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Data updated: May 26, 2026

GLUCAGON (glucagon hydrochloride)

Metabolic Approved 1960-11-14

Glucagon treats severe low blood sugar in both children and adults living with diabetes. It is also used as a diagnostic tool during radiologic imaging for adult patients. In these procedures, it helps by temporarily stopping movement in the gastrointestinal tract to allow for clearer examinations.

Source: FDA Label • QUAD PHARMS
Jump to: Indications Approvals Trials Competitors Similar Safety Patents

How GLUCAGON Works

This medication works by activating specific receptors in the liver, which triggers the breakdown of stored glycogen into glucose for release into the bloodstream. For its use in imaging, it acts on smooth muscles to relax the stomach and intestines. To effectively raise blood sugar, the patient must have adequate glycogen stores available in the liver.

Source: FDA Label
11
Indications
--
Phase 3 Trials
5
Priority Reviews
65
Years on Market

Details

Status
Discontinued
First Approved
1960-11-14
Routes
Injection, INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS, INTRAMUSCULAR, INTRAVENOUS, INJECTION
Dosage Forms
Injectable, POWDER, INJECTABLE

Companies

QUAD PHARMS Fresenius Kabi Lupin Viatris Cipla AMPHASTAR PHARMS INC Eli Lilly
Active Ingredient: GLUCAGON HYDROCHLORIDE

GLUCAGON Approval History

1961
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Original
New Indication
New Form
Label Update
98 FDA actions from 1960 to 2025 · 4 indication expansions
Sep 2025 ORIGINAL
Update
Jul 2025 SUPPL
Label · Labeling
FDA Letter Label
Jul 2025 ORIGINAL
Update

What GLUCAGON Treats

1 indications

GLUCAGON is approved for 1 conditions since its original approval in 1960. These indications span multiple therapeutic areas including oncology, immunology, and more.

  • Hypoglycemia
Source: FDA Label

GLUCAGON Competitive Set

Pro

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

Direct competitors

4

Same target(s) AND same indication — head-to-head.

ZEGALOGUE
ZEALAND PHARMA
2021 2 indic.
GVOKE KIT
XERIS
2019 1 indic.

Indication competitors

6

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

GVOKE VIALDX
XERIS
2019 2 indic.
LEVOCARNITINE SF
NOVITIUM PHARMA
2019 5 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.

Drugs Similar to GLUCAGON

3 of 9

FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.

BAQSIMI
GLUCAGON
1 shared
AMPHASTAR PHARMS INC
Shared indications:
Hypoglycemia
CARNITOR
LEVOCARNITINE
1 shared
LEADIANT BIOSCI INC
Shared indications:
Hypoglycemia
CARNITOR SF
LEVOCARNITINE
1 shared
LEADIANT BIOSCI INC
Shared indications:
Hypoglycemia
View all 9 similar drugs Pro
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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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Ongoing clinical trials by development phase

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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.

GLUCAGON FDA Label Details

Indications & Usage

FDA Label (PDF)

GLUCAGON is indicated for the treatment of Hypoglycemia.

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Data Sources

FDA Approval: ANDA071023 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

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