Regulatory status

Status at a glance

503A compounding status

Not nominated

We found no pending nomination for the 503A bulks list. Unless the substance has another legal pathway (for example, a USP monograph or use in an FDA-approved drug), 503A pharmacies generally may not compound with it.

Status recorded · FDA source document

FDA approval
An FDA-approved product contains this peptide
503B outsourcing
Not determined
Anti-doping (WADA)
Not on the WADA Prohibited List
DEA schedule
Not a controlled substance

About peptide status

Most peptides discussed here are not FDA-approved for any use, and products labeled “research use only” are not for human use. Removal from Category 2 does not authorize compounding. PCAC votes are non-binding recommendations; FDA and HHS make the final decisions.

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Status as of

Key takeaway

Glucagon (brands include Gvoke and the nasal powder Baqsimi) is a pancreatic hormone that raises blood sugar fast, used as emergency treatment for severe low blood sugar in people with diabetes. It signals the liver to release stored glucose. Glucagon products have long been FDA-approved in the U.S., and modern forms include ready-to-use injectors and a needle-free nasal powder.

At a glance

What it is
A pancreatic peptide hormone that raises blood glucose (counter-regulatory to insulin)
Approved for
Severe hypoglycemia in diabetes; also a diagnostic aid to relax the gastrointestinal tract during imaging
Key fact
A single nasal dose raises blood glucose comparably to injected glucagon in adults with type 1 diabetes
Route
Subcutaneous, intramuscular, or intravenous injection, or nasal powder
Evidence strength
FDA approved

Summary

Glucagon is a pancreatic hormone that raises blood sugar fast. Learn its role in severe hypoglycemia, how nasal and injectable forms compare, and its status.

What is glucagon?

Glucagon is a 29-amino-acid hormone made by the pancreas that works opposite to insulin: when blood sugar drops, glucagon raises it. As a medicine it is the emergency rescue treatment for severe hypoglycemia, the dangerous low-blood-sugar episodes that can occur in people with diabetes, especially those on insulin. It is sold as the ready-to-use Gvoke injector and Baqsimi, a nasal powder, among other products. The GlucaGen HypoKit emergency kit was discontinued in the U.S. in 2024.

How does glucagon work?

Glucagon binds glucagon receptors on liver cells and switches on the pathways that release glucose. It stimulates glycogenolysis, the breakdown of stored glycogen into glucose, and gluconeogenesis, the making of new glucose, so the liver pushes glucose into the bloodstream and blood sugar rises within minutes. This is why it works as a rescue treatment when someone with hypoglycemia is unable to eat or drink.

Because the effect depends on the liver having glucose stores to release, glucagon can be less effective when those stores are depleted, such as in prolonged fasting or starvation. Glucagon also relaxes the smooth muscle of the gastrointestinal tract, which is the basis of its separate use as a diagnostic aid during certain imaging studies. In a trial in adults with type 1 diabetes, a nasal powder formulation raised blood glucose about as effectively as injected glucagon, with the practical advantage of needing no injection or mixing in an emergency.

Is it FDA-approved?

Editor’s note

Status: Yes. Glucagon is approved for severe hypoglycemia and as a diagnostic aid for gastrointestinal imaging. The table shows when each product was approved: Product | Type | FDA approval Glucagon for injection, including the recombinant GlucaGen | Injection | Approved for decades Gvoke | Newer ready-to-use injector | 2019 Baqsimi | Newer ready-to-use nasal powder | 2019

Category: FDA-approved · Primary body area: Digestive & weight

Yes. Glucagon is approved for severe hypoglycemia and as a diagnostic aid for gastrointestinal imaging. The table shows when each product was approved:

Study findings for Glucagon
Product Type FDA approval
Glucagon for injection, including the recombinant GlucaGenInjectionApproved for decades
GvokeNewer ready-to-use injector2019
BaqsimiNewer ready-to-use nasal powder2019

What is glucagon prescribed for?

Glucagon is prescribed as emergency treatment for severe hypoglycemia in people with diabetes, typically given by a caregiver when the person cannot safely take sugar by mouth. Injectable forms are also used to relax the gut during radiologic procedures. It is contraindicated in pheochromocytoma (a catecholamine-producing tumor) and in insulinoma.

What are the side effects?

According to the injectable and nasal powder labels, common side effects include:

  • Nausea and vomiting
  • Headache
  • Injection-site reactions, or nasal and eye symptoms with the nasal powder

More serious considerations include:

  • A sharp rise in blood pressure in people with pheochromocytoma
  • Low blood sugar rebound in people with insulinoma
  • Rare allergic reactions

Sources: FDA prescribing information for GlucaGen, Gvoke, and Baqsimi; a randomized trial of nasal glucagon in adults with type 1 diabetes (Rickels et al., Diabetes Care, 2016, DOI: 10.2337/dc15-1498), indexed on PubMed. This document is educational and does not constitute medical advice.

Registered human trials

0 registered human trials on ClinicalTrials.gov that we reviewed

Sources

  1. [1]

    discontinued

    Primary novomedlink.com

  2. [2]
  3. [3]

    Gvoke (PDF)

    Primary U.S. Food and Drug Administration

  4. [4]

    Baqsimi (PDF)

    Primary U.S. Food and Drug Administration

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