Lonapegsomatropin

Summary

Lonapegsomatropin (CHEMBL4298185) is an approved protein (ATC H01AC09); indicated across 5 conditions including pituitary dwarfism and turner syndrome.

At a glance

• Status: Approved (max clinical phase 4)
• Modality: Protein
• ATC class: H01AC09
• Indications: 5 conditions
• Clinical trials: 4

Identifiers

Drug identity and classification

Field	Value
ChEMBL ID	CHEMBL4298185
Name	Lonapegsomatropin
Type	Protein
Max phase	4
ATC	H01AC09

Also known as: ACP-011, Lonapegsomatropin, Lonapegsomatropin tcgd, Lonapegsomatropin-tcgd, Lonapegsomatropina, Lonapegsomatropine, Stem-stat ortho, Skytrofa, TRANSCONPEG-HGH, TransConPEG hGh, rhGH-PEG, LONAPEGSOMATROPIN

Targets

Targets

No target linkage available.

Bioactivity

No ChEMBL bioactivity rows at pChembl ≥ 5 (expected for biologics / antibodies).

Target pathways

No target-pathway data for this drug (no mapped target genes).

Indications & clinical

Indications

1 approved indication. FDA phase 4, plus an anticancer drug’s labelled cancer uses (which ChEMBL often logs at phase 3).

Indication	Phase	MONDO	EFO
pituitary dwarfism	4	MONDO:0006909	EFO:1001109

3 diseases in clinical trials (phase 1–3, investigational — not approved indications). Highest ChEMBL trial phase per disease; a non-cancer approved use is occasionally logged at phase 3 here.

Disease (in trials)	Phase	MONDO	EFO
Turner syndrome	2	MONDO:0019499	MONDO:0019499
osteoarthritis	1	MONDO:0005178	MONDO:0005178
dog disease	1	MONDO:0024919

1 further indication record had no mapped disease name (EFO/MeSH-only) or were duplicates, and are omitted.

Clinical trials

Total trials: 4.

Phase distribution

Phase	Trials
PHASE3	3
PHASE2	1

Top trials by phase / activity

NCT	Phase	Status	Title
NCT07221851	PHASE3	RECRUITING	Trial Investigating the Efficacy and Safety of Weekly Lonapegsomatropin Compared to Daily Somatropin in Children and Adolescents With Short Stature or Growth Failure Due to Growth Hormone Sufficient Disorders
NCT04615273	PHASE3	COMPLETED	A Trial to Compare the Efficacy and Safety of Once-weekly Lonapegsomatropin With Placebo and a Daily Somatropin Product in Adults With Growth Hormone Deficiency
NCT05171855	PHASE3	COMPLETED	A Trial to Investigate Long Term Efficacy and Safety of Lonapegsomatropin in Adults With Growth Hormone Deficiency
NCT05690386	PHASE2	ACTIVE_NOT_RECRUITING	A Trial to Investigate Different Doses of Lonapegsomatropin Compared to Somatropin in Individuals With Turner Syndrome

Clinical evidence (CIViC)

No CIViC predictive evidence (expected for non-precision-medicine drugs).

Pharmacology

Pharmacogenomics

No PharmGKB pharmacogenomic data curated for this drug.

Related molecules

Related molecules

No competitor molecules sharing a primary target (ChEMBL phase ≥2 or PubChem drug-class).