Last reviewed 2026-05-15 · How we verify

Glucagon Hydrochloride Solution

Eli Lilly and Company · Phase 3 active Small molecule

Glucagon Hydrochloride Solution is a Glucagon receptor agonist Small molecule drug developed by Eli Lilly and Company. It is currently in Phase 3 development for Severe hypoglycemia in patients with diabetes mellitus, Diagnostic aid in radiologic examination of the gastrointestinal tract. Also known as: GlucaGen®.

Glucagon binds to glucagon receptors on hepatic cells to stimulate glycogenolysis and gluconeogenesis, rapidly raising blood glucose levels.

Glucagon binds to glucagon receptors on hepatic cells to stimulate glycogenolysis and gluconeogenesis, rapidly raising blood glucose levels. Used for Severe hypoglycemia in patients with diabetes mellitus, Diagnostic aid in radiologic examination of the gastrointestinal tract.

Likelihood of approval

61.3% vs 58.3% industry baseline

If approved by FDA: likely 2028–2030

Steps remaining: NDA/BLA submission

Confidence: High

Why this estimate

Baseline phase 3 → approval rate +58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
Big-pharma sponsor +3.0pp
Eli Lilly and Company is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.

Predicted approval windows by jurisdiction (conditional on FDA approval)

Regulator	Country	Likely year	Lag vs FDA
FDA	US	2028–2030	—
EMA	EU	2029–2031	+0.7 yr
MHRA	GB	2029–2031	+0.7 yr
Health Canada	CA	2029–2032	+0.9 yr
TGA	AU	2029–2032	+1.2 yr
PMDA	JP	2029–2032	+1.5 yr
NMPA	CN	2030–2033	+2.3 yr
MFDS	KR	2029–2032	+1.4 yr
CDSCO	IN	2029–2033	+1.8 yr
ANVISA	BR	2030–2033	+2.3 yr

Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).

Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.

At a glance

Generic name	Glucagon Hydrochloride Solution
Also known as	GlucaGen®
Sponsor	Eli Lilly and Company
Drug class	Glucagon receptor agonist
Target	Glucagon receptor (GCGR)
Modality	Small molecule
Therapeutic area	Endocrinology
Phase	Phase 3

Mechanism of action

Glucagon is a peptide hormone that activates G-protein coupled glucagon receptors, primarily on hepatocytes. This triggers intracellular signaling cascades that promote the breakdown of stored glycogen to glucose and the synthesis of new glucose from precursors, effectively counteracting hypoglycemia. The hydrochloride salt formulation allows for parenteral administration in acute hypoglycemic emergencies.

Approved indications

Severe hypoglycemia in patients with diabetes mellitus
Diagnostic aid in radiologic examination of the gastrointestinal tract

Common side effects

Nausea
Vomiting
Hyperglycemia
Injection site reactions

Key clinical trials

Primary sources

Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.

Source	Used for
ClinicalTrials.gov	Trial enrolment, design, endpoints, results

Competitive intelligence

For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:

Glucagon Hydrochloride Solution CI brief — competitive landscape report
Glucagon Hydrochloride Solution updates RSS · CI watch RSS
Eli Lilly and Company portfolio CI

Frequently asked questions about Glucagon Hydrochloride Solution

What is Glucagon Hydrochloride Solution?

Glucagon Hydrochloride Solution is a Glucagon receptor agonist drug developed by Eli Lilly and Company, indicated for Severe hypoglycemia in patients with diabetes mellitus, Diagnostic aid in radiologic examination of the gastrointestinal tract.

How does Glucagon Hydrochloride Solution work?

Glucagon binds to glucagon receptors on hepatic cells to stimulate glycogenolysis and gluconeogenesis, rapidly raising blood glucose levels.

What is Glucagon Hydrochloride Solution used for?

Glucagon Hydrochloride Solution is indicated for Severe hypoglycemia in patients with diabetes mellitus, Diagnostic aid in radiologic examination of the gastrointestinal tract.

Who makes Glucagon Hydrochloride Solution?

Glucagon Hydrochloride Solution is developed by Eli Lilly and Company (see full Eli Lilly and Company pipeline at /company/eli-lilly).

Is Glucagon Hydrochloride Solution also known as anything else?

Glucagon Hydrochloride Solution is also known as GlucaGen®.

What drug class is Glucagon Hydrochloride Solution in?

Glucagon Hydrochloride Solution belongs to the Glucagon receptor agonist class. See all Glucagon receptor agonist drugs at /class/glucagon-receptor-agonist.

What development phase is Glucagon Hydrochloride Solution in?

Glucagon Hydrochloride Solution is in Phase 3.

What are the side effects of Glucagon Hydrochloride Solution?

Common side effects of Glucagon Hydrochloride Solution include Nausea, Vomiting, Hyperglycemia, Injection site reactions.

What does Glucagon Hydrochloride Solution target?

Glucagon Hydrochloride Solution targets Glucagon receptor (GCGR) and is a Glucagon receptor agonist.

Drug class: All Glucagon receptor agonist drugs
Target: All drugs targeting Glucagon receptor (GCGR)
Manufacturer: Eli Lilly and Company — full pipeline
Therapeutic area: All drugs in Endocrinology
Indication: Drugs for Severe hypoglycemia in patients with diabetes mellitus
Indication: Drugs for Diagnostic aid in radiologic examination of the gastrointestinal tract
Also known as: GlucaGen®

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing