Cyclarity Therapeutics Receives FDA Investigational New Drug Clearance for UDP-003 to expand Atherosclerosis Clinical Development Program into the United States

NOVATO, Calif., Nov. 12, 2026 (GLOBE NEWSWIRE) -- Cyclarity Therapeutics, Inc., a clinical-stage biotechnology company developing cyclodextrin therapeutics to reverse atherosclerotic cardiovascular diseases and metabolic diseases of aging, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for UDP-003. UDP-003, designed by Cyclarity’s proprietary AI-enabled computational platform, is engineered to bind and extract oxidized cholesterol to restore cellular function and spur atherosclerotic plaque regression.

The IND clearance authorizes the expansion of Cyclarity Therapeutics’ Phase 1b trials to the United States, complementing the ongoing study in Australia. The study (NCT06813339; CTx-001) is a multi-dose, intravenous administration trial evaluating the safety of UDP-003 in patients with Coronary Artery Disease. It includes pre- and post- CCTA imaging to evaluate coronary plaque status and inflammation. Cyclarity plans to launch an expanded Phase 1b trial in the U.S. in Q1 of 2027.

“Clearance of the IND for UDP-003 represents a major milestone in the drug’s clinical development,” says Dr. Matthew O’Connor, co-CEO, “We are looking forward to executing Phase 1b trials at Cedars-Sinai Medical Center in Los Angeles. We are excited for the progress this accomplishment will bring.”

About UDP-003
UDP-003 is an investigational injectable small molecule (cyclodextrin) designed using Cyclarity’s proprietary AI-enabled computational platform to shrink plaque by the selective removal of oxidized cholesterol, and specifically 7-ketocholesterol.

About Cyclarity Therapeutics
Cyclarity Therapeutics, Inc. and Cyclarity Therapeutics Australia Pty Ltd., are pursuing a mission to treat the underlying causes of age-related disease. The company develops simple and direct interventions targeting oxidized cholesterol using rationally designed molecules, to provide the first true disease-modifying treatments for common age-related conditions such as atherosclerosis, heart attack, and stroke. Its products are based on novel derivatives of a well-known, safe compound and a new way of looking at cardiovascular disease. For more information, please visit www.cyclaritytx.com or send an email to press@cyclaritytx.com.