Mpox (formerly known as monkeypox)
For more information on mpox diagnosis, please reference the CDC information and the National STD Curriculum.
For mpox treatment considerations, please reference the CDC Treatment and the CDC Treatment Access Information.
• Efficacy of tecovirimat (TPOXX) is being evaluated for the treatment of mpox via a NIAID-funded clinical trial led by ATCG. For more information, please visit STOMP or call (855) 876-9997.
• Use of tecovirimat (TPOXX) for the treatment of mpox is available through an expanded access protocol held by the CDC. For more information, please visit CDC Obtaining Tecovirimat or call CDC Emergency Operations Center (EOC) at (770) 488-7100 or email poxvirus@cdc.gov.
As part of the U.S. government’s response to the mpox outbreak, the Administration for Strategic Preparedness & Response (ASPR) has pre-positioned oral TPOXX throughout the country. For more information on TPOXX distribution from the Strategic National Stockpile, pre-positioning, and contingency supplies, please visit ASPR.
From May 27, 2022 – August 7, 2023, 7,653 patients were prescribed or treated with tecovirimat for mpox, according to CDC.
SIGA Technologies has donated over 1,800 courses of TPOXX (tecovirimat) capsules and its matching placebo to the National Institute of Allergy and Infectious Diseases (NIAID) for the Study of Tecovirimat for Human Monkeypox Virus (STOMP).
Mpox: Democratic Republic of the Congo (DRC)
SIGA Technologies has been supporting investigators and health agencies in DRC and elsewhere in Africa since 2019 in an effort to reduce the devastating impacts of mpox disease in these regions.
SIGA Technologies has donated over 500 courses of TPOXX (tecovirimat) capsules and its matching placebo to NIAID for use in the conduct of Tecovirimat for Treatment of Monkeypox Virus.
Historically, mpox cases in Africa have predominantly occurred in central and western African countries, including the Central African Republic (CAR), the Democratic Republic of the Congo (DRC), and Nigeria. Cases tended to occur sporadically, and outbreaks tended to be small and self-limited. Since 2016, however, cases have been rising in these countries and spreading to other countries. Contributing factors to the increase in cases include decline in immunity due to the cessation of smallpox vaccination, food insecurity that has led to greater reliance on wildlife meat consumption, changes in ecology due to climate change that may be increasing human-animal contact, and the development of sexual transmission. SIGA Technologies has been supporting investigators and health agencies in CAR, DRC, and elsewhere in Africa since 2019 in an effort to reduce the devastating impacts of mpox in these regions.
Since 2019, SIGA has donated TPOXX (tecovirimat) capsules and its matching placebo to support both expanded access and randomized clinical trial studies. TPOXX (tecovirimat) donations are also intended to support emergency use in low-and-middle-income countries (LMIC), including DRC and other countries on the African continent with mpox cases. As part of our ongoing pharmacovigilance, SIGA continues to perform safety monitoring of TPOXX (tecovirimat) use and provides information regarding the safety of TPOXX (tecovirimat) to trial investigators. SIGA also offers scientific advice and access to our proprietary TPOXX (tecovirimat) assay in support of trial conduct.
Regulators in African countries require randomized clinical trials demonstrating efficacy and drug approval before TPOXX (tecovirimat) can be used routinely in clinical and public health practice. Should mpox studies deliver results that contribute to TPOXX (tecovirimat) approval as treatment for mpox in these countries, SIGA is committed to making TPOXX (tecovirimat) available on an affordable basis for mpox-related indication in the DRC.
(Note: Tecovirimat-SIGA is approved by the EMA and MHRA for the treatment of monkeypox, cowpox, smallpox, and complications from vaccinia virus; TPOXX is approved by the U.S. FDA and Health Canada for the treatment of smallpox. TPOXX, Tecovirimat-SIGA is not approved as a treatment for mpox outside of the EU and UK.)