Clinical trials
OXT‑NEO is the focus of a clinical development programme conducted in accordance with regulatory requirements applicable to healthcare products under development.
Several successive studies, including preclinical studies and Phase I to III clinical trials, have been conducted with academic and regulatory supervision, in collaboration with research teams specialised in Prader‑Willi syndrome.
OXT‑NEO is currently in clinical development and does not at this time have marketing authorisation for the Prader‑Willi syndrome indication.
Phase I clinical study – OTBB1
Single intranasal administration of oxytocin in neonates with Prader-Willi syndrome
Phase II clinical study – OTBB2 (Tauber, 2017)
Repeated intranasal administration of oxytocin in infants with Prader-Willi syndrome.
Follow-up study of children treated in OTBB2 – OT2suite (Valette 2025)
OT2suite is a follow-up study of children treated in the OTBB2 clinical trial, at the age of four, compared to a cohort of untreated children. (link to publication).
Phase III clinical trial – OTBB3
The European phase III study OTBB3 aims to assess the effects of oxytocin on sucking and swallowing problems as well as on behavioural and social interaction disorders in newborns and infants with Prader-Willi syndrome
Follow-up study of children treated in OTBB3 – OTBB3 Follow-up
OTBB3 Follow-up is a follow-up study of children treated in the OTBB3 clinical trial, up to the age of four, compared to a cohort of untreated children.
International Phase III Pivotal Clinical Study – OTBB4
The goal of the Phase III international study OTBB4 will be to study the safety and efficacy of OXT-NEO in neonates and infants less than 3 months old with Prader-Willi syndrome.
OTBB4 is currently under preparation.