Drugs / DB-2304
last change Nov 2025 re-read 3 minutes ago

DB-2304

Developed for
lupus erythematosus
Investigated by
DualityBio Inc.

Trials 1

202520262027
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1/2 NCT06625671 Oct 2024 → Jun 2027 expected lupus erythematosus DualityBio Inc. Recruiting No outcome recorded

News releases announcing trial results or a regulatory action · 2

DateIssuerRelease
2025-11-24 DualityBio Inc. Results Duality Biologics Orally Presents Phase 1 Healthy Volunteer Data for First-in-Class BDCA2-Targeted ADC DB-2304 at Autumn Immunology Conference 2025 dualitybiologics.com ↗
Results demonstrated that DB-2304 was generally safe and well-tolerated in healthy participants, showed approximately linear pharmacokinetics (PK), and effectively reached and engaged the intended target, validating its pharmacological mechanism.
2024-11-04 DualityBio Inc. Regulatory DualityBio's First-in-Class ADC Drug DB-2304 for Autoimmune Diseases Completes First Global Patient Dosing in Phase I Clinical Trial dualitybiologics.com ↗
DB-2304, the first-in-class BDCA2 ADC drug targeting autoimmune diseases, developed based on its proprietary DIMAC platform and holding global patents, has received Clinical Trial Notification (CTN) approval from Australia's Therapeutic Goods Administration (TGA) and completed the first global patient dosing.

Evidence & citations 1 cited value

Every value below carries the sentence it was read from. 1 source stands behind the page.

FieldValueCited text
Known as DB-2304 ClinicalTrials.gov intervention name — accepted as the source's own label NCT06625671 ↗