MHRA-101400-PIP01-24

Key Facts

Active Substance
Active Substance:
  • nirogacestat hydrobromide
Invented Name
  • Not yet available in the United Kingdom (Ogsiveo in the United States and European Union).
  • Ogsiveo
PIP Number MHRA-101400-PIP01-24
Pharmaceutical form(s)
Pharmaceutical form(s):
  • Film-coated tablet
Therapeutic area
Therapeutic area:
  • Oncology
Conditions / Indications
Conditions / Indications:
  • Treatment of soft tissue sarcoma
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
11/02/2025
Compliance Check Procedure Number
Compliance procedure number
MHRA-101400-PIP01-24-C1

Decision Document

Decision Document Decision Document on a Paediatric Investigation Plan (PIP):nirogacestat hydrobromide.pdf
Published Date 16/07/2026