Track lonapegsomatropin in Peptimes™
Lonapegsomatropin-tcgd is a long-acting prodrug of somatropin (human growth hormone): somatropin attached to a methoxypolyethylene glycol carrier through a TransCon linker. It is the active ingredient in Skytrofa. (Source: DailyMed label.)
Is lonapegsomatropin FDA-approved?
Yes, as a specific product: Skytrofa (lonapegsomatropin-tcgd) for injection is FDA-approved for the uses in its label.
Lonapegsomatropin
Also: lonapegsomatropin-tcgd, TransCon hGH, ACP-011
- 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.
Skytrofa (lonapegsomatropin-tcgd) for injection
Subcutaneous
Children 1 year and older, above the label's minimum weight, with growth failure due to inadequate secretion of growth hormone; 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
heiGHt, a phase 3 randomized trial in 161 children with growth hormone deficiency who had not been treated before: height velocity at 52 weeks was higher with lonapegsomatropin than with somatropin, and adverse events, tolerability and immunogenicity were similar.
Source: PMID 34272849, checked 1 Nov 2026
- In humans
foresiGHt, a randomized trial in 259 adults with growth hormone deficiency: at 38 weeks, lonapegsomatropin reduced trunk fat and increased lean mass compared with placebo.
Source: PMID 41420532, checked 1 Nov 2026
How to track it in Peptimes
Add lonapegsomatropin 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 lonapegsomatropin or any other compound.
More sources
- FDA, Drugs@FDA, BLA 761177 (Skytrofa), checked 1 Nov 2026: product, route and marketing status.
- FDA, Global Substance Registration System, Lonapegsomatropin, checked 1 Nov 2026: the names TransCon hGH and ACP-011.
Related pages
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