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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: 28 Sep 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 Myelodysplastic syndromes
  • No development reported Cancer; Colorectal cancer; Haematological malignancies; Uveal melanoma
  • Discontinued Acute myeloid leukaemia

Most Recent Events

  • 28 Sep 2025 No recent reports of development identified for phase-I development in Myelodysplastic-syndromes(Combination therapy, Second-line therapy or greater) in Australia (PO, Capsule)
  • 28 Sep 2025 No recent reports of development identified for phase-I development in Myelodysplastic-syndromes(Combination therapy, Second-line therapy or greater) in Finland (PO, Capsule)
  • 18 Sep 2025 No development reported - Phase-I for Colorectal cancer (In the elderly, Combination therapy, Late-stage disease, Metastatic disease, Second-line therapy or greater, In adults) in France (PO)

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