Peptide

Somapacitan

Modified growth hormone injected once a week instead of daily. For children and adults with growth hormone deficiency.

Regulatory status

Approved (FDA / EMA)

Family

Long-acting growth hormone (weekly)

Scientific evidence

High

Number of findings

Where it acts

Hormones and metabolism · Bones and muscles

Also known as

somapacitan, somapacitan-beco, Sogroya, NNC0195-0092

Regulatory status

FDA (US): Approved (2020, Sogroya) for adults with GH deficiency; in 2023 for children from age 2.5 with GH deficiency; expanded in 2026 to other pediatric causes of short stature (small for gestational age, Noonan, idiopathic short stature).

EMA (EU): Approved (2021, Sogroya); indicated in children from age 3 and adolescents with GH deficiency and in adults with GH deficiency.

Dose

Children: 0.16 mg/kg once a week (phase 3 REAL 4 trial and FDA label). Adults: start with 1.5 mg weekly; 2 mg in women on oral estrogen and 1 mg in people over 65, adjusting according to IGF-1 (FDA Sogroya label).

Safety

Similar to daily growth hormone: headache, colds, pain in the extremities, injection-site reactions; in adults, back or joint pain. Risks: tumor growth, hyperglycemia, intracranial hypertension, slipped capital femoral epiphysis in children. Contraindicated with active cancer or in critically ill patients. Only under endocrinology supervision.

Interactions

Oral estrogens reduce the IGF-1 response; may require adjusting antidiabetic drugs, glucocorticoids, or thyroid hormone.

Differences between women and men

The FDA label states a higher starting dose (2 mg/week) in women taking oral estrogens, because these reduce the IGF-1 response.

Effect by goal · level of evidence

Growth in children with GH deficiency

improves High RCT (AA) in people

11.2 cm/year

Phase 3 REAL 4 with 200 treatment-naive children: growth velocity at 52 weeks of 11.2 cm/year with the weekly dose versus 11.7 cm/year with daily GH (non-inferior), with less treatment burden.

View the study (RCT) →

In depth

Where it acts

Hormones and metabolism, Bones and muscles

How it works

It is growth hormone with a small modification that binds it reversibly to albumin in the blood. This makes it last much longer in the body, and one weekly injection is enough. Once free, it acts the same as the body's own hormone, increasing IGF-1.

What the evidence says

In people

Growth in children with GH deficiency. Phase 3 REAL 4 trial with 200 treatment-naive children: growth velocity at 52 weeks was 11.2 cm/year with the weekly dose versus 11.7 cm/year with daily GH (noninferior), with less treatment burden. PubMed 36062966

References

PubMed 36062966

Information, not medical advice. Prescription or unapproved peptides should only be used under medical supervision.