DUR‑928 is the lead product candidate in DURECT’s Epigenetic Regulator program. It is an endogenous, orally bioavailable small molecule that has been shown in nonclinical studies to modulate the activity of nuclear receptors playing an important regulatory role in cellular functions such as lipid homeostasis, inflammation, and cell survival.
DUR‑928 is a sulfated oxysterol—representing a new class of therapeutics with a novel mechanism of action. DUR‑928 epigenetically modifies gene activity without changing the DNA sequence itself.
Over 150 individuals have been dosed with DUR‑928 by oral (PO), intramuscular (IM), or intravascular (IV) administration in a series of Phase 1 clinical trials. DUR‑928 was well tolerated at all doses. There was minimal food effect in the oral administration studies and no accumulation with repeat dosing in any of these studies.
DUR-928 is an investigational product and has not been approved by the FDA for marketing in the U.S. for any indication.
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