Amgen’s Phase 3 Gout Trial Pits Subcutaneous Pegloticase Against IV Dosing

Amgen Inc (AMGN) announced an update on their ongoing clinical study.

Amgen Tests New Gout Treatment Options in Late-Stage Trial. Amgen Inc. is running a Phase 3 trial (NCT07388498) to compare two ways of giving pegloticase, a drug for hard-to-treat gout. The study tracks how well each method keeps uric acid at target levels over six months, which could shape future treatment choices for patients who do not respond to standard care.

Both study arms use pegloticase, also known as KRYSTEXXA, together with oral methotrexate. One group receives pegloticase as a shot under the skin every two weeks, while the other gets it through a drip into a vein on the same schedule. The goal is to see if the simpler shot can match or beat the IV route in results and safety.

The trial is interventional and randomized, meaning participants are assigned by chance to one of the two treatment groups. It uses a parallel design, with both groups treated at the same time, and is double-blind so neither patients nor doctors know which route is being used, keeping the focus on fair comparison for treatment benefit.

The primary purpose is treatment, not prevention or diagnosis, and the main outcome is the share of patients who keep uric acid below 6 mg/dL during Month 6. This simple target mirrors real-world goals doctors use when managing gout. A positive readout could back a shift toward more flexible dosing options in high-need patients.

The study was first submitted on Jan. 29, 2026, signaling the formal start of regulatory tracking and site activation. The most recent update was filed on Feb. 27, 2026, showing the record is being actively maintained and that operational details, such as enrollment or protocol tweaks, may be evolving as sites recruit.

Primary completion will occur when the Month 6 data are collected for the main outcome measure, which will be the first major trigger for market-moving news. Final completion will follow later, once all safety and longer follow-up data are in, and could influence labeling discussions and the scope of use across different gout populations.

For investors, this study matters because pegloticase is already an important therapy in severe, uncontrolled gout, and a proven subcutaneous option could expand its reach. Easier dosing might boost adherence, support higher pricing power, or help defend share against emerging gout drugs that target uric acid through new mechanisms.

The trial also has implications for partners and competitors in the gout space, including makers of oral urate-lowering drugs and biologics targeting inflammation. If Amgen can show similar or better outcomes with subcutaneous dosing, it may raise the bar for convenience and outcomes, supporting sentiment on AMGN while pressuring rivals to match ease of use.

While no results are available yet and the study is still recruiting, the active update status suggests steady progress that investors should watch as a medium-term pipeline catalyst. The study is ongoing with details and future updates available on the ClinicalTrials portal.

To learn more about AMGN’s potential, visit the Amgen Inc drug pipeline page.