Overview
No overview information available.
Indication
1.用于治疗接受胰岛素治疗的糖尿病患者发生的严重低血糖反应。 2.进行胃肠道检查时用于暂时抑制肠道蠕动。 3.评估糖尿病患者的胰岛β细胞的最大分泌情况。
Associated Conditions
No associated conditions information available.
Research Report
A Comprehensive Clinical and Pharmacological Review of Biosynthetic Glucagon: From Molecular Mechanisms to Modern Therapeutic Formulations
Executive Summary
Glucagon, a critical counter-regulatory hormone to insulin, serves as a life-saving intervention for severe hypoglycemia. The advent of biosynthetic glucagon, produced via recombinant DNA technology or chemical peptide synthesis, marked a significant departure from historically impure animal-derived preparations. This report provides an exhaustive analysis of biosynthetic glucagon, examining its biochemical structure, physiological function, molecular mechanism of action, and pharmacokinetic profile. A central theme is the evolution of its manufacturing, which has led to a critical regulatory and market divergence between innovator products derived from recombinant DNA and generic versions produced by chemical synthesis.
The therapeutic landscape for severe hypoglycemia has been fundamentally transformed in recent years. This transformation is characterized by a paradigm shift away from cumbersome, multi-step reconstitution emergency kits, which are prone to user error in high-stress situations, toward a new generation of stable, ready-to-use (RTU) formulations. This report details the clinical profiles of these innovative products, including the intranasal powder Baqsimi, the liquid injectable auto-injector Gvoke, and the glucagon analog dasiglucagon, Zegalogue.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2022/07/12 | Phase 2 | Withdrawn | |||
2022/05/18 | Not Applicable | Completed | |||
2021/10/13 | Not Applicable | Completed | |||
2018/09/12 | Phase 3 | Completed | |||
2017/12/20 | Phase 3 | Completed | |||
2017/07/13 | Phase 3 | Completed | |||
2017/06/05 | Phase 1 | Completed | |||
2016/01/21 | Phase 2 | Completed | |||
2008/09/03 | Phase 1 | Completed | Hospira, now a wholly owned subsidiary of Pfizer |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
Health Canada Drug Approvals
Approved Product | Company | DIN | Dosage Form | Strength | Market Date |
|---|---|---|---|---|---|
| No Health Canada approvals found for this drug. | |||||
CIMA AEMPS Drug Approvals
Approved Product | Company | Registration Number | Pharmaceutical Form | Prescription Type | Status |
|---|---|---|---|---|---|
| No CIMA AEMPS (Spain) approvals found for this drug. | |||||
Philippines FDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Philippines FDA approvals found for this drug. | |||||
Saudi SFDA Drug Approvals
Approved Product | Company | License Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Saudi SFDA approvals found for this drug. | |||||
Malaysia NPRA Drug Approvals
Approved Product | Company | Registration Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No Malaysia NPRA approvals found for this drug. | |||||
UK EMC Drug Information
Medicine Name | MA Holder | MA Number | Pharmaceutical Form | Active Ingredient | Authorization Date |
|---|---|---|---|---|---|
| No UK EMC drug information found for this drug. | |||||
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