Drugs / Dasiglucagon
Dasiglucagon
Regulatory milestones approvals, filings & regulatory actions · 7 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed congenital isolated hyperinsulinism 3 milestones | |||||
| Rejected (CRL) | US (FDA) | — | congenital isolated hyperinsulinism | 2024-10-08 | “Complete Response Letter (CRL) for dasiglucagon in CHI for up to three weeks of dosing” zealandpharma.com ↗ |
| Rejected (CRL) | US (FDA) | — | congenital isolated hyperinsulinism | 2023-12-23 | “Complete Response Letter for dasiglucagon in congenital hyperinsulinism for up to three weeks of dosing” zealandpharma.com ↗ |
| Filed | US (FDA) | — | congenital isolated hyperinsulinism | 2023-08-17 | “Submitted new drug application (NDA) to the US Food and Drug Administration (FDA) for dasiglucagon for the treatment of congenital hyperinsulinism.” zealandpharma.com ↗ |
| Filed severe nonproliferative diabetic retinopathy 1 milestone | |||||
| Filed | EU (EMA) | — | severe nonproliferative diabetic retinopathy | 2023-08-17 | “Submitted marketing authorization application (MAA) to the European Medicines Agency (EMA) for dasiglucagon for the treatment of severe hypoglycemia in adults, adolescents and...” zealandpharma.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| Label expansion | US (FDA) | ZEGALOGUE | — | 2026-06-18 | fda.gov ↗ |
| Approved | EU (EMA) | Zegalogue | — | 2024-07-24 | europa.eu ↗ |
| Approved | US (FDA) | ZEGALOGUE | — | 2021-03-22 | fda.gov ↗ |
Trials 24
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT04192019 | Apr 2023 → Apr 2024 | hypoglycemia, type 1 diabetes mellitus | Insel Gruppe AG, University Hospital Bern | Withdrawn | No outcome recorded |
| Phase 14 trials | ||||||
| Phase 1 | NCT06588504 | Sep 2024 → Jul 2025 | type 1 diabetes mellitus | Novo Nordisk A/S | Completed | No outcome recorded |
| Phase 1 | NCT03735225 | Nov 2018 → Jun 2019 | hypoglycemia | Zealand Pharma | Completed | No outcome recorded |
| Phase 1 | NCT02390141 | Apr → Jul 2015 | hypoglycemia | Zealand Pharma | Completed | No outcome recorded |
| Phase 1 | NCT02367053 | Dec 2014 → Apr 2015 | hypoglycemia | Zealand Pharma | Completed | No outcome recorded |
| Phase 29 trials | ||||||
| Phase 2 | NCT05454709 | Dec 2023 | type 1 diabetes mellitus | Inreda Diabetic B.V. | Withdrawn | No outcome recorded |
| Phase 2 | NCT04824872 | Feb 2023 | hypoglycemia | Zealand Pharma | Withdrawn | No outcome recorded |
| Phase 2 | NCT04836273 | Aug 2021 → May 2022 | hyperinsulinemic hypoglycemia, hypoglycemia | Filip Krag Knop | Completed | No outcome recorded |
| Phase 2 | NCT04764968 | Apr → Dec 2021 | hypoglycemia, type 1 diabetes mellitus | Steno Diabetes Center Copenhagen | Completed | No outcome recorded |
| Phase 2 | NCT04449692 | Jul 2020 → Jan 2021 | hypoglycemia, type 1 diabetes mellitus | Steno Diabetes Center Copenhagen | Completed | No outcome recorded |
| Phase 2 | NCT03984370 | Sep 2019 → Feb 2020 | hyperinsulinemic hypoglycemia, hypoglycemia | University Hospital, Gentofte, Copenhagen | Completed | No outcome recorded |
| Phase 2 | NCT02916251 | Dec 2016 → Apr 2017 | type 1 diabetes mellitus | Zealand Pharma | Completed | No outcome recorded |
| Phase 2 | NCT02971228 | Nov 2016 → May 2017 | type 1 diabetes mellitus | Zealand Pharma | Completed | No outcome recorded |
| Phase 2 | NCT02660008 | Jan → Jun 2016 | hypoglycemia | Zealand Pharma | Completed | No outcome recorded |
| Phase 2/32 trials · 1 met primary | ||||||
| Phase 2/3 | NCT04172441 | Jun 2020 → Feb 2022 | congenital isolated hyperinsulinism | Zealand Pharma | Completed | Met primary |
| Phase 2/3 | NCT03840278 | May → Jul 2019 | type 1 diabetes mellitus | Massachusetts General Hospital | Completed | No outcome recorded |
| Phase 38 trials · 3 met primary · 1 missed | ||||||
| Phase 3 | NCT05378672 | May 2023 → Oct 2024 | hypoglycemia, type 1 diabetes mellitus | Zealand Pharma | Completed | No outcome recorded |
| Phase 3 | NCT03941236 | May 2019 → Jan 2025 overdue | congenital isolated hyperinsulinism | Zealand Pharma | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03895697 | Mar → Jul 2019 | hypoglycemia, type 1 diabetes mellitus | Zealand Pharma | Completed | No outcome recorded |
| Phase 3 | NCT03777176 | Feb 2019 → Aug 2020 | congenital isolated hyperinsulinism | Zealand Pharma | Completed | Missed primary |
| Phase 3 | NCT03688711 | Nov 2018 → Mar 2019 | hypoglycemia, type 1 diabetes mellitus | Zealand Pharma | Completed | Met primary |
| Phase 3 | NCT03667053 | Sep 2018 → Jun 2019 | hypoglycemia | Zealand Pharma | Completed | Met primary |
| Phase 3 | NCT03378635 | Dec 2017 → Apr 2018 | hypoglycemia, type 1 diabetes mellitus | Zealand Pharma | Completed | Met primary |
| Phase 3 | NCT03216226 | Jun 2017 → Feb 2018 | hypoglycemia, type 1 diabetes mellitus | Zealand Pharma | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 3
| Date | Issuer | Release |
|---|---|---|
| 2024-10-08 | Zealand Pharma | Regulatory Zealand Pharma provides U.S. regulatory update on dasiglucagon in congenital hyperinsulinism zealandpharma.com ↗
U.S. Food and Drug Administration (FDA) issues Complete Response Letter (CRL) for dasiglucagon in CHI for up to three weeks of dosing due to the timing of a third-party manufacturing facility reinspection |
| 2024-05-31 | Zealand Pharma | Regulatory Zealand Pharma announces positive CHMP opinion for dasiglucagon for treatment of severe hypoglycemia in diabetes from European Medicines Agency zealandpharma.com ↗ |
| 2023-12-23 | Zealand Pharma | Regulatory U.S. Food and Drug Administration issues Complete Response Letter for dasiglucagon in congenital hyperinsulinism for up to three weeks of dosing due to inspection findings at third-party manufacturing facility zealandpharma.com ↗
U.S. Food and Drug Administration issues Complete Response Letter for dasiglucagon in congenital hyperinsulinism for up to three weeks of dosing due to inspection findings at third-party manufacturing facility |
All press releases naming this drug 5 releases
Evidence & citations 8 cited values
Every value below carries the sentence it was read from. 25 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Dasiglucagon | “subcutaneous glucagon analog Dasiglucagon (Zealand Pharma, Copenhagen, Denmark)” NCT04192019 ↗ |
| Known as | ZP-GA-1 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297741 ↗ |
| Known as | ZP4207 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT02367053 ↗ |
| Action | Activate | “Dasiglucagon is a specific and full glucagon receptor agonist designed to mimic the effects of glucagon” NCT03735225 ↗1“Glucagon receptor agonist” CHEMBL4297741 ↗ |
| Modality | Peptide | “ZP4207 (peptide analogue of human glucagon)” NCT02660008 ↗ |
| Route | Intramuscular | “single dose of ZP4207 in ascending doses (s.c. and i.m.)” NCT02367053 ↗ |
| Route | Subcutaneous | “single dose of ZP4207 in ascending doses (s.c. and i.m.)” NCT02367053 ↗ |
| Target | GCGR | “Glucagon receptor agonist” CHEMBL4297741 ↗ |