Lonapegsomatropin, sold under the brand name Skytrofa, is a human growth hormone used for the treatment of growth hormone deficiency.[1][3] Lonapegsomatropin is a prodrug of somatropin.[1]
| Clinical data | |
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| Trade names | Skytrofa |
| Other names | Lonapegsomatropin-tcgd; rhGH-PEG; ACP-011; ΤransConPEG hGh; WHO-10598 |
| License data | |
| Routes of administration | Subcutaneous injection |
| Drug class | Growth hormone receptor agonist |
| ATC code | |
| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
| PubChem SID | |
| DrugBank | |
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| ChEMBL | |
| Chemical and physical data | |
| Formula | C1051H1627N269O317S9[C2H4O]4n |
Lonapegsomatropin was approved for medical use in the United States in August 2021,[1][2][5] and in the European Union in January 2022.[3]
Medical uses
editLonapegsomatropin is a growth hormone therapy indicated to treat growth hormone deficiency.[1][3]
History
editThe US Food and Drug Administration granted the application for lonapegsomatropin orphan drug designation.[6]
References
edit- ^ a b c d e "Skytrofa- lonapegsomatropin-tcgd injection, powder, lyophilized, for solution". DailyMed. Retrieved 30 September 2021.
- ^ a b "Skytrofa: FDA-Approved Drugs". U.S. Food and Drug Administration (FDA). Retrieved 25 August 2021.
- ^ a b c d "Skytrofa EPAR". European Medicines Agency. 10 November 2021. Retrieved 16 March 2022.
- ^ "Skytrofa Product information". Union Register of medicinal products. Retrieved 3 March 2023.
- ^ "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 (Press release). 25 August 2021. Retrieved 25 August 2021.
- ^ Advancing Health Through Innovation: New Drug Therapy Approvals 2021 (PDF). U.S. Food and Drug Administration (FDA) (Report). 13 May 2022. Archived from the original on 6 December 2022. Retrieved 22 January 2023.
This article incorporates text from this source, which is in the public domain.
Further reading
edit- Thornton PS, Maniatis AK, Aghajanova E, Chertok E, Vlachopapadopoulou E, Lin Z, et al. (July 2021). "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. doi:10.1210/clinem/dgab529. PMC 8530727. PMID 34272849.
External links
edit- Clinical trial number NCT02781727 for "A Phase 3 Trial of the Safety, Tolerability and Efficacy of TransCon hGH Weekly Versus Daily hGH in Children With Growth Hormone Deficiency (GHD)" at ClinicalTrials.gov
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