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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 Acute myeloid leukaemia; Liposarcoma; Myelofibrosis; Soft tissue sarcoma
  • Phase I Colorectal cancer; Myelodysplastic syndromes
  • No development reported Cancer; Haematological malignancies; Uveal melanoma

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 Novartis terminates a phase-I/II clinical trials in Acute myeloid leukaemia (Combination therapy, Second-line therapy or greater) in Hungary, Malaysia, Italy, Hong Kong, Turkey, USA, Israel and Turkey (PO) due to reasons unrelated to safety concerns, after enrolling 14 patients (NCT05155709)
  • 20 Aug 2024 Novartis terminates phase-I trial in Myelodysplastic syndromes (Combination therapy, Second-line therapy or greater) and Acute myeloid leukaemia (Second-line therapy or greater, Combination therapy) in Spain, Singapore, Germany, Italy, USA, Finland and Australia (PO) (NCT03940352)

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