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Rintatolimod - AIM ImmunoTech

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Drug Profile

Rintatolimod - AIM ImmunoTech

Alternative Names: AMP-516; AMP-518; Ampligen; Atvogen; Mismatched double-stranded RNA - AIM ImmunoTech; Poly I:Poly C12U; Poly I:polyC12U; poly(I) poly(C12,U); Rintamod; Vaccine-adjuvant-poly-I-polyC12U; Vaccine-adjuvant-rintatolimod

Latest Information Update: 01 Oct 2025

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At a glance

  • Originator Hemispherx Biopharma
  • Developer AIM ImmunoTech; Centre for Human Drug Research; Erasmus MC; National Cancer Institute (USA); Roswell Park Cancer Institute; United States Army Medical Research Institute of Infectious Diseases; University of Pittsburgh
  • Class Adjuvants; Antineoplastics; Antiretrovirals; Antivirals; Oligonucleotides
  • Mechanism of Action HIV replication inhibitors; Immunostimulants; Interferon stimulants; Ribonuclease 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; Pancreatic cancer; Ebola virus infections; Chronic fatigue syndrome; HIV infections; Malignant melanoma
  • New Molecular Entity Yes
  • Available For Licensing Yes

Highest Development Phases

  • Marketed Chronic fatigue syndrome; HIV infections; Malignant melanoma; Renal cell carcinoma
  • Phase II Colorectal cancer; Pancreatic cancer; Post acute COVID 19 syndrome; Triple negative breast cancer
  • Phase I/II Adenocarcinoma; COVID 2019 infections; Influenza virus infections; Ovarian cancer; Peritoneal cancer
  • Suspended Prostate cancer
  • No development reported Ebola virus infections; Hepatitis B; Influenza A virus infections
  • Discontinued Smallpox; West Nile virus infections; Western equine encephalitis virus infections; Zika virus infection

Most Recent Events

  • 25 Sep 2025 AIM ImmunoTech has patent protection for Rintatolimod in Cancer in Japan
  • 28 Jul 2025 Updated adverse events and efficacy data from a phase Ib/II DURIPANC trial in Adenocarcinoma released by AIM ImmunoTech
  • 19 Jun 2025 Roswell Park Cancer Institute, AIM ImmunoTech, National Cancer Institute and University of Pittsburgh terminates a phase I/II trial in Ovarian cancer (Combination therapy, Neoadjuvant therapy, Second-line therapy or greater, Recurrent, Late-stage disease) in USA (Intraperitoneal), due to lack of funding (NCT02432378)

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