{{Short description|Antiviral medication}} {{Use dmy dates|date=March 2023}} {{Drugbox | verifiedrevid = | drug_name = | INN = | type = <!-- empty --> | image = Tecovirimat structure.svg | image_class = skin-invert-image | width = 300 | alt = | caption =
<!-- Clinical data --> | pronounce = | tradename = Tpoxx | Drugs.com = {{drugs.com|monograph|tecovirimat}} | MedlinePlus = | licence_CA = <!-- Health Canada may use generic or brand name (generic name preferred) --> | licence_EU = <!-- EMA uses INN (or special INN_EMA) --> | DailyMedID = Tecovirimat | licence_US = <!-- FDA may use generic or brand name (generic name preferred) --> | pregnancy_AU = <!-- A/B1/B2/B3/C/D/X --> | pregnancy_AU_comment = | pregnancy_category= | routes_of_administration = By mouth, intravenous | class = | ATCvet = | ATC_prefix = J05 | ATC_suffix = AX24 | ATC_supplemental =
<!-- Legal status --> | legal_AU = <!-- S2, S3, S4, S5, S6, S7, S8, S9 or Unscheduled --> | legal_AU_comment = | legal_BR = <!-- OTC, A1, A2, A3, B1, B2, C1, C2, C3, C4, C5, D1, D2, E, F --> | legal_BR_comment = | legal_CA = Rx-only | legal_CA_comment = <ref name="auto">{{cite web | title=Notice: Multiple Additions to the Prescription Drug List (PDL) [2022-01-24] | website=Health Canada | date=24 January 2022 | url=https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/prescription-drug-list/notices-changes/multiple-additions-2022-01-24.html | access-date=28 May 2022 | archive-date=29 May 2022 | archive-url=https://web.archive.org/web/20220529183045/https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/prescription-drug-list/notices-changes/multiple-additions-2022-01-24.html | url-status=live }}</ref><ref>{{cite web | title=New Medicines Approved in 2018 | website=Health Canada | date=15 January 2020 | url=https://www.canada.ca/en/patented-medicine-prices-review/services/npduis/analytical-studies/meds-entry-watch-2018/new-medicines-approved-2018.html | access-date=28 May 2022 | archive-date=29 May 2022 | archive-url=https://web.archive.org/web/20220529015241/https://www.canada.ca/en/patented-medicine-prices-review/services/npduis/analytical-studies/meds-entry-watch-2018/new-medicines-approved-2018.html | url-status=live }}</ref><ref>{{cite web | title=Summary Basis of Decision (SBD) for Tpoxx | website=Health Canada | date=23 October 2014 | url=https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00578&lang=en | access-date=29 May 2022 | archive-date=29 May 2022 | archive-url=https://web.archive.org/web/20220529192839/https://hpr-rps.hres.ca/reg-content/summary-basis-decision-detailTwo.php?linkID=SBD00578&lang=en | url-status=live }}</ref> | legal_DE = <!-- Anlage I, II, III or Unscheduled --> | legal_DE_comment = | legal_NZ = <!-- Class A, B, C --> | legal_NZ_comment = | legal_UK = <!-- GSL, P, POM, CD, CD Lic, CD POM, CD No Reg POM, CD (Benz) POM, CD (Anab) POM or CD Inv POM / Class A, B, C --> | legal_UK_comment = | legal_US = Rx-only | legal_US_comment = <ref name="Tpoxx FDA label">{{cite web | title=Tpoxx- tecovirimat monohydrate capsule | website=DailyMed | date=2 December 2021 | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fce826ab-4d6a-4139-a2ee-a304a913a253 | access-date=23 April 2022 | archive-date=23 April 2022 | archive-url=https://web.archive.org/web/20220423230712/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fce826ab-4d6a-4139-a2ee-a304a913a253 | url-status=live }}</ref> | legal_EU = Rx-only | legal_EU_comment = <ref name="Tecovirimat SIGA EPAR" /> | legal_UN = <!-- N I, II, III, IV / P I, II, III, IV --> | legal_UN_comment = | legal_status = <!-- For countries not listed above -->
<!-- Pharmacokinetic data --> | bioavailability = | protein_bound = | metabolism = | metabolites = | onset = | elimination_half-life = | duration_of_action = | excretion =
<!-- Identifiers --> | index2_label = as monohydrate | CAS_number = 869572-92-9 | CAS_supplemental = | PubChem = 16124688 | IUPHAR_ligand = | DrugBank = DB12020 | ChemSpiderID_Ref = {{chemspidercite|correct|chemspider}} | ChemSpiderID = 17281586 | UNII_Ref = {{fdacite|correct|FDA}} | UNII = F925RR824R | KEGG_Ref = {{keggcite|correct|kegg}} | KEGG = D09390 | KEGG2_Ref = {{keggcite|correct|kegg}} | KEGG2 = D11557 | ChEBI = | ChEMBL_Ref = {{ebicite|correct|EBI}} | ChEMBL = 1257073 | NIAID_ChemDB = | PDB_ligand = | synonyms = ST-246
<!-- Chemical and physical data --> | IUPAC_name = ''N''-[(1''R'',2''R'',6''S'',7''S'',8''S'',10''R'')-3,5-Dioxo-4-azatetracyclo[5.3.2.0<sup>2,6</sup>.0<sup>8,10</sup>]dodec-11-en-4-yl]-4-(trifluoromethyl)benzamide | C=19 | H=15 | F=3 | N=2 | O=3 | SMILES = FC(F)(F)c1ccc(cc1)C(=O)NN1C(=O)C2C(C3C=CC2C2CC32)C1=O | StdInChI_Ref = {{stdinchicite|correct|chemspider}} | StdInChI = 1S/C19H15F3N2O3/c20-19(21,22)9-3-1-8(2-4-9)16(25)23-24-17(26)14-10-5-6-11(13-7-12(10)13)15(14)18(24)27/h1-6,10-15H,7H2,(H,23,25) | StdInChI_comment = | StdInChIKey_Ref = {{stdinchicite|correct|chemspider}} | StdInChIKey = CSKDFZIMJXRJGH-UHFFFAOYSA-N | density = | density_notes = | melting_point = | melting_high = | melting_notes = | boiling_point = | boiling_notes = | solubility = | sol_units = | specific_rotation = }}
'''Tecovirimat''', sold under the brand name '''Tpoxx''' among others,<ref name="nyt-2018-07">{{cite news |vauthors=McNeil Jr DG |title=Drug to Treat Smallpox Approved by F.D.A., a Move Against Bioterrorism |url=https://www.nytimes.com/2018/07/13/health/smallpox-drug-fda-bioterrorism.html |website=The New York Times |date=13 July 2018 |access-date=16 July 2018 |archive-date=28 March 2019 |archive-url=https://web.archive.org/web/20190328145843/https://www.nytimes.com/2018/07/13/health/smallpox-drug-fda-bioterrorism.html |url-status=live }}</ref> is an antiviral medication with activity against orthopoxviruses such as smallpox and mpox.<ref name="Tpoxx FDA label" /><ref>{{cite journal | vauthors = Nakoune E, Olliaro P | title = Waking up to monkeypox | journal = BMJ | volume = 377 | article-number = o1321 | date = May 2022 | pmid = 35613732 | doi = 10.1136/bmj.o1321 | s2cid = 249047112 | doi-access = free }}</ref><ref>{{cite journal | vauthors = Adler H, Gould S, Hine P, Snell LB, Wong W, Houlihan CF, Osborne JC, Rampling T, Beadsworth MB, Duncan CJ, Dunning J, Fletcher TE, Hunter ER, Jacobs M, Khoo SH, Newsholme W, Porter D, Porter RJ, Ratcliffe L, Schmid ML, Semple MG, Tunbridge AJ, Wingfield T, Price NM | display-authors = 6 | title = Clinical features and management of human monkeypox: a retrospective observational study in the UK | journal = The Lancet. Infectious Diseases | date = May 2022 | volume = 22 | issue = 8 | pages = 1153–1162 | pmid = 35623380 | doi = 10.1016/S1473-3099(22)00228-6 | pmc = 9300470 | s2cid = 249057804 }}</ref> In 2018 it was the first antipoxviral drug approved in the United States.
The drug works by blocking cellular transmission of orthopoxviruses, thus preventing disease.<ref name="NEJMoa1705688">{{cite journal | vauthors = Grosenbach DW, Honeychurch K, Rose EA, Chinsangaram J, Frimm A, Maiti B, Lovejoy C, Meara I, Long P, Hruby DE | display-authors = 6 | title = Oral Tecovirimat for the Treatment of Smallpox | journal = The New England Journal of Medicine | volume = 379 | issue = 1 | pages = 44–53 | date = July 2018 | pmid = 29972742 | pmc = 6086581 | doi = 10.1056/NEJMoa1705688 }}</ref>
Tecovirimat has been effective in laboratory testing; it has been shown to protect animals from mpox and rabbitpox and causes no serious side effects in humans.<ref name="nyt-2018-07" /> Tecovirimat was first used for treatment in December 2018, after a laboratory-acquired vaccinia virus infection.<ref>{{cite journal | vauthors = Whitehouse ER, Rao AK, Yu YC, Yu PA, Griffin M, Gorman S, Angel KA, McDonald EC, Manlutac AL, de Perio MA, McCollum AM, Davidson W, Wilkins K, Ortega E, Satheshkumar PS, Townsend MB, Isakari M, Petersen BW | display-authors = 6 | title = Novel Treatment of a Vaccinia Virus Infection from an Occupational Needlestick - San Diego, California, 2019 | journal = MMWR. Morbidity and Mortality Weekly Report | volume = 68 | issue = 42 | pages = 943–946 | date = October 2019 | pmid = 31647789 | pmc = 6812835 | doi = 10.15585/mmwr.mm6842a2 | url = https://www.cdc.gov/mmwr/volumes/68/wr/pdfs/mm6842a2-H.pdf | access-date = 2 August 2022 | archive-date = 2 August 2022 | archive-url = https://web.archive.org/web/20220802054811/https://www.cdc.gov/mmwr/volumes/68/wr/pdfs/mm6842a2-H.pdf | url-status = live }}</ref>
As of 2014 two million doses of tecovirimat were stockpiled in the US Strategic National Stockpile should an orthopoxvirus-based bioterror attack occur.<ref>{{cite journal | vauthors = Damon IK, Damaso CR, McFadden G | title = Are we there yet? The smallpox research agenda using variola virus | journal = PLOS Pathogens | volume = 10 | issue = 5 | article-number = e1004108 | date = May 2014 | pmid = 24789223 | pmc = 4006926 | doi = 10.1371/journal.ppat.1004108 | doi-access = free }}</ref><ref>{{cite web|url=https://www.sciencenews.org/article/first-smallpox-treatment-one-step-closer-fda-approval|title=FDA approves the first smallpox treatment| vauthors = Cunningham A |date=13 July 2018|access-date=4 May 2018|archive-date=12 July 2018|archive-url= https://web.archive.org/web/20180712230149/https://www.sciencenews.org/article/first-smallpox-treatment-one-step-closer-fda-approval|url-status=live }}</ref> The U.S. Food and Drug Administration (FDA) considers it to be a first-in-class medication.<ref>{{cite report | title=New Drug Therapy Approvals 2018 | website=U.S. Food and Drug Administration (FDA) | date=January 2019 | url=https://www.fda.gov/media/120357/download | format=PDF | access-date=16 September 2020 | archive-date=17 September 2020 | archive-url=https://web.archive.org/web/20200917055627/https://www.fda.gov/media/120357/download | url-status=dead }}</ref>
== Medical uses == In the United States, tecovirimat is indicated for the treatment of human smallpox disease.<ref name="Tpoxx FDA label" /><ref>{{cite journal | last=Jordan | first=R. | title=An overview of tecovirimat for smallpox treatment and expanded anti-orthopox use | journal=Expert Review of Anti-infective Therapy | volume=20 | year=2022 | issue=3 | pages=901–913 | doi=10.1080/14787210.2020.1819791 | pmid=32882158 | pmc=9491074}}</ref>
In the European Union it is indicated for the treatment of smallpox, mpox, and cowpox.<ref name="Tecovirimat SIGA EPAR" /> Tecovirimat can be taken by mouth and should be taken with a fatty meal.<ref name="cdc" /> While tecovirimat did not show efficacy against mpox in monotherapy in clinical setting, in vitro assays showed strong inhibition of both vaccinia and mpox in combination therapies.<ref>{{Cite journal | vauthors = Witwit H, Cubitt B, Khafaji R, Castro EM, Goicoechea M, Lorenzo MM, Blasco R, Martinez-Sobrido L, de la Torre JC |date=January 2025 |title=Repurposing Drugs for Synergistic Combination Therapies to Counteract Monkeypox Virus Tecovirimat Resistance |journal=Viruses |language=en |volume=17 |issue=1 |page=92 |doi=10.3390/v17010092 |doi-access=free |pmid=39861882 |issn=1999-4915|pmc=11769280 }}</ref>
==Mechanism of action== Tecovirimat inhibits the function of orthopoxvirus VP37 envelope wrapping protein,<ref name="Tpoxx FDA label" /> a major envelope protein required for the production of extracellular virus. Tecovirimat acts as a molecular glue that promotes the dimerization of VP37.<ref name="Vernuccio et al 2025">{{cite journal |vauthors=Vernuccio R, Martínez León A, Poojari CS, etal |title=Structural insights into tecovirimat antiviral activity and poxvirus resistance |journal=Nature Microbiology |volume=10 |pages=734–748 |date=2025 |issue=3 |doi=10.1038/s41564-025-01936-6|pmid=39939832 |pmc=11879855 }}</ref> The drug prevents the virus from leaving an infected cell, hindering the spread of the virus within the body.<ref>{{cite journal |vauthors=Yang G, Pevear DC, Davies MH, Collett MS, Bailey T, Rippen S, Barone L, Burns C, Rhodes G, Tohan S, Huggins JW, Baker RO, Buller RL, Touchette E, Waller K, Schriewer J, Neyts J, DeClercq E, Jones K, Hruby D, Jordan R |display-authors=6 |title=An orally bioavailable antipoxvirus compound (ST-246) inhibits extracellular virus formation and protects mice from lethal orthopoxvirus Challenge |journal=Journal of Virology |volume=79 |issue=20 |pages=13139–13149 |date=October 2005 |pmid=16189015 |pmc=1235851 |doi=10.1128/JVI.79.20.13139-13149.2005}}</ref>
Antimicrobial resistance to tecovirimat was described in vitro in cowpox virus during treatment already in 2005, prior to licensure.<ref name="cdc">{{Cite journal |last=Gigante |first=Crystal M. |date=2024 |title=Notes from the Field: Mpox Cluster Caused by Tecovirimat-Resistant Monkeypox Virus — Five States, October 2023–February 2024 |journal=MMWR. Morbidity and Mortality Weekly Report |language=en-us |volume=73 |issue=40 |pages=903–905 |doi=10.15585/mmwr.mm7340a3 |pmid=39388389 |issn=0149-2195|pmc=11466377 }}</ref> Since the global 2022–2023 mpox outbreak, resistance has been described with long treatment courses among severely immunocompromised persons, but also in people without prior treatment, suggesting human-to-human transmission.<ref name="cdc" /> Tecovirimat resistance mutations identified in clinical MPXV isolates map to the VP37 dimer interface and prevent drug-induced dimerization.<ref name="Vernuccio et al 2025" />
==Chemistry== The first synthesis of tecovirimat was published in a patent filed by scientists at SIGA Technologies in 2004. It is made in two steps from cycloheptatriene.<ref name=AUpatent>{{cite patent |country=AU |number=2004249250|status=patent |pubdate=2004-12-29 |fdate=2004-06-18 |pridate=2003-06-20 |invent1 = Bailey, Thomas R. |invent2 = Jordan, Robert |invent3 = Rippin, Susan R. |title=Compounds, compositions and methods for treatment and prevention of orthopoxvirus infections and associated diseases |assign1=SIGA Pharmaceuticals Inc }}</ref>
:650px
A Diels–Alder reaction of cycloheptatriene with maleic anhydride forms the main ring system<ref>{{cite journal |doi=10.1246/bcsj.44.2993 |doi-access=free |title=Re-examination of the Cycloaddition of Cycloheptatriene with Maleic Anhydride |year=1971 | vauthors = Ishitobi H, Tanida H, Tori K, Tsuji T |journal=Bulletin of the Chemical Society of Japan |volume=44 |issue=11 |pages=2993–3000 }}</ref> and then in the second step a reaction with 4-trifluormethylbenzhydrazide gives the cyclic imide of the drug.<ref name=AUpatent/><ref>{{cite journal |doi=10.1021/acs.oprd.9b00144 |title=Review of the Patent Literature: Synthesis and Final Forms of Antiviral Drugs Tecovirimat and Baloxavir Marboxil |year=2019 | vauthors = Hughes DL |journal=Organic Process Research & Development |volume=23 |issue=7 |pages=1298–1307 |s2cid=197172102 }}</ref>
==History== Originally researched by the National Institute of Allergy and Infectious Diseases, the drug was owned by Viropharma and discovered in collaboration with scientists at the United States Army Medical Research Institute of Infectious Diseases. It is owned and manufactured by SIGA Technologies.<ref>{{cite journal |vauthors=Brown B, Fricke I, Imarogbe C, González AA, Batista OA, Mensah P, Chacon-Cruz E |date=21 November 2023 |title=Immunopathogenesis of ''Orthopoxviridae'': insights into immunology from smallpox to monkeypox (mpox) |journal=Explor Immunol |volume=3 |pages=525–553 |doi=10.37349/ei.2023.00119|doi-access=free }}</ref> SIGA and Viropharma were issued a patent for tecovirimat in 2012.<ref>{{US patent|8124643}}</ref>
=== Clinical trials === As of 2009, the results of clinical trials supported its use against smallpox and other related orthopoxviruses. It showed potential for a variety of uses including preventive healthcare, as a post-exposure therapeutic, as a therapeutic, and an adjunct to vaccination.<ref>{{Cite web |url=http://www.siga.com/index.php?ID=9 |title=SIGA Technologies |access-date=18 September 2009 |archive-date=20 February 2012 |archive-url=https://web.archive.org/web/20120220165844/http://www.siga.com/index.php?ID=9 }}</ref>
As of 2008, it was permitted for phase II trials by the U.S. Food and Drug Administration (FDA). In phase I trials, tecovirimat was generally well tolerated with no serious adverse events.<ref>{{cite journal | vauthors = Jordan R, Tien D, Bolken TC, Jones KF, Tyavanagimatt SR, Strasser J, Frimm A, Corrado ML, Strome PG, Hruby DE | display-authors = 6 | title = Single-dose safety and pharmacokinetics of ST-246, a novel orthopoxvirus egress inhibitor | journal = Antimicrobial Agents and Chemotherapy | volume = 52 | issue = 5 | pages = 1721–1727 | date = May 2008 | pmid = 18316519 | pmc = 2346641 | doi = 10.1128/AAC.01303-07 }}</ref> Due to its importance for biodefense, the FDA designated tecovirimat for fast-track status, creating a path for expedited FDA review and eventual regulatory approval. In July 2018, the FDA approved tecovirimat for the treatment of smallpox.<ref>{{cite web|url=https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm613496.htm|title=Press Announcements - FDA approves the first drug with an indication for treatment of smallpox| author = Office of the Commissioner |website= Food and Drug Administration (FDA)|date=24 March 2020|access-date=14 July 2018|archive-date=23 April 2019|archive-url=https://web.archive.org/web/20190423072008/https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm613496.htm|url-status=dead}}</ref> the first antipoxviral drug approved in the United States.<ref>{{cite press release |title=FDA approves the first drug with an indication for treatment of smallpox |url=https://www.fda.gov/news-events/press-announcements/fda-approves-first-drug-indication-treatment-smallpox |website=U.S. Food and Drug Administration (FDA) |access-date=1 August 2018 |date=13 July 2018 |archive-date=23 April 2019 |archive-url=https://web.archive.org/web/20190423072008/https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm613496.htm |url-status=dead }}</ref><ref>{{cite press release|url=https://investor.siga.com/news-releases/news-release-details/us-food-and-drug-administration-approves-siga-technologies|title=U.S. Food and Drug Administration Approves Siga Technologies' Tpoxx (tecovirimat) for the Treatment of Smallpox|website=SIGA|access-date=14 July 2018|archive-date=21 September 2018|archive-url=https://web.archive.org/web/20180921045623/http://investor.siga.com/news-releases/news-release-details/us-food-and-drug-administration-approves-siga-technologies|url-status=live}}</ref> In August 2022, the AIDS Clinical Trials Group (ACTG) began a randomized, placebo-controlled, double-blinded trial on the safety and efficacy of tecovirimat for mpox, known as STOMP (Study of Tecovirimat for Human mpox Virus), aiming to enroll at least 500 participants with acute mpox infection.<ref>{{Cite web |last=National Institute of Allergy and Infectious Diseases (NIAID) |date=12 September 2022 |others=SIGA Technologist |title=A Randomized, Placebo-Controlled, Double-Blinded Trial of the Safety and Efficacy of Tecovirimat for the Treatment of Human Monkeypox Virus Disease |url=https://clinicaltrials.gov/ct2/show/NCT05534984 |access-date=16 September 2022 |archive-date=20 September 2022 |archive-url=https://web.archive.org/web/20220920163558/https://clinicaltrials.gov/ct2/show/NCT05534984 |url-status=live }}</ref><ref>{{Cite web |title=Trial Launching to Study Tecovirimat as Monkeypox Treatment |url=https://www.contagionlive.com/view/trial-launching-to-study-tecovirimat-as-monkeypox-treatment |access-date=16 September 2022 |website=Contagion Live |date=16 September 2022 |language=en |archive-date=16 September 2022 |archive-url=https://web.archive.org/web/20220916154518/https://www.contagionlive.com/view/trial-launching-to-study-tecovirimat-as-monkeypox-treatment |url-status=live }}</ref>
== Society and culture == === Legal status === In November 2021, the Committee for Medicinal Products for Human Use of the European Medicines Agency recommended to grant SIGA Technologies Netherlands B.V a marketing authorization under exceptional circumstances for tecovirimat, intended to treat orthopoxvirus disease (smallpox, mpox, cowpox, and vaccinia complications) in adults and in children who weigh at least {{convert|13|kg|lb}}<ref name="Tecovirimat SIGA: Pending EC decision">{{cite web | title=Tecovirimat SIGA: Pending EC decision | website=European Medicines Agency | date=11 November 2021 | url=https://www.ema.europa.eu/en/medicines/human/summaries-opinion/tecovirimat-siga | access-date=13 November 2021 | archive-date=13 November 2021 | archive-url=https://web.archive.org/web/20211113051720/https://www.ema.europa.eu/en/medicines/human/summaries-opinion/tecovirimat-siga | url-status=live }} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.</ref> Tecovirimat was approved for medical use in the European Union in January 2022.<ref name="Tecovirimat SIGA EPAR">{{cite web | title=Tecovirimat SIGA EPAR | website=European Medicines Agency | date=10 November 2021 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/tecovirimat-siga | access-date=23 April 2022 | archive-date=16 May 2022 | archive-url=https://web.archive.org/web/20220516151355/https://www.ema.europa.eu/en/medicines/human/EPAR/tecovirimat-siga | url-status=live }} Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.</ref><ref>{{cite web |title=Summary of Product Characteristics |url=https://www.ema.europa.eu/en/documents/product-information/tecovirimat-siga-epar-product-information_en.pdf |website=European Medicines Agency |access-date=24 May 2022 |archive-date=21 May 2022 |archive-url=https://web.archive.org/web/20220521134209/https://www.ema.europa.eu/en/documents/product-information/tecovirimat-siga-epar-product-information_en.pdf |url-status=live }}</ref><ref>{{cite web | title=Tecovirimat SIGA Product information | website=Union Register of medicinal products | url=https://ec.europa.eu/health/documents/community-register/html/h1600.htm | access-date=3 March 2023}}</ref>
In December 2021, Health Canada approved oral tecovirimat for the treatment of smallpox in people weighing at least {{convert|13|kg|lb}}.<ref name="auto"/><ref>{{cite press release |author=<!--Not stated--> |title=SIGA Announces Health Canada Regulatory Approval of Oral Tpoxx |url=https://investor.siga.com/news-releases/news-release-details/siga-announces-health-canada-regulatory-approval-oral-tpoxxr |publisher=Siga Technologies |date=1 December 2021 |access-date=24 May 2022 |archive-date=24 May 2022 |archive-url=https://web.archive.org/web/20220524072038/https://investor.siga.com/news-releases/news-release-details/siga-announces-health-canada-regulatory-approval-oral-tpoxxr |url-status=live }}</ref>
As of August 2022, Tpoxx was available in the US only through the Strategic National Stockpile as a Centers for Disease Control and Prevention investigational new drug.<ref>{{cite web | title=Information for Healthcare Providers on Obtaining and Using TPOXX (Tecovirimat) for Treatment of Monkeypox | website=U.S. Centers for Disease Control and Prevention (CDC) | date=22 July 2022 | url=https://www.cdc.gov/poxvirus/monkeypox/clinicians/obtaining-tecovirimat.html | access-date=1 August 2022 | archive-date=31 July 2022 | archive-url=https://web.archive.org/web/20220731125437/https://www.cdc.gov/poxvirus/monkeypox/clinicians/obtaining-tecovirimat.html | url-status=live }}</ref><ref>{{Cite journal |date=19 July 2022 |title=Steps for Clinicians to Order Medication to Treat Monkeypox |url=https://emergency.cdc.gov/newsletters/coca/071922.htm |journal=Coca Now |access-date=24 July 2022 |archive-date=2 August 2022 |archive-url=https://web.archive.org/web/20220802054814/https://emergency.cdc.gov/newsletters/coca/071922.htm |url-status=live }}</ref> As of 2022, intravenous Tpoxx had no lower weight cap and can be used in infants under the investigational new drug protocol.<ref>{{cite web |title=Monkeypox Outbreak: Updates on the Epidemiology, Testing, Treatment, and Vaccination |url=https://emergency.cdc.gov/coca/ppt/2022/072622_slides.pdf |website=U.S. Centers for Disease Control and Prevention|access-date=27 July 2022 |archive-date=2 August 2022 |archive-url=https://web.archive.org/web/20220802054812/https://emergency.cdc.gov/coca/ppt/2022/072622_slides.pdf |url-status=live }}</ref>
As of 2024, tecovirimat use in the US outside of a clinical trial should adhere to the CDC Investigational New Drug protocol in order to prevent mutations and to include surveillance to prevent spread of resistant virus.<ref name="cdc" />
== References == {{reflist}}
== External links == * {{cite web| url = https://druginfo.nlm.nih.gov/drugportal/name/tecovirimat | archive-url = https://web.archive.org/web/20191205083707/https://druginfo.nlm.nih.gov/drugportal/name/tecovirimat | url-status = dead | archive-date = 5 December 2019 | publisher = U.S. National Library of Medicine| work = Drug Information Portal| title = Tecovirimat }} * {{cite web| url = https://druginfo.nlm.nih.gov/drugportal/name/tecovirimat%20monohydrate | archive-url = https://web.archive.org/web/20210507015838/https://druginfo.nlm.nih.gov/drugportal/name/tecovirimat%20monohydrate | url-status = dead | archive-date = 7 May 2021 | publisher = U.S. National Library of Medicine| work = Drug Information Portal| title = Tecovirimat monohydrate }}
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