Amgen Inc (AMGN) announced an update on their ongoing clinical study.
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Amgen’s New Evolocumab Study Puts Bioavailability in Focus for Heart-Drug Investors. The phase 1 trial, officially titled “An Open-label, Phase 1, Single Dose, Randomized, Parallel-group Study to Evaluate the Relative Bioavailability of Two Evolocumab (AMG 145) Drug Products,” aims to see how much of each version of the drug gets into the body and why that matters for future product strategy.
The study tests two subcutaneous versions of evolocumab, labeled Drug Substance A and Drug Substance B. Both are injectable forms of Amgen’s cholesterol-lowering antibody and are designed to deliver the same active ingredient while potentially offering flexibility in manufacturing, supply, or future device or formulation options.
The trial is interventional and randomized, meaning healthy volunteers are randomly assigned to one of the two drug products. The design is open-label and parallel-group with no masking, so both doctors and participants know which version is used, and the main goal is basic science rather than direct patient benefit.
The study was first submitted on February 12, 2026, marking the formal launch of this early-stage work. The most recent update was filed on February 25, 2026, signaling that the design and status are current, while future entries on primary and final completion will show when topline and full data are expected to lock.
For investors, the key takeaway is that Amgen is investing in the long-term life cycle of evolocumab (AMGN), a core asset in the PCSK9 cholesterol franchise. Success could support cost-efficient supply, help defend market share against competitors like Regeneron and Sanofi, and sustain margins, although near-term stock impact is likely modest until data hint at clear manufacturing or product advantages.
The study is currently recruiting and remains active, with further details and ongoing updates available on the ClinicalTrials portal.
To learn more about AMGN’s potential, visit the Amgen Inc drug pipeline page.