Efficacy of rintatolimod in the treatment of chronic fatigue syndrome/myalgic encephalomyelitis (CFS/ME)
Open accessAbstract
Chronic fatigue syndrome/ Myalgic encephalomyelitis (CFS/ME) is a poorly understood seriously debilitating disorder in which disabling fatigue is an universal symptom in combination with a variety of variable symptoms. The only drug in advanced clinical development is rintatolimod, a mismatched double stranded polymer of RNA (dsRNA). Rintatolimod is a restricted Toll-Like Receptor 3 (TLR3) agonist lacking activation of other primary cellular inducers of innate immunity (e.g.- cytosolic helicases). Rintatolimod also activates interferon induced proteins that require dsRNA for activity (e.g.- 2'-5' adenylate synthetase, protein kinase R). Rintatolimod has achieved statistically significant improvements in primary endpoints in Phase II and Phase III double-blind, randomized, placebo-controlled clinical trials with a generally well tolerated safety profile and supported by open-label trials in the United States and Europe. The chemistry, mechanism of action, clinical trial data, and current regulatory status of rintatolimod for CFS/ME including current evidence for etiology of the syndrome are reviewed.
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Rintatolimod (ampligen), a specific activator of inflammatory mediator toll-like receptor 3, has been deployed in ME/CFS treatment for decades, with varying efficacy.
“Rintatolimod (ampligen), a specific activator of inflammatory mediator toll-like receptor 3 (TLR3) has been deployed in ME/CFS treatment for decades, with varying efficacy11,12.”
From Leveraging Prior Knowledge of Endocrine Immune Regulation in the Therapeutically-relevant Phenotyping of Women with Chronic Fatigue Syndrome (2019) · cites this paper as [12]
Rintatolimod is sometimes effective in ME/CFS, but a means of identifying good candidates for this treatment remains elusive.
“Likewise, rintatolimod (Ampligen) is sometimes effective11,12, but a means of identifying good candidates for this course of treatment remains similarly elusive.”
From Leveraging Prior Knowledge of Endocrine Immune Regulation in the Therapeutically-relevant Phenotyping of Women with Chronic Fatigue Syndrome (2019) · cites this paper as [12]
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Frémont, M., Vaeyens, F., Herst, C. V., et al. (2005) · Clinical and Vaccine Immunology · doi:10.1128/cdli.12.10.1259-1260.2005 · Cited by 2 · see citing works
Erim (1996) · doi:10.1002/(sici)1097-4598(199605)19:5
Flagged first, then by citations
Research works printed but not linked: 1
- Strauss KI. Elimination and degradation of AMPLIGEN (poly I: polyC12U) in humans after intravenous infusion Ph.D. thesis Philadelphia (PA) Hahnemann University 1991
Cited by
Sorted by citations
Morris, M. C., Cooney, K. E., Sedghamiz, H., Abreu, M., Collado, F., Balbin, E. G., Craddock, T. J. A., Klimas, N. G., Broderick, G., & Fletcher, M. A. (2019) · Clinical Therapeutics · doi:10.1016/j.clinthera.2019.03.002 · Cited by 14 · see citing works
- Authors
- Mitchell, W. M.
- Affiliations
- Vanderbilt University (US)
- Corresponding author
- Mitchell, William M
- ORCID
- Mitchell, William M
- Venue
- Expert Review of Clinical Pharmacology
- Publisher
- Informa UK Limited
- Published
- 2016-05-25
- Volume
- 9
- Issue
- 6
- Pages
- 755-770
- ISSN
- 1751-2433 (ISSN-L)
- 1751-2441
- PMC
- PMC4917909
- OpenAlex
- W2321182980
- Cited by
- 57
- References
- 92
- Citations by year
- 2026: 4 · 2025: 5 · 2024: 8 · 2023: 10 · 2022: 10 · 2021: 7 · 2020: 3 · 2019: 5 · 2018: 1 · 2017: 4
- FWCI
- 0.48
- Type
- journal article
- Language
- en
- Open access
- hybrid
- doi.org
- Licence
- Locations
- Expert Review of Clinical Pharmacology (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- Figshare (submittedVersion, cc-by)
- Figshare (cc-by)
- Topics
- Health Sciences › Medicine › Psychiatry and Mental health › Fibromyalgia and Chronic Fatigue Syndrome Research
- Health Sciences › Medicine › Neurology › Long-Term Effects of COVID-19
- Health Sciences › Medicine › Gastroenterology › Gastrointestinal motility and disorders
- Keywords
- chronic fatigue syndrome, double-stranded RNA, Toll-like receptor 3 agonist, innate immunity, 2',5'-oligoadenylate synthetase, PKR, drug efficacy, drug safety, regulatory status
- MeSH terms
- Animals, Humans, Immunity, Innate, Poly I-C, Poly U, RNA, Double-Stranded, Fatigue Syndrome, Chronic, Randomized Controlled Trials as Topic, Toll-Like Receptor 3
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
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