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Prescription medicine

Somapacitan Brand names: Sogroya

Somapacitan (Sogroya) is a prescription medicine. No generic is listed in FDA's NDC Directory.

  • No generic listed

Check it at the source: the somapacitan FDA label on DailyMed (effective February 25, 2026); every somapacitan label on DailyMed.

Highlights of the record

FDA label of February 25, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026

Used for

From the label: indications and usage

SOGROYA is indicated for the treatment of pediatric patients aged 2.5 years and older with:

Growth failure due to inadequate secretion of endogenous growth hormone (GH).

Forms and strengths

  • 3.3 mg/ml
  • 6.7 mg/ml
  • 10 mg/ml

Injection (solution).

On the market

Generic approvals
No generic approved
Labelers listed (NDC)
1 of which 0 under generic applications, 1 under brand applications, repackagers included

Supply and safety

Pharmacy cost (NADAC)
Not in the survey
Shortage (FDA)
No current entry
Recalls by its makers (FDA)
No recall recorded
FAERS reports
156 through July 30, 2026

What is somapacitan used for?

From the label: indications and usage

SOGROYA is indicated for the treatment of pediatric patients aged 2.5 years and older with:

Growth failure due to inadequate secretion of endogenous growth hormone (GH).

Short stature born small for gestational age (SGA) and with no catch-up growth by 2 years of age.

Growth failure associated with Noonan syndrome (NS).

Idiopathic Short Stature (ISS). SOGROYA is indicated for the replacement of endogenous GH in adults with growth hormone deficiency (GHD). SOGROYA is a human growth hormone analog indicated for: Pediatric Patients: Treatment of pediatric patients aged 2.5 years and older with:

Growth failure due to inadequate secretion of endogenous growth hormone (GH). […]

Source: FDA drug label (SOGROYA), Novo Nordisk, effective February 25, 2026 (SPL set eadd03b4-adc3-4b88-8a24-9d205c5b85aa), via openFDA; the full label on DailyMed

Is there a generic for somapacitan (Sogroya)?

No generic somapacitan is approved (Drugs@FDA, October 8, 2026).

Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)

What does the somapacitan label say about other medicines?

The somapacitan label names 4 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.

Medicine namedSectionWhat the label says
Corticotropinwarnings and precautionsPatients receiving somatropin therapy who have or are at risk for corticotropin deficiency may be at risk for reduced serum cortisol levels and/or unmasking of central (secondary) hypoadrenalism.
Cortisonedrug interactionsReplacement Glucocorticoid Treatment Clinical Impact: Microsomal enzyme 11β-hydroxysteroid dehydrogenase type 1 (11βHSD-1) is required for conversion of cortisone to its active metabolite, cortisol, in hepatic and adipose tissue. GH inhibits 11βHSD-1. … following initiation of SOGROYA [see Warnings and Precautions ()]. Examples: Cortisone acetate and prednisone may be affected more than others because conversion of these drugs to their biologically active metabolites …
Prednisonedrug interactionsReplacement Glucocorticoid Treatment Clinical Impact: Microsomal enzyme 11β-hydroxysteroid dehydrogenase type 1 (11βHSD-1) is required for conversion of cortisone to its active metabolite, cortisol, in hepatic and adipose tissue. GH inhibits 11βHSD-1. … SOGROYA [see Warnings and Precautions ()]. Examples: Cortisone acetate and prednisone may be affected more than others because conversion of these drugs to their biologically active metabolites is dependent on the …
SomatropincontraindicationsSystemic hypersensitivity reactions have been reported postmarketing with somatropin [see Warnings and Precautions ( 5.2 )].

Check somapacitan against other medicines

Source: FDA drug label (SOGROYA), Novo Nordisk, effective February 25, 2026 (SPL set eadd03b4-adc3-4b88-8a24-9d205c5b85aa), via openFDA; the full label on DailyMed

What do FAERS reports show for somapacitan?

The FDA Adverse Event Reporting System holds 156 reports that list somapacitan among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 10 are coded as a death and 42 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.

The most reported reactions

  • Headache (named in the label)14
  • Arthralgia (named in the label)7
  • Pyrexia (named in the label)6
  • Condition Aggravated (a use or a product term, not a reaction)5
  • Hypoglycaemia5
  • Pain In Extremity (named in the label)5
  • Rash5
  • Vomiting (named in the label)5

Side effects: the label's list and every FAERS reaction

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026

What next?

Somapacitan side effects
the label's list beside FAERS reports
Check an interaction
what two or more labels say about each other