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Siremadlin - Novartis Oncology

Drug Profile

Siremadlin - Novartis Oncology

Alternative Names: HDM-201; NVP-HDM201

Latest Information Update: 28 Jan 2020

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At a glance

  • Originator Novartis
  • Developer 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.

  • New Molecular Entity Yes

Highest Development Phases

  • Phase I/II Liposarcoma; Myelofibrosis
  • Phase I Acute myeloid leukaemia; Colorectal cancer; Haematological malignancies; Myelodysplastic syndromes; Solid tumours; Uveal melanoma
  • Preclinical Cancer

Most Recent Events

  • 09 Jan 2020 Novartis withdraws a phase I/II trial in Acute myeloid (Combination therapy, Second-line therapy or greater, First-line therapy) leukaemia in Israel andGermany, prior to enrolment as the study design may not be optimal given the changing Acute myeloid leukaemia treatment landscape (NCT03760445)
  • 16 Oct 2019 Novartis completes a phase I/II trial in Liposarcoma (Combination therapy, Metastatic disease, Second-line therapy or greater) in Canada, France, Germany, Singapore, Spain and Taiwan (NCT02343172) (EudraCT2014-003604-75)
  • 09 Oct 2019 Centre Leon Berard plans the phase II MegaMOST trial for Solid tumours (Combination therapy, Late-stage disease, Metastatic disease) in France (ET19-073; NCT04116541; EudraCT2019-001494-88)
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