 Comparator | Mar 2026 → May 2027 expected | type 1 diabetes mellitus | Steno Diabetes Center Copenhagen | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT04949867 Comparator | May 2021 → Apr 2022 | type 1 diabetes mellitus | Steno Diabetes Center Copenhagen | Completed | No outcome recorded |
| Phase 4 | NCT04053712 Comparator | Jul 2019 → Mar 2021 | hypoglycemia, type 1 diabetes mellitus | Steno Diabetes Center Copenhagen | Completed | No outcome recorded |
| Phase 4 | NCT02078726 Comparator | Apr 2014 → May 2018 | colon carcinoma | University of California, San Francisco | Completed | No outcome recorded |
| — | NCT03835013 Comparator | Feb 2019 → Nov 2021 | cardiovascular disorder | Cambridge University Hospitals NHS Foundation Trust | Completed | No outcome recorded |
| — | NCT03526445 Comparator | May 2018 → Jun 2019 | NAFLD1, diabetes mellitus | Steno Diabetes Center Copenhagen | Completed | No outcome recorded |
| — | NCT03217175 Comparator | Aug 2017 → Mar 2018 | type 1 diabetes mellitus | Massachusetts General Hospital | Terminated | No outcome recorded Stop: Business |
| — | NCT03061227 Comparator | Feb 2017 → Jan 2019 | diabetes mellitus, metabolic syndrome X | University Hospital Tuebingen | Completed | No outcome recorded |
| — | NCT00005889 Background | Oct 1999 → ? | hyperglycemia | National Center for Research Resources (NCRR) | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 27
| Date | Issuer | Release |
|---|---|---|
| 2025-03-17 | Xeris Pharmaceuticals | Regulatory Xeris Announces Approval of Supplemental New Drug Application (sNDA) of Gvoke VialDx™ (glucagon) for Use as a Diagnostic Aid xerispharma.com ↗ |
| 2021-08-23 | Xeris Pharmaceuticals | Regulatory Xeris Pharmaceuticals Announces Approval of Supplemental New Drug Application (sNDA) of Gvoke® Kit for the Treatment of Severe Hypoglycemia xerispharma.com ↗
Xeris Pharmaceuticals, Inc. (Nasdaq: XERS), a pharmaceutical company leveraging its novel formulation technology platforms to develop and commercialize ready-to-use injectable drug formulations, today announced that its supplemental new drug application (sNDA) of Gvoke® Kit was approved by the Food and Drug Administration (FDA) for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes ages 2 years and above. |
| 2021-04-29 | Xeris Pharmaceuticals | Regulatory Xeris Pharmaceuticals Receives U.K. MHRA Approval of Ogluo® (glucagon) Injection for the Treatment of Severe Hypoglycaemia in Adults, Adolescents, and Children Aged 2 Years and Over With Diabetes Mellitus xerispharma.com ↗
the United Kingdom’s Medicines and Healthcare Regulatory Agency (MHRA) has approved Ogluo® (glucagon) injection for the treatment of severe hypoglycaemia in adults, adolescents, and children aged 2 years and over with diabetes mellitus. |
| 2021-02-12 | Xeris Pharmaceuticals | Regulatory Xeris Pharmaceuticals Receives European Commission Approval of Ogluo™ (glucagon) Injection for the Treatment of Severe Hypoglycaemia in Adults, Adolescents, and Children Aged 2 Years and Over With Diabetes Mellitus xerispharma.com ↗
Xeris Pharmaceuticals, Inc. (Nasdaq: XERS), a specialty pharmaceutical company leveraging its novel formulation technology platforms to develop and commercialize ready-to-use injectable and infusible drug formulations, today announced that the European Commission (EC) has approved Ogluo™ (glucagon) injection for the treatment of severe hypoglycaemia in adults, adolescents, and children aged 2 years and over with diabetes mellitus. |
| 2020-12-11 | Xeris Pharmaceuticals | Regulatory Xeris Pharmaceuticals Receives Positive CHMP Opinion for Ogluo™, Its Ready-To-Use (RTU) Glucagon for Injection, for the Treatment of Severe Hypoglycaemia in Adults, Adolescents, and Children Aged 2 Years and Over With Diabetes Mellitus xerispharma.com ↗
Xeris Pharmaceuticals, Inc. (Nasdaq: XERS), a specialty pharmaceutical company leveraging its novel formulation technology platforms to develop and commercialize ready-to-use (RTU) injectable and infusible drug formulations, announced that yesterday the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive Opinion for Ogluo™ (glucagon). |
| 2020-06-15 | Xeris Pharmaceuticals | Results Xeris Pharmaceuticals Announces Positive Results From the Outpatient Stage of a Phase 2 Study of Its Developmental Gvoke Ready-to-Use (RTU) Micro™ Glucagon in Adults at Risk of Hypoglycemia During and After Aerobic Exercise xerispharma.com ↗
Results show that pretreatment with 150 µg of RTU glucagon was adequate to maintain normal blood glucose levels during prolonged, moderate-to-intense aerobic exercise. |
| 2020-05-22 | Xeris Pharmaceuticals | Results Xeris Pharmaceuticals Announces Positive Findings From the Outpatient Portion of a Phase 2 Proof-of-Concept Study of Its Developmental Ready-to-Use (RTU) Glucagon in Patients at Risk of Postprandial Hypoglycemia Following Bariatric Surgery xerispharma.com ↗ |
| 2020-01-06 | Xeris Pharmaceuticals | Results Xeris Pharmaceuticals Announces Positive Results from the In-Clinic Stage of a Phase 2 Study of Its Developmental Ready-To-Use (RTU) Glucagon in Patients at Risk of Hypoglycemia During and after Aerobic Exercise xerispharma.com ↗
Results from the in-clinic stage of the Phase 2 Exercise-Induced Hypoglycemia (EIH) study show that a mini dose of RTU glucagon was adequate to maintain normal blood glucose levels during prolonged, moderate-to-intense aerobic exercise. |
| 2019-12-10 | Xeris Pharmaceuticals | Results Xeris Pharmaceuticals Announces Positive Topline Results From the In-clinic Stage of the Phase 2 Study of Its Developmental Ready-to-use (RTU) Glucagon in Patients at Risk of Postprandial Hypoglycemia Following Bariatric Surgery xerispharma.com ↗ |
| 2019-09-10 | Xeris Pharmaceuticals | Regulatory Xeris Pharmaceuticals Receives U.S. FDA Approval for GVOKE™ (glucagon), the First Ready-to-use Stable Liquid Glucagon for Severe Hypoglycemia xerispharma.com ↗ |
| 2019-07-24 | Eli Lilly and Company | Regulatory BAQSIMI™ (glucagon) Nasal Powder 3 mg, the First and Only Nasally Administered Glucagon to Treat Severe Hypoglycemia in Adults and Children with Diabetes Ages Four Years and Older, Approved by FDA lilly.com ↗
The U.S. Food and Drug Administration (FDA) has approved BAQSIMI™ (glucagon) nasal powder 3 mg for the treatment of severe hypoglycemia in people with diabetes ages four years and above, Eli Lilly and Company (NYSE: LLY) announced today. |
| 2019-06-17 | Xeris Pharmaceuticals | Results Xeris Pharmaceuticals Announces Additional Positive Outcomes from a Global Phase 3 Clinical Trial of Its Investigational Ready-to-Use Glucagon xerispharma.com ↗
The results demonstrated comparable efficacy between the two groups for achieving a plasma glucose of >70 mg/dl or ≥20 mg/dl increase in plasma glucose concentration within 30 minutes of glucagon administration. |
| 2019-06-06 | Xeris Pharmaceuticals | Regulatory Xeris Pharmaceuticals Receives Notification of PDUFA Date Extension for Gvoke™ xerispharma.com ↗
The new PDUFA goal date is September 10, 2019. |
| 2019-06-04 | Adocia | Results Adocia Announces Scientific Data Presentations at the American Diabetes Association® 79th Scientific Sessions adocia.com ↗
BioChaperone Glucagon Exenatide (BC Glu Exe), a Stable Combination of Glucagon (Glu) and Exenatide (Exe) Achieved Larger Body Weight (BW) Loss than Exe Alone in DIO Mice |
| 2019-02-12 | Adocia | Results Adocia to Present New Clinical Data on BioChaperone® Technology at ATTD 2019 adocia.com ↗
BioChaperone Glucagon, A Stable Ready-To-Use Liquid Glucagon Formulation Enabled By Biochaperone Technology, Is Well Tolerated And Quickly Restores Euglycemia After Insulin-Induced Hypoglycemia |
| 2018-12-20 | Xeris Pharmaceuticals | Regulatory European Medicines Agency Grants Orphan Drug Designation for Xeris’ Investigational Ready-to-Use Glucagon for the Treatment of Non-Insulinoma Pancreatogenous Hypoglycaemia Syndrome (NIPHS) xerispharma.com ↗ |
| 2018-11-15 | Xeris Pharmaceuticals | Results Xeris Pharmaceuticals Releases Additional Phase 3 Clinical Trial Data on Its Ready-to-Use Liquid Glucagon Pen xerispharma.com ↗
These data outline the glucagon pen’s efficacy in prompt and complete resolution of hypoglycemia in both adults and children with diabetes, as well as simplicity to facilitate successful administration during these critical settings. |
| 2018-10-23 | Xeris Pharmaceuticals | Regulatory Xeris Pharmaceuticals Announces FDA Acceptance for Review of NDA for Its Ready-to-Use Glucagon Rescue Pen xerispharma.com ↗ |
| 2018-06-25 | Xeris Pharmaceuticals | Results Xeris Pharmaceuticals Announces Positive Phase 3 Clinical Trial Data on Its Investigational Ready-to-Use Glucagon Rescue Pen xerispharma.com ↗
In that study, all participants (100%) treated with the Xeris rescue pen achieved plasma glucose of >70 mg/dL or ≥ 20 mg/dl increase within 30 minutes of injection. |
| 2018-06-14 | Adocia | Results Adocia to Present Six Abstracts at the American Diabetes Association® 78th Scientific Sessions adocia.com ↗ |
| 2018-05-21 | Xeris Pharmaceuticals | Results Xeris Pharmaceuticals Announces New Results From Ready-To-Use Liquid Glucagon Clinical Development Program xerispharma.com ↗
In a pilot study, patients with Type 1 diabetes (T1D) experienced normalization of plasma glucose levels and demonstrated complete resolution of symptoms of severe, experimentally induced hypoglycemia following a rescue dose of the company’s glucagon formulation. |
| 2018-05-21 | Xeris Pharmaceuticals | Regulatory DA Grants Orphan Drug Designation (ODD) for Xeris Pharmaceuticals' Ready-to-Use Glucagon for the Treatment of Hyperinsulinemic Hypoglycemia (HH). xerispharma.com ↗ |
| 2018-05-01 | Xeris Pharmaceuticals | Results Xeris Pharmaceuticals Achieves Phase 3 Milestones of its Ready-to-Use Glucagon Rescue Pen for the Treatment of Severe Hypoglycemia xerispharma.com ↗
Xeris has also announced results from a Human Factors usability and reliability study which showed 99% of participants were able to successfully administer a full dose of glucagon with Xeris’ rescue pen. |
| 2017-11-20 | Adocia | Results Adocia Reports Topline Results of BioChaperone® Glucagon Phase 1 Study adocia.com ↗
BioChaperone Glucagon , a ready -to-inject stable aqueous formulation of human glucagon, was found to be safe and well tolerated in people with type 1 diabetes |
| 2015-09-15 | Locemia Solutions ULC | Results T1D Exchange to Present Several Abstracts at the 51st European Association for the Study of Diabetes (EASD) Annual Meeting locemia.com ↗
Preliminary clinical trial data have demonstrated that a new, user-‐friendly, needle-‐free delivery system is as effective in children and adolescents as the injected form of glucagon. |
| 2015-06-06 | Locemia Solutions ULC | Results T1D Exchange to Present Abstracts on Pressing Type 1 Diabetes Issues at ADA Scientific Sessions locemia.com ↗ |
| 2015-02-18 | Locemia Solutions ULC | Results T1D Exchange Presents Data on New Form of Glucagon “Rescue” Treatment for Severe Hypoglycemia locemia.com ↗
Preliminary clinical trials have demonstrated that Locemia’s needle-free Glucagon Nasal Powder is as effective as the traditional injected form of glucagon in treating diabetes-related severe hypoglycemia. |
All press releases naming this drug 47 releases
Evidence & citations 28 cited values
Every value below carries the sentence it was read from. 116 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Glucagon | “Exploratory Study of Additional Use of Scopolamine Butylbromide, Glucagon or NPO-11 Following Single Dose of NPO-11 in Healthy Adult Men” NCT00740324 ↗106“Intranasal glucagon is administered at the dose of 3 mg. This corresponds to the administration of a single dose of Baqsimi®.” NCT05206149 ↗ “1 mg subcutaneous injection of G-Pen (glucagon injection) administered via auto-injector” NCT03738865 ↗ “A solution of 5 ng glucagon /Unit Lyumjev is injcetd subcutaneously” NCT06854861 ↗ “BIOD-961 is a lyophilized glucagon formulation.” NCT02403648 ↗ “native glucagon” NCT03667053 ↗ “Glucagon” NCT05500586 ↗ “glucagon” NCT02459938 ↗ |
| Known as | Baqsimi | “The main purpose of this study is to evaluate the safety and tolerability of a study drug called nasal glucagon (Baqsimi) in pediatric participants with type 1 diabetes (T1D)...” NCT04992312 ↗ |
| Known as | BC Glucagon | “BioChaperone® Glucagon (BC Glucagon) formulation 1” NCT03176524 ↗ |
| Known as | BIOD-961 | “BIOD-961 is a lyophilized glucagon formulation.” NCT02403648 ↗ |
| Known as | Dry-Mist nasal glucagon | “Dry-Mist nasal glucagon” NCT02402933 ↗ |
| Known as | G-Pen | “receive 1 mg G-Pen (glucagon injection) during one episode and 1 mg Lilly Glucagon during the other episode.” NCT02656069 ↗1“1 mg subcutaneous injection of G-Pen (glucagon injection) administered via auto-injector” NCT03738865 ↗ |
| Known as | G-Pen (glucagon injection) | “A single 0.5 mg subcutaneous (SC) injection of G-Pen (glucagon injection)” NCT03091673 ↗1“G-Pen™ (glucagon injection)” NCT02423980 ↗ |
| Known as | G-Pen Mini | “G-Pen Mini™ (glucagon injection)” NCT02660242 ↗ |
| Known as | G-Pump | “0.15 or 0.3 mg G-Pump™ (glucagon infusion) administered from OmniPod® pump” NCT02733588 ↗ |
| Known as | GlucaGen | “Glucagon (GlucaGen)” NCT02459938 ↗ |
| Known as | GlucaGen HypoKit | “Drug: GlucaGen HypoKit” NCT03667053 ↗ |
| Known as | Glucagon for Injection | “a freshly reconstituted formulation of glucagon that has poor stability in solution, Glucagon for Injection (Eli Lilly)” NCT02018627 ↗ |
| Known as | Glucagon RTU | “Glucagon RTU is a sterile subcutaneous injectable non-aqueous solution formulation supplied in a vial and administered via syringe.” NCT03770637 ↗ |
| Known as | Gvoke HypoPen | “A ready-to-use, liquid stable glucagon, administered subcutaneously by glucagon autoinjector (GAI), Gvoke HypoPen (glucagon injection; Xeris Pharmaceuticals), was evaluated for...” PMID 34620618 ↗ Oct 2021 |
| Known as | ING | “AIM: To investigate the specific effects of intranasal glucagon (ING) on plasma glucose, endogenous glucose production (EGP) and lipid concentration.” PMID 28730676 ↗ Sep 2017 |
| Known as | Lilly Glucagon | “receive 1 mg G-Pen (glucagon injection) during one episode and 1 mg Lilly Glucagon during the other episode.” NCT02656069 ↗1“Lilly glucagon 30 micrograms, subcutaneous injection” NCT02018627 ↗ |
| Known as | LY900018 | “A Study of Nasal Glucagon (LY900018) in Pediatric Participants With Type 1 Diabetes” NCT04992312 ↗ |
| Known as | MDG | “subcutaneously-given mini-dose glucagon (MDG) as an alternative to carbohydrate consumption” NCT03970772 ↗ |
| Known as | mini-dose glucagon | “mini-dose glucagon” NCT02660242 ↗ |
| Known as | Mini-glucagon | “Drug: Mini-glucagon” NCT01680653 ↗ |
| Known as | Native glucagon | “Glucagon (Native glucagon)” NCT02916251 ↗ |
| Known as | Novo Glucagon | “1 mg subcutaneous injection of Novo Glucagon (glucagon injection)” NCT03738865 ↗ |
| Known as | Xeris glucagon | “Xeris glucagon 50 micrograms, subcutaneous injection” NCT02018627 ↗ |
| Known as | XeriSol glucagon | “XeriSol glucagon is an investigational drug that is a stable, soluble liquid glucagon formulation that can be injected or administered through an insulin pump.” NCT03424044 ↗1“micro-doses of a new formulation of stable glucagon, Xerisol Glucagon (Xeris Pharmaceuticals), will be non-inferior” NCT02018627 ↗ |
| Known as | ZP-Glucagon | “Glucagon (ZP-Glucagon)” NCT02459938 ↗ |
| Action | Restore | “supplementing glucagon in the late postprandial period” PMID 15793249 ↗ Apr 2005 |
| Modality | Peptide | “synthetic glucagon peptide” NCT02937558 ↗ |
| Route | Intravenous | “glucagon IV for 24 hours” NCT00005889 ↗ |