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Thiotepa - Shorla Oncology

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Drug Profile

Thiotepa - Shorla Oncology

Alternative Names: SH-105; TEPYLUTE

Latest Information Update: 28 Jun 2024

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At a glance

  • Originator Shorla Pharma
  • Developer Shorla Oncology
  • Class Antineoplastics; Aziridines; Myeloablative agonists; Organothiophosphorus compounds
  • Mechanism of Action Alkylating agents; DNA synthesis 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 No

Highest Development Phases

  • Registered Adenocarcinoma
  • Clinical Phase Unknown Bladder cancer
  • Preclinical Brain metastases

Most Recent Events

  • 25 Jun 2024 Registered for Adenocarcinoma in USA (IV) - First global approval
  • 09 Jan 2024 The US FDA assigns PDUFA action date of (29/06/2024) for SH 105 for Ovarian cancer and Breast cancer.
  • 09 Jan 2024 The US FDA accepts NDA for SH 105 for Adenocarcinoma for review

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