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Siremadlin - Novartis Oncology

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Drug Profile

Siremadlin - Novartis Oncology

Alternative Names: HDM-201; NVP-HDM201

Latest Information Update: 10 Jan 2025

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At a glance

  • Originator Novartis
  • Developer National Cancer Institute (France); Novartis; Novartis Oncology
  • Class Antineoplastics; Chlorobenzenes; Imidazoles; Pyridines; Pyrimidines; Pyrroles; Small molecules
  • Mechanism of Action Proto-oncogene protein c-mdm2 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 Solid tumours
  • Phase I/II Liposarcoma; Myelofibrosis; Soft tissue sarcoma
  • Phase I Colorectal cancer; Myelodysplastic syndromes
  • No development reported Cancer; Haematological malignancies; Uveal melanoma
  • Discontinued Acute myeloid leukaemia

Most Recent Events

  • 10 Jan 2025 Efficacy and adverse events data from the phase II trial in Solid tumours presented at the 49th European Society for Medical Oncology Congress (ESMO-2024)
  • 08 Jan 2025 Discontinued - Phase-I for Acute myeloid leukaemia (Combination therapy, Second-line therapy or greater) in Singapore (PO)
  • 08 Jan 2025 Discontinued - Phase-I for Acute myeloid leukaemia (Second-line therapy or greater, Combination therapy) in Germany (PO)

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