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Naltrexone - Biostax/Statera BioPharma

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Drug Profile

Naltrexone - Biostax/Statera BioPharma

Alternative Names: CYTO 201; CYTO-201 - Biostax; CYTO-205; IRT-103; IRT-104; LDN - Biostax; Lodonal; Low-dose naltrexone - Biostax; STAT 201; STAT 205; STAT-200 AIMS™; STAT-200: noroxymorphone-n-substituted-methyl cyclopropyl analogs

Latest Information Update: 28 Jan 2025

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At a glance

  • Originator Nonindustrial source
  • Developer Biostax; GB Pharma Holdings; Penn State Milton S. Hershey Medical Center; Statera BioPharma
  • Class Anti-inflammatories; Antineoplastics; Antivirals; Cyclopropanes; Drug withdrawal therapies; Ethers; Eye disorder therapies; Irritable bowel syndrome therapies; Ketones; Morphinans; Non-opioid analgesics; Small molecules
  • Mechanism of Action Opioid receptor antagonists; Virus replication inhibitors
  • Orphan Drug Status

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

    Yes - Ulcerative colitis; Crohn's disease
  • New Molecular Entity No
  • Available For Licensing Yes

Highest Development Phases

  • Marketed Autoimmune disorders; Cancer
  • Registered HIV infections
  • Phase II Crohn's disease
  • No development reported Cervical cancer; COVID 2019 infections

Most Recent Events

  • 28 Jan 2025 No recent reports of development identified for phase-I development in COVID-2019-infections in USA (PO, Capsule)
  • 29 Aug 2023 Biostax Corp signs a research collaboration agreement with Immgenuity to focus on using naltrexone and JKB 122 with Immgenuity’s IMTV014 both independently and together to achieve remission with HIV patients
  • 20 Apr 2023 Statera Biopharma amends royalty-bearing license agreement with Biostax for the rights to low dose naltrexone

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