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SKYTROFA (LONAPEGSOMATROPIN-TCGD)
SKYTROFA (generic name: LONAPEGSOMATROPIN-TCGD) is a Recombinant Human Growth Hormone [EPC] drug developed by ASCENDIS PHARMA ENCOCRINOLOGY DIV A/S. It is currently FDA-approved for Pediatric Growth Failure, Adult Growth Hormone Deficiency.
SKYTROFA binds to the GH receptor, triggering signal transduction and various pharmacodynamic effects, including growth stimulation in pediatric GHD.
SKYTROFA (Lonapegsomatropin) is a growth hormone receptor agonist, classified as an agonist drug. It is used to treat conditions such as Turner Syndrome, Short Stature Homeobox Gene Mutation, Idiopathic Short Stature, Small for Gestational Age at Delivery, and Growth Hormone Deficiency.
At a glance
| Generic name | LONAPEGSOMATROPIN-TCGD |
|---|---|
| Sponsor | ASCENDIS PHARMA ENCOCRINOLOGY DIV A/S |
| Drug class | Recombinant Human Growth Hormone [EPC] |
| Target | growth hormone (GH) receptor |
| Therapeutic area | Other |
| Phase | FDA-approved |
Mechanism of action
SKYTROFA, a pegylated human growth hormone, works by binding to the growth hormone receptor on target cells. This binding activates intracellular signaling that leads to multiple effects such as increased IGF-1 production, which promotes bone growth and metabolism.
Approved indications
- Pediatric Growth Failure
- Adult Growth Hormone Deficiency
Common side effects
- Infection, viral
- Pyrexia
- Cough
- Nausea and vomiting
- Hemorrhage
- Diarrhea
- Abdominal pain
- Arthralgia and arthritis
- Edema
- Central (secondary) hypothyroidism
Drug interactions
- Glucocorticoid Replacement Treatment (e.g., cortisone acetate, prednisone)
- Pharmacologic Glucocorticoid Therapy and Supraphysiologic Glucocorticoid Treatment
- Cytochrome P450-Metabolized Drugs
- Oral Estrogen
- Insulin and/or Other Antihyperglycemic Agents
Key clinical trials
- A Multicenter, Open-Label, Extension Trial to Investigate Long Term Efficacy and Safety of Lonapegsomatropin in Adults With Growth Hormone Deficiency (Phase 3)
- A Pivotal, Parallel-Arm, Phase 3, Open-Label, Active-controlled, Global, Multicenter, Randomized Basket Trial Investigating the Efficacy and Safety of Once-weekly Lonapegsomatropin Compared to Daily S (Phase 3)
- A US Multi-center, Prospective, Non-interventional, Long Term, Effectiveness and Safety Study of Patients Treated With SKYTROFA (Lonapegsomatropin) (N/A)
- A Prospective, Non-interventional (NIS), Long-term, Post-Authorisation Safety Study (PASS) of Patients Treated With Lonapegsomatropin (N/A)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- SKYTROFA CI brief — competitive landscape report
- SKYTROFA updates RSS · CI watch RSS
- ASCENDIS PHARMA ENCOCRINOLOGY DIV A/S portfolio CI
Frequently asked questions about SKYTROFA
What is SKYTROFA?
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What is the generic name of SKYTROFA?
What drug class is SKYTROFA in?
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What does SKYTROFA target?
Related
- Drug class: All Recombinant Human Growth Hormone [EPC] drugs
- Target: All drugs targeting growth hormone (GH) receptor
- Manufacturer: ASCENDIS PHARMA ENCOCRINOLOGY DIV A/S — full pipeline
- Therapeutic area: All drugs in Other
- Indication: Drugs for Pediatric Growth Failure
- Indication: Drugs for Adult Growth Hormone Deficiency
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing