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REVIEW PAPER
Tecovirimat for the treatment of monkeypox: A review of clinical trials
 
 
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1
Katedra Nauk Farmaceutycznych, Uniwersytet Jana Długosza w Częstochowie
 
2
Zakład Badań nad Żywieniem i Lekami, Uniwersytet Jagielloński Collegium Medicum
 
 
Submission date: 2025-08-05
 
 
Final revision date: 2025-10-27
 
 
Acceptance date: 2025-11-26
 
 
Online publication date: 2025-12-18
 
 
Corresponding author
Łukasz Dobrek   

Katedra Nauk Farmaceutycznych, Uniwersytet Jana Długosza w Częstochowie, Polska
 
 
 
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ABSTRACT
Monkeypox (mpox) is a disease caused by infection with the monkeypox virus, which was previously endemic in Africa and has been reported in numerous countries on other continents since 2003. Clinically, patients initially present with lymphadenopathy and flu-like prodromal symptoms, followed by a generalized rash. Mpox infection is also associated with several health complications, including pneumonia, sepsis, encephalitis, and ocular damage. Treatment is primarily symptomatic and involves relieving pain and fever, managing skin lesions, and administering antibiotics for secondary infections. Potential antiviral treatments for mpox include virostatic drugs effective against smallpox viruses. The aim of this study was to identify clinical trials from the last 10 years evaluating the potential efficacy of tecovirimat, brincidofovir, and cidofovir in treating mpox infection, using the PubMed and ClinicalTrials.gov databases. The review revealed that currently ongoing or recruiting studies are exclusively assessing the efficacy and safety of tecovirimat. This drug has demonstrated activity against the mpox virus in preclinical studies using experimental models of the disease induced in nonhuman primates. Tecovirimat's efficacy has also been clinically confirmed in case reports of patients treated with this virostatic agent. However, the results of randomized clinical trials identified during the review are inconsistent. The STOMP and PALM007 trials did not demonstrate a benefit of tecovirimat in patients with mpox, while studies conducted in Italy and Japan indicate clinical efficacy of the drug. Given the inconclusive clinical evaluation of tecovirimat so far, the results of ongoing studies are awaited and should provide further evidence to better assess the role of tecovirimat in the pharmacotherapy of mpox.
eISSN:2545-1898
ISSN:0033-2100
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