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Lutetium 177 rosopatamab tetraxetan - Telix Pharmaceuticals

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Drug Profile

Lutetium 177 rosopatamab tetraxetan - Telix Pharmaceuticals

Alternative Names: 177-Lu-DOTA-Rosopatamab - Telix Pharmaceuticals; 177Lu-DOTA-rosopatamab; 177Lu-DOTA-rosopatamb; 177Lu-DOTA-TLX591; 177Lu-DOTA-TLX591-CHO; 177Lu-TLX-591; Lutetium 177 DOTA rosopatamab - Telix Pharmaceuticals; Lutetium 177 rosopatamab - Telix Pharmaceuticals; lutetium-177 rosopatamab tetraxetan; TLX 591; TLX591-Tx; TLX591t; TX591

Latest Information Update: 20 Mar 2026

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At a glance

  • Originator Telix Pharmaceuticals
  • Class Antineoplastics; Immunoconjugates; Monoclonal antibodies; Radioisotopes; Radiopharmaceuticals
  • Mechanism of Action Ionising radiation emitters
  • Orphan Drug Status

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

    No
  • New Molecular Entity Yes
  • Available For Licensing Yes

Highest Development Phases

  • Phase III Prostate cancer

Most Recent Events

  • 10 Mar 2026 Drug interactions, adverse event and pharmacokinetic data from a phase III ProstACT Global trial in Prostate cancer released by Telix Pharmaceuticals
  • 20 Feb 2026 Telix Pharmaceuticals terminates a phase-III clinical trials in Prostate cancer (Combination therapy, Hormone refractory, Metastatic disease, Second-line therapy or greater) in New Zealand and Australia (IV), to focus on the ongoing phase III Global trial aimed at accelerating development and approval under an IND (NCT04876651)
  • 08 Dec 2025 Telix plans to submits clinical trial application (CTA) to the European Medicines Agency (EMA) for ProstACT Global phase III trial for the treatment of Prostate cancer

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