CT004 – Intravenous melatonin for peadiatric emergence delirium
CT004 is being developed for the prevention and management of emergence delirium (ED) in children following general anaesthesia. The programme has the potential to become the first intravenous treatment specifically designed to address this common and distressing complication of paediatric anaesthesia.
CT004 is a preservative-free intravenous formulation of melatonin, the body’s endogenous sleep and circadian hormone. The formulation is designed to support the body’s normal recovery after anaesthesia by helping to stabilize the sleep-wake cycle during the immediate post-operative period.
The intravenous formulation enables rapid and predictable onset, precise dosing and exact timing, avoids variability associated with oral administration and first-pass metabolism, and integrates seamlessly into established hospital and post-anaesthesia care unit (PACU) workflows.
Unlike traditional sedatives, CT004 is designed to support physiological recovery without causing deep sedation or respiratory depression. The intravenous formulation allows rapid and controlled administration in a hospital setting and may offer a novel approach to improving recovery following general anaesthesia.
Early clinical evidence suggests that intravenous melatonin may reduce the incidence and severity of emergence delirium, improve recovery quality, and decrease the need for rescue medication during the immediate post-operative period.
Addressing a significant unmet need in paediatric anaesthesia
Emergence delirium is a common complication in children recovering from general anaesthesia. It affects approximately 25–30% of children and up to 40–50% of preschool-aged patients, particularly those undergoing sevoflurane-based anaesthesia.
Children experiencing emergence delirium may present with confusion, agitation, inconsolable crying, disorientation, and hyperactive behaviour during recovery. While episodes are often transient, they can be highly distressing for children, families, and healthcare professionals and may complicate post-operative recovery.
Emergence delirium can increase the burden on healthcare staff, require additional monitoring and interventions, and prolong recovery times. Episodes may also result in accidental removal of intravenous lines, surgical dressings, or monitoring equipment, increasing the complexity of post-operative care.
Despite its prevalence and clinical impact, there are currently no approved treatments and no established standard of care for the prevention or treatment of paediatric emergence delirium. Management remains largely reactive and relies on off-label use of sedatives, analgesics, or anaesthetic agents, which may prolong recovery and carry safety concerns.
Supporting smoother recovery after anaesthesia
Melatonin is of particular interest in paediatric perioperative care because of its central role in regulating the sleep-wake cycle and its favourable safety profile. CT004 is being developed as a targeted treatment designed to address the underlying physiological disruption associated with emergence delirium while supporting a smoother recovery from anaesthesia.
By combining a well-characterized endogenous hormone with a hospital-ready intravenous formulation, CT004 has the potential to offer a novel therapeutic option for a condition that continues to represent a significant unmet medical need in paediatric anaesthesia.
Development path
Cessatech and the University Hospital of Copenhagen, Rigshospitalet, will jointly outline the regulatory strategy and final development plan, that could lead to regulatory approval of this new treatment option. Under the collaboration agreement, the University Hospital of Copenhagen, Rigshospitalet, initiated a Phase II clinical trial (MELA-PAED) in 2025, as well as a pre-clinical study of the pharmacokinetics of the oral melatonin in preterm pigs. Cessatech retains worldwide commercial rights to CT004.