Nxera Pharma wide awake to opportunity for insomnia treatment

Daridorexant is a dual orexin receptor antagonist being developed by Nxera for the treatment of adult patients with insomnia and is approved and marketed in Japan as QUVIVIQ®.

A Phase 3 trial of daridorexant in South Korea met both primary and secondary efficacy endpoints of subjective total sleep time (sTST), subjective latency to sleep onset (sLSO) and subjective wake after sleep onset (sWASO).

Based locally at Granta Park, the company plans to submit a marketing authorisation application for daridorexant in South Korea in the first quarter of 2026, with approval there expected in the first quarter of 2027.

Daridorexant is approved and being marketed in Japan as QUVIVIQ® under a commercialisation agreement between Nxera and Shionogi. QUVIVIQ®, discovered by Idorsia Pharmaceuticals, is marketed by Idorsia in the US, Canada, and multiple European countries and by Simcere in China and Hong Kong.

Insomnia, characterised by difficulties in sleep onset and/or sleep maintenance, impacts both physical and mental health. The condition is highly prevalent in South Korea, affecting 15-25 per cent of the adult population, or approximately 6.5-11 million people.

MinBok Lee, President and Representative Director of Nxera Pharma Korea, said: “Insomnia is highly prevalent in South Korea and represents a serious health condition that significantly affects patients’ daily lives.

“We are very encouraged by the positive results from this Phase 3 study, which represents a critical milestone as we prepare to submit a marketing authorisation application in the first quarter of 2026. This progress brings patients in South Korea suffering from insomnia one step closer to gaining access to an important new treatment option. With QUVIVIQ® already available in the United States, Europe and Japan, we are committed to working towards making this medicine available to patients in South Korea as quickly as possible.”

Today, Nxera has announced the formation of a Metabolic Advisory Council comprising world-leading industry experts to provide scientific, clinical, and strategic guidance as the company advances its pipeline of therapies targeting obesity and metabolic disorders. The three founding members of the council are Professor Sir Stephen O’Rahilly (University of Cambridge), Professor Tricia Tan (Imperial College London) and Dr. Mads Tang-Christensen (Novo Nordisk).

Prof. O’Rahilly currently serves as Professor of Clinical Biochemistry and Medicine at the University of Cambridge, Director of the MRC Metabolic Diseases Unit, an Honorary Consultant Physician at Addenbrookes Hospital and a Fellow of Pembroke College, Cambridge. He is internationally recognised for his pioneering research into the genetic and molecular basis of human metabolic and endocrine diseases.

Professor Tricia Tan is Chair in Metabolic Medicine and Endocrinology at Imperial College London and Imperial College Healthcare NHS Trust, and Director of R&D at NW London Pathology. She has over 20 years' experience in gut hormone research and physiological studies into the impact of gut hormones on appetite and metabolic regulation. She has completed several Phase 1 trials on gut hormone analogs and co-founded the obesity therapeutics spin-out company Zihipp Ltd. (now part of Pfizer).

Dr. Mads Tang-Christensen has more than 20 years of leadership experience in obesity and metabolic disease research across the pharmaceutical and biotech sectors. Mads is currently CSO at Antag Therapeutics, Embark Laboratories and Incipiam Pharma. He has held various leadership roles in diabetes and obesity at Novo Nordisk, most recently Corporate Vice President, where he was the Global Head of Obesity and Liver Disease Research.

Dr. Patrik Foerch, Chief Scientific Officer and President of Nxera Pharma UK, said: “The formation of the Metabolic Advisory Council marks an important milestone in our ambition to deliver best-in-class therapies for obesity and metabolic disorders. Sir Stephen, Professor Tan, and Dr. Tang-Christensen each bring exceptional expertise that will directly influence our scientific strategy and clinical development plans.

“Their collective insight will enable us to accelerate the progression of our next-generation metabolic programs, ensuring our pipeline is shaped by the highest standards of scientific rigor and real-world patient need.”