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Alisertib - Takeda Oncology

Drug Profile

Alisertib - Takeda Oncology

Alternative Names: Alisertib sodium; Alsertib; MLN 8237; MLN8237-004

Latest Information Update: 25 Mar 2024

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At a glance

  • Originator Millennium Pharmaceuticals
  • Developer Fox Chase Cancer Center; M. D. Anderson Cancer Center; Massachusetts General Hospital; Mayo Clinic; Millennium; National Cancer Institute (USA); Northwestern University; Ohio State University Comprehensive Cancer Center; Puma Biotechnology; Takeda Oncology; UNC Lineberger Comprehensive Cancer Center; University of Texas M. D. Anderson Cancer Center; Washington University School of Medicine; Weill Cornell Medical College
  • Class 3-ring heterocyclic compounds; Amines; Antineoplastics; Azepines; Benzazepines; Benzoic acids; Fluorobenzenes; Halogenated hydrocarbons; Phenyl ethers; Pyrimidines; Small molecules
  • Mechanism of Action Aurora kinase A inhibitors
  • Orphan Drug Status

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

    Yes - Small cell lung cancer
  • New Molecular Entity Yes

Highest Development Phases

  • Phase III Peripheral T-cell lymphoma
  • Phase II Acute myeloid leukaemia; Breast cancer; Small cell lung cancer
  • Phase I/II Squamous cell cancer
  • Discontinued B-cell lymphoma; Brain cancer; Burkitt's lymphoma; Cancer; Diffuse large B cell lymphoma; Follicular lymphoma; Gastric cancer; Gynaecological cancer; HER2 negative breast cancer; Lymphoma; Mesothelioma; Myelodysplastic syndromes; Myelofibrosis; Non-Hodgkin's lymphoma; Non-small cell lung cancer; Oesophageal cancer; Ovarian cancer; Prostate cancer; Solid tumours

Most Recent Events

  • 20 Mar 2024 US FDA announces allowance to proceed with the phase II ALISCA-Breast1 trial in HER2-negative breast cancer, under IND application
  • 20 Mar 2024 Puma Biotechnology plans a phase III trial in HER2-negative breast cancer (Metastatic disease, Combination therapy)
  • 20 Mar 2024 Puma Biotechnology plans the phase II ALISCA-Breast1 trial in HER2-negative breast cancer (Metastatic disease, Second-line therapy or greater, Combination therapy) in 2H of 2024 (PO)
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