MHRA-101826-PIP01-25

Key Facts

Active Substance
Active Substance:
  • Orforglipron
Invented Name
Not available at present
PIP Number MHRA-101826-PIP01-25
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Capsules, hard Age-appropriate oral solid dosage form
Therapeutic area
Therapeutic area:
  • Endocrinology-Gynaecology-Fertility-metabolism
Conditions / Indications
Conditions / Indications:
  • Treatment of obesity
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
Yes
Compliance Check Decision Date
Compliance opinion date
15/10/2025
Compliance Check Procedure Number
Compliance procedure number
MHRA-101826-PIP01-25-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):Orforglipron.pdf
Published Date 17/12/2025