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Varlitinib - Array BioPharma/ASLAN Pharmaceuticals

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Drug Profile

Varlitinib - Array BioPharma/ASLAN Pharmaceuticals

Alternative Names: ARRY-334543; ARRY-543; ASLAN-001; QBT-01; SPS-4370; VAR; Varlitinib tosylate

Latest Information Update: 17 Sep 2025

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At a glance

  • Originator Array BioPharma
  • Developer Array BioPharma; ASLAN Pharmaceuticals; National University Hospital (Singapore)
  • Class Antineoplastics; Diamines; Oxazoles; Quinazolines; Small molecules; Thiazoles
  • Mechanism of Action Epidermal growth factor receptor antagonists; ERBB 2 receptor antagonists; ERBB 4 receptor antagonists
  • Orphan Drug Status

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

    Yes - Biliary cancer; Cholangiocarcinoma; Gastric cancer
  • New Molecular Entity Yes

Highest Development Phases

  • Discontinued Biliary cancer; Cholangiocarcinoma; Gastric cancer; HER2 positive breast cancer; Liver cancer; Solid tumours; Triple negative breast cancer

Most Recent Events

  • 10 Sep 2025 National Cancer Centre terminates a phase II trial for HER2-positive-breast-cancer (Combination therapy, Metastatic disease, Second-line therapy or greater) in Singapore (PO) due to difficulty in enrolling patients with the illness under study (NCT07166367)
  • 17 Jul 2024 Discontinued - Phase-I for Biliary cancer (Combination therapy, Late-stage disease, Metastatic disease) in Japan (PO)
  • 17 Jul 2024 Discontinued - Phase-I for Solid tumours (Combination therapy) in Singapore (PO)

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