Amgen’s FORWARD II Gout Study: What a Less Frequent Krystexxa Schedule Could Mean for Investors
Amgen Inc (AMGN) announced an update on their ongoing clinical study.
Easter Sale - 70% Off TipRanks
- Unlock hedge fund-level data and powerful investing tools for smarter, sharper decisions
- Discover top-performing stock ideas and upgrade to a portfolio of market leaders with Smart Investor Picks
Amgen’s FORWARD II Phase 4 study, officially titled “A Phase 4, Randomized, Double-blind, Multicenter Non-inferiority Trial… in Participants With Uncontrolled Refractory Gout,” tests whether a less frequent dose of Krystexxa (pegloticase) with methotrexate works as well as the current schedule. The goal is to show that giving the drug every four weeks keeps uric acid under control almost as reliably as every two weeks, which would be a major convenience gain for patients.
The trial compares two active regimens of pegloticase plus methotrexate, both aimed at hard-to-treat gout that does not respond to standard drugs. One arm uses 16 mg of pegloticase by IV every four weeks and the other starts with 8 mg every two weeks, with both arms receiving weekly oral methotrexate to boost response and lower immune reactions.
The study is an interventional, randomized Phase 4 trial, meaning patients are assigned by chance to one of the dosing schedules. It uses a parallel design, triple blinding for patients, clinicians and investigators, and focuses on treatment outcomes, keeping the analysis clean and reducing bias in how results are reported.
The double-blind phase lasts 24 weeks, followed by a 24-week open-label extension where everyone receives the four-week dosing. Key timing signals include the first submission date of January 19, 2024 and a major update filed on April 7, 2026, with the trial now listed as completed and moving toward data readout and potential label or practice changes.
For investors, the update matters because a successful non-inferiority result could support a more convenient dosing schedule for Krystexxa, potentially expanding use and improving adherence. That would strengthen Amgen’s gout franchise, slightly raise long-term revenue expectations, and sharpen its competitive stance versus other urate-lowering options, even though direct biologic rivals remain limited.
With the FORWARD II study now completed and recently updated in the registry, investors should watch for detailed results on the ClinicalTrials portal and subsequent company disclosures.
To learn more about AMGN’s potential, visit the Amgen Inc drug pipeline page.
