Lonapegsomatropin Reference

Plain English

What it is

Lonapegsomatropin, sold under the brand name Skytrofa, is an FDA-approved prescription medicine. It is a long-acting form of human growth hormone (somatropin) made with recombinant DNA technology, and it is given as a once-weekly shot under a doctor's care.

What people use it for

Doctors prescribe it to replace growth hormone in people whose bodies do not make enough, a rare condition called growth hormone deficiency. The FDA approved it for children in 2021 and for adults in July 2025. This is a clinician-prescribed medicine, not a self-directed community compound.

What the science shows

Because it is an approved drug, it has been tested in human trials, including the foresiGHt Phase 3 trial that supported the adult approval. pepSmart shows only label-reference information for it. Commonly reported reactions include swelling in the limbs in adults and things like infections, fever, cough, and nausea in children.

The catch

Under federal law, distributing human growth hormone for uses the FDA has not approved is illegal. It is also banned in sport at all times by anti-doping rules (WADA category S2). The prescribing label lists serious conditions, such as certain acute critical illnesses, in which it should not be used.

Reference summary

Lonapegsomatropin is a label-verified long-acting somatropin product for pediatric and adult growth hormone deficiency. pepSmart surfaces label-reference content only.

Regulatory and posture

Categories

GH Release, Hormonal

Aliases

Skytrofa, Lonapegsomatropin-tcgd, Long-acting pediatric somatropin

Evidence posture

human - Prescription human growth hormone product (pediatric and adult growth hormone deficiency). WADA-prohibited at all times under category S2. Possession or distribution outside an FDA-approved indication is restricted by the Anabolic Steroid Control Act.

Regulatory status

FDA-approved prescription medication (Skytrofa). Approved for pediatric growth hormone deficiency in 2021 and, since July 28, 2025, for adults with growth hormone deficiency on the basis of the foresiGHt Phase 3 trial. WADA-prohibited under category S2 at all times. Distribution and possession outside an approved indication is restricted under the United States Anabolic Steroid Control Act.

Content review status

label verified

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