BAQSIMI (glucagon)
BAQSIMI treats severe hypoglycemia in adults and children aged one year and older who have diabetes. It is used for emergency situations where blood sugar levels have dropped to dangerously low levels. This medication helps patients with diabetes quickly raise their blood glucose concentration during these critical episodes.
How BAQSIMI Works
BAQSIMI works by activating glucagon receptors in the liver, which stimulates the breakdown of stored glycogen. This process triggers the release of glucose into the bloodstream to increase blood sugar levels. The medication requires the patient to have existing hepatic glycogen stores to produce this effect.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2019-07-24
- Patent Cliff
- 2039
- Routes
- NASAL
- Dosage Forms
- POWDER
BAQSIMI Approval History
What BAQSIMI Treats
2 indicationsBAQSIMI is approved for 2 conditions since its original approval in 2019. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Hypoglycemia
- Diabetes
BAQSIMI Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Direct competitors
Same target(s) AND same indication — head-to-head.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
What's emerging in BAQSIMI's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications BAQSIMI treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to BAQSIMI
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
40 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT03139305 GIO B | TRIMDFH 954476 | Ph 1 | active not recruiting | Effect of Prolonged (72 Hour) Glucagon Administration on Energy Expenditure in Healthy Obese Subjects |
| NCT02817659 GIO | TRIMDFH 778967 | Ph 1 | active not recruiting | To Determine Tolerability to Glucagon Infusion in Obese Subjects |
| NCT06558422 | AAAU9702 P30DK063608, K12DK133995 | Ph 1 | not yet recruiting | Human Models of Selective Insulin Resistance: Pancreatic Clamp |
| NCT05724134 | AAAU3014 3P30DK063608 | Ph 1 | completed | Pancreatic Clamp in NAFLD |
| NCT07300982 SIGNAL | Pro00117291 R01DK141090 | Ph 1, Ph 2 | not yet recruiting | Studies of Insulin and Glucagon Action in the Liver |
| NCT06588504 | NN9515-7675 U1111-1300-1855, jRCT2071240050 | Ph 1 | completed | Research Study in Japan to Compare Dasiglucagon With Glucagon in Treating Very Low Levels of Blood Sugar in Asian Adults With Type 1 Diabetes and Testing of Dasiglucagon for the Same Condition in Japanese Adolescents |
| NCT03241706 | 2016-7982 | Ph 1 | active not recruiting | Liver Glycogen and Hypoglycemia in Humans |
| NCT02078726 results posted | 14-13185 | Ph 4 | completed | Glucagon Use in Colonoscopies |
| NCT05960565 | EU CT 2022-502455-57-01 | Ph 2 | terminated | Glucagon Enhanced Insulin Absorption in Diabetes Mellitus Type 1 |
| NCT03965130 results posted | 0209020997_a MISP58340 | Ph 1 | completed | The Effect of Glucagon on Rates of Hepatic Mitochondrial Oxidation in Man Assessed by PINTA |
| NCT06126354 | AAAU7680 3P30DK063608 | Ph 1 | withdrawn | Dexamethasone/Pancreatic Clamp P&F |
| NCT03255629 results posted | 2016-27 1R44DK107114 | Ph 1, Ph 2 | completed | Closed-Loop Glucagon Pump for Treatment of Post-Bariatric Hypoglycemia |
| NCT04053712 DHCL2019 | H-19026331 2019-001631-31, 2019043528 | Ph 4 | completed | Dual-hormone Closed-loop Glucose Control in Type 1 Diabetes |
| NCT04949867 DHCL2021 | H-21000207 2020-005836-31, 2021-0409-34 | Ph 4 | completed | Dual-Hormone Closed-Loop Glucose Control in Adolescents With Type 1 Diabetes |
| NCT02748369 | 16-000085 U24DK100469 | Ph 1 | completed | In Vivo Assessment of Cellular Metabolism in Humans |
| NCT02910518 | BEQ13941 2016-001498-34, U1111-1183-8636 | Ph 1 | completed | 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 |
| NCT04347252 | Pro00065698_1 R01DK101991 | Ph 1 | completed | Glucagon Regulation of Glucose Metabolism |
| NCT02971228 dasiglucagon results posted | ZP4207-16051 | Ph 2 | completed | Feasibility Trial Testing the Bionic Pancreas With ZP4207 |
| NCT03490942 results posted | XSGO-AF01 | Ph 2 | terminated | Glucagon Infusion in T1D Patients With Recurrent Severe Hypoglycemia: Effects on Counter-Regulatory Responses |
| NCT02937558 results posted | XSGO-CH01 1R44DK105691-01 | Ph 2 | completed | CSI-Glucagon for Prevention of Hypoglycemia in Children With Congenital Hyperinsulinism |
| NCT03533179 GLUCAGON | Glucagon+Beta-blocker | Ph 4 | completed | Glucagon's Cardiovascular Effects With and Without Beta-blocker-induced Cardioinhibition |
| NCT02778113 results posted | 16424 I8R-MC-IGBD, AMG 101 | Ph 1 | completed | A Study of Glucagon Administered in Different Forms and Routes to Healthy Adults |
| NCT03091673 results posted | XSGP-302 | Ph 3 | completed | Glucose Response of G-Pen (Glucagon Injection) in Pediatric T1D Patients |
| NCT01640834 results posted | 14576 I1R-MC-GLBR, 2011-006178-19 | Ph 1 | completed | Study of LY2409021 in Participants With Type 1 Diabetes |
| NCT03444467 | NN9513-4290 U1111-1180-8217, 2016-001173-33 | Ph 1 | completed | First Research Study to Compare a Possible New Medicine NNC9204-1513 to the Medicine Glucagon, in Healthy People. |
| NCT02237053 GLEE | TRIMDFH 601205 | Ph 1 | completed | Effects of Glucagon Administration on Energy Expenditure |
| NCT02490098 | CLASS-13 | Ph 2 | withdrawn | Closed-loop Control of Postprandial Glucose Levels in Children and Adults With Type 1 Diabetes |
| NCT02516150 results posted | 2015P001323 | Ph 4 | completed | Effect of Ethanol Intoxication on the Anti-Hypoglycemic Action of Glucagon |
| NCT02423980 results posted | XSGP-202 | Ph 2 | completed | G-Pen™ for Hypoglycemia Rescue in T1D Patients |
| NCT00823940 | 111497 | Ph 1 | completed | A Phase 1 Study to Evaluate the Safety and Tolerability of GSK1362885 in Healthy Normal Subjects |
| NCT02798250 | CLASS-Safety study - Part 2 | Ph 2 | completed | Safety of Overestimation of a Meal Insulin Bolus in the Context of Dual-hormone Closed-loop Operation - Part 2 |
| NCT02626936 | CLASS Safety meal study | Ph 2 | completed | Safety of Overestimation of a Meal Insulin Bolus in the Context of Dual-hormone Closed-loop Operation |
| NCT02367053 | ZP4207-14013 | Ph 1 | completed | Single Ascending Doses of ZP4207 Administered in HV and in T1D to Evaluate Safety, Tolerability PKs and PDs of ZP4207 Compared to a Comparator |
| NCT01155206 Glucagon | 07-0394-A | Ph 4 | completed | Acute Regulation of Intestinal and Hepatic Lipoprotein Production by Glucagon |
| NCT01674283 | OVO-12-08 | Ph 4 | withdrawn | Effect of Glucagon on Uterine Contractility at the Time of Embryo Transfer in in Vitro Fertilization |
| NCT01300260 results posted | 11371 H9X-MC-GBCI | Ph 1 | completed | Effect of LY2189265 on Insulin Secretion in Response to Intravenous Glucose |
| NCT01916265 | PCDiab01 | Ph 1 | completed | Trial to Compare the Relative Pharmacodynamic Properties of Different Glucagon Dosages |
| NCT01828125 | Mini-doses glucagon | Ph 2 | withdrawn | Efficacy of Small Subcutaneous Glucagon Dose to Treat Hypoglycemia in Adults With Type 1 Diabetes |
| NCT00797823 results posted | IRB4311 | Ph 2 | completed | Sensor-Augmented Insulin Delivery: Insulin Plus Glucagon Versus Insulin Alone |
| NCT00817271 | D1020C00018 | Ph 1 | completed | To Evaluate the Response to Glucagon During Hypoglycemia |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
BAQSIMI FDA Label Details
Indications & Usage
FDA Label (PDF)BAQSIMI is indicated for the treatment of Hypoglycemia; Diabetes.
BAQSIMI Patents & Exclusivity
Patents (3 active)
Exclusivity
Pro Intelligence Preview
Deep insights for BAQSIMI
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2039
- • 3 active patents
Trial Analysis
- • 41 total trials
- • Stage: Declining
Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment