TheraRadar
Data updated: May 26, 2026

GVOKE VIALDX (glucagon)

Metabolic Approved 2019-09-10

GVOKE VIALDX is indicated for the treatment of Severe Hypoglycemia; Diabetes.

Source: FDA Label • XERIS
Jump to: Indications Approvals Trials Competitors Similar Safety Patents
2
Indications
--
Phase 3 Trials
6
Years on Market

Details

Status
Prescription
First Approved
2019-09-10
Patent Cliff
2036

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Routes
INTRAVENOUS
Dosage Forms
SOLUTION

Companies

XERIS
Active Ingredient: GLUCAGON

GVOKE VIALDX Approval History

2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
6 FDA actions from 2019 to 2025 · 1 indication expansions
Mar 2025 SUPPL
Efficacy
FDA Letter Label
Dec 2023 SUPPL
Label · Labeling
FDA Letter Label
Aug 2021 SUPPL
Label · Labeling
FDA Letter Label

What GVOKE VIALDX Treats

2 indications

GVOKE VIALDX is approved for 2 conditions since its original approval in 2019. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Severe Hypoglycemia
  • Diabetes
Source: FDA Label

GVOKE VIALDX Competitive Set

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Three rings of competition based on shared molecular targets and treated indications.

Indication competitors

10

Same indication, different mechanism — what else might this patient receive?

KIRSTY
BIOCON BIOLOGICS
2025 1 indic.
MERILOG
SANOFI-AVENTIS U.S.
2025 1 indic.
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Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.

What's emerging in GVOKE VIALDX's indications

See all emerging drugs →

Phase 3 candidates targeting molecules with no FDA-approved drug, in indications GVOKE VIALDX treats. First-in-class if their pivotal trials read out positive.

Frexalimab SAR441344
Sanofi
CD40LG · monoclonal antibody (anti-CD40L, Fc-engineered to avoid platelet activation) · 4 Phase 3 trials

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Clinical Trial Registry

40 trials
Trial Sponsor ID Phase Status Title
NCT03139305 GIO B TRIMDFH 954476 Ph 1 active not recruiting Effect of Prolonged (72 Hour) Glucagon Administration on Energy Expenditure in Healthy Obese Subjects
NCT02817659 GIO TRIMDFH 778967 Ph 1 active not recruiting To Determine Tolerability to Glucagon Infusion in Obese Subjects
NCT06558422 AAAU9702 P30DK063608, K12DK133995 Ph 1 not yet recruiting Human Models of Selective Insulin Resistance: Pancreatic Clamp
NCT05724134 AAAU3014 3P30DK063608 Ph 1 completed Pancreatic Clamp in NAFLD
NCT07300982 SIGNAL Pro00117291 R01DK141090 Ph 1, Ph 2 not yet recruiting Studies of Insulin and Glucagon Action in the Liver
NCT06588504 NN9515-7675 U1111-1300-1855, jRCT2071240050 Ph 1 completed Research Study in Japan to Compare Dasiglucagon With Glucagon in Treating Very Low Levels of Blood Sugar in Asian Adults With Type 1 Diabetes and Testing of Dasiglucagon for the Same Condition in Japanese Adolescents
NCT03241706 2016-7982 Ph 1 active not recruiting Liver Glycogen and Hypoglycemia in Humans
NCT02078726 results posted 14-13185 Ph 4 completed Glucagon Use in Colonoscopies
NCT05960565 EU CT 2022-502455-57-01 Ph 2 terminated Glucagon Enhanced Insulin Absorption in Diabetes Mellitus Type 1
NCT03965130 results posted 0209020997_a MISP58340 Ph 1 completed The Effect of Glucagon on Rates of Hepatic Mitochondrial Oxidation in Man Assessed by PINTA
NCT06126354 AAAU7680 3P30DK063608 Ph 1 withdrawn Dexamethasone/Pancreatic Clamp P&F
NCT03255629 results posted 2016-27 1R44DK107114 Ph 1, Ph 2 completed Closed-Loop Glucagon Pump for Treatment of Post-Bariatric Hypoglycemia
NCT04053712 DHCL2019 H-19026331 2019-001631-31, 2019043528 Ph 4 completed Dual-hormone Closed-loop Glucose Control in Type 1 Diabetes
NCT04949867 DHCL2021 H-21000207 2020-005836-31, 2021-0409-34 Ph 4 completed Dual-Hormone Closed-Loop Glucose Control in Adolescents With Type 1 Diabetes
NCT02748369 16-000085 U24DK100469 Ph 1 completed In Vivo Assessment of Cellular Metabolism in Humans
NCT02910518 BEQ13941 2016-001498-34, U1111-1183-8636 Ph 1 completed A Study to Demonstrate Bioequivalence Between Insulin Glulisine U300 and Insulin Glulisine U100 After a Single Subcutaneous Dose Using the Euglycemic Clamp Technique, in Patients With Type 1 Diabetes Mellitus
NCT04347252 Pro00065698_1 R01DK101991 Ph 1 completed Glucagon Regulation of Glucose Metabolism
NCT02971228 dasiglucagon results posted ZP4207-16051 Ph 2 completed Feasibility Trial Testing the Bionic Pancreas With ZP4207
NCT03490942 results posted XSGO-AF01 Ph 2 terminated Glucagon Infusion in T1D Patients With Recurrent Severe Hypoglycemia: Effects on Counter-Regulatory Responses
NCT02937558 results posted XSGO-CH01 1R44DK105691-01 Ph 2 completed CSI-Glucagon for Prevention of Hypoglycemia in Children With Congenital Hyperinsulinism
NCT03533179 GLUCAGON Glucagon+Beta-blocker Ph 4 completed Glucagon's Cardiovascular Effects With and Without Beta-blocker-induced Cardioinhibition
NCT02778113 results posted 16424 I8R-MC-IGBD, AMG 101 Ph 1 completed A Study of Glucagon Administered in Different Forms and Routes to Healthy Adults
NCT03091673 results posted XSGP-302 Ph 3 completed Glucose Response of G-Pen (Glucagon Injection) in Pediatric T1D Patients
NCT01640834 results posted 14576 I1R-MC-GLBR, 2011-006178-19 Ph 1 completed Study of LY2409021 in Participants With Type 1 Diabetes
NCT03444467 NN9513-4290 U1111-1180-8217, 2016-001173-33 Ph 1 completed First Research Study to Compare a Possible New Medicine NNC9204-1513 to the Medicine Glucagon, in Healthy People.
NCT02237053 GLEE TRIMDFH 601205 Ph 1 completed Effects of Glucagon Administration on Energy Expenditure
NCT02490098 CLASS-13 Ph 2 withdrawn Closed-loop Control of Postprandial Glucose Levels in Children and Adults With Type 1 Diabetes
NCT02516150 results posted 2015P001323 Ph 4 completed Effect of Ethanol Intoxication on the Anti-Hypoglycemic Action of Glucagon
NCT02423980 results posted XSGP-202 Ph 2 completed G-Pen™ for Hypoglycemia Rescue in T1D Patients
NCT00823940 111497 Ph 1 completed A Phase 1 Study to Evaluate the Safety and Tolerability of GSK1362885 in Healthy Normal Subjects
NCT02798250 CLASS-Safety study - Part 2 Ph 2 completed Safety of Overestimation of a Meal Insulin Bolus in the Context of Dual-hormone Closed-loop Operation - Part 2
NCT02626936 CLASS Safety meal study Ph 2 completed Safety of Overestimation of a Meal Insulin Bolus in the Context of Dual-hormone Closed-loop Operation
NCT02367053 ZP4207-14013 Ph 1 completed Single Ascending Doses of ZP4207 Administered in HV and in T1D to Evaluate Safety, Tolerability PKs and PDs of ZP4207 Compared to a Comparator
NCT01155206 Glucagon 07-0394-A Ph 4 completed Acute Regulation of Intestinal and Hepatic Lipoprotein Production by Glucagon
NCT01674283 OVO-12-08 Ph 4 withdrawn Effect of Glucagon on Uterine Contractility at the Time of Embryo Transfer in in Vitro Fertilization
NCT01300260 results posted 11371 H9X-MC-GBCI Ph 1 completed Effect of LY2189265 on Insulin Secretion in Response to Intravenous Glucose
NCT01916265 PCDiab01 Ph 1 completed Trial to Compare the Relative Pharmacodynamic Properties of Different Glucagon Dosages
NCT01828125 Mini-doses glucagon Ph 2 withdrawn Efficacy of Small Subcutaneous Glucagon Dose to Treat Hypoglycemia in Adults With Type 1 Diabetes
NCT00797823 results posted IRB4311 Ph 2 completed Sensor-Augmented Insulin Delivery: Insulin Plus Glucagon Versus Insulin Alone
NCT00817271 D1020C00018 Ph 1 completed To Evaluate the Response to Glucagon During Hypoglycemia
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Active Pipeline

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

GVOKE VIALDX FDA Label Details

Indications & Usage

FDA Label (PDF)

GVOKE VIALDX is indicated for the treatment of Severe Hypoglycemia; Diabetes.

View full patent landscape →
2 OB patents · 2 families · 45 international docs across 19 countries

GVOKE VIALDX Patents & Exclusivity

Latest Patent: Apr 2036

Patents (2 active)

US9649364 Expires Apr 22, 2036
US11590205 Expires Apr 22, 2036
Source: FDA Orange Book

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Revenue Insights

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Patent Timeline

  • • Cliff: 2036
  • • 9 active patents

Trial Analysis

  • • Clinical trial tracking
  • • Development stage analysis

Competitive Landscape

  • • 20 similar drugs
  • • Same target/indication analysis
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Data Sources

FDA Approval: NDA212097 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.