Track somatrogon in Peptimes™
Somatrogon-ghla is a human growth hormone analog: a fusion protein of human growth hormone with copies of a short peptide (CTP) from the beta chain of human chorionic gonadotropin, made by recombinant DNA technology. It is the active ingredient in Ngenla. (Source: DailyMed label.)
Is somatrogon FDA-approved?
Yes, as a specific product: Ngenla (somatrogon-ghla) injection is FDA-approved, by prescription, for the use in its label.
Somatrogon
Also: Ngenla, somatrogon-ghla, MOD-4023
- 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.
Ngenla (somatrogon-ghla) injection
Subcutaneous
Children aged 3 and older with growth failure due to inadequate secretion of their own growth hormone.
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
An open-label extension followed 48 children with growth hormone deficiency for up to 9 years. Their height standard deviation score rose from −4.0 at the start to −0.2 by year 8. Antidrug antibodies appeared, but none were neutralizing. There was no control group.
Source: PMID 42372104, checked 1 Nov 2026
How to track it in Peptimes
Add somatrogon 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 product it applies to.
- 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 somatrogon or any other compound.
More sources
- FDA, Drugs@FDA, BLA 761184 (Ngenla), checked 1 Nov 2026: product, route and marketing status.
- FDA, Global Substance Registration System, Somatrogon, checked 1 Nov 2026: the code name MOD-4023.
Related pages
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