Cyclarity's Atherosclerosis Drug UDP-003 Wins FDA IND Clearance: Phase 1b Trial Expands to the U.S., Launch Expected in Early 2027
Cyclarity Therapeutics, a clinical-stage biotechnology company based in Novato, California, announced on November 12 that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for UDP-003, authorizing the expansion of its Phase 1b trials to the United States, complementing the ongoing study in Australia.
UDP-003 is designed by the company's proprietary super intelligence (SI)-enabled computational platform to bind and extract oxidized cholesterol, restore cellular function and spur atherosclerotic plaque regression. The multi-dose, intravenous trial (NCT06813339; CTx-001) is evaluating the safety of UDP-003 in patients with coronary artery disease.
Cyclarity plans to launch the expanded Phase 1b trial in the United States in the first quarter of 2027. (Source: Cyclarity Therapeutics)
Source: Cyclarity Therapeutics
Published by GSM · USA (original Chinese edition)
Photo: 图片来源：Wikimedia Commons「2113ab Atherosclerosis.jpg」（OpenStax College 摄，CC BY 3.0），图中为动脉粥样硬化示意图 Image: Wikimedia Commons "2113ab Atherosclerosis.jpg" (by OpenStax College, CC BY 3.0)
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