Hanmi is developing the HM17321 therapy as a potential first-in-class treatment that could promote weight loss while helping preserve lean body mass.
Tirzepatide has gained attention as a treatment option for metabolic conditions, particularly because of its role in managing blood glucose levels and supporting weight management in eligible patients.
The FDA approval was supported by findings from the Phase 3a ONWARDS clinical program, which evaluated once-weekly Awiqli® in adults with type 2 diabetes.
The approval marks the first oral PCSK9 inhibitor, offering patients an alternative to injectable therapies traditionally used to reduce LDL cholesterol levels.
The setback comes at a crucial time as competition intensifies in the fast-growing market for lower-cost versions of Novo Nordisk’s blockbuster diabetes and obesity medicine.
Under the agreement, Novo Nordisk will internally assess Vivani’s investigational NPM-139 implant, which utilizes the company’s proprietary NanoPortal technology to deliver semaglutide continuously over extended periods through a miniature subdermal device.
Researchers found that postmenopausal women taking hormone therapy while receiving tirzepatide lost approximately 35% more weight than women treated with tirzepatide alone.
Under the agreement, Lilly will obtain exclusive worldwide rights, excluding South Korea, to develop, manufacture, and commercialise sonefpeglutide, a long-acting GLP-2 analogue.
Wegovy® pill is the first oral glucagon-like peptide-1 (GLP-1) receptor agonist approved for weight management.
The innovation aims to enhance fluid drainage, speed up recovery, and potentially reduce the need for additional corrective procedures.