AnnJi Pharmaceutical announced on October 5, 2026, that its experimental drug AJ201 (also called rosolutamide) is moving into a Phase 3 clinical trial for Kennedy's Disease, also known as Spinal and Bulbar Muscular Atrophy (SBMA).
The trial, called ROMA-KD, follows encouraging results from a 2025 Phase 2 study. Approximately 200 Kennedy's Disease patients are expected to enroll in the trial at research sites around the world, with the United States as a key location.
The U.S. FDA has already given AJ201 Fast Track status, which can accelerate its review. It also has Orphan Drug status in the U.S. and Europe, which supports treatments for rare diseases. The next step is opening U.S. trial sites and enrolling patients to complete the study.
AnnJi has also established an SBMA Patient and Care Partner Advisory Council together with the Kennedy's Disease Association, to ensure that people living with Kennedy's Disease and their families have a voice as the research moves forward.
This is a meaningful step forward for the Kennedy’s Disease community and everyone impacted by the disease. A potential treatment is now in the final stage of testing, bringing new hope to patients and families.
The Kennedy's Disease Association will keep our community updated as the trial progresses.
Read the News Release: AnnJi Pharmaceutical Advances AJ201 into Pivotal Phase 3 ROMA-KD Trial for Spinal and Bulbar Muscular Atrophy (SBMA)
