Somapacitan

Somapacitan
Clinical data
Trade namesSogroya
Other namesNNC0195-0092, somapacitan-beco
AHFS/Drugs.comMonograph
MedlinePlusa622020
License data
Pregnancy
category
Routes of
administration		Subcutaneous[3][4]
Drug classHuman growth hormone analog
ATC code
Legal status
Legal status
Identifiers
CAS Number
PubChem CID
DrugBank
ChemSpider
UNII
KEGG
ChEMBL
Chemical and physical data
FormulaC1038H1609N273O319S9
Molar mass23305.42 g·mol−1

Somapacitan, sold under the brand name Sogroya, is a growth hormone medication.[3][10] Somapacitan is a human growth hormone analog.[3] Somapacitan-beco is produced in Escherichia coli by recombinant DNA technology.[3]

The most common side effects include: back pain, joint paint, indigestion, a sleep disorder, dizziness, tonsillitis, swelling in the arms or lower legs, vomiting, adrenal insufficiency, hypertension, increase in blood creatine phosphokinase (a type of enzyme), weight increase, and anemia.[10][4]

It was approved for medical use in the United States in August 2020,[10][13][14][4] and in the European Union in March 2021.[11]

Somapacitan is the first human growth hormone (hGH) therapy that adults only take once a week by injection under the skin; other FDA-approved hGH formulations for adults with growth hormone deficiency must be administered daily.[10] It contains a small non-covalent moiety that reversibly binds to serum albumin which slows down elimination.[15]

  1. ^ a b "Sogroya APMDS". Therapeutic Goods Administration (TGA). 7 March 2022. Retrieved 23 March 2022.
  2. ^ "Updates to the Prescribing Medicines in Pregnancy database". Therapeutic Goods Administration (TGA). 21 December 2022. Archived from the original on 3 April 2022. Retrieved 2 January 2023.
  3. ^ a b c d e "Sogroya- somapacitan-beco injection, solution". DailyMed. 1 October 2021. Archived from the original on 23 April 2022. Retrieved 23 April 2022.
  4. ^ a b c Cite error: The named reference FDA snapshot was invoked but never defined (see the help page).
  5. ^ "Sogroya". Therapeutic Goods Administration (TGA). Retrieved 23 March 2022.[permanent dead link]
  6. ^ Anvisa (15 September 2023). "RDC Nº 816 - Listas de Substâncias Entorpecentes, Psicotrópicas, Precursoras e Outras sob Controle Especial" [Collegiate Board Resolution No. 816 - Lists of Narcotic, Psychotropic, Precursor, and Other Substances under Special Control] (in Brazilian Portuguese). Diário Oficial da União (published 18 September 2023). Archived from the original on 19 October 2023. Retrieved 19 October 2023.
  7. ^ "Details for: Sogroya". Health Canada. 27 November 2023. Retrieved 3 March 2024.
  8. ^ "Summary Basis of Decision (SBD) for Sogroya". Health Canada. 1 September 2012. Retrieved 11 December 2023.
  9. ^ "Notice: Multiple additions to the Prescription Drug List (PDL) [2023-10-26]". Health Canada. 26 October 2023. Retrieved 3 January 2024.
  10. ^ a b c d e "FDA approves weekly therapy for adult growth hormone deficiency". U.S. Food and Drug Administration (FDA) (Press release). 1 September 2020. Archived from the original on 1 September 2020. Retrieved 1 September 2020. Public Domain This article incorporates text from this source, which is in the public domain.
  11. ^ a b Cite error: The named reference Sogroya EPAR was invoked but never defined (see the help page).
  12. ^ "Sogroya Product information". Union Register of medicinal products. Archived from the original on 5 March 2023. Retrieved 3 March 2023.
  13. ^ "FDA approves once-weekly Sogroya for the treatment of adult growth hormone deficiency". Novo Nordisk (Press release). 28 August 2020. Archived from the original on 1 September 2020. Retrieved 1 September 2020.
  14. ^ "Sogroya: FDA-Approved Drugs". U.S. Food and Drug Administration (FDA). Archived from the original on 29 October 2020. Retrieved 2 September 2020.
  15. ^ Yuen KC, Miller BS, Boguszewski CL, Hoffman AR (February 2022). Mancini A, Persani L, Arosio M, Kreitschmann-Andermahr I (eds.). "Usefulness and Potential Pitfalls of Long-Acting Growth Hormone Analogs". Front Endocrinol. 12. Frontiers Media SA: 32. doi:10.3389/fendo.2021.637209. ISBN 978-2-88974-443-5. PMC 7943875. PMID 33716988. Archived from the original on 30 September 2022. Retrieved 24 April 2022.