Trial reportAntimicrobial agents and chemotherapy2012
Safety and pharmacokinetics of the anti-orthopoxvirus compound ST-246 following a single daily oral dose for 14 days in human volunteers.
Trial report in Antimicrobial agents and chemotherapy, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 31 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
31 citing papers in PubMed, 52 citations in OpenAlex.
- Oral Tecovirimat for the Treatment of Smallpox.The New England journal of medicine · 2018Trial
- A comprehensive overview of monkeypox virus disease.Tropical medicine and health · 2026Review
- Tecovirimat: A journey from discovery to mechanistic insights in poxvirus inhibition.PLoS pathogens · 2025Review
- Mpox: what sexual health physicians need to know?International journal of impotence research · 2024Review
- Bisbenzimide compounds inhibit the replication of prototype and pandemic potential poxviruses.Microbiology spectrum · 2024Article
- Cardiac glycosides inhibit early and late vaccinia virus protein expression.The Journal of general virology · 2024Article
- Clinical and Translational Pharmacology Considerations for Anti-infectives Approved Under the FDA Animal Rule.Clinical pharmacokinetics · 2023Review
- Review
- Monkeypox Virus Infections in Humans.Clinical microbiology reviews · 2022Review
- New Perspectives on Antimicrobial Agents: Tecovirimat for Treatment of Human Monkeypox Virus.Antimicrobial agents and chemotherapy · 2022Review
- Management of patients with monkeypox virus infection and contacts in the community and in healthcare settings: a French position paper.Clinical microbiology and infection : the official publication of the European Society of Clinical Microbiology and Infectious Diseases · 2022Review
- Antiviral Treatment against Monkeypox: A Scoping Review.Tropical medicine and infectious disease · 2022Article
- All That We Need to Know About the Current and Past Outbreaks of Monkeypox: A Narrative Review.Cureus · 2022Review
- Therapeutic strategies to address monkeypox.Expert review of anti-infective therapy · 2022Article
- A Glance at the Development and Patent Literature of Tecovirimat: The First-in-Class Therapy for Emerging Monkeypox Outbreak.Viruses · 2022Review
- Development and Validation of a Method of Liquid Chromatography Coupled with Tandem Mass Spectrometry for Quantification of ST-246 (Tecovirimat) in Human Plasma.Molecules (Basel, Switzerland) · 2022Article
- A PBPK Model of Ternary Cyclodextrin Complex of ST-246 Was Built to Achieve a Reasonable IV Infusion Regimen for the Treatment of Human Severe Smallpox.Frontiers in pharmacology · 2022Article
- An overview of tecovirimat for smallpox treatment and expanded anti-orthopoxvirus applications.Expert review of anti-infective therapy · 2021Review
- Drug Development against Smallpox: Present and Future.Antimicrobial agents and chemotherapy · 2020Review
- The development and approval of tecoviromat (TPOXXAntiviral research · 2019Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
17 authors at 3 institutions in 1 country.
Funding
Abstract
ST-246 is being evaluated as a treatment for pathogenic orthopoxvirus infections in humans. To this end, a phase 2, double-blind, randomized, placebo-controlled, multicenter trial was conducted to assess the safety, tolerability, and pharmacokinetics (PK) of ST-246 when administered as a single daily oral dose (400 mg or 600 mg) for 14 days in fed adult volunteers. ST-246 was safe and well tolerated, with no deaths or serious adverse events reported during the study. There was a low incidence of treatment-emergent adverse events (TEAEs), the most common of which were mild nausea and headache. There were no clinically significant results from laboratory assessments, vital sign measurements, physical examinations, or electrocardiograms. The PK and dose proportionality of ST-246 were determined. The PK analysis showed that steady state was achieved by day 5 for the ST-246 400-mg treatment group and by day 6 for the 600-mg group. The dose proportionality analysis showed that the 400- and 600-mg ratio of dose-normalized peak drug concentration in plasma (C(max)) and relative exposure for each dosing interval (AUC(τ)) ranged from 80% to 85%. However, the 90% confidence intervals did not include 1.0, so dose proportionality could not be concluded. Overall, ST-246 was shown to be safe, and the PK was predictable. These results support further testing of ST-246 in a multicenter pivotal clinical safety study for licensure application.
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.