Isosceles Pharmaceuticals Announces Acceptance of IPI201 for Phase I First-in-Human Clinical Trial
Novel intravenous anti-inflammatory candidate advances to Phase I evaluation to assess safety, tolerability, and pharmacokinetics.
WILMINGTON, NC, UNITED STATES, February 11, 2026 /EINPresswire.com/ -- Isosceles Pharmaceuticals today announced that its patented investigational candidate, IPI201, has been accepted to proceed into a Phase I first-in-human clinical trial, marking a milestone in the company’s development pipeline. The study is expected to initiate first patient, first dose in April, beginning with dosing in healthy volunteers.IPI201 is a novel proprietary intravenous formulation being developed to address conditions characterized by excessive inflammation major and significant unmet medical needs. Acceptance into Phase I represents a critical transition from preclinical development to human evaluation, a stage that the vast majority of drug candidates never reach, approximately 90% of investigational therapies fail prior to entering Phase I clinical trials.
“This acceptance is a defining moment for Isosceles and for the IPI201 program,” said Brett Lanier, President of Isosceles Pharmaceuticals. “Advancing a compound into a first-in-human study reflects the strength of our science, our execution, and our belief that IPI201 has the potential to meaningfully impact inflammatory disease pathways where current therapies fall short. We are particularly excited to begin dosing healthy volunteers as the first step in establishing a strong clinical foundation.”
The Phase I trial is designed to evaluate the safety, tolerability, and pharmacokinetics of IPI201, providing essential data to guide subsequent clinical development and future indication-specific studies.
“Reaching Phase I is one of the most important inflection points in the life of a therapeutic program,” said Timothy R. Wright, Chairman of the Board of Directors of Isosceles Pharmaceuticals. “This milestone validates the disciplined strategy the team has pursued and positions the company to generate meaningful clinical data in the near term. We are proud of the progress made and enthusiastic about what lies ahead for IPI201.”
Isosceles Pharmaceuticals remains committed to advancing innovative therapies that address serious unmet medical needs and looks forward to sharing additional updates as the Phase I trial progresses.
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About Isosceles Pharmaceuticals
Isosceles Pharmaceuticals is a clinical-stage biotechnology company focused on the development of innovative therapies targeting inflammatory and immune-mediated conditions. The company leverages proprietary formulations and a disciplined development strategy to efficiently advance promising candidates into the clinic.
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