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Lonapegsomatropin · Skytrofa, ACP-011

Recombinant protein · Agonist of growth hormone receptor (GHR) · developed by Ascendis Pharma Encocrinology Div

Approved FDA, Aug 2021

ASND Developer

1 Registered trials

What is Lonapegsomatropin?

Lonapegsomatropin is a pegylated human growth hormone (somatropin) given as a once-weekly subcutaneous injection. It binds the growth hormone receptor on target cells, producing direct and IGF-1-mediated effects on skeletal growth and metabolism. It is studied in adult growth hormone deficiency.

Summary written with AI from the sources listed at the end of this page.

At a glance

Also known as: Skytrofa, ACP-011
Drug type: Recombinant protein
Targets: growth hormone receptor (GHR)
Mechanism: Agonist of growth hormone receptor (GHR)
Pathways: IGF-1 mediated effects, chondrocyte differentiation and proliferation, hepatic glucose output, lipolysis, protein synthesis
Therapy area: Endocrine
Developer: Ascendis Pharma Encocrinology Div A/S (ASND)
FDA status: Approved as Skytrofa (August 25, 2021), BLA761177 · FDA label
UNII: OP35X9610Y

✅ FDA-approved uses

Growth failure due to inadequate secretion of endogenous growth hormone in pediatric patients 1 year and older who weigh at least 11.5 kg
Growth hormone deficiency in adults (replacement of endogenous growth hormone)

From the indications section of the FDA label (version of Jul 23, 2026). Read the full label for the exact wording, limitations and safety information.

🧪 Clinical trials

Trial	Phase	Condition	Status	Sponsor
NCT05171855	Phase 3	Adult Growth Hormone Deficiency	Completed	ASND

Trials of the companies BioRadar tracks, from ClinicalTrials.gov, most advanced phase first.

Conditions studied

Adult Growth Hormone DeficiencyEndocrine System DiseasesHormone Deficiency

Other drugs acting on GHR

Somatropin FDA approved TV-1106 Phase 2

More from Ascendis Pharma Encocrinology Div

Navepegritide FDA approved Palopegteriparatide FDA approved TransCon CNP FDA approved ACP-001 Phase 2 Resiquimod Hydrogel-based Phase 1/2 TransCon hGH Phase 3 TransCon Treprostinil Phase 1

Sources

Updated Oct 11, 2026. Something wrong or missing? Report it on the ASND page.

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Data: FDA (Drugs@FDA, Purple Book, DailyMed), NIH (NCI Thesaurus, GSRS, RxNorm), ClinicalTrials.gov • Informational purposes only, not medical or investment advice. • All drugs A–Z