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1. Zegalogue
1. 1544300-84-6
2. Dasiglucagon [inn]
3. Dasiglucagon [usan]
4. Dasiglucagon [who-dd]
5. Dasiglucagon [usan:inn]
6. Unii-ad4j2o47fq
7. Ad4j2o47fq
8. Zp-ga-1
9. Dtxsid501336774
10. Zp4207
11. Zp-4207
12. His-ser-gln-gly-thr-phe-thr-ser-asp-tyr-ser-lys-tyr-leu-asp-aib-ala-arg-ala-glu-glu-phe-val-lys-trp-leu-glu-ser-thr
13. L-threonine, L-histidyl-l-seryl-l-glutaminylglycyl-l-threonyl-l-phenylalanyl-l-threonyl-l-seryl-l-alpha-aspartyl-l-tyrosyl-l-seryl-l-lysyl-l-tyrosyl-l-leucyl-l-alpha-aspartyl-2-methylalanyl-l-alanyl-l-arginyl-l-alanyl-l-alpha-glutamyl-l-alpha
Molecular Weight | 3381.6 g/mol |
---|---|
Molecular Formula | C152H222N38O50 |
XLogP3 | -15.9 |
Hydrogen Bond Donor Count | 52 |
Hydrogen Bond Acceptor Count | 55 |
Rotatable Bond Count | 110 |
Exact Mass | 3380.6030550 g/mol |
Monoisotopic Mass | 3379.5997002 g/mol |
Topological Polar Surface Area | 1450 Ų |
Heavy Atom Count | 240 |
Formal Charge | 0 |
Complexity | 7900 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 30 |
Undefined Atom Stereocenter Count | 0 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
Dasiglucagon is an antihypoglycemic agent indicated for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes aged 6 years and above.
Treatment of hypoglycaemia
Dasiglucagon works to increase blood glucose levels under normal and hypoglycemic conditions. After administration of dasiglucagon in adult patients with type 1 diabetes, the mean glucose increase from baseline at 90 minutes was 168 mg/dL. In pediatric patients with type 1 diabetes aged seven to 17 years, the mean glucose increase at 60 minutes after administration of dasiglucagon was 162 mg/dL.
Absorption
Following subcutaneous administration of 0.6 mg dasiglucagon, the mean peak plasma concentration was 5110 pg/mL (1510 pmol/L). Tmax was 35 minutes. In pediatric patients with type 1 diabetes, the mean peak plasma concentration of 3920 pg/mL occurred at around 21 minutes. Dasiglucagon has a higher absorption rate than traditional reconstituted glucagon.
Volume of Distribution
The mean apparent volume of distribution ranged from 47 L to 57 L after subcutaneous administration.
Like endogenous glucagon, dasiglucagon undergoes proteolytic degradation pathways in blood, liver, and kidney.
The half-life was approximately 30 minutes following subcutaneous administration. Dasiglucagon has a longer plasma elimination half-life than traditional reconstituted glucagon.
Dasiglucagon is an analog of glucagon, which is a peptide hormone responsible for increasing blood glucose levels. It has the same mechanism of action as endogenous glucagon by acting as an agonist at glucagon receptors, which are G-coupled receptors expressed throughout the body. Dasiglucagon binds to glucagon receptors in the liver, which activates Gs and Gq, and consequently, adenylate cyclase. Adenyl cyclase increases intracellular cyclic AMP, which stimulates glycogenolysis and glucogenesis in the liver. As glucose is primarily released from liver glycogen stores, hepatic stores of glycogen are crucial for dasiglucagon to exert its antihypoglycemic effects.
Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34276
Submission : 2019-11-21
Status : Active
Type : II
Bachem Group is a public, innovation-driven company specializing in the development and manufacturing of peptides and oligonucleotides.
GDUFA
DMF Review : N/A
Rev. Date :
Pay. Date :
DMF Number : 34276
Submission : 2019-11-21
Status : Active
Type : II
Details:
Zegalogue (dasiglucagon) is a glucagon receptor agonist, peptide drug candidate, which is currently being evaluated for the treatment of hypoglycemia in pediatric patients.
Lead Product(s): Dasiglucagon
Therapeutic Area: Endocrinology Brand Name: Zegalogue
Study Phase: Phase IIIProduct Type: Hormone
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 10, 2024
Lead Product(s) : Dasiglucagon
Therapeutic Area : Endocrinology
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Zealand Updates on Dasiglucagon For Congenital Hyperinsulinism in U.S.
Details : Zegalogue (dasiglucagon) is a glucagon receptor agonist, peptide drug candidate, which is currently being evaluated for the treatment of hypoglycemia in pediatric patients.
Product Name : Zegalogue
Product Type : Hormone
Upfront Cash : Inapplicable
September 10, 2024
Details:
ZP4207 (dasiglucagon) is a glucagon receptor agonist, peptide drug candidate, which is currently being evaluated for the treatment of congenital hyperinsulinism.
Lead Product(s): Dasiglucagon
Therapeutic Area: Genetic Disease Brand Name: Zegalogue
Study Phase: Phase IIIProduct Type: Hormone
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 10, 2024
Lead Product(s) : Dasiglucagon
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
US FDA Declines to Approve Zealand's Drug for Low Blood Sugar in Infants
Details : ZP4207 (dasiglucagon) is a glucagon receptor agonist, peptide drug candidate, which is currently being evaluated for the treatment of congenital hyperinsulinism.
Product Name : Zegalogue
Product Type : Hormone
Upfront Cash : Inapplicable
August 10, 2024
Details:
Zegalogue (dasiglucagon) is a glucagon receptor agonist, peptide drug candidate, recieved positive opinioin from EMA for the treatment of severe hypoglycemia.
Lead Product(s): Dasiglucagon
Therapeutic Area: Endocrinology Brand Name: Zegalogue
Study Phase: Approved FDFProduct Type: Hormone
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable May 31, 2024
Lead Product(s) : Dasiglucagon
Therapeutic Area : Endocrinology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Zealand Pharma Gets Positive CHMP Opinion for Dasiglucagon in Severe Hypoglycemia
Details : Zegalogue (dasiglucagon) is a glucagon receptor agonist, peptide drug candidate, recieved positive opinioin from EMA for the treatment of severe hypoglycemia.
Product Name : Zegalogue
Product Type : Hormone
Upfront Cash : Inapplicable
May 31, 2024
Details:
ZP4207 (dasiglucagon) is a glucagon receptor agonist, peptide drug candidate, which is currently being evaluated for the treatment of congenital hyperinsulinism.
Lead Product(s): Dasiglucagon
Therapeutic Area: Genetic Disease Brand Name: Zegalogue
Study Phase: Phase IIIProduct Type: Hormone
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable December 21, 2023
Lead Product(s) : Dasiglucagon
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
US FDA Declines to Approve Zealand Pharma's Drug for Low Blood Sugar in Infants
Details : ZP4207 (dasiglucagon) is a glucagon receptor agonist, peptide drug candidate, which is currently being evaluated for the treatment of congenital hyperinsulinism.
Product Name : Zegalogue
Product Type : Hormone
Upfront Cash : Inapplicable
December 21, 2023
Details:
ZP4207 (dasiglucagon) is being investigated by Zealand Pharma for subcutaneous continuous infusion using a wearable pump system as a potential treatment of congenital hyperinsulinism in pediatric patients 7 days of age and older.
Lead Product(s): Dasiglucagon
Therapeutic Area: Genetic Disease Brand Name: Zegalogue
Study Phase: Phase IIIProduct Type: Hormone
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable August 30, 2023
Lead Product(s) : Dasiglucagon
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : ZP4207 (dasiglucagon) is being investigated by Zealand Pharma for subcutaneous continuous infusion using a wearable pump system as a potential treatment of congenital hyperinsulinism in pediatric patients 7 days of age and older.
Product Name : Zegalogue
Product Type : Hormone
Upfront Cash : Inapplicable
August 30, 2023
Details:
ZP4207 (dasiglucagon) subcutaneous injection is a glucagon receptor agonist and indicated for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes aged 6 years and above.
Lead Product(s): Dasiglucagon
Therapeutic Area: Genetic Disease Brand Name: Zegalogue
Study Phase: Phase II/ Phase IIIProduct Type: Hormone
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 30, 2023
Lead Product(s) : Dasiglucagon
Therapeutic Area : Genetic Disease
Highest Development Status : Phase II/ Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : ZP4207 (dasiglucagon) subcutaneous injection is a glucagon receptor agonist and indicated for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes aged 6 years and above.
Product Name : Zegalogue
Product Type : Hormone
Upfront Cash : Inapplicable
June 30, 2023
Details:
Zegalogue (dasiglucagon) subcutaneous injection is a glucagon receptor agonist and indicated for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes aged 6 years and above.
Lead Product(s): Dasiglucagon
Therapeutic Area: Endocrinology Brand Name: Zegalogue
Study Phase: Approved FDFProduct Type: Hormone
Sponsor: Novo Nordisk
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable June 26, 2023
Lead Product(s) : Dasiglucagon
Therapeutic Area : Endocrinology
Highest Development Status : Approved FDF
Partner/Sponsor/Collaborator : Novo Nordisk
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Zegalogue (dasiglucagon) subcutaneous injection is a glucagon receptor agonist and indicated for the treatment of severe hypoglycemia in pediatric and adult patients with diabetes aged 6 years and above.
Product Name : Zegalogue
Product Type : Hormone
Upfront Cash : Inapplicable
June 26, 2023
Details:
The net proceeds will be used for supporting the late stage rare disease assets, including Zegalogue (dasiglucagon), a glucagon analog that acts to increase blood sugar levels, being developed for the treatment of congenital hyperinsulinism.
Lead Product(s): Dasiglucagon
Therapeutic Area: Genetic Disease Brand Name: Zegalogue
Study Phase: Phase IIIProduct Type: Hormone
Sponsor: Danske Bank
Deal Size: $218.9 million Upfront Cash: Undisclosed
Deal Type: Private Placement March 30, 2023
Lead Product(s) : Dasiglucagon
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Danske Bank
Deal Size : $218.9 million
Deal Type : Private Placement
Details : The net proceeds will be used for supporting the late stage rare disease assets, including Zegalogue (dasiglucagon), a glucagon analog that acts to increase blood sugar levels, being developed for the treatment of congenital hyperinsulinism.
Product Name : Zegalogue
Product Type : Hormone
Upfront Cash : Undisclosed
March 30, 2023
Details:
The net proceeds will be used for supporting the late stage rare disease assets, including Zegalogue (dasiglucagon), a glucagon analog that acts to increase blood sugar levels, being developed for the treatment of congenital hyperinsulinism.
Lead Product(s): Dasiglucagon
Therapeutic Area: Nutrition and Weight Loss Brand Name: Zegalogue
Study Phase: Phase IIIProduct Type: Hormone
Sponsor: Danske Bank
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Private Placement March 30, 2023
Lead Product(s) : Dasiglucagon
Therapeutic Area : Nutrition and Weight Loss
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Danske Bank
Deal Size : Undisclosed
Deal Type : Private Placement
Details : The net proceeds will be used for supporting the late stage rare disease assets, including Zegalogue (dasiglucagon), a glucagon analog that acts to increase blood sugar levels, being developed for the treatment of congenital hyperinsulinism.
Product Name : Zegalogue
Product Type : Hormone
Upfront Cash : Undisclosed
March 30, 2023
Details:
Dasiglucagon (ZP4207) is a glucagon analog that is stable in aqueous solution and is thus suitable for administration via chronic subcutaneous infusion via pump.Phase 3 study demonstrates that dasiglucagon treatment resulted in a significant reduction in glucose infusion rate.
Lead Product(s): Dasiglucagon
Therapeutic Area: Genetic Disease Brand Name: Zegalogue
Study Phase: Phase IIIProduct Type: Hormone
Sponsor: Inapplicable
Deal Size: Inapplicable Upfront Cash: Inapplicable
Deal Type: Inapplicable September 19, 2022
Lead Product(s) : Dasiglucagon
Therapeutic Area : Genetic Disease
Highest Development Status : Phase III
Partner/Sponsor/Collaborator : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Details : Dasiglucagon (ZP4207) is a glucagon analog that is stable in aqueous solution and is thus suitable for administration via chronic subcutaneous infusion via pump.Phase 3 study demonstrates that dasiglucagon treatment resulted in a significant reduction in...
Product Name : Zegalogue
Product Type : Hormone
Upfront Cash : Inapplicable
September 19, 2022
Regulatory Info : RX
Registration Country : USA
Brand Name : ZEGALOGUE
Dosage Form : SOLUTION;SUBCUTANEOUS
Dosage Strength : EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)
Packaging :
Approval Date : 2021-03-22
Application Number : 214231
Regulatory Info : RX
Registration Country : USA
Regulatory Info : RX
Registration Country : USA
Brand Name : ZEGALOGUE (AUTOINJECTOR)
Dosage Form : SOLUTION;SUBCUTANEOUS
Dosage Strength : EQ 0.6MG BASE/0.6ML (EQ 0.6MG BASE/0.6ML)
Packaging :
Approval Date : 2021-03-22
Application Number : 214231
Regulatory Info : RX
Registration Country : USA
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PharmaCompass offers a list of Dasiglucagon API manufacturers, exporters & distributors, which can be sorted by GMP, USDMF, JDMF, KDMF, CEP (COS), WC, Price,and more, enabling you to easily find the right Dasiglucagon manufacturer or Dasiglucagon supplier for your needs.
Send us enquiries for free, and we will assist you in establishing a direct connection with your preferred Dasiglucagon manufacturer or Dasiglucagon supplier.
PharmaCompass also assists you with knowing the Dasiglucagon API Price utilized in the formulation of products. Dasiglucagon API Price is not always fixed or binding as the Dasiglucagon Price is obtained through a variety of data sources. The Dasiglucagon Price can also vary due to multiple factors, including market conditions, regulatory modifications, or negotiated pricing deals.
A Dasiglucagon manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Dasiglucagon, including repackagers and relabelers. The FDA regulates Dasiglucagon manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Dasiglucagon API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
A Dasiglucagon supplier is an individual or a company that provides Dasiglucagon active pharmaceutical ingredient (API) or Dasiglucagon finished formulations upon request. The Dasiglucagon suppliers may include Dasiglucagon API manufacturers, exporters, distributors and traders.
click here to find a list of Dasiglucagon suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Dasiglucagon DMF (Drug Master File) is a document detailing the whole manufacturing process of Dasiglucagon active pharmaceutical ingredient (API) in detail. Different forms of Dasiglucagon DMFs exist exist since differing nations have different regulations, such as Dasiglucagon USDMF, ASMF (EDMF), JDMF, CDMF, etc.
A Dasiglucagon DMF submitted to regulatory agencies in the US is known as a USDMF. Dasiglucagon USDMF includes data on Dasiglucagon's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Dasiglucagon USDMF is kept confidential to protect the manufacturer’s intellectual property.
click here to find a list of Dasiglucagon suppliers with USDMF on PharmaCompass.
Dasiglucagon Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.
GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).
PharmaCompass offers a list of Dasiglucagon GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Dasiglucagon GMP manufacturer or Dasiglucagon GMP API supplier for your needs.
A Dasiglucagon CoA (Certificate of Analysis) is a formal document that attests to Dasiglucagon's compliance with Dasiglucagon specifications and serves as a tool for batch-level quality control.
Dasiglucagon CoA mostly includes findings from lab analyses of a specific batch. For each Dasiglucagon CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.
Dasiglucagon may be tested according to a variety of international standards, such as European Pharmacopoeia (Dasiglucagon EP), Dasiglucagon JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Dasiglucagon USP).