Tecovirimat SIGA – Indication restricted following lack of efficacy in mpox trials
11/05/2026
Medicines for human use
Direct healthcare professional communication (DHPC)
New patients should not initiate Tecovirimat SIGA for the treatment of mpox. This restriction is based on data from recently completed clinical trials, showing that Tecovirimat SIGA lacked efficacy in generally immunocompetent patients with active mpox lesions under the settings studied.
Product information
- Product name
- Tecovirimat SIGA
- Active substance
- Tecovirimat monohydrate
- Authorisation holder
- SIGA Technologies Netherlands B.V.
- Human or veterinary medicine
- Human Medicine
- Target audience
- Healthcare professionals