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Intramuscular Glucagon
Intramuscular Glucagon 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. Also known as: GlucaGen HypoKit, 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.
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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.
| 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 | Intramuscular Glucagon |
|---|---|
| Also known as | GlucaGen HypoKit, GlucaGen® |
| Sponsor | Eli Lilly and Company |
| Drug class | Glucagon receptor agonist |
| Target | GCGR (glucagon receptor) |
| Modality | Small molecule |
| Therapeutic area | Endocrinology / Diabetes |
| Phase | Phase 3 |
Mechanism of action
Glucagon is a peptide hormone that activates glucagon receptors (GCGRs) on hepatocytes, triggering intracellular signaling cascades that promote the breakdown of stored glycogen and synthesis of new glucose. This mechanism is used acutely to reverse severe hypoglycemia by rapidly mobilizing endogenous glucose production. Intramuscular administration provides a non-intravenous route for emergency treatment when oral glucose is not feasible.
Approved indications
- Severe hypoglycemia in patients with diabetes
Common side effects
- Nausea
- Vomiting
- Headache
- Hyperglycemia
- Injection site reactions
Key clinical trials
- A Study of Nasal Glucagon (LY900018) in Japanese Participants With Diabetes Mellitus (PHASE3)
- Efficacy and Safety of Nasal Glucagon for Treatment of Hypoglycemia in Adults (PHASE3)
- A Study of Nasal Glucagon in Participants With Type 1 Diabetes Mellitus (PHASE1)
- Evaluate the Immunogenicity of a Novel Glucagon Formulation (PHASE3)
- Study of LY2409021 in Participants With Type 1 Diabetes (PHASE1)
- Assessment of Intranasal Glucagon in Children and Adolescents With Type 1 Diabetes (PHASE2, PHASE3)
- Pharmacokinetics (PK) and Pharmacodynamics (PD) of Mayne Glucagon for Injection Compared With Glucagen® (Novo Nordisk) in Healthy Volunteers (PHASE1)
- Pharmacokinetics and Pharmacodynamics of BIOD-961 vs. Marketed Glucagons (PHASE1)
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:
- Intramuscular Glucagon CI brief — competitive landscape report
- Intramuscular Glucagon updates RSS · CI watch RSS
- Eli Lilly and Company portfolio CI
Frequently asked questions about Intramuscular Glucagon
What is Intramuscular Glucagon?
How does Intramuscular Glucagon work?
What is Intramuscular Glucagon used for?
Who makes Intramuscular Glucagon?
Is Intramuscular Glucagon also known as anything else?
What drug class is Intramuscular Glucagon in?
What development phase is Intramuscular Glucagon in?
What are the side effects of Intramuscular Glucagon?
What does Intramuscular Glucagon target?
Related
- Drug class: All Glucagon receptor agonist drugs
- Target: All drugs targeting GCGR (glucagon receptor)
- Manufacturer: Eli Lilly and Company — full pipeline
- Therapeutic area: All drugs in Endocrinology / Diabetes
- Indication: Drugs for Severe hypoglycemia in patients with diabetes
- Also known as: GlucaGen HypoKit, GlucaGen®
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing