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Sogroya
Published
Product name
Sogroya
Active ingredient
Somapacitan
Submission type
New biological entity
Decision
Approved
Decision date
Registration date
What this medicine was approved for
Sogroya (somapacitan) was approved for the following therapeutic use:
Sogroya is indicated for the replacement of endogenous growth hormone (GH) in adults with growth hormone deficiency (AGHD).
How this medicine works
Somapacitan is a long‑acting recombinant human growth hormone derivative. It consists of 191 amino acids similar to endogenous human growth hormone, with a single substitution in the amino acid backbone (L101C) to which an albumin binding moiety has been attached. The albumin binding moiety (side‑chain) consists of a fatty acid moiety and a hydrophilic spacer attached to position 101 of the protein.The mechanism of action of somapacitan is either directly via the growth hormone (GH)‑receptor and/or indirectly via insulin like growth factor‑1 (IGF-I) produced in tissues throughout the body, but predominantly by the liver. When growth hormone deficiency is treated with somapacitan, a normalisation of body composition (that is, decreased body fat mass, increased lean body mass) and of metabolic action is achieved.
Why the TGA approved or did not approve this medicine
The decision was based on quality (chemistry and manufacturing), nonclinical (pharmacology and toxicology), clinical (pharmacology, safety and efficacy) and risk management plan information submitted by the sponsor. The benefit-risk profile of Sogroya was considered favourable for the therapeutic use approved.