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Milciclib maleate - Nerviano Medical Sciences/Tiziana Life Sciences

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Drug Profile

Milciclib maleate - Nerviano Medical Sciences/Tiziana Life Sciences

Alternative Names: PHA 848125C; PHA-125; PHA-848125; PHA-848125AC; TZLS-201

Latest Information Update: 05 Jan 2023

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At a glance

  • Originator Nerviano Medical Sciences
  • Developer Nerviano Medical Sciences; Tiziana Life Sciences
  • Class 3-ring heterocyclic compounds; Amides; Antineoplastics; Piperazines; Pyrazolones; Quinazolines; Small molecules
  • Mechanism of Action CDC2 protein kinase inhibitors; Cyclin-dependent kinase 2 inhibitors; Cyclin-dependent kinase 4 inhibitors; Cyclin-dependent kinase 5 inhibitors; Cyclin-dependent kinase-activating kinase inhibitors; TrkA receptor antagonists
  • Orphan Drug Status

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

    Yes - Malignant thymoma; Thymic epithelial tumour
  • New Molecular Entity Yes

Highest Development Phases

  • Phase II Liver cancer; Malignant thymoma
  • Phase I/II Glioma
  • Phase I Solid tumours
  • No development reported Malignant-mesothelioma

Most Recent Events

  • 27 Dec 2022 Tiziana Life Sciences files an IND application with the US FDA in USA for Non-small cell lung cancer
  • 16 Dec 2022 Tiziana Life Sciences plans a phase-II trial for Non-small cell lung cancer (Combination therapy, Late-stage disease) in March 2023 (PO) (NCT05651269)
  • 16 Jun 2022 Tiziana Life Sciences plans to submit an Investigational New Drug (IND) application to initiate a phase II trial in Non-small cell lung cancer by 2Q of 2022
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