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Entolimod - Statera BioPharma

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Drug Profile

Entolimod - Statera BioPharma

Alternative Names: CBLB-502; CYTO-601; CYTO-601 ARS; CYTO-602; CYTO-602 Oncology; Entolimod™; STAT-600; STAT-601

Latest Information Update: 27 May 2025

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At a glance

  • Originator Cleveland BioLabs
  • Developer Statera BioPharma; Tivic Health
  • Class Anti-ischaemics; Antidotes; Antineoplastics; Chemoprotectants; Peptides; Radioprotectives; Recombinant proteins
  • Mechanism of Action Apoptosis inhibitors; NF-kappa B modulators; Toll-like receptor 5 agonists
  • Orphan Drug Status

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

    Yes - Acute radiation syndrome
  • New Molecular Entity Yes

Highest Development Phases

  • Phase III Acute radiation syndrome
  • Phase II Colorectal cancer
  • Phase I Neutropenia
  • Preclinical Radiation injuries
  • No development reported Reperfusion injury; Solid tumours

Most Recent Events

  • 14 May 2025 Tivic Health announces intention to submit BLA to US FDA for Acute radiation syndrome
  • 28 Apr 2025 Phase-I clinical trials in Neutropenia (Parenteral), prior to April 2025 (Tivic Health pipeline, April 2025)
  • 22 Apr 2025 Phase-I development in Acute radiation syndrome is ongoing in USA (IM, Injection)

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