The TAIN project

TAIN stands for Treatment of Adrenal Insufficiency in Neonates and Infants and was supported by the European Commission through its 7th Framework Programme. TAIN started on the 1st December 2011.


The aim of TAIN was to develop a new formulation of Hydrocortisone - 
Infacort® - that can be used from birth and specifically in the age range of 0-2 years (neonates & infants). Hydrocortisone is an essential glucocorticoid hormone used as a replacement therapy for the treatment of the rare disease adrenal insufficiency - where the body cannot produce sufficient cortisol. The problem of effective Hydrocortisone replacement is especially acute in this young patient range, for whom no licensed therapy exists.


TAIN involved European leaders in drug development, neonatology and paediatric pharmacology. A Paediatric Investigation Plan (PIP) was developed that enabled clinical trials to be carried out to provide sufficient evidence of safety and efficacy for Infacort® to allow submission of a Paediatric Use Medicines Authorisation (PUMA) to the European Medicines Agency (EMA).


TAIN also aimed to raise awareness of paediatric adrenal insufficiency by working closely with parents, patient groups and clinicians. This allowed the work being conducted through TAIN to benefit the widest possible number of children, their families and health professionals.


The TAIN Project was successfully completed on the 30th November 2016 with the submission of a Paediatric Use Market Authorisation (PUMA) application to the European Medicines Agency. 


The TAIN project