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Tuvusertib - EMD Serono Research & Development Institute

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Drug Profile

Tuvusertib - EMD Serono Research & Development Institute

Alternative Names: ATR kinase inhibitor - EMD Serono Research & Development Institute; M-1774; MSC2584415A; VRT-1363004; VXc-400

Latest Information Update: 19 Jan 2026

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At a glance

  • Originator EMD Serono Research & Development Institute
  • Developer EMD Serono Research & Development Institute; Merck KGaA; National Cancer Institute (USA)
  • Class Amides; Antineoplastics; Imidazoles; Pyrazoles; Pyridines; Pyrimidines; Small molecules
  • Mechanism of Action ATR protein 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 II Astrocytoma; Endometrial cancer; Fallopian tube cancer; Merkel cell carcinoma; Ovarian cancer; Peritoneal cancer
  • Phase I/II Non-small cell lung cancer
  • Phase I Solid tumours

Most Recent Events

  • 29 Dec 2025 Curie Institute terminates the phase I POP-ART trial for Solid tumors (Combination therapy, Late-stage disease, Metastatic disease, Second-line therapy or greater) in France (IV), because industrial development of tuvusertib has been halted, leaving no scientific or ethical justification to continue (NCT06337630)
  • 19 Dec 2025 Phase-II clinical trials in Astrocytoma (Second-line therapy or greater, Recurrent) in Spain (PO) (NCT07417761)
  • 11 Nov 2025 Grupo Espanol De Investigacion En Neurooncologia plans a phase II trial for Astrocytoma (Recurrent) in Spain (PO, Tablet) in September 2025 (CTIS2025-521843-19-00)

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