ZP9830 / Zealand Pharma - LARVOL DELTA

Upcoming events next 12 months (GlobeNewswire) - "In the second half of 2025, Zealand Pharma expects to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) and initiate a Phase 3 clinical trial of glepaglutide (EASE-5) that is anticipated to provide further confirmatory evidence for a regulatory submission in the U.S. and to support regulatory submissions outside the U.S. and the EU. In parallel, the company is engaging in partnership discussions for future commercialization...Zealand Pharma is ready to resubmit the New Drug Application for dasiglucagon for up to three weeks of dosing and to submit the requested analyses from existing continuous glucose monitoring datasets to support use beyond three weeks...In parallel, the company is engaging in partnership discussions for future commercialization....Zealand Pharma expects to complete the first-in-human clinical trial with ZP9830 in the fourth quarter of 2025 and report topline data in the first half of 2026."

EMA filing • FDA filing • New P3 trial • P1 data • Immunology • Rare Diseases • Short Bowel Syndrome

Chronic inflammation – progressing the pipeline (GlobeNewswire) - "ZP9830, Kv1.3 ion channel blocker. Zealand Pharma initiated the first-in-human clinical trial with ZP9830, a Kv.1.3 ion channel blocker in late 2024 and anticipates completing this trial in 2025. The company believes this candidate holds potential to treat a broad range of cell-mediated autoimmune diseases."

Trial completion date • Immunology

A Research Study Looking at the Safety of Single Doses of ZP9830 and How it Works in the Body of Healthy Participants (clinicaltrials.gov) - P1 | N=92 | Recruiting | Sponsor: Zealand Pharma

New P1 trial • Immunology

Zealand Pharma Announces Financial Results for the First Quarter of 2024 (GlobeNewswire) - "ZP9830, Kv1.3 Ion Channel Blocker. Zealand expects to initiate the first-in-human clinical trial of ZP9830 in the second half of 2024."

New trial • Inflammation