Ozanimod, the drug invented at Scripps Research that won FDA approval last year for relapsing forms of multiple sclerosis, has been approved in the United States for a second high-need medical condition, ulcerative colitis.

Ed Roberts and Hugh Rosen
Edward Roberts, PhD, (left) and fellow Scripps Research professor Hugh Rosen, MD, PhD, invented ozanimod (marketed as Zeposia®), which addresses overactive immune responses. The novel drug was approved for multiple sclerosis in 2020 and now is approved for ulcerative colitis.

The once-daily oral drug, sold by Bristol Myers Squibb under the name Zeposia®, can now be prescribed to treat adults with moderate to severe forms of the inflammatory bowel disease. Notably, it’s the first drug in a novel class of immune-modulating compounds to be approved for ulcerative colitis, which affects about 1 million people in the United States.

“For patients with ulcerative colitis, this oral drug offers a better and more convenient option to control disease progression and improve quality of life,” says Hugh Rosen, MD, PhD, who invented ozanimod along with fellow Scripps Research professor Edward Roberts, PhD, and their laboratory colleagues. “The hope is that this will lead to fewer dangerous complications or serious infections than current treatment options, providing a steadier path for newly diagnosed patients as well as those failing other treatments.”

Ulcerative colitis is a relapsing, chronic autoimmune disease of the large intestine and rectum, in which the lining of the colon becomes inflamed and develops tiny open sores, or ulcers. The condition, as with other inflammatory bowel diseases, is driven in large part by an overactive immune response.

The need for a new treatment option is great, as many patients with ulcerative colitis have an inadequate response or do not respond at all to currently available therapies. Existing therapies also come with a significant risk of serious infections including tuberculosis and blood clotting.

Ozanimod is also in late-stage clinical trials for the treatment of Crohn’s disease, another type of inflammatory bowel disease. While ulcerative colitis affects the colon and rectum, Crohn’s disease may act on any part of the gastrointestinal tract and also affect the entire thickness of the bowel wall.