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ART 6043

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Drug Profile

ART 6043

Alternative Names: ART-6043

Latest Information Update: 26 Feb 2026

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At a glance

  • Originator Artios Pharma
  • Class Antineoplastics; Small molecules
  • Mechanism of Action DNA polymerase theta inhibitors
  • Orphan Drug Status

    Orphan designation is assigned by a regulatory body to encourage companies to develop drugs for rare diseases.

    No
  • New Molecular Entity Yes

Highest Development Phases

  • Phase I/II Solid tumours

Most Recent Events

  • 23 Feb 2026 ART 6043 receives Fast track status from the US FDA for HER2-Negative breast cancer (Combination therapy, Late-stage disease, Metastatic disease, Second-line therapy or greater (9461036)
  • 17 Nov 2025 Artios Pharma plans a phase II trial for HER2-negative breast cancer (Metastatic disease) in November 2025
  • 17 Oct 2025 Efficacy, adverse events, pharmacodynamics, drug interaction and pharmacokinetics data from a phase I/IIa trial in Solid tumours released by Artios Pharma

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