CLINICAL TRIALS PROFILE FOR DASIGLUCAGON HYDROCHLORIDE

All Clinical Trials for DASIGLUCAGON HYDROCHLORIDE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT03216226 ↗	A Trial to Evaluate the Immunogenicity of Dasiglucagon and GlucaGen in Patients With Type 1 Diabetes Mellitus	Completed	SynteractHCR	Phase 3	2017-06-28	The trial's objective is to evaluate the immunogenicity of repeated single doses of dasiglucagon* and GlucaGen following subcutaneous (SC) administration in patients with type 1 diabetes mellitus (T1DM) and further to evaluate the safety and tolerability of dasiglucagon and GlucaGen. *dasiglucagon is the proposed International Nonproprietary Name (pINN) for ZP4207
NCT03216226 ↗	A Trial to Evaluate the Immunogenicity of Dasiglucagon and GlucaGen in Patients With Type 1 Diabetes Mellitus	Completed	Zealand Pharma	Phase 3	2017-06-28	The trial's objective is to evaluate the immunogenicity of repeated single doses of dasiglucagon* and GlucaGen following subcutaneous (SC) administration in patients with type 1 diabetes mellitus (T1DM) and further to evaluate the safety and tolerability of dasiglucagon and GlucaGen. *dasiglucagon is the proposed International Nonproprietary Name (pINN) for ZP4207
NCT02916251 ↗	ZP4207(Dasiglucagon) Administered to T1D Patients to Assess the PK and PD Compared to Marketed Glucagon	Completed	Zealand Pharma	Phase 2	2016-12-01	The trial is a single-centre, randomised, sequential, cross-over trial assessing pharmacokinetic and pharmacodynamic responses after micro-doses of ZP4207 (dasiglucagon*) administered subcutaneously to patients with type 1 diabetes mellitus under euglycaemic and hypoglycaemic conditions and compared to marketed glucagon. *dasiglucagon is the proposed International Nonproprietary Name (pINN) for ZP4207
NCT02971228 ↗	Feasibility Trial Testing the Bionic Pancreas With ZP4207	Completed	Beta Bionics, Inc.	Phase 2	2016-11-01	The purpose of this study was to determine whether the Bionic Pancreas with ZP4207 (dasiglucagon*) was feasible to improve glycemic control in adults with type 1 diabetes mellitus. *dasiglucagon is the proposed International Nonproprietary Name (pINN) for ZP4207
NCT02971228 ↗	Feasibility Trial Testing the Bionic Pancreas With ZP4207	Completed	Massachusetts General Hospital	Phase 2	2016-11-01	The purpose of this study was to determine whether the Bionic Pancreas with ZP4207 (dasiglucagon*) was feasible to improve glycemic control in adults with type 1 diabetes mellitus. *dasiglucagon is the proposed International Nonproprietary Name (pINN) for ZP4207
NCT02971228 ↗	Feasibility Trial Testing the Bionic Pancreas With ZP4207	Completed	Zealand Pharma	Phase 2	2016-11-01	The purpose of this study was to determine whether the Bionic Pancreas with ZP4207 (dasiglucagon*) was feasible to improve glycemic control in adults with type 1 diabetes mellitus. *dasiglucagon is the proposed International Nonproprietary Name (pINN) for ZP4207

Clinical Trial Conditions for DASIGLUCAGON HYDROCHLORIDE

Condition Name

Condition Name for DASIGLUCAGON HYDROCHLORIDE
Intervention	Trials
Hypoglycemia	11
Diabetes Mellitus, Type 1	6
Congenital Hyperinsulinism	3
Type 1 Diabetes	3

Condition MeSH

Condition MeSH for DASIGLUCAGON HYDROCHLORIDE
Intervention	Trials
Hypoglycemia	13
Diabetes Mellitus, Type 1	11
Diabetes Mellitus	10
Congenital Hyperinsulinism	5

Clinical Trial Locations for DASIGLUCAGON HYDROCHLORIDE

Trials by Country

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Trials by Country for DASIGLUCAGON HYDROCHLORIDE
Location	Trials
United States	21
Germany	8
Denmark	4
Israel	3
Canada	3

Trials by US State

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Trials by US State for DASIGLUCAGON HYDROCHLORIDE
Location	Trials
California	5
Texas	3
Pennsylvania	3
Colorado	3
Massachusetts	2

Clinical Trial Progress for DASIGLUCAGON HYDROCHLORIDE

Clinical Trial Phase

Clinical Trial Phase for DASIGLUCAGON HYDROCHLORIDE
Clinical Trial Phase	Trials
Phase 3	8
Phase 2/Phase 3	2
Phase 2	8

Clinical Trial Status

Clinical Trial Status for DASIGLUCAGON HYDROCHLORIDE
Clinical Trial Phase	Trials
Completed	12
Not yet recruiting	4
Recruiting	3

Clinical Trial Sponsors for DASIGLUCAGON HYDROCHLORIDE

Sponsor Name

Sponsor Name for DASIGLUCAGON HYDROCHLORIDE
Sponsor	Trials
Zealand Pharma	15
Massachusetts General Hospital	2
Steno Diabetes Center Copenhagen	2

Sponsor Type

Sponsor Type for DASIGLUCAGON HYDROCHLORIDE
Sponsor	Trials
Industry	19
Other	7

Dasiglucagon Hydrochloride: Clinical Trials Update, Market Analysis, and Projections

Introduction

Dasiglucagon hydrochloride, marketed under the brand name Zegalogue, is a glucagon analog developed by Zealand Pharma for the treatment of severe hypoglycemia in patients with diabetes and congenital hyperinsulinism (CHI). Here, we delve into the latest updates from clinical trials, market analysis, and future projections for this promising medication.

Clinical Trials Update

Severe Hypoglycemia in Diabetes

Dasiglucagon has demonstrated robust efficacy in clinical trials for treating severe hypoglycemia in patients with diabetes. In adult and pediatric phase 3 studies, dasiglucagon showed a significant increase in blood glucose levels compared to placebo. The median time to glucose recovery was 10 minutes in dasiglucagon groups, significantly faster than the 30-40 minutes observed in placebo groups[4][5].

Congenital Hyperinsulinism (CHI)

In infants with CHI, dasiglucagon has shown promising results in reducing the need for intravenous glucose to maintain euglycemia. A randomized, crossover, double-blind study followed by an open-label phase demonstrated that dasiglucagon significantly reduced the intravenous glucose infusion rate compared to placebo. This reduction highlights dasiglucagon's potential as a treatment for CHI, a condition with limited current therapeutic options[3].

Regulatory Update

The U.S. Food and Drug Administration (FDA) has been reviewing dasiglucagon under a New Drug Application (NDA) in two parts: one for dosing up to three weeks and another for use beyond three weeks. While the FDA issued a Complete Response Letter (CRL) for the initial part due to a third-party manufacturing facility reinspection, Zealand Pharma is committed to addressing these issues and submitting additional analyses from continuous glucose monitoring (CGM) datasets by the end of 2024[1].

Market Analysis

Current Market Landscape

The market for hypoglycemia treatments is dominated by native glucagon products, but dasiglucagon is poised to be the first approved glucagon analog. Its stability in aqueous solution, ease of use via autoinjector and prefilled syringe, and superior efficacy compared to traditional glucagon products position it as a significant competitor[5].

Target Market

Dasiglucagon targets patients with diabetes, particularly those with type 1 diabetes who are at high risk of severe hypoglycemia. Additionally, it addresses the unmet medical need in infants and children with CHI, a rare but severe condition. The drug's potential to reduce the need for intravenous glucose in CHI patients and its rapid action in diabetes-related hypoglycemia make it an attractive option for both patient groups[1][3].

Competitive Advantage

Dasiglucagon's key advantages include its rapid onset of action, higher glycokinetic response compared to glucagon, and longer plasma exposure. These characteristics, combined with its ease of administration, make it a more convenient and effective option for patients and caregivers[2].

Market Projections

Growth Potential

Given its superior efficacy and convenience, dasiglucagon is expected to capture a significant share of the hypoglycemia treatment market. The drug's approval and subsequent market entry are anticipated to drive growth, particularly in the diabetes management sector.

Revenue Projections

With its unique benefits and the lack of approved glucagon analogs, dasiglucagon is projected to generate substantial revenue. As it gains market acceptance and becomes a standard treatment for severe hypoglycemia, revenue is expected to increase steadily over the next few years.

Expansion into New Indications

Beyond its current indications, dasiglucagon may be explored for other conditions involving hypoglycemia or glucose regulation. This potential for expansion into new therapeutic areas further enhances its market projection and growth potential.

Safety and Efficacy

Safety Profile

Clinical trials have shown that dasiglucagon has a similar safety profile to reconstituted glucagon, with the most common side effects being nausea and vomiting. No serious adverse events or deaths were reported in the studies[2].

Efficacy Highlights

Dasiglucagon has consistently demonstrated its ability to rapidly increase blood glucose levels, with a median recovery time of 10 minutes in both adult and pediatric patients. This rapid action is crucial in preventing neuroglycopenia and other serious complications of severe hypoglycemia[4].

"Dasiglucagon demonstrated robust superiority to placebo with a median time to glucose recovery of 10 minutes across the three studies, and importantly, the drug led to recovery in all subjects, i.e., there were no non-responders."[4]

Key Takeaways

• Clinical Efficacy: Dasiglucagon has shown significant efficacy in treating severe hypoglycemia in diabetes and reducing IV glucose needs in CHI.
• Regulatory Status: The FDA is reviewing dasiglucagon under an NDA, with additional analyses pending for use beyond three weeks.
• Market Potential: Dasiglucagon is poised to capture a significant market share due to its superior efficacy, convenience, and stability.
• Safety Profile: The drug has a favorable safety profile similar to reconstituted glucagon.
• Future Projections: Expected to drive growth in the hypoglycemia treatment market and potentially expand into new indications.

FAQs

Q: What is dasiglucagon used for?

A: Dasiglucagon is used to treat severe hypoglycemia in patients with diabetes and to manage congenital hyperinsulinism (CHI) in infants and children.

Q: How does dasiglucagon compare to traditional glucagon?

A: Dasiglucagon has a higher glycokinetic response, longer plasma exposure, and a more convenient administration method compared to traditional glucagon products.

Q: What are the common side effects of dasiglucagon?

A: The most common side effects of dasiglucagon are nausea and vomiting.

Q: What is the regulatory status of dasiglucagon in the U.S.?

A: The FDA has issued a Complete Response Letter for the initial part of the NDA due to a third-party manufacturing facility reinspection, but Zealand Pharma is working to address these issues.

Q: What is the potential market impact of dasiglucagon?

A: Dasiglucagon is expected to capture a significant share of the hypoglycemia treatment market due to its superior efficacy and convenience.

Sources

1. Zealand Pharma provides U.S. regulatory update on dasiglucagon in congenital hyperinsulinism - Biospace
2. Dasiglucagon - Wikipedia
3. Dasiglucagon in Children with Congenital Hyperinsulinism up to 1 year of age - PubMed
4. 214231Orig1s000SumR.pdf - FDA
5. 214231Orig1s000MedR.pdf - FDA