Rintatolimod - Hemispherx Biopharma

Drug Profile

Rintatolimod - Hemispherx Biopharma

Alternative Names: Ampligen; Mismatched double-stranded RNA - Hemispherx Biopharma; Poly I:Poly C12U; Poly I:polyC12U; poly(I) poly(C12,U); Rintamod

Latest Information Update: 20 Apr 2018

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At a glance

  • Originator Hemispherx Biopharma
  • Developer Hemispherx Biopharma; Roswell Park Cancer Institute; United States Army Medical Research Institute of Infectious Diseases; University of Pittsburgh
  • Class Adjuvants; Antivirals; Nucleotides; RNA
  • Mechanism of Action Interferon stimulants; RNA synthesis inhibitors; Toll-like receptor 3 agonists; VP35 protein inhibitors
  • Orphan Drug Status

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

    Yes - Renal cell carcinoma; Ebola virus infections; HIV infections; Chronic fatigue syndrome; Malignant melanoma
  • New Molecular Entity Yes
  • Available For Licensing Yes - Chronic fatigue syndrome

Highest Development Phases

  • Registered Chronic fatigue syndrome
  • Phase I/II Breast cancer; Colorectal cancer; Influenza virus infections; Ovarian cancer; Peritoneal cancer
  • Clinical Phase Unknown Pancreatic cancer
  • Preclinical Ebola virus infections; West Nile virus infections; Zika virus infection
  • Research Coronavirus infections; Influenza A virus infections
  • Suspended HIV infections
  • No development reported Hepatitis B; Malignant melanoma; Renal cell carcinoma
  • Discontinued Smallpox; Western equine encephalitis virus infections

Most Recent Events

  • 17 Apr 2018 US FDA approves a Compassionate Care Programme for Myalgic encephalomyelitis/Chronic fatigue syndrome before April 2018
  • 17 Apr 2018 Hemispherx Biopharma plans a Compassionate Care Programme for Myalgic encephalomyelitis/Chronic fatigue syndrome (ME/CFS) in USA
  • 04 Apr 2018 Hemispherx amends its agreement with myTomorrows to expands rintatolimod Early Access Programme for Chronic fatigue syndrome to Canada
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