Skytrofa FDA Approval History
Last updated by Judith Stewart, BPharm on July 29, 2025.
FDA Approved: Yes (First approved August 25, 2021)
Brand name: Skytrofa
Generic name: lonapegsomatropin-tcgd
Dosage form: Lyophilized Powder for Injection
Company: Ascendis Pharma A/S
Treatment for: Pediatric Growth Hormone Deficiency, Adult Human Growth Hormone Deficiency
Skytrofa (lonapegsomatropin-tcgd) is a human growth hormone used for the treatment of growth hormone deficiency.
- Skytrofa is indicated for the:
- treatment of pediatric patients 1 year and older who weigh at least 11.5 kg and have growth failure due to inadequate secretion of endogenous growth hormone (GH).
- replacement of endogenous growth hormone in adults with growth hormone deficiency (GHD). - Skytrofa contains lonapegsomatropin-tcgd, a long-acting prodrug of somatropin that is administered once weekly. Somatropin is used in human growth hormone therapies that are administered once daily.
- Skytrofa is administered once-weekly via subcutaneous injection into the abdomen, buttock, or thigh.
- Warnings and precautions associated with Skytrofa include hypersensitivity reactions, increased risk of malignancy progression, decreased insulin sensitivity, intracranial hypertension, fluid retention, hypoadrenalism, hypothyroidism, increased risk of slipped capital femoral epiphysis, increased risk of scoliosis progression, and pancreatitis.
- Common adverse reactions (≥ 5%):
- in pediatric patients include viral infection, pyrexia, cough, nausea and vomiting, hemorrhage, diarrhea, abdominal pain, and arthralgia and arthritis.
- in adult patients include peripheral edema.
Development timeline for Skytrofa
Further information
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