BRIEF—NIH starts enrollment for US clinical trial evaluating TPOXX for monkeypox

On Friday, the US National Institutes of Health (NIH), the nation’s medical research agency, announced the start of enrollment for a Phase III USA- based clinical trial evaluating tecovirimat (trade name TPOXX) for the treatment of monkeypox.

The trial is sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the NIH.

Study investigators aim to enroll more than 500 people from clinical research sites nationwide and adults and children of any age with monkeypox are eligible to enroll in the trial.

TPOXX is currently approved for the treatment of smallpox in the USA but has been used on compassionate use basis for the treatment of monkeypox throughout the current outbreak.

TPOXX is approved for monkeypox in Europe and the UK.

Tecovirimat, manufactured by US firm SIGA Technologies, is approved by the US Food and Drug Administration for the treatment of smallpox.

“Monkeypox can be an extremely painful infection that lasts for weeks,” said NIAID director Dr Anthony Fauci.

“We currently lack efficacy data that would help us understand how well this drug may mitigate painful monkeypox symptoms and prevent serious outcomes. This clinical trial was designed to answer those important questions,” he added.