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Jordan R, Leeds JM, Tyavanagimatt S, Hruby DE. Development of ST-246® for Treatment of Poxvirus Infections. Viruses. 2010 Nov;2(11):2409–35.
Jordan R, Chinsangaram J, Bolken TC, Tyavanagimatt SR, Tien D, Jones KF, et al. Safety and pharmacokinetics of the antiorthopoxvirus compound ST-246 following repeat oral dosing in healthy adult subjects. Antimicrob Agents Chemother. 2010 Jun;54(6):2560–6.
Chinsangaram J, Honeychurch KM, Tyavanagimatt SR, Bolken TC, Jordan R, Jones KF, et al. Pharmacokinetic comparison of a single oral dose of polymorph form i versus form V capsules of the antiorthopoxvirus compound ST-246 in human volunteers. Antimicrob Agents Chemother. 2012 Jul;56(7):3582–6.
Jordan R, Tien D, Bolken TC, Jones KF, Tyavanagimatt SR, Strasser J, et al. Single-dose safety and pharmacokinetics of ST-246, a novel orthopoxvirus egress inhibitor. Antimicrob Agents Chemother. 2008 May;52(5):1721–7.
Chinsangaram J, Honeychurch KM, Tyavanagimatt SR, Leeds JM, Bolken TC, Jones KF, et al. Safety and pharmacokinetics of the anti-orthopoxvirus compound ST-246 following a single daily oral dose for 14 days in human volunteers. Antimicrob Agents Chemother. 2012 Sep;56(9):4900–5.
Grosenbach DW, Honeychurch K, Rose EA, Chinsangaram J, Frimm A, Maiti B, et al. Oral Tecovirimat for the Treatment of Smallpox. N Engl J Med. 2018 Jul;379(1):44–53.
Adler H, Gould S, Hine P, Snell LB, Wong W, Houlihan CF, et al. Clinical features and management of human monkeypox: a retrospective observational study in the UK. Lancet Infect Dis [Internet]. 2022 Jun 2; Available from: https://doi.org/10.1016/S1473-3099(22)00228-6
EMA EMA. Tecovirimat SIGA [Internet]. Available from: https://www.ema.europa.eu/en/medicines/human/EPAR/tecovirimat-siga
FDA. U.S. Food and Drug Administration. FDA approves the first drug with an indication for treatment of smallpox [Internet]. Available from: https://www.fda.gov/news-events/press-announcements/fda-approves-first- drug-indication-treatment-smallpox
Shchelkunov SN. Orthopoxvirus genes that mediate disease virulence and host tropism. Adv. Virol. 2012, 524743. 2012.
Jordan R, Goff A, Frimm A, Corrado ML, Hensley LE, Byrd CM, et al. ST-246 antiviral efficacy in a nonhuman primate monkeypox model: determination of the minimal effective dose and human dose justification. Antimicrob Agents Chemother. 2009 May;53(5):1817–22.
Hill QA, Harrison LC, Padmakumar AD, Owen RG, Prasad KR, Lucas GF, et al. A fatal case of transplantation-mediated alloimmune thrombocytopenia following liver transplantation. Hematology [Internet]. 2017;22(3):162–7. Available from: https://www.embase.com/search/results?subaction=viewrecord&id=L612885 313&from=export
Leeds JM, Fenneteau F, Gosselin NH, Mouksassi M-S, Kassir N, Marier JF, et al. Pharmacokinetic and pharmacodynamic modeling to determine the dose of ST-246 to protect against smallpox in humans. Antimicrob Agents Chemother. 2013 Mar;57(3):1136–43.
FDA. U.S. Food and Drug Administration. Product Development Under the Animal Rule [Internet]. Available from: https://www.fda.gov/regulatory- information/search-fda-guidance-documents/product-development-under- animal-rule
Drug I, Limited HR. Register Of Innovative Drugs Products for Human Use - Active Data Protection Period Register Of Innovative Drugs Products for Human Use - Active Data Protection Period [Internet]. 2023. p. 1–40. Available from: https://www.canada.ca/content/dam/hc- sc/documents/services/drugs-health-products/drug-products/applications- submissions/register-innovative-drugs/reg-innov-dr-eng.pdf
GlobeNewswire. SIGA Announces Health Canada Regulatory Approval of Oral TPOXX® [Internet]. 2021. Available from: https://www.globenewswire.com/news- release/2021/12/01/2344305/9738/en/SIGA-Announces-Health-Canada- Regulatory-Approval-of-Oral-TPOXX.html