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Updated: Jul 13, 2025

Comparative Analysis of Human Growth Hormone in Serum Using SPRi, Nano-SPRi and ELISA Assays
Published on: January 7, 2016
Long acting growth hormone (LAGH), an update
Margaret Steiner Grillo1, Jacklyn Frank1, Paul Saenger1
1Pediatric Endocrinology, NYU Langone Hospital-Long Island, Mineola, NY, United States.
New long-acting growth hormone (GH) formulations offer improved patient adherence by reducing daily injection frequency. These advanced therapies demonstrate comparable safety and efficacy to daily somatropin, addressing a long-standing need in pediatric endocrinology.
Area of Science:
- Endocrinology
- Pharmacology
- Biotechnology
Background:
- Growth hormone (GH) deficiency historically treated with pituitary-derived GH.
- Recombinant GH (somatropin) introduced in 1985, requiring daily subcutaneous injections.
- Pediatric endocrine community sought long-acting GH formulations to improve patient adherence.
Purpose of the Study:
- To review the development and efficacy of long-acting recombinant GH formulations.
- To assess the safety and tolerability profiles of these novel therapies.
- To evaluate the impact on patient adherence compared to daily injections.
Main Methods:
- Review of four distinct long-acting GH formulation types: pegylated, prodrug, albumin-binding, and fusion proteins.
- Analysis of Phase 3 clinical study data for non-inferiority and safety.
- Assessment of adherence profiles in clinical trials.
Main Results:
- Four long-acting GH formulations are available or nearing approval.
- All formulations demonstrated non-inferiority to daily somatropin in Phase 3 studies.
- Safety and tolerability profiles are comparable to daily somatropin, with excellent adherence.
Conclusions:
- Long-acting recombinant GH formulations represent a significant advancement in treating GH deficiency.
- These therapies offer a convenient alternative to daily injections, improving patient adherence.
- The developed formulations maintain safety and efficacy, meeting a critical clinical need.
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