MHRA-101785-PIP01-25

Key Facts

Active Substance
Active Substance:
  • (R)-3-(1-cyclopropyl-3-(2-fluoro-4-(trifluoromethoxy)benzyl)ureido)piperidine-1-carboxamide (JNT- 517)
Invented Name
Not yet available
PIP Number MHRA-101785-PIP01-25
Pharmaceutical form(s)
  • ORAL POWDER
  • Tablet
  • Granules for oral suspension
Therapeutic area
Therapeutic area:
  • Endocrinology-Gynaecology-Fertility-metabolism
Conditions / Indications
Conditions / Indications:
  • Treatment of hyperphenylalaninemia
Route(s) of administration
Route(s) of administration:
  • Oral use
PIP applicant
Decision Type
Decision Type
P: decision agreeing on a paediatric investigation plan, with or without partial waiver(s) or deferrals(s)
Compliance Check
Compliance Check
No
Compliance Check Decision Date
Compliance Check Procedure Number

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):(R)-3-(1-cyclopropyl-3-(2-fluoro-4-(trifluoromethoxy)benzyl)ureido)piperidine-1-carboxamide (JNT-517).pdf
Published Date 14/07/2025