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{{Use dmy dates|date=August 2021}}
{{Use dmy dates|date=August 2021}}
{{Infobox drug
{{Infobox drug
| drug_name =
| INN =
| type = <!-- empty -->
| image =
| image =
| width =
| width =
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| Drugs.com =
| Drugs.com =
| MedlinePlus =
| MedlinePlus =
| licence_EU = <!-- EMA uses INN (or special INN_EMA) -->
| DailyMedID = Lonapegsomatropin
| DailyMedID = Lonapegsomatropin
| licence_US = <!-- FDA may use generic or brand name (generic name preferred) -->
| pregnancy_AU = <!-- A / B1 / B2 / B3 / C / D / X -->
| pregnancy_AU = <!-- A / B1 / B2 / B3 / C / D / X -->
| pregnancy_AU_comment =
| pregnancy_AU_comment =
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| routes_of_administration = [[Subcutaneous injection]]
| routes_of_administration = [[Subcutaneous injection]]
| class = Growth hormone receptor agonist
| class = Growth hormone receptor agonist
| ATCvet =
| ATC_prefix = H01
| ATC_prefix = H01
| ATC_suffix = AC09
| ATC_suffix = AC09
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| legal_US_comment = <ref name="Skytrofa FDA label">{{cite web | title=Skytrofa- lonapegsomatropin-tcgd injection, powder, lyophilized, for solution | website=DailyMed | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9229f871-bc61-4ddc-8122-d126d40e36ac | access-date=30 September 2021}}</ref><ref name="Skytrofa NDA 761177" />
| legal_US_comment = <ref name="Skytrofa FDA label">{{cite web | title=Skytrofa- lonapegsomatropin-tcgd injection, powder, lyophilized, for solution | website=DailyMed | url=https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9229f871-bc61-4ddc-8122-d126d40e36ac | access-date=30 September 2021}}</ref><ref name="Skytrofa NDA 761177" />
| legal_EU = Rx-only
| legal_EU = Rx-only
| legal_EU_comment = <ref name="Lonapegsomatropin EPAR">{{cite web | title=Lonapegsomatropin Ascendis Pharma EPAR | website=European Medicines Agency | date=10 November 2021 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/lonapegsomatropin-ascendis-pharma | access-date=16 March 2022}}</ref>
| legal_EU_comment = <ref name="Skytrofa EPAR">{{cite web | title=Skytrofa EPAR | website=European Medicines Agency | date=10 November 2021 | url=https://www.ema.europa.eu/en/medicines/human/EPAR/lonapegsomatropin-ascendis-pharma | access-date=16 March 2022}}</ref><ref>{{cite web | title=Skytrofa Product information | website=Union Register of medicinal products | url=https://ec.europa.eu/health/documents/community-register/html/h1607.htm | access-date=3 March 2023}}</ref>
| legal_UN = <!-- N I, II, III, IV / P I, II, III, IV -->
| legal_UN = <!-- N I, II, III, IV / P I, II, III, IV -->
| legal_UN_comment =
| legal_UN_comment =
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}}
}}


'''Lonapegsomatropin''', sold under the brand name '''Skytrofa''', is a human [[growth hormone]] used for the treatment of [[growth hormone deficiency]].<ref name="Skytrofa FDA label" /> Lonapegsomatropin is a [[prodrug]] of [[somatropin]].<ref name="Skytrofa FDA label" />
'''Lonapegsomatropin''', sold under the brand name '''Skytrofa''', is a human [[growth hormone]] used for the treatment of [[growth hormone deficiency]].<ref name="Skytrofa FDA label" /><ref name="Skytrofa EPAR" /> Lonapegsomatropin is a [[prodrug]] of [[somatropin]].<ref name="Skytrofa FDA label" />


Lonapegsomatropin was approved for medical use in the United States in August 2021.<ref name="Skytrofa FDA label" /><ref name="Skytrofa NDA 761177">{{cite web | title=Skytrofa: FDA-Approved Drugs | website=U.S. [[Food and Drug Administration]] (FDA) | url=https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761177 | access-date=25 August 2021}}</ref><ref>{{cite press release | title=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 | website=Ascendis Pharma | date=25 August 2021 | url=https://investors.ascendispharma.com/news-releases/news-release-details/ascendis-pharma-announces-us-food-and-drug-administration | access-date=25 August 2021}}</ref>
Lonapegsomatropin was approved for medical use in the United States in August 2021,<ref name="Skytrofa FDA label" /><ref name="Skytrofa NDA 761177">{{cite web | title=Skytrofa: FDA-Approved Drugs | website=U.S. [[Food and Drug Administration]] (FDA) | url=https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761177 | access-date=25 August 2021}}</ref><ref>{{cite press release | title=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 | website=Ascendis Pharma | date=25 August 2021 | url=https://investors.ascendispharma.com/news-releases/news-release-details/ascendis-pharma-announces-us-food-and-drug-administration | access-date=25 August 2021}}</ref> and in the European Union in January 2022.<ref name="Skytrofa EPAR" />


==Medical uses==
==Medical uses==
Lonapegsomatropin is a [[growth hormone therapy]] indicated to treat growth hormone deficiency.<ref name="Skytrofa FDA label" /><ref name="Lonapegsomatropin EPAR" />
Lonapegsomatropin is a [[growth hormone therapy]] indicated to treat growth hormone deficiency.<ref name="Skytrofa FDA label" /><ref name="Skytrofa EPAR" />


== History ==
== History ==
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==External links==
==External links==
* {{cite web | url = https://druginfo.nlm.nih.gov/drugportal/name/lonapegsomatropin | publisher = U.S. National Library of Medicine | work = Drug Information Portal | title = Lonapegsomatropin }}
* {{ClinicalTrialsGov|NCT02781727|A Phase 3 Trial of the Safety, Tolerability and Efficacy of TransCon hGH Weekly Versus Daily hGH in Children With Growth Hormone Deficiency (GHD)}}
* {{ClinicalTrialsGov|NCT02781727|A Phase 3 Trial of the Safety, Tolerability and Efficacy of TransCon hGH Weekly Versus Daily hGH in Children With Growth Hormone Deficiency (GHD)}}


Latest revision as of 00:13, 15 March 2024

Lonapegsomatropin
Clinical data
Trade namesSkytrofa
Other namesLonapegsomatropin-tcgd; rhGH-PEG; ACP-011; ΤransConPEG hGh; WHO-10598
License data
Routes of
administration		Subcutaneous injection
Drug classGrowth hormone receptor agonist
ATC code
Legal status
Legal status
Identifiers
CAS Number
PubChem SID
DrugBank
UNII
KEGG
ChEMBL
Chemical and physical data
FormulaC1051H1627N269O317S9[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

[edit]

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

History

[edit]

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

References

[edit]
  1. ^ a b c d e "Skytrofa- lonapegsomatropin-tcgd injection, powder, lyophilized, for solution". DailyMed. Retrieved 30 September 2021.
  2. ^ a b "Skytrofa: FDA-Approved Drugs". U.S. Food and Drug Administration (FDA). Retrieved 25 August 2021.
  3. ^ a b c d "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. Public Domain This article incorporates text from this source, which is in the public domain.

Further reading

[edit]
[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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