Lonapegsomatropin

Lonapegsomatropin

Clinical data
Trade names	Skytrofa
Other names	Lonapegsomatropin-tcgd; rhGH-PEG; ACP-011; ΤransConPEG hGh; WHO-10598
License data	US DailyMed: Lonapegsomatropin
Routes of administration	Subcutaneous injection
Drug class	Growth hormone receptor agonist
ATC code	H01AC09 (WHO)
Legal status
Legal status	US: ℞-only[1][2] EU: Rx-only[3][4]
Identifiers
CAS Number	1934255-39-6
PubChem SID	381128171
DrugBank	DB16220
UNII	OP35X9610Y
KEGG	D11486
ChEMBL	ChEMBL4298185
Chemical and physical data
Formula	C1051H1627N269O317S9[C2H4O]4n

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]

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

Lonapegsomatropin is a growth hormone therapy indicated to treat growth hormone deficiency.^[1][3]

History

The US Food and Drug Administration granted the application for lonapegsomatropin orphan drug designation.^[6]

References

1. "Skytrofa- lonapegsomatropin-tcgd injection, powder, lyophilized, for solution". DailyMed. Retrieved 30 September 2021.
2. "Skytrofa: FDA-Approved Drugs". U.S. Food and Drug Administration (FDA). Retrieved 25 August 2021.
3. "Skytrofa EPAR". European Medicines Agency. 10 November 2021. Retrieved 16 March 2022.
4. "Skytrofa Product information". Union Register of medicinal products. Retrieved 3 March 2023.
5. "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.
6. 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

• 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

• 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