The company plans to seek South Korean approval for Qelbree by 2030 after a 156-patient bridging study in children and adolescents.
Alvogen Korea said on Monday it will begin a phase three bridging trial in South Korea for Qelbree, a non-stimulant attention deficit hyperactivity disorder medicine whose active ingredient is viloxazine. The company is aiming to bring the treatment to the domestic market in the first half of 2030, pending trial results and regulatory approval.
The Korean study is designed to assess the drug, known in the trial as AK-D101, in children and adolescents aged six to 17. According to Alvogen Korea, the Ministry of Food and Drug Safety cleared the trial plan on 17 June, and the company will enrol 156 patients in a randomised, double-blind, placebo-controlled, multi-centre study. The trial is expected to run until July 2027.
Qelbree was developed by the US drugmaker Supernus Pharmaceuticals and has already been approved in the United States for paediatric ADHD. The US Food and Drug Administration first authorised the extended-release capsule in April 2021 for patients aged six to 17, after phase three studies showed better symptom improvement than placebo. The approval was later expanded to adults in May 2022, making it the first non-stimulant ADHD medicine approved for adults in 20 years, according to reports on the FDA decision.
A key distinction of viloxazine, according to the hospital professor cited by Alvogen Korea, is that it is not a stimulant and works differently from atomoxetine, another non-stimulant treatment. Kim Boong-Nyun, the lead investigator, said viloxazine inhibits norepinephrine reuptake and also shows partial agonist activity at the serotonin 5-HT2C receptor, a profile that may make it useful for patients for whom methylphenidate-based stimulants are not suitable or for whom other options are needed.
Alvogen Korea said the project is part of a broader effort to strengthen its central nervous system portfolio and widen treatment choices for Korean families affected by ADHD. The company’s major shareholder, Lotus Pharmaceutical, signed an exclusive licence deal with Supernus in May 2025 and secured development and commercial rights for Qelbree in South Korea and other key Asian markets.
Disclaimer: This content is for informational purposes only and is not intended to be a substitute for professional medical judgment, advice, diagnosis, or treatment.
