Is glucagon FDA-approved, and what does the research show?

What is glucagon?

Glucagon is a hormone made in the pancreas, and the medicine called glucagon is a man-made copy of it ¹, ². The copy is a single chain of 29 amino acids, the units a protein is built from, and it is identical to the human hormone ¹, ². Gvoke's glucagon is made by chemical synthesis; GlucaGen's is made in yeast by recombinant DNA ¹, ⁵.

The labels call it an antihypoglycemic agent, a medicine that raises blood sugar ¹, ². Where insulin lowers blood sugar, glucagon raises it; its approved use is in people with diabetes ¹, ². The GlucaGen label also calls it a gastrointestinal motility inhibitor, a medicine that briefly stills the gut ⁵.

Is glucagon FDA-approved?

Yes. Glucagon is approved by FDA as a prescription medicine, and the current labels record an initial U.S. approval in 1960 ³, ⁴, ⁵.

Several products carry it today. Drugs@FDA lists Gvoke, an injection under the skin from Xeris, under new drug application, NDA, 212097, approved September 10, 2019 ⁶. It lists Baqsimi, a nasal powder now held by Amphastar, under NDA 210134, approved July 24, 2019 ⁷. Both hold marketing status "Prescription" there as of November 6, 2026, when the data were last updated ⁶, ⁷.

The labels approve glucagon "for the treatment of severe hypoglycemia" in people with diabetes ³, ⁴. Gvoke covers "adult and pediatric patients aged 2 years and older," and Baqsimi, since a supplement approved in March 2025, those "aged 1 year and older" ³, ⁴, ⁷. Severe hypoglycemia is blood sugar so low that the person "requires the help of others to recover" ¹, ².

A second use is diagnostic. GlucaGen, Gvoke VialDx and generic glucagon for injection are approved "as a diagnostic aid for use during radiologic examinations to temporarily inhibit movement of the gastrointestinal tract in adult patients" ⁵, ³, ⁹. Drugs@FDA lists GlucaGen and Gvoke VialDx as discontinued, GlucaGen with FDA's note that it was not discontinued for safety or effectiveness reasons ¹⁰, ⁶.

Some older forms have left the market. Novo Nordisk's GlucaGen HypoKit, a vial-and-syringe kit under an application FDA approved in 1998, was discontinued in the United States on July 1, 2024 ¹¹, ¹⁰. The maker's notice gave the reason as a shortfall of prefilled syringes from a vendor ¹¹. Generic glucagon injection kits from Amphastar, Mylan, Lupin and Cipla, and Fresenius Kabi's glucagon for injection, stay listed as "Prescription" ⁸.

No label lists a use for weight, muscle, energy or aging; glucagon is a rescue and diagnostic medicine, not a wellness, weight or performance peptide ³, ⁴, ⁵. It reaches a patient by a licensed clinician's prescription ¹, ².

See the FDA status of every peptide, updated weekly.

How does glucagon work?

Glucagon raises blood sugar by switching on glucagon receptors, the docking sites on liver cells that answer to the hormone ¹, ². The liver stores sugar as glycogen, and the receptor signal breaks glycogen down and releases glucose into the blood ¹, ². The labels add that "hepatic stores of glycogen are necessary for glucagon to produce an antihypoglycemic effect" ¹, ². Outside the liver, glucagon relaxes the smooth muscle of the stomach, duodenum, small bowel and colon, which is why radiologists use it to still the gut ⁵. That is the labels' account of an approved drug ¹, ², ⁵.

The same receptor is one target of several newer drugs in trials for obesity and related conditions. Survodutide, retatrutide and mazdutide each act on the glucagon receptor as well as the GLP-1 (glucagon-like peptide-1) receptor, the target of semaglutide, by their ClinicalTrials.gov entries ¹², ¹³, ¹⁴. A result from one of them is not a result for glucagon ¹², ¹³, ¹⁴.

What does the research show?

Glucagon sits on the top step of the evidence scale, FDA approval, and the label trials ran in people with diabetes ¹, ². The adult trials gave insulin to lower blood sugar under supervision, then tested whether the product raised it as well as injected glucagon ¹⁵, ¹, ². Success meant blood sugar back above 70 mg/dL, or up by 20 mg/dL or more, at or within 30 minutes ¹, ².

Studied in people for Gvoke: two randomized, blinded crossover trials in 80 and 81 adults aged 18 to 74 with type 1 diabetes ¹. In a crossover trial each person has both treatments, on separate days ¹. Pooled, 98.7 percent reached success on Gvoke against 100 percent on the glucagon kit, within the margin the trials set for showing it no worse than the kit, called non-inferiority ¹. The mean time to success was 13.8 minutes on Gvoke and 10 minutes on the kit ¹.

Studied in children for Gvoke: a single-arm study, with no comparison group, followed 31 children aged 2 to under 18 with type 1 diabetes ¹. All 30 who could be evaluated reached a rise of at least 25 mg/dL ¹.

Studied in people for Baqsimi: two randomized, open-label crossover trials, with no blinding, compared the nasal powder with injected glucagon in adults ². In the first, 70 adults with type 1 diabetes enrolled, and all 66 evaluated reached success on both ². In the second, 83 adults enrolled, 77 with type 1 and 6 with type 2 diabetes ². Of the 80 evaluated, 98.8 percent (79) reached success on Baqsimi against 100 percent on the injection ². Mean time to success was 11.6 against 9.9 minutes in the first trial and 15.9 against 12.1 in the second ².

Studied in children for Baqsimi: in 48 children aged 4 to under 17 with type 1 diabetes, every child in both arms reached a 20 mg/dL rise within 20 minutes ². A later open-label study gave the nasal powder to seven children aged 1 to under 4 ⁴. All seven had a rise of at least 20 mg/dL from a normal starting glucose within 30 minutes ⁴.

An earlier published trial tested the nasal powder. Rickels and colleagues, published online December 17, 2015, in Diabetes Care, ran a randomized crossover noninferiority trial at eight centers in 75 adults with type 1 diabetes ¹⁵. Success came at all but one nasal visit and at every injection visit, 98.7 against 100 percent ¹⁵. Mean time to success was 16 minutes with the nasal powder against 13 with the injection ¹⁵. The authors wrote that the trial ran in a controlled setting but held the results applicable to real-world severe hypoglycemia ¹⁵.

Among this page's sources, no trial tested glucagon for weight, body composition or performance as of November 10, 2026 ¹⁵, ¹, ², ⁴. All of the treatment trials above enrolled people with diabetes ¹⁵, ¹, ², ⁴.

What are the side effects?

Nausea and vomiting lead. In the two Gvoke adult trials, 154 adults with type 1 diabetes received the injection ¹. Within 12 hours, 30 percent reported nausea, 16 percent vomiting, 7 percent raised swelling at the injection site and 5 percent headache ¹. Among the 31 children, 45 percent had nausea, 39 percent low blood sugar, 19 percent vomiting and 7 percent headache ¹. The label adds that "hypertension and tachycardia have occurred with glucagon treatment" ¹.

Baqsimi adds nose and eye effects. Pooled from its two adult trials, 153 adults took it; 26.1 percent had nausea, 18.3 percent headache, 15.0 percent vomiting and 12.4 percent upper respiratory tract irritation ². On a questionnaire, 58.8 percent reported more watery eyes, 42.5 percent nasal congestion, 39.2 percent nasal itching and 34.6 percent a runny nose ². Among 36 children on Baqsimi, 30.6 percent vomited, 25.0 percent had a headache and 16.7 percent had nausea ². Three of 124 patients across three trials formed antibodies to the drug, none of the kind that blocks the drug ².

The labels contraindicate glucagon in people with pheochromocytoma, a tumor of the adrenal gland, "because of the risk of substantial increase in blood pressure" ³, ⁵. They contraindicate it in insulinoma, a tumor of the pancreas, "because of the risk of hypoglycemia" ³, ⁵. They also contraindicate it after a prior hypersensitivity reaction to glucagon or its excipients, its inactive ingredients ³. The label says "serious hypersensitivity reactions have been reported with glucagon and include anaphylactic shock with breathing difficulties and hypotension" ³.

For the diagnostic use, glucagonoma, a glucagon-producing tumor, is a fourth contraindication ³, ⁵. The labels warn that glucagon "is effective in treating hypoglycemia only if sufficient hepatic glycogen is present" ¹, ². People "in states of starvation, with adrenal insufficiency or chronic hypoglycemia" may not respond and "should be treated with glucose" ¹, ².

A skin rash, necrolytic migratory erythema, has been reported after continuous glucagon infusion, a use these products are not approved for ¹, ³. People on beta-blockers "may have a transient increase in pulse and blood pressure" ¹, ². With indomethacin, glucagon "may lose its ability to raise blood glucose or may even produce hypoglycemia," and it "may increase the anticoagulant effect of warfarin" ¹, ². Post-marketing, the GlucaGen label lists injection-site reactions, dizziness, weakness, pallor, diarrhea, drowsiness, decreased blood pressure and "hypoglycemia and hypoglycemic coma" ⁵.

In sport

WADA's 2026 Prohibited List does not name glucagon, Gvoke, Baqsimi or GlucaGen ¹⁶. The World Anti-Doping Agency, WADA, puts "insulins and insulin-mimetics" in section S4.4.2 among hormone and metabolic modulators, but glucagon appears nowhere on the list ¹⁶.

What JumpstartMD offers

JumpstartMD does not prescribe glucagon. Our peptide library covers it so you have the facts on its FDA status and the evidence, current as of November 10, 2026.

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Compounded medications are not FDA-approved, and FDA does not review their safety, effectiveness, or quality before they are marketed. A licensed clinician decides after an evaluation whether a peptide is appropriate for you, and not every patient will qualify.