API Suppliers
US DMFs Filed
CEP/COS Certifications
0
JDMFs Filed
0
Other Certificates
0
Other Suppliers
0
0
USA (Orange Book)
0
Europe
0
Canada
0
Australia
0
South Africa
0
Uploaded Dossiers
0
U.S. Medicaid
0
Annual Reports
0
0
USFDA Orange Book Patents
0
USFDA Exclusivities
0
Blog #PharmaFlow
0
News
EDQM
0
USP
0
JP
0
Other Listed Suppliers
0
0
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.
Lead Product(s): Glepaglutide
Therapeutic Area: Gastroenterology Product Name: ZP1848
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable December 22, 2023
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.
Lead Product(s): Glepaglutide
Therapeutic Area: Gastroenterology Product Name: ZP1848
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Danske Bank A/S
Deal Size: $102.5 million Upfront Cash: Undisclosed
Deal Type: Private Placement October 04, 2022
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.
Lead Product(s): Glepaglutide
Therapeutic Area: Gastroenterology Product Name: ZP1848
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Danske Bank
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Private Placement October 04, 2022
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.
Lead Product(s): Glepaglutide
Therapeutic Area: Gastroenterology Product Name: ZP1848
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable January 20, 2022
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.
Lead Product(s): Glepaglutide
Therapeutic Area: Gastroenterology Product Name: ZP1848
Highest Development Status: Phase IIIProduct Type: Peptide
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable June 29, 2021