A Glance at the Development and Patent Literature of Tecovirimat: The First-in-Class Therapy for Emerging Monkeypox Outbreak

Abstract

Monkeypox disease (MPX) is currently considered a global threat after COVID-19. European Medicines Agency (EMA) approved Tecovirimat in capsule dosage form (200 mg) as the first treatment for MPX in January 2022. This article highlights Tecovirimat’s development and patent literature review and is believed to benefit the scientists working on developing MPX treatments. The literature for Tecovirimat was gathered from the website of SIGA Technologies (developer of Tecovirimat), regulatory agencies (EMA, United States Food and Drug Administration (USFDA), and Health Canada), PubMed, and freely accessible clinical/patent databases. Tecovirimat was first recognized as an anti-orthopoxvirus molecule in 2002 and developed by SIGA Technologies. The USFDA and Health Canada have also recently approved Tecovirimat to treat smallpox in 2018 and 2021, respectively. The efficacy of Tecovirimat was verified in infected non-human primates (monkeys) and rabbits under the USFDA’s Animal Rule. Most clinical studies have been done on Tecovirimat’s safety and pharmacokinetic parameters. The patent literature has revealed inventions related to the capsule, injection, suspension, crystalline forms, amorphous form, and drug combinations (Tecovirimat + cidofovir) and process for preparing Tecovirimat. The authors foresee the off-label use of Tecovirimat in the USA and Canada for MPX and other orthopoxvirus infections. The authors also trust that there is immense scope for developing new Tecovirimat-based treatments (new drug combinations with other antivirals) for orthopoxvirus and other viral diseases. Drug interaction studies and drug resistance studies on Tecovirimat are also recommended. Tecovirimat is believed to handle the current MPX outbreak and is a new hope of biosecurity against smallpox or orthopoxvirus-related bioterrorism attack.

Therapeutic strategies for human poxvirus infections: Monkeypox (mpox), smallpox, molluscipox, and orf

“…Tecovirimat has been documented by Grosenbach et al [ 36 ] for the oral treatment of smallpox. It was further hailed as the first-in-class therapy for the emerging mpox outbreak [ 37 ]. Delaune and Iseni [ 38 ] highlighted the difficulties to develop new drugs targeting an eradicated disease under the FDA “animal efficacy rule” with the few, and imperfect, animal models available.…”

Monkeypox - new epidemiological threat? Review of the current literature

“…zarejestrowany przez EMA (European Medicines Agency) jako lek stosowany w leczeniu małpiej ospy u osób dorosłych i dzieci o masie ciała co najmniej 13 kilogramów. [18] Tecovirimat działa poprzez hamowanie wirusowego białka otoczki VP37, które blokuje końcowe etapy dojrzewania wirusa i uwalniania z zakażonej komórki. [15] Chociaż skuteczność tego środka przeciwko małpiej ospie u ludzi nie została przetestowana, badania wykazały poprawę przeżywalności po zakażeniu śmiertelnymi dawkami wirusa ospy małpiej u zwierząt leczonych tecovirimatem w porównaniu ze zwierzętami otrzymującymi placebo w różnych stadiach choroby.…”

Comprehensive update on the monkeypox outbreak

“…Investigational New Drug (IND) protocol (CDC, 2022c;Almehmadi et al, 2022). Tecovirimat is accessible as an injectable drug for intravenous administration and as an oral capsule (Almehmadi et al, 2022).…”

“…Currently, there are no antivirals approved for MPX. However, an antiviral drug called “tecovirimat,” also known as ST-246 or TPOXX approved for the treatment of smallpox, has been made accessible to treat MPXV through an expanded access Investigational New Drug (IND) protocol ( CDC, 2022c ; Almehmadi et al, 2022 ). Tecovirimat is accessible as an injectable drug for intravenous administration and as an oral capsule ( Almehmadi et al, 2022 ).…”

“…However, an antiviral drug called “tecovirimat,” also known as ST-246 or TPOXX approved for the treatment of smallpox, has been made accessible to treat MPXV through an expanded access Investigational New Drug (IND) protocol ( CDC, 2022c ; Almehmadi et al, 2022 ). Tecovirimat is accessible as an injectable drug for intravenous administration and as an oral capsule ( Almehmadi et al, 2022 ). Currently, tecovirimat is only suggested for patients with severe MPX disease or who are at higher risk for severe MPX (immunocompromised people, pregnant or lactating women, or children with atopic dermatitis) and those with concurrent illnesses ( CDC, 2022c ).…”