Recently, the FDA announced accelerated approval for Gilead Sciences' Hepcludex (Bulevirtide-gmod) injection for the treatment of chronic hepatitis D virus (HDV) infection in adults without cirrhosis or with compensated cirrhosis . This is the first FDA-approved therapy for the treatment of chronic HDV infection; previously, the FDA had granted it Breakthrough Therapy Designation and Orphan Drug Designation. This is not only the first FDA-approved therapy for chronic HDV infection, but also a key breakthrough in the global treatment of hepatitis D.

Hepcludex was jointly developed by Gilead Sciences and MYR GmbH. In 2021, Gilead acquired MYR GmbH for approximately €1.45 billion, recognizing the immense potential of this world-first HDV attachment inhibitor. As an HDV attachment inhibitor targeting NTCP (sodium taurocholic acid cotransport peptide) , Hepcludex inhibits HDV infection by binding to the HDV receptor NTCP on the hepatocyte membrane, blocking the attachment of HDV to NTCP.

Hepcludex first received marketing approval from the European Medicines Agency (EMA) in 2020, becoming the world's first approved HDV-specific treatment. After six years of development, the FDA granted it Breakthrough Therapy Designation and Orphan Drug Designation, culminating in this accelerated approval.
It is worth noting that although Hepcludex has not yet entered the Chinese market, in January 2026, the NMPA conditionally approved Huahui Anjian's ribevirtadalafil injection (trade name: Huayounuo), making it the first HDV treatment drug approved in China. Currently, the global HDV treatment development pipeline has entered a diversified and rapidly advancing stage, with multiple innovative drugs targeting different targets and having different mechanisms at different stages of clinical trials, marking a new era of "blooming flowers" in the treatment of hepatitis D.
The approval of Hepcludex in the US is not only another triumph for Gilead in the field of viral hepatitis, but also a significant milestone in the global prevention and control of hepatitis D. In the future, with the launch of more drugs and the optimization of combination regimens, a functional cure for hepatitis D will gradually become possible.

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