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Lonapegsomatropin

Generic Name
Lonapegsomatropin
Brand Names
Skytrofa, Skytrofa (previously Lonapegsomatropin Ascendis Pharma)
Drug Type
Biotech
CAS Number
1934255-39-6
Unique Ingredient Identifier
OP35X9610Y

Overview

Lonapegsomatropin, also known as TransCon hGH or ACP 001, is a methoxypegylated prodrug of human growth hormone (somatropin) indicated for the treatment of children 1 year and older, weighing at least 11.5 kg, with growth failure due to insufficient growth hormone secretion. Unlike somatropin, which requires daily dosing, lonapegsomatropin can be administered as a single weekly dose. Lonapegsomatropin was granted FDA approval on 25 August 2021. It was later approved by the European Commission on 13 January 2022.

Background

Lonapegsomatropin, also known as TransCon hGH or ACP 001, is a methoxypegylated prodrug of human growth hormone (somatropin) indicated for the treatment of children 1 year and older, weighing at least 11.5 kg, with growth failure due to insufficient growth hormone secretion. Unlike somatropin, which requires daily dosing, lonapegsomatropin can be administered as a single weekly dose. Lonapegsomatropin was granted FDA approval on 25 August 2021. It was later approved by the European Commission on 13 January 2022.

Indication

In the US, lonepegsomatropin is indicated in the treatment of growth failure due to inadequate growth hormone secretion in patients one year and older who weigh at least 11.5 kg. In Europe, lonepegsomatropin is indicated to treat growth failure in children and adolescents aged from three years up to 18 years due to insufficient endogenous growth hormone secretion or growth hormone deficiency.

Associated Conditions

  • Growth Failure

FDA Approved Products

Skytrofa
Manufacturer:Ascendis Pharma Endocrinology, Inc.
Route:SUBCUTANEOUS
Strength:13.3 mg in 1 1
Approved: 2022/10/28
NDC:73362-011
Skytrofa
Manufacturer:Ascendis Pharma Endocrinology, Inc.
Route:SUBCUTANEOUS
Strength:3 mg in 1 1
Approved: 2022/10/28
NDC:73362-003
Skytrofa
Manufacturer:Ascendis Pharma Endocrinology, Inc.
Route:SUBCUTANEOUS
Strength:11 mg in 1 1
Approved: 2022/10/28
NDC:73362-010
Skytrofa
Manufacturer:Ascendis Pharma Endocrinology, Inc.
Route:SUBCUTANEOUS
Strength:4.3 mg in 1 1
Approved: 2022/10/28
NDC:73362-005
Skytrofa
Manufacturer:Ascendis Pharma Endocrinology, Inc.
Route:SUBCUTANEOUS
Strength:9.1 mg in 1 1
Approved: 2022/10/28
NDC:73362-009

Singapore Approved Products

No Singapore products found for this drug

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