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.
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
Clinical Trials
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FDA Drug Approvals
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Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Ascendis Pharma Endocrinology, Inc. | 73362-007 | SUBCUTANEOUS | 6.3 mg in 1 1 | 9/4/2025 | |
| Ascendis Pharma Endocrinology, Inc. | 73362-013 | SUBCUTANEOUS | 1.4 mg in 1 1 | 9/4/2025 | |
| Ascendis Pharma Endocrinology, Inc. | 73362-009 | SUBCUTANEOUS | 9.1 mg in 1 1 | 9/4/2025 | |
| Ascendis Pharma Endocrinology, Inc. | 73362-004 | SUBCUTANEOUS | 3.6 mg in 1 1 | 9/4/2025 |
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