Drugs / ATX-559
last change Jan 2026 re-read 3 minutes ago

ATX-559

targets DHX9 via inhibition

Developed for
colon carcinoma · endometrial cancer · female breast carcinoma · rectum adenocarcinoma
Investigated by
Accent Therapeutics

Trials 1

20252026
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1 NCT06625515 Oct 2024 → Jan 2026 colon carcinoma, endometrial cancer, female breast carcinoma, rectum adenocarcinoma Accent Therapeutics Terminated No outcome recorded

News releases announcing trial results or a regulatory action · 4

DateIssuerRelease
2025-10-22 Accent Therapeutics Results Accent Therapeutics Presents New Preclinical Data on Lead Clinical Programs ATX-295 and ATX-559 at the 2025 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics accenttx.com ↗
Accent Therapeutics, a clinical-stage biopharmaceutical company pioneering a new class of small molecule precision cancer therapies, today announced new preclinical data on its two lead programs: the novel KIF18A inhibitor, ATX-295, and the first-in-class DHX9 inhibitor, ATX-559.
2025-04-28 Accent Therapeutics Results Accent Therapeutics Presents Data Supporting Therapeutic Potential of First-in-Class DHX9 Inhibitor, ATX-559, and Novel KIF18A Inhibitor, ATX-295, at the AACR Annual Meeting 2025 accenttx.com ↗
ATX-559, a first-in-class oral DHX9 inhibitor, shown to induce potent and selective tumor growth inhibition in preclinical models of cancers with high genomic instability and replication stress
2025-04-15 Accent Therapeutics Regulatory Accent Therapeutics Announces First Patient Dosed in Phase 1/2 Trial of Novel KIF18A Inhibitor ATX-295 and Receives FDA Fast Track Designation for Lead Assets ATX-295 and DHX9 Inhibitor ATX-559 accenttx.com ↗
In addition, the company has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for ATX-295 for the treatment of adult patients with advanced/metastatic platinum-resistant or refractory ovarian cancer, and for ATX-559, a first-in-class potent and selective inhibitor of DHX9, for the treatment of adult patients with unresectable/metastatic dMMR/MSI-H colorectal cancer post checkpoint inhibitor treatment.
2024-10-24 Accent Therapeutics Regulatory Accent Therapeutics Announces FDA Clearance of IND Application for ATX-559, a First-In-Class Oral DHX9 Inhibitor accenttx.com ↗
today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for ATX-559, a first-in-class DHX9 inhibitor.

Evidence & citations 3 cited values

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

FieldValueCited text
Known as ATX-559 ClinicalTrials.gov intervention name — accepted as the source's own label NCT06625515 ↗
Action Inhibit “inhibits a protein called DHX9” NCT06625515 ↗
Target DHX9 “inhibits a protein called DHX9” NCT06625515 ↗