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Actinium-225 SKL 35501 - SK Biopharmaceuticals

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Drug Profile

Actinium-225 SKL 35501 - SK Biopharmaceuticals

Alternative Names: 225-Ac FL-091; Actinium-225 FL 091 - Full-Life Technologies; FL-091; SKL-35501

Latest Information Update: 03 Sep 2026

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At a glance

  • Originator Full-Life Technologies
  • Developer SK biopharmaceuticals
  • Class Antineoplastics; Radioisotopes; Radiopharmaceuticals; Small molecules
  • 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 I Solid tumours

Most Recent Events

  • 03 Sep 2026 SK biopharmaceuticals plans a first in human phase I trial for Solid tumours (Second-line therapy or greater, Late-stage disease) in the USA and South Korea in first half 2026
  • 08 May 2026 Phase-I clinical trials in Solid tumours (Late-stage disease, Second-line therapy or greater) in South Korea (IV) prior to May 2026 (SK Biopharmaceuticals pipeline, August 2026) (NCT07812805)
  • 08 May 2026 Phase-I clinical trials in Solid tumours (Late-stage disease, Second-line therapy or greater) in USA (IV) prior to May 2026 (SK Biopharmaceuticals pipeline, August 2026) (NCT07812805)

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