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Emavusertib - Aurigene Oncology/Curis

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Drug Profile

Emavusertib - Aurigene Oncology/Curis

Alternative Names: AU 4948; CA 4948

Latest Information Update: 14 Apr 2025

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At a glance

  • Originator Aurigene Discovery Technologies
  • Developer Curis; University of Leipzig
  • Class Amides; Amines; Antianaemics; Antineoplastics; Antirheumatics; Morpholines; Oxazoles; Pyridines; Pyrrolidines; Small molecules
  • Mechanism of Action Clk dual-specificity kinase inhibitors; Fms-like tyrosine kinase 3 inhibitors; IRAK4 protein inhibitors
  • Orphan Drug Status

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

    Yes - Acute myeloid leukaemia; Non-Hodgkin's lymphoma; Myelodysplastic syndromes
  • New Molecular Entity Yes

Highest Development Phases

  • Phase II Anaemia
  • Phase I/II Acute myeloid leukaemia; Malignant melanoma; Myelodysplastic syndromes; Non-Hodgkin's lymphoma
  • Phase I Gastric cancer; Oesophageal cancer
  • Preclinical Adenocarcinoma; Rheumatoid arthritis

Most Recent Events

  • 04 Apr 2025 University of Florida suspends a phase I/II trial in Malignant melanoma (Combination therapy, Metastatic disease) in USA (PO) (NCT05669352)
  • 31 Mar 2025 Curis receives supportive feedback from the US FDA and EMA on the possibility of pursuing an accelerated approval path for emavusertib
  • 31 Mar 2025 Curis announces intention to pursue an accelerated approval path for emavusertib

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