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GlucaGen® HypoKit®
GlucaGen® HypoKit® is a Glucagon receptor agonist Small molecule drug developed by Adocia. It is currently in Phase 3 development for Severe hypoglycemia in patients with diabetes.
GlucaGen HypoKit is a glucagon formulation designed to rapidly raise blood glucose levels in patients experiencing severe hypoglycemia.
GlucaGen HypoKit is a glucagon formulation designed to rapidly raise blood glucose levels in patients experiencing severe hypoglycemia. 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).
| 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 | GlucaGen® HypoKit® |
|---|---|
| Sponsor | Adocia |
| Drug class | Glucagon receptor agonist |
| Target | Glucagon receptor (GCGR) |
| Modality | Small molecule |
| Therapeutic area | Endocrinology / Diabetes |
| Phase | Phase 3 |
Mechanism of action
Glucagon is a hormone that binds to glucagon receptors on hepatic cells, stimulating glycogenolysis and gluconeogenesis to increase blood glucose concentration. The HypoKit formulation aims to provide a ready-to-use, user-friendly delivery system for emergency glucagon administration in hypoglycemic episodes, particularly in diabetes patients.
Approved indications
- Severe hypoglycemia in patients with diabetes
Common side effects
- Nausea
- Vomiting
- Headache
- Hyperglycemia (rebound)
Key clinical trials
- 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 (PHASE1)
- Trial to Confirm the Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in T1DM Children (PHASE3)
- A Trial to Confirm the Efficacy and Safety of Dasiglucagon in the Treatment of Hypoglycemia in Type 1 Diabetes Subjects (PHASE3)
- A Trial to Evaluate the Immunogenicity of Dasiglucagon and GlucaGen in Patients With Type 1 Diabetes Mellitus (PHASE3)
- G-Pen Compared to Glucagen Hypokit for Severe Hypoglycemia Rescue in Adults With Type 1 Diabetes (PHASE3)
- Evaluate the Immunogenicity of a Novel Glucagon Formulation (PHASE3)
- A Trial to Investigate the Safety and the Pharmacokinetic, Pharmacodynamic Characteristics of Two BioChaperone® Glucagon Formulations Compared to Marketed GlucaGen® in Subjects With T1DM (PHASE1)
- A Study to Evaluate Safety, Pharmacokinetics, and Pharmacodynamics of a Single Dose of SAR438544 in Comparison to Glucagon in Type 1 Diabetes Mellitus Patients Under Induced Hypoglycemia (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:
- GlucaGen® HypoKit® CI brief — competitive landscape report
- GlucaGen® HypoKit® updates RSS · CI watch RSS
- Adocia portfolio CI
Frequently asked questions about GlucaGen® HypoKit®
What is GlucaGen® HypoKit®?
How does GlucaGen® HypoKit® work?
What is GlucaGen® HypoKit® used for?
Who makes GlucaGen® HypoKit®?
What drug class is GlucaGen® HypoKit® in?
What development phase is GlucaGen® HypoKit® in?
What are the side effects of GlucaGen® HypoKit®?
What does GlucaGen® HypoKit® target?
Related
- Drug class: All Glucagon receptor agonist drugs
- Target: All drugs targeting Glucagon receptor (GCGR)
- Manufacturer: Adocia — full pipeline
- Therapeutic area: All drugs in Endocrinology / Diabetes
- Indication: Drugs for Severe hypoglycemia in patients with diabetes
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing