EMEA-003019-PIP01-21 - paediatric investigation plan

Sodium 2,2-dimethylbutyrate (HST5040)

Key facts

• Active Substance:
  Sodium 2,2-dimethylbutyrate (HST5040)
• Therapeutic area:
  Endocrinology-Gynaecology-Fertility-Metabolism
• Decision number:
  P/0254/2023
• PIP number:
  EMEA-003019-PIP01-21
• Pharmaceutical form(s):
  Oral solution
• Condition(s) / indication(s):
  Treatment of inborn errors of amino acid metabolism
• Route(s) of administration:
  Oral use
• Contact for public enquiries:

  Hemoshear Therapeutics Inc.; E-mail: [e-mail] ; Tel.: [phone]

• Decision type:
  P: decision agreeing on a investigation plan, with or without partial waiver(s) and or deferral(s)
• Decision date:
  14/07/2023

Decision

P/0254/2023 : EMA decision of 14 July 2023 on the agreement of a paediatric investigation plan for sodium 2,2-dimethylbutyrate (HST5040) (EMEA-003019-PIP01-21)

Reference Number: EMA/303990/2023