Track somapacitan in Peptimes™
Somapacitan-beco is an analog of human growth hormone: 191 amino acids with one substitution, to which an albumin-binding side chain is attached. It is the active ingredient in Sogroya. (Source: DailyMed label.)
Is somapacitan FDA-approved?
Yes, as a specific product: Sogroya (somapacitan-beco) injection is FDA-approved for the uses in its label.
Somapacitan
Also: somapacitan-beco, NNC0195-0092, NN8640
- Status label in the Peptimes Library
- FDA Approved
- Routes in Peptimes
- Subcutaneous
- Updated
- 1 Nov 2026
US regulatory status
FDA approval belongs to the product below, for its route and the uses in its label. Label uses are shortened unless quoted.
Sogroya (somapacitan-beco) injection
Subcutaneous
Children aged 2.5 years and older with growth failure due to inadequate secretion of growth hormone, short stature after being born small for gestational age without catch-up growth, growth failure with Noonan syndrome, or idiopathic short stature; growth hormone replacement in adults with growth hormone deficiency.
Source: DailyMed label, checked 1 Nov 2026
Investigational
No, for the product and uses above.
Source: Drugs@FDA, checked 1 Nov 2026
What studies have looked at
Each point says who or what was studied and what the study reported, with its source and the date we checked it. These are findings from the sources cited, not advice or a promise of any result.
- In humans
REAL 1, a phase 3 randomized trial in 301 adults with growth hormone deficiency not treated before: at 34 weeks somapacitan reduced truncal fat percentage compared with placebo, with adverse events similar to the growth hormone used for comparison.
Source: PMID 32022863, checked 1 Nov 2026
How to track it in Peptimes
Add somapacitan in My Protocols and set the schedule you already follow: days of the week, times of day and a start date. Peptimes never suggests an amount when you log or schedule a dose. Its Library entry shows the status label “FDA Approved”; the entry above gives the detail.
- Logging: the amount you took and how you feel.
- Injection sites: each dose records the site, and Insights shows where you’ve injected and how recently. It never suggests where to inject next.
- Reminders and history: reminders at your times, Dose History, the Calendar and CSV or JSON export work as described on the peptide tracker app page.
Peptimes is a tracking app, not medical advice. Talk to a licensed clinician about your treatment. Peptimes doesn’t sell somapacitan or any other compound.
More sources
- FDA, Drugs@FDA, BLA 761156 (Sogroya), checked 1 Nov 2026: product, route and marketing status.
- FDA, Global Substance Registration System, Somapacitan, checked 1 Nov 2026: the code names NNC0195-0092 and NN8640.
Related pages
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