TPOXX (tecovirimat) / SIGA Technologies - LARVOL DELTA

Clinical Outcomes of Mpox Disease in Patients Treated with Tecovirimat. (PubMed, Clin Infect Dis) - "We described common reasons for tecovirimat initiation and hospitalization. There were racial inequities in hospitalization and treatment delays. More research and focused efforts to mitigate these inequities are needed. These findings may better inform decisions for treatment initiation and hospitalization for mpox."

Clinical data • Journal • Human Immunodeficiency Virus • Infectious Disease

Expanding the antiviral arsenal: N-arylated 1,2,4-oxadiazol-5(4H)-ones show high activity against orthopoxviruses. (PubMed, Eur J Med Chem) - "The synthesized derivatives showed activity higher than that of Cidofovir, although they were less effective than that of Tecovirimate. This work highlights the potential of oxadiazolone-based scaffolds as broad-spectrum antipoxviral agents that meet the unmet need for therapy against emerging and re-emerging orthopoxviral threats."

Journal

Tecovirimat for Severe Mpox Virus Infection in an Immunocompromised Patient. (PubMed, Actas Dermosifiliogr) - No abstract available

Journal • Infectious Disease

Mpox Among Pregnant Women and Their Infants in the U.S. Outbreak, 2022-2023. (PubMed, Obstet Gynecol) - "In this descriptive report of pregnant and recently pregnant women with clade II mpox, there were no adverse maternal outcomes. Two neonates were diagnosed with mpox among 23 pregnancies with known outcomes. There were no reported adverse events related to tecovirimat administration in pregnant mothers."

Journal • Infectious Disease

From neglected to notoriety: a review of Mpox clinical features, virology, epidemiology, treatment and prevention strategies. (PubMed, Eur J Clin Microbiol Infect Dis) - "Mpox has transitioned from a neglected zoonosis to a re-emerging global health threat. Sustained surveillance, robust and targeted public health interventions, and equitable access to diagnostics, vaccines, and antiviral treatments are critical to managing potential future mpox outbreaks."

Journal • Review • Infectious Disease

Monkeypox virus shedding despite tecovirimat treatment in a cohort in Toronto, Canada. (PubMed, J Infect Dis) - "Our findings suggest that tecovirimat does not significantly impact the duration of infectious MPXV shedding from skin lesions, aligning with recent randomized trial results. These findings highlight the need for alternative antiviral strategies and continued genomic surveillance to monitor resistance emergence."

Journal • Infectious Disease

Tecovirimat Is Active against Various MPXV Strains, while Cidofovir, Brincidofovir, Trifluridine, and Gemcitabine Have No Detectable MPXV-Specific Antiviral Activity. (PubMed, Virus Res) - "The EC50 values of CDV, BCV, TFT, and dFdC against MPXVRTEC/A290V were 18, 1.8, 3.8, and 0.02 µM, respectively; however, the apparent anti-MPXV activity of these four agents was highly associated with their cytotoxicity as they were examined with qualitative and quantitative cell-based-morphometric assays. The data strongly show that none the four agents examined exhibited significant anti-MPXV activity and indicate that effective anti-MPXV agents active against wild-type and drug-resistant variants are urgently needed."

Journal

Tecovirimat for Treatment of Monkeypox Virus - Study Extension Providing Standard of Care Only (clinicaltrials.gov) - P=N/A | N=328 | Completed | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Pediatrics

Mpox infection: A state-of-the-art overview of epidemiological, molecular, and clinical aspects following the 2024 public health emergency. (PubMed, J Infect Public Health) - "Although antiviral therapies, such as tecovirimat, cidofovir, and brincidofovir, remain effective, resistance is emerging among immunocompromised patients. Enhanced diagnostics, including WHO-approved rapid molecular tests, along with preventive strategies such as zoonotic risk reduction and equitable vaccine distribution, are critical. Continued genomic monitoring, enhanced global surveillance and interdisciplinary collaboration are essential to prevent future outbreaks and strengthen global preparedness."

Journal • Review • Infectious Disease

A Severe Form of Mpox Infection and the Current Epidemiological Status in Romania. (PubMed, Microorganisms) - "Mpox infection was confirmed through PCR from skin lesion, serum, saliva, urine, rectal, nasal, and pharyngeal swab samples, with high viral loads persisting despite prolonged Tecovirimat therapy. The patient developed immune reconstitution inflammatory syndrome following the initiation of antiretroviral therapy. This case emphasizes the challenges of treating Mpox in immunocompromised patients."

Journal • Candidiasis • Human Immunodeficiency Virus • Infectious Disease • Pneumonia • Pulmonary Disease • Respiratory Diseases • Tuberculosis

A Mini Review on Monkey-Pox: Outbreak, Challenges, and Management Strategies. (PubMed, Infect Disord Drug Targets) - "However, certain medications, such as tecovirimat and cidofovir, as well as specific vaccines (such as MVA-BN), can aid in recovery. A One Health strategy, which encompasses the care of humans, animals, and the environment in a unified approach, is crucial to preventing future outbreaks. To keep everyone safe, we must prepare for and strengthen our response to Mpox."

Journal • Preclinical • Infectious Disease

Mpox: disease manifestations and therapeutic development. (PubMed, J Virol) - "Current antiviral agents, including tecovirimat and brincidofovir, have demonstrated uncertain or disappointing efficacy in preclinical and clinical studies, underscoring the urgent need for further therapeutic development. We highlight the importance of innovative experimental models that can authentically replicate mpox disease manifestations and serve as robust platforms for therapeutic testing. Advancing these research efforts is critical for responding to the ongoing mpox emergency and for sustaining preparedness against future poxvirus epidemics."

Journal • Review • Infectious Disease

EMA Launches Review of Tecovirimat Effectiveness for Mpox (Medscape) - "The European Medicines Agency (EMA) has initiated a review of Tecovirimat SIGA, also called TPOXX, a medicine used to treat mpox...Approval for Tecovirimat SIGA was granted under 'exceptional circumstances' provisions, based only on pharmacodynamic and pharmacokinetic studies, because the disease is rare and sporadic, so human studies were not available...The review follows publication of preliminary results from two clinical trials. In the randomized, placebo-controlled PALM007 trial involving 597 children and adults with laboratory-confirmed clade I mpox in the Democratic Republic of the Congo (DRC), results reported in April in The New England Journal of Medicine showed that the drug did not reduce the duration of mpox lesions (median time to resolution, 7 vs 8 days)...The other trial, STOMP, involved people from multiple countries with mild-to-moderate laboratory-confirmed or presumptive clade II mpox."

EMA filing • Infectious Disease

The Role of Public Health Interventions and Control Measures During Mpox Outbreaks: Enhancing Strategies for Disease Prevention and Management. (PubMed, Public Health Chall) - "Oral and intravenous antivirals like tecovirimat and cidofovir are used only in emergency settings, as the clinical trials on their efficacy are still in progress...ACAM 2000, IMVAMUNE, and Dryvax are the available vaccines. Non-pharmacological interventions like hand hygiene, social distancing, and personal protective equipment can significantly reduce viral transmission, whereas early diagnosis can limit the prevalence by providing timely public health interventions."

Journal • Infectious Disease • Musculoskeletal Pain • Novel Coronavirus Disease • Pain

Tecovirimat for Treatment of Monkeypox Virus - Study Extension Providing Standard of Care Only (clinicaltrials.gov) - P=N/A | N=400 | Active, not recruiting | Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Pediatrics

A Primer on Monkeypox Infection: An Emerging Threat to Global Public Health. (PubMed, Arch Med Res) - "However, antiviral medications, such as tecovirimat, brincidofovir, and cidofovir, as well as vaccinia immune globulin intravenous (VIGIV), are available as therapeutic options. This review emphasizes an overview of the history, etiology, epidemiology, structure, reservoirs, transmission, virus phylogeny, genome organization, clinical cases and symptoms, diagnosis, treatment, and prevention of mpox with recent updates. Therefore, a multifaceted approach is essential and includes improved surveillance, early diagnosis, isolation of index cases, immunization, and adoption of a "One Health" approach to prevent an mpox outbreak."

Journal • Review • Infectious Disease

Tecovirimat at a crossroads: What the PALM007 trial tells us. (PubMed, Med) - "The double-blind, randomized, placebo-controlled PALM007 trial did not report any significant differences between placebo and tecovirimat regarding the time-to-lesion resolution or the virological clearance for the treatment of clade I Mpox virus infection in the Democratic Republic of Congo.1 We discuss how these results compare with other clinical trials and what lessons can be drawn for future therapeutics strategies."

Journal • Infectious Disease

Recent Progress in the Discovery of Anti-Mpox Agents. (PubMed, Med Res Rev) - "As no specific drugs for mpox are available, tecovirimat and brincidofovir for the treatment of smallpox infection are recommended to treat Mpox infection. The purpose of this review is to provide reference for further development of Mpox virus antiviral drugs by summarizing the resolving Mpox virus target protein structures and its mechanism of action, drugs with potential anti-Mpox virus activity, in vitro and in vivo inhibitory activity detection methods of anti-Mpox virus drugs, and the prevention of drug resistance. We hope to facilitate the discovery of antiviral drugs for MPXV by providing insights into the further development of appropriate anti-Mpox drugs based on currently available viral protein targets."

Journal • Review • Infectious Disease

Coinfections with monkeypox virus and varicella-zoster virus: a systematic review of case reports and case series. (PubMed, Arch Virol) - "This review highlights the complex interplay between monkeypox virus and VZV in coinfections, emphasizing the need for heightened awareness, standardized diagnostic protocols, and tailored management strategies. It is important to consider coinfections when making diagnoses, especially in places where mpox is common or in cases in which the patient is at high risk."

Journal • Review • Herpes Zoster • Infectious Disease • Varicella Zoster

Safety profile of tecovirimat in Congolese mpox patients enrolled in a randomized controlled trial (IAS-HIV 2025) - "Although it has not shown superiority over standard treatment, Tecovirimat is safe. The study shows that the basic conditions of patients with MPox and concomitant diseases can lead to unfavorable outcomes and must be taken seriously."

Clinical • Infectious Disease

Tecovirimat for mpox - primary clinical outcome results from the randomized part of the Unity clinical trial (IAS-HIV 2025) - No abstract available

Clinical • Clinical data

Mpox-IRIS in people with HIV: insights from a cohort in Rio de Janeiro, Brazil (IAS-HIV 2025) - "Tecovirimat and steroids were prescribed to four participants... Mpox-IRIS may significantly influence the pathogenesis and prolonged course of mpox. Early ART initiation remains critical for immune recovery and viral clearance. Strengthening HIV care pathways with a focus on early diagnosis and ART adherence is essential for improving outcomes in mpox management."

Human Immunodeficiency Virus • Infectious Disease • Ophthalmology • CD4

Functional characteristics of plitidepsin as an antiviral treatment against monkeypox virus infection. (PubMed, Antiviral Res) - "Additionally, the limited efficacy of current smallpox antivirals, such as Tecovirimat and Brincidofovir, alongside growing concerns about the emergency of tecovirimat resistance mutants, underscores the need for new therapeutic options. These findings indicate plitidepsin as a promising candidate for mpox treatment. Further studies are needed to explore its potential as a standalone or combination therapy, supporting clinical evaluation for mpox treatment."

Journal • Infectious Disease • Oncology • EEF1A1

Concurrent Mpox and HSV-1 Proctitis in a Young Male With AIDS: A Case Report of Treatment Failure. (PubMed, Case Rep Infect Dis) - "Despite initial treatment with oral tecovirimat, acyclovir, and antiretrovirals, the patient's condition worsened, requiring readmission. The patient received intravenous tecovirimat, vaccinia immune globulin, and brincidofovir. Sigmoidoscopy revealed extensive rectal and sigmoid lesions that necessitated prolonged hospitalization and pain management. This case emphasizes the complexity of treating severe coinfections in immunocompromised patients, highlighting the need for a multidisciplinary approach and consideration of alternative therapies when standard treatment fails."

Journal • Human Immunodeficiency Virus • Infectious Disease • Pain • CD4

Recent advances and perspectives in therapeutics for mpox. (PubMed, Bioorg Med Chem Lett) - "Current therapeutic approaches primarily rely on smallpox vaccines and a limited number of broad-spectrum antiviral agents, such as tecovirimat, lacking specific drugs against MPXV...In this review, we summarized the characteristics of MPXV in terms of viral structure, genome, and replication while reporting the recent progress in the development of small molecule anti-MPXV agents. Additionally, we discussed major obstacles in anti-MPXV drug development, including insufficient understanding of virus biology, the lack of reliable disease models, and limited resources for conducting large-scale clinical evaluations, and provided insights and perspectives for anti-MPXV therapies, with the aims of accelerating the development of effective treatments and contributing to preparedness against emerging orthopoxvirus threats."

Journal • Review • Infectious Disease