Lead Product(s) : Glepaglutide
Therapeutic Area : Gastroenterology
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Zealand Pharma Submits New Drug Application to the US FDA for Glepaglutide in Short Bowel Syndrome
Details : ZP1848 (glepaglutide) is a long-acting GLP-2 analog synthetic peptide, which is currently being evaluated for the treatment of patients with short bowel syndrome.
Brand Name : ZP1848
Molecule Type : Peptide
Upfront Cash : Not Applicable
December 22, 2023
Lead Product(s) : Glepaglutide
Therapeutic Area : Gastroenterology
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Glepaglutide
Therapeutic Area : Gastroenterology
Study Phase : Phase III
Sponsor : Danske Bank A/S
Deal Size : $102.5 million
Deal Type : Private Placement
Details : The net proceeds from the offering are intended to support the Phase 3 EASE clinical program for glepaglutide (ZP1848) and potential regulatory submission for SBS, and pursue a strong strategic partner for future commercialization.
Brand Name : ZP1848
Molecule Type : Peptide
Upfront Cash : Undisclosed
October 04, 2022
Lead Product(s) : Glepaglutide
Therapeutic Area : Gastroenterology
Highest Development Status : Phase III
Sponsor : Danske Bank A/S
Deal Size : $102.5 million
Deal Type : Private Placement
Lead Product(s) : Glepaglutide
Therapeutic Area : Gastroenterology
Study Phase : Phase III
Sponsor : Danske Bank
Deal Size : Undisclosed
Deal Type : Private Placement
Zealand Pharma Announces Directed Issue And Private Placement Of Approximately 4.5M New Shares
Details : The net proceeds from the offering are intended to support the Phase 3 EASE clinical program for glepaglutide (ZP1848) and potential regulatory submission for SBS, and pursue a strong strategic partner for future commercialization.
Brand Name : ZP1848
Molecule Type : Peptide
Upfront Cash : Undisclosed
October 04, 2022
Lead Product(s) : Glepaglutide
Therapeutic Area : Gastroenterology
Highest Development Status : Phase III
Sponsor : Danske Bank
Deal Size : Undisclosed
Deal Type : Private Placement
Lead Product(s) : Glepaglutide
Therapeutic Area : Gastroenterology
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : Phase 3 trial (EASE-SBS 1) enrollment completed for ZP1848 (glepaglutide), a long-acting GLP-2 analog in development as a potential treatment option for short bowel syndrome. Full trial results of EASE-SBS 1 expected in the third quarter of 2022.
Brand Name : ZP1848
Molecule Type : Peptide
Upfront Cash : Not Applicable
January 20, 2022
Lead Product(s) : Glepaglutide
Therapeutic Area : Gastroenterology
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Lead Product(s) : Glepaglutide
Therapeutic Area : Gastroenterology
Study Phase : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
Details : The pivotal trial is a randomized, double-blind and placebo-controlled study, with both once- and twice-weekly dosing regimens. The U.S. Food and Drug Administration (FDA) has granted orphan drug designation for glepaglutide for the treatment of SBS.
Brand Name : ZP1848
Molecule Type : Peptide
Upfront Cash : Not Applicable
June 29, 2021
Lead Product(s) : Glepaglutide
Therapeutic Area : Gastroenterology
Highest Development Status : Phase III
Sponsor : Not Applicable
Deal Size : Not Applicable
Deal Type : Not Applicable
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