Lonapegsomatropin Explained
| Tradename: | Skytrofa |
| Dailymedid: | Lonapegsomatropin |
| Routes Of Administration: | Subcutaneous injection |
| Class: | Growth hormone receptor agonist |
| Atc Prefix: | H01 |
| Atc Suffix: | AC09 |
| Legal Us: | Rx-only |
| Legal Us Comment: | [1] |
| Legal Eu: | Rx-only |
| Legal Eu Comment: | [2] [3] |
| Cas Number: | 1934255-39-6 |
| Pubchemsubstance: | 381128171 |
| Drugbank: | DB16220 |
| Unii: | OP35X9610Y |
| Kegg: | D11486 |
| Chembl: | 4298185 |
| Synonyms: | Lonapegsomatropin-tcgd; rhGH-PEG; ACP-011; ΤransConPEG hGh; WHO-10598 |
| Chemical Formula: | C1051H1627N269O317S9[C<sub>2</sub>H<sub>4</sub>O]4n |
Lonapegsomatropin, sold under the brand name Skytrofa, is a human growth hormone used for the treatment of growth hormone deficiency. Lonapegsomatropin is a prodrug of somatropin.
Lonapegsomatropin was approved for medical use in the United States in August 2021,[4] [5] and in the European Union in January 2022.
Medical uses
Lonapegsomatropin is a growth hormone therapy indicated to treat growth hormone deficiency.
History
The US Food and Drug Administration granted the application for lonapegsomatropin orphan drug designation.[6]
Further reading
- Thornton PS, Maniatis AK, Aghajanova E, Chertok E, Vlachopapadopoulou E, Lin Z, Song W, Christoffersen ED, Breinholt VM, Kovalenko T, Giorgadze E, Korpal-Szczyrska M, Hofman PL, Karpf DB, Shu AD, Beckert M . 6 . Weekly Lonapegsomatropin in Treatment-Naïve Children with Growth Hormone Deficiency: The Phase 3 heiGHt Trial . The Journal of Clinical Endocrinology and Metabolism . 106. 11. 3184–3195. July 2021 . 34272849 . 10.1210/clinem/dgab529 . 8530727 . free .
Notes and References
- Web site: Skytrofa- lonapegsomatropin-tcgd injection, powder, lyophilized, for solution . DailyMed . 30 September 2021.
- Web site: Skytrofa EPAR . European Medicines Agency . 10 November 2021 . 16 March 2022.
- Web site: Skytrofa Product information . Union Register of medicinal products . 3 March 2023.
- Web site: Skytrofa: FDA-Approved Drugs . U.S. Food and Drug Administration (FDA) . 25 August 2021.
- Ascendis Pharma A/S Announces U.S. Food and Drug Administration Approval of Skytrofa (lonapegsomatropin-tcgd), the First Once-weekly Treatment for Pediatric Growth Hormone Deficiency . Ascendis Pharma . 25 August 2021 . 25 August 2021.
- Advancing Health Through Innovation: New Drug Therapy Approvals 2021 . U.S. Food and Drug Administration (FDA) . 13 May 2022 . PDF . 22 January 2023 . 6 December 2022 . https://web.archive.org/web/20221206210020/https://www.fda.gov/media/155227/download . live .
