Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
G-Pen · 4 trials · 5 indications
Number of subjects with an increase in plasma glucose concentration from below 54 mg/dL (3 mmol/L) to greater than 70 mg/dL (3.89 mmol/L) or an increase in plasma glucose concentration \> 20 mg/dL (\> 1.11 mmol/L) within 30 minutes after administration of glucagon
Increase in plasma glucose concentration from below 50.0 mg/dL to greater than 70.0 mg/dL within 30 minutes after receiving glucagon
Number of subjects with an increase in plasma glucose concentration from below 50 mg/dL to greater than 70 mg/dL within 30 minutes after administration of glucagon
Number of subjects with an increase in plasma glucose concentration from below 50 mg/dL to greater than 70 mg/dL within 30 minutes after administration of glucagon
Number of subjects with either an increase in plasma glucose concentration from below 50 mg/dL to greater than 70 mg/dL or an increase in from baseline in plasma glucose concentration of at least 20 mg/dL within 30 minutes after administration of glucagon
Number of serious adverse events (SAEs) per treatment group
| Arm | Type | Description |
|---|---|---|
| G-Pen followed by Novo Glucagon | EXPERIMENTAL | 1 mg G-Pen at the first treatment visit followed by 1 mg Novo Glucagon at the second treatment visit |
| Novo Glucagon followed by G-Pen | ACTIVE_COMPARATOR | 1 mg Novo Glucagon at the first treatment visit followed by 1 mg G-Pen at the second treatment visit |
| G-Pen followed by Lilly Glucagon | OTHER | 1 mg G-Pen at the first treatment visit followed by 1 mg Lilly Glucagon at the second treatment visit |
| Lilly Glucagon followed by G-Pen | OTHER | 1 mg Lilly Glucagon at the first treatment visit followed by 1 mg G-Pen at the second treatment visit |
| G-Pen first, then Lilly Glucagon | OTHER | A single 1 mg subcutaneous (SC) injection of G-Pen (glucagon injection) with a 7-28 day wash-out, followed by a single 1 mg SC injection of Lilly Glucagon (glucagon injection \[rDNA origin\]) |
| Lilly Glucagon first, then G-Pen | OTHER | A single 1 mg SC injection of Lilly Glucagon (glucagon injection \[rDNA origin\]) with a 7-28 day wash-out, followed by a single 1 mg SC injection of G-Pen (glucagon injection) |
| G-Pen(TM) 1 mg | EXPERIMENTAL | G-Pen(TM) (glucagon injection), single 1 mg subcutaneous (SC) injection |
| G-Pen(TM) 0.5 mg | EXPERIMENTAL | G-Pen(TM) (glucagon injection), single 0.5 mg SC injection |
| Lilly Glucagon(TM) 1 mg | ACTIVE_COMPARATOR | Lilly Glucagon(TM) \[glucagon for injection (rDNA origin)\], single 1 mg SC injection |
| Name | Type | Description |
|---|---|---|
| G-Pen | DRUG | 1 mg subcutaneous injection of G-Pen (glucagon injection) administered via auto-injector |
| Novo Glucagon | DRUG | 1 mg subcutaneous injection of Novo Glucagon (glucagon injection) |
| Lilly Glucagon | DRUG | 1 mg subcutaneous injection of Lilly Glucagon (glucagon injection \[RNDA Origin\]) |
| G-Pen (glucagon injection) | DRUG | 1 mg of pre-mixed liquid Xeris glucagon delivered via auto-injector |
| Lilly Glucagon (glucagon injection [rDNA origin]) | DRUG | 1 mg of Lilly glucagon reconstituted from lyophilized powder |
| G-Pen(TM) 1 mg | DRUG | - |
| Lilly Glucagon(TM) 1 mg | DRUG | - |
| G-Pen(TM) 0.5 mg | DRUG | - |
Inclusion Criteria: 1. Males and non-pregnant females diagnosed with type 1 diabetes (T1D) for at least 24 months. 2. Current usage of daily insulin treatment that includes having an assigned "correction factor" for managing hyperglycemia. 3. Age 18 to 75 years, inclusive. 4. Random serum C-peptide...
G-Pen is an investigational glucagon injection being developed for the treatment of severe hypoglycemia, including insulin-induced hypoglycemia, in adults with type 1 diabetes. It is designed to rescue patients from dangerously low blood sugar episodes. G-Pen is a small molecule therapeutic in the metabolic area and is currently in Phase 3 clinical development.
G-Pen is being developed by Xeris Biopharma Holdings, Inc., a biopharmaceutical company traded on NASDAQ under the ticker symbol XERS. The company is conducting clinical trials to evaluate G-Pen for the rescue treatment of severe hypoglycemia in adults with type 1 diabetes.
G-Pen is in Phase 3 clinical development. It has completed multiple Phase 3 trials, including studies comparing it to Lilly Glucagon and Glucagen Hypokit for hypoglycemia rescue in adults with type 1 diabetes. G-Pen is not yet approved by the FDA and remains an investigational drug.
G-Pen has completed several clinical trials, including NCT02656069 and NCT03439072, which compared G-Pen to Lilly Glucagon for hypoglycemia rescue in adults with type 1 diabetes. Another completed trial, NCT03738865, compared G-Pen to Glucagen Hypokit for severe hypoglycemia rescue. An earlier Phase 2 trial, NCT01972152, studied its safety and pharmacokinetics.
G-Pen is a glucagon injection, meaning it delivers the hormone glucagon to raise blood glucose levels. Glucagon counteracts the effects of insulin by stimulating the liver to release stored glucose into the bloodstream, which helps correct severe hypoglycemia. This mechanism is critical for emergency rescue from insulin-induced low blood sugar.
G-Pen is a glucagon injection product, but it is not the same as other marketed glucagon products. It is being developed by Xeris Biopharma as an investigational formulation of glucagon for severe hypoglycemia rescue. Clinical trials have compared G-Pen directly to Lilly Glucagon and Glucagen Hypokit.