Overview
The World Health Organization declared smallpox, a contagious and sometimes fatal infectious disease, eradicated in 1980. However, there have been longstanding concerns that smallpox may be used as a bioweapon. Tecovirimat is an antiviral drug that was identified via a high-throughput screen in 2002. It is effective against all orthopoxviruses, including vaccinia, cowpox, ectromelia, rabbitpox, monkeypox, and Variola (smallpox) virus. Tecovirimat was approved by the FDA in July 2018 as the first drug ever approved to treat smallpox. Tecovirimat was later approved by Health Canada in December 2021, followed by the approval from the European Commission in January 2022. Other than smallpox, tecovirimat is also indicated to treat complications due to replication of the vaccinia virus following vaccination against smallpox, and to treat monkeypox and cowpox in adults and children. Tecovirimat is available as both oral and intravenous formulations.
Indication
Tecovirimat is an inhibitor of the orthopoxvirus VP37 envelope wrapping protein and is indicated for the treatment of human smallpox disease in adults and pediatric patients weighing at least 3 kg. The efficacy of tecovirimat may be reduced in immunocompromised patients. In Europe, it is also indicated to treat complications due to replication of the vaccinia virus following vaccination against smallpox. In Europe, tecovirimat is also used to treat monkeypox and cowpox in adults and children.
Associated Conditions
- Complication of Smallpox Vaccination
- Cow pox
- Monkeypox
- Variola Major (Smallpox)
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2024/12/06 | N/A | Recruiting | |||
2023/12/05 | Phase 4 | Recruiting | Miquel Ekkelenkamp | ||
2022/10/28 | Phase 3 | Recruiting | |||
2022/09/29 | Phase 2 | Completed | |||
2022/09/10 | Phase 3 | Active, not recruiting | |||
2022/09/09 | Phase 3 | Suspended | Marina Klein | ||
2022/05/19 | N/A | NO_LONGER_AVAILABLE | U.S. Army Medical Research and Development Command | ||
2021/07/21 | Phase 3 | Completed | |||
2021/07/12 | Phase 2 | Active, not recruiting | |||
2020/07/24 | Phase 4 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| SIGA Technologies, Inc. | 50072-200 | ORAL | 200 mg in 1 1 | 4/9/2021 | |
| SIGA Technologies, Inc. | 50072-010 | INTRAVENOUS | 10 mg in 1 mL | 4/9/2021 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
SIGA Technologies Netherlands B.V.,Prinsenhil 29,4825 AX Breda,Netherlands | Authorised | 1/6/2022 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||
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