Lonapegsomatropin
FDA approved · RxLong-acting growth hormone
Also known as: Skytrofa
Strong, human-grade evidence
- Regulatory standing. FDA-approved prescription medicine
- Human trials. Backed by controlled human studies
- Registered human trials. 8 registered studies on ClinicalTrials.gov, most advanced Phase 3
- 1 cited source. Includes primary / regulatory sources
Computed with the same four public criteria as every profile. The human-evidence grade on an indexed profile is set automatically and may change when it is hand-reviewed. It is not a safety score, not a purity rating, and not medical advice, and not a claim that this compound treats, cures, or prevents any condition.
What it is
Lonapegsomatropin, sold as Skytrofa, is a long-acting prodrug of somatropin (human growth hormone). Somatropin is attached to a carrier through a linker that slowly releases active, unmodified growth hormone over about a week, allowing less frequent injections than daily growth hormone.
What the evidence shows
It is FDA-approved for growth failure due to inadequate endogenous growth hormone secretion in pediatric patients, and has also been approved for adults with growth hormone deficiency, supported by Phase 3 trials. Use outside approved indications is not established by human evidence.
Key facts
Registered human trials
Live from ClinicalTrials.gov, refreshed daily.
A Phase 2 Clinical Trial to Evaluate Efficacy, Safety, and Tolerability of Navepegritide in Combination With Lonapegsomatropin in Children With Achondroplasia
A Trial to Compare the Efficacy and Safety of Once-weekly Lonapegsomatropin With Placebo and a Daily Somatropin Product in Adults With Growth Hormone Deficiency
A Trial to Investigate Different Doses of Lonapegsomatropin Compared to Somatropin in Individuals With Turner Syndrome
Safety, Tolerability and Efficacy of TransCon hGH Weekly Versus Daily hGH in Chinese Pediatric Growth Hormone Deficiency
Published literature
Live from Europe PMC. This is how much has been published, not how much is proven in humans.
Weekly Lonapegsomatropin in Treatment-Naïve Children With Growth Hormone Deficiency: The Phase 3 heiGHt Trial.
What do we do now that the long-acting growth hormone is here?
Safety and Efficacy of Lonapegsomatropin in Children With Growth Hormone Deficiency: enliGHten Trial 2-Year Results.
Long-acting growth hormone in the treatment of growth hormone deficiency in children: a systematic literature review and network meta-analysis.
Sources
Risks, side effects and study doses are only published on hand-reviewed profiles. Want this one reviewed, or spotted something wrong? Tell us.