Zealand Pharma announces positive Phase 1a topline results with Kv1.3 channel blocker ZP9830
Press release – No. 4 / 2026
Zealand Pharma announces positive Phase 1a topline results with Kv1.3 channel blocker ZP9830
- Single doses of ZP9830 were well tolerated, with no serious or severe adverse events or dose-limiting safety findings observed at any dose level
- ZP9830 exhibited a pharmacokinetic profile in line with predictions based on preclinical data, and exploratory pharmacodynamic biomarkers showed robust, dose-dependent activity consistent with Kv1.3 target engagement
- ZP9830 is a highly potent and selective Kv1.3 channel blocker with potential to address a broad range of immune-mediated inflammatory disorders
- Development program is progressing rapidly and as planned, with Phase 1a multiple ascending dose data and Phase 1b/2a initiation expected in H2 2026
Copenhagen, Denmark, February 18, 2026 – Zealand Pharma A/S (NASDAQ:ZEAL) (CVR-no. 20045078), a biotechnology company transforming the future of metabolic health, today announced positive Phase 1a single ascending dose (SAD) topline results for the company's Kv1.3 channel blocker, ZP9830. The first-in-human, single-center, randomized, double-blind, placebo-controlled, SAD part of the combined SAD/multiple ascending dose (MAD) Phase 1a trial was designed to evaluate safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of ZP9830 following administration to healthy male participants.
ZP9830 was well tolerated in this single ascending dose trial, with no dose-limiting safety findings or other safety concerns observed. All treatment-emergent adverse events (TEAEs) were non-serious and mild in severity. No clinically relevant safety findings were observed in vital signs, 12-lead electrocardiogram (ECG) recordings, physical examinations, or safety laboratory parameters. PK parameters increased in a dose-proportional manner across the investigated dose range, and data from the intravenous cohort indicated a very high bioavailability of the subcutaneous formulation.
"We are very pleased with the Phase 1a single ascending dose results, which demonstrated favorable safety and tolerability, and a PK/PD profile consistent with our expectations for a highly differentiated, immunological therapy with a novel mechanism of action," said David Kendall, MD, Chief Medical Officer of Zealand Pharma. "Importantly, these data also underscore the strength of Zealand Pharma's proprietary peptide engineering capabilities in addressing historically challenging targets and further reinforce our confidence in ZP9830 as a promising Kv1.3 channel blocker with potential in multiple autoimmune and inflammatory diseases with unmet medical need."
About the Phase 1a trial
The first-in-human single ascending dose (SAD) part of the combined SAD/multiple ascending dose (MAD) Phase 1a trial (ClinicalTrials.gov ID: NCT06682975) was conducted in healthy male participants to investigate the effects of single ascending doses of ZP9830 administered subcutaneously across a wide dose range, as well as intravenously at one dose level. The main objectives were to assess safety, tolerability, and pharmacokinetics, with proof of mechanism as an additional exploratory objective. The SAD part of the trial included a suitable pharmacological model to explore immunomodulatory activity and provide early confirmation that ZP9830 affects immune cell biology as intended. The MAD part of this Phase 1a trial is ongoing and is evaluating the effects associated with extended exposure to ZP9830.
About ZP9830
ZP9830 is a potent and selective Kv1.3 channel blocker with the potential to treat a broad range of immune-mediated inflammatory diseases. Kv1.3 is a potassium ion channel that is selectively upregulated on effector memory T cells, which play a central role in autoimmunity and chronic inflammation through the release of pro-inflammatory cytokines that drive tissue damage.
The anti-inflammatory effects of Kv1.3 channel blockade have been demonstrated in preclinical models of immunological disorders. The selective expression of Kv1.3 on effector memory T cells makes it an attractive therapeutic target, as inhibition is expected to preserve the protective functions of the broader immune system.
About Zealand Pharma A/S
Zealand Pharma A/S (NASDAQ:ZEAL) is a biotechnology company focused on advancing medicines for obesity and metabolic health. Combining more than 25 years of peptide R&D expertise with a proprietary data platform that leverages advanced data‑driven and AI/ML approaches, Zealand Pharma aims to lead a new era in obesity and metabolic health.
To date, more than ten Zealand Pharma‑invented drug candidates have entered clinical development, of which two products have reached the market and three candidates are in late-stage development. The Company has collaborations with global pharmaceutical and biotechnology partners for research, development, and commercialization.
Founded in 1998, Zealand Pharma is headquartered in Copenhagen, Denmark, with a U.S. presence in Boston, Massachusetts. Learn more at www.zealandpharma.com.
Forward-looking statements
This press release contains "forward-looking statements", as that term is defined in the Private Securities Litigation Reform Act of 1995 in the United States, as amended, even though no longer listed in the United States this is used as a definition to provide Zealand Pharma's expectations or forecasts of future events regarding the research, development and commercialization of pharmaceutical products, the timing of the company's pre-clinical and clinical trials and the reporting of data therefrom. These forward-looking statements may be identified by words such as "aim," "anticipate," "believe," "could," "estimate," "expect," "forecast," "goal," "intend," "may," "plan," "possible," "potential," "will," "would" and other words and terms of similar meaning. You should not place undue reliance on these statements, or the scientific data presented. The reader is cautioned not to rely on these forward-looking statements. Such forward-looking statements are subject to risks, uncertainties and inaccurate assumptions, which may cause actual results to differ materially from expectations set forth herein and may cause any or all of such forward-looking statements to be incorrect, and which include, but are not limited to, unexpected costs or delays in clinical trials and other development activities due to adverse safety events, patient recruitment or otherwise; unexpected concerns that may arise from additional data, analysis or results obtained during clinical trials; our ability to successfully market both new and existing products; changes in reimbursement rules and governmental laws and related interpretation thereof; government-mandated or market-driven price decreases for our products; introduction of competing products; production problems at third party manufacturers; dependency on third parties, for instance contract research or development organizations; unexpected growth in costs and expenses; our ability to affect the strategic reorganization of our businesses in the manner planned; failure to protect and enforce our data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; regulatory authorities may require additional information or further studies, or may reject, fail to approve or may delay approval of our drug candidates or expansion of product labeling; failure to obtain regulatory approvals in other jurisdictions; exposure to product liability and other claims; interest rate and currency exchange rate fluctuations; unexpected contract breaches or terminations; inflationary pressures on the global economy; and political uncertainty. If any or all of such forward-looking statements prove to be incorrect, our actual results could differ materially and adversely from those anticipated or implied by such statements. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. All such forward-looking statements speak only as of the date of this company announcement and are based on information available to Zealand Pharma as of the date of this announcement. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. Information concerning pharmaceuticals (including compounds under development) contained within this material is not intended as advertising or medical advice.
Contacts
Adam Lange (Investors)
Vice President, Investor Relations
Zealand Pharma
[email protected]
Neshat Ahmadi (Investors)
Investor Relations Manager
Zealand Pharma
[email protected]
Rachel James-Owens (Media)
Vice President, Corporate Communications and Media Relations
Zealand Pharma
[email protected]
Amber Fennell, Jessica Hodgson, Sean Leous (Media)
ICR Healthcare
[email protected]
+44 (0) 7739 658 783
