Monkeypox Treatment Candidate Seeks U.S. FDA Fast Track Status

South Korea-based Hyundai Bioscience announced yesterday it has decided to submit a request for a fast track processing to the U.S. Food and Drug Administration (FDA) for CP-COV03, an oral antiviral medicine for the treatment of monkeypox.

According to recently published research, Niclosamide, the active ingredient of CP-COV03, has already been shown to have excellent efficacy against the monkeypox type of virus.

Niclosamide-based CP-COV03, a cell-directed drug instead of other virus-directed drugs, is a broad-spectrum antiviral drug candidate that promotes cellular autophagy, which induces cells to recognize the virus as a foreign substance and then destroy it.

The scientific community considers the drug's pharmacological mechanism of action applicable to many viral infections.

Researchers at Kansas State University published a study in the scientific journal Vaccines on July 21, 2020, in which Niclosamide demonstrably lowered the proliferation of vaccinia virus, a virus within the same family as the monkeypox virus, up to 100% level even at a concentration as low as one micromole.

Hyundai Bioscience confirmed on May 25, 2022, plans to submit data related to the results of animal studies of CP-COV03 to the FDA as swiftly as possible.

"CP-COV03 is a universal antiviral drug with niclosamide as the main ingredient, which can fight nearly all virus types," commented Oh Sang Ki, CEO of Hyundai Bioscience in a related press statement.

"If CP-COV03 is approved as a treatment for monkeypox with the FDA's fast-track designation, we will witness the birth of another innovative antiviral drug comparable to penicillin - the epitome of the 20th century's 'wonder antibiotics."

Currently, SIGA Technologies's TPOXX® (tecovirimat, ST-246®), a novel small-molecule drug, is approved in the U.S., Canada, U.K., and Europe for the treatment of smallpox and monkeypox.

Monkeypox outbreak breaking news is posted at Vax-Before-Travel.

Note: The press release was manually curated for mobile readers.