Aligos Therapeutics Receives USAN Approval for Pevifoscorvir Sodium, First Generic Name for Hepatitis B Drug Candidate
核心洞察
The United States Adopted Names Council (搜索) has approved pevifoscorvir sodium (搜索) as the nonproprietary name for ALG-000184, marking the first generic name for an Aligos Therapeutics compound.
Pevifoscorvir sodium (搜索) is a potential best-in-class oral capsid assembly modulator being developed for chronic hepatitis B virus infection treatment.
The drug candidate is currently advancing through Phase 2 B-Supreme study with interim data projected in 2026 and topline data anticipated in 2027.
Aligos Therapeutics announced that the United States Adopted Names (USAN) Council has adopted pevifoscorvir sodium (搜索) as the nonproprietary name for ALG-000184, a drug candidate under investigation for chronic hepatitis B virus (HBV) infection. This milestone represents the first generic name approval for a compound developed by the clinical-stage biopharmaceutical company.
The USAN Council, comprising members from the Food and Drug Administration (搜索) (FDA), American Medical Association (AMA), United States Pharmacopeia (USP), and American Pharmacists Association (APhA), is responsible for developing standardized nonproprietary drug names that ensure consistent identification and support international recognition across markets.
Clinical Development Progress
Pevifoscorvir sodium (搜索), also referred to as "pevy," is being developed as a potent oral small molecule capsid assembly modulator (CAM-E) for chronic HBV infection. The compound was initially derived from intellectual property licensed from Dr. Raymond Schinazi's laboratory at Emory University and subsequently optimized by Aligos.
Phase 1 studies have demonstrated promising results for pevifoscorvir sodium (搜索). After single and multiple daily doses, the drug candidate was well-tolerated by study participants with no safety signals observed. The studies also showed linear pharmacokinetics and excellent antiviral activity.
In longer-term Phase 1 studies, pevifoscorvir sodium (搜索) administered at 300mg once daily for up to 96 weeks, both as monotherapy and in combination with entecavir, demonstrated sustained reductions in multiple HBV markers including HBV DNA, RNA, HBsAg, HBeAg, and HBcrAg.
Regulatory Pathway and Future Studies
The drug candidate has established a regulatory pathway acknowledged by the FDA, European Medicines Agency (EMA), and China's National Medical Products Administration (NMPA) for subsequent studies utilizing the chronic suppressive pathway.
Phase 1 96-week dosing has been completed, with final and post-treatment follow-up data expected to be presented at the American Association for the Study of Liver Disease's The Liver Meeting in 2025.
The Phase 2 B-Supreme study initiated in August 2025, with interim data projected for 2026 and topline data anticipated in 2027.
Company Leadership Perspective
"The adoption of pevifoscorvir sodium (搜索), or pevy, marks the first generic name for a compound at Aligos," stated Lawrence Blatt, PhD, MBA, Chairman, President, and Chief Executive Officer of Aligos Therapeutics. "As we continue to progress our Phase 2 B-Supreme study, we look forward to adopting this new name. This milestone showcases our continued innovation in the liver and viral disease space and reinforces our commitment to improving patient outcomes."
About Aligos Therapeutics
Aligos Therapeutics is a clinical-stage biotechnology company focused on developing therapies for liver and viral diseases, including chronic hepatitis B virus infection, metabolic dysfunction-associated steatohepatitis (MASH), and coronaviruses. The company applies a science-driven approach to advance its pipeline of therapeutics targeting high unmet medical needs.