Growth Hormone Research History: Discovery, Key Trials and Regulatory Timeline

What this page covers

Growth hormone is one of the most extensively documented hormones in endocrinology, and its literature stretches from early clinical descriptions of pituitary excess through to modern biosimilar and long-acting product reports. This page assembles that record in chronological order, restricted to the peer-reviewed sources cited below. Every date on this page belongs to a publication or to an approval reported inside one of those publications; no date, author or figure appears here unless it is supported by a linked citation. This page is for educational purposes only and is not medical advice; consult a licensed physician for any question about diagnosis or treatment. Background physiology is summarised separately on PeptideU's growth hormone overview.

Before the hormone had a name: acromegaly and gigantism

The oldest thread in the growth hormone record is not the hormone itself but the syndrome of its excess. A 2016 review in Neuroendocrinology set out the history of acromegaly, describing how the condition was recognised, named and progressively linked to the pituitary gland as clinical and pathological observations accumulated (PMID 25572320). The reviewers reported that acromegaly's history is inseparable from the history of pituitary pathology, because the gland was implicated through case description long before hormone measurement was possible (PMID 25572320).

A second historical review, published in Acta Clinica Croatica in 2024, traced gigantism and acromegaly through history, covering how figures of unusual stature and the characteristic facial and skeletal features were recorded in earlier medical and non-medical sources (PMID 40104235). Taken together, these two reviews are the historical anchor of the growth hormone literature: the study of excess preceded the study of the molecule (PMID 40104235, PMID 25572320).

Who discovered growth hormone, as the cited record describes it

The sources verified for this page do not attribute the discovery of growth hormone to a single named individual or a single dated experiment. What they do document is the sequence in which understanding developed: clinical syndromes of hormone excess were catalogued first, as the acromegaly histories describe (PMID 25572320), and the pituitary origin of the growth phenotype was recognised through that clinical work (PMID 40104235). Readers looking for named attributions and precise discovery dates will find them inside those historical reviews rather than paraphrased here, because this page does not restate dates it cannot cite.

From pituitary-derived material to recombinant medicine

The modern era of the literature is defined by recombinant human growth hormone. A 2012 review in the Indian Journal of Pediatrics addressed biosimilar growth hormone, describing recombinant human growth hormone products and the regulatory expectations applied to follow-on versions once originator patents expired (PMID 22108957). The reviewers reported that growth hormone was among the earliest recombinant proteins for which biosimilar frameworks had to be defined, making it a reference case for the wider biosimilar field (PMID 22108957).

That framing was extended in a 2025 article in Pharmaceutical Medicine, which reviewed the challenges and opportunities of developing biosimilars generally, including the analytical comparability, immunogenicity assessment and regulatory submission steps required of a follow-on biologic (PMID 40739434). Researchers described biosimilar development as a comparability exercise rather than a repeat of the original clinical programme (PMID 40739434).

Secretagogues and releasing hormone: a parallel research line

Alongside work on the hormone itself, a separate research line pursued molecules that act upstream of pituitary release. A 2006 review in Combinatorial Chemistry & High Throughput Screening surveyed growth hormone secretagogues, the peptide and small-molecule compounds studied for their ability to stimulate growth hormone release through the secretagogue receptor rather than by supplying the hormone directly (PMID 16533150). The review placed this class in the context of receptor discovery and medicinal-chemistry screening programmes of that period (PMID 16533150).

Growth hormone-releasing hormone itself has remained an active research subject beyond its role in stimulating pituitary output. A 2022 paper in Endocrinology examined growth hormone-releasing hormone in the setting of endothelial inflammation, extending investigation of the peptide into vascular biology (PMID 36503995). The study is an example of how the growth hormone axis has been studied for signalling effects outside linear growth (PMID 36503995).

Diagnosis: testing, accuracy and cut-offs

Any history of growth hormone therapy is also a history of how deficiency was defined. A 2023 article in Endocrine Connections provided a global view of diagnosis and testing for growth hormone deficiency across the ages, examining the accuracy of stimulation testing, the caveats attached to it, and the diagnostic cut-offs used in different settings (PMID 37052176). The authors reported that cut-off values and assay practices have not been uniform internationally, which complicates comparison between cohorts and across decades (PMID 37052176). That variability is relevant to reading older literature, because the population labelled as deficient depended on the test and threshold in use (PMID 37052176).

Long-acting products: the 2022 first-approval reports

Two drug-profile reports published in 2022 document the arrival of long-acting growth hormone products in the regulatory record. A 2022 article in Paediatric Drugs profiled lonapegsomatropin and recorded its first approval for paediatric growth hormone deficiency, describing it as a long-acting growth hormone product (PMID 34709591). A companion profile in Drugs, also published in 2022, covered somatrogon and reported its first approval as a long-acting recombinant human growth hormone for paediatric growth hormone deficiency (PMID 35041176).

These first-approval articles are the standard format in which the literature records a regulatory milestone: they summarise the development programme and the indication granted, without being clinical trials themselves (PMID 34709591, PMID 35041176). No dosing information from either profile is reproduced on this page.

Skeletal, musculoskeletal and endocrine findings: What Studies Report

Much of what is known about growth hormone excess and growth hormone exposure comes from studies of associated conditions rather than from safety trials of a single product. A 2023 update in Endocrinology and Metabolism reviewed acromegaly and bone, reporting that skeletal involvement in acromegaly has been characterised in terms of bone quality and fracture risk rather than bone density alone (PMID 38164073). The reviewers described vertebral fractures as a recognised skeletal concern in acromegaly literature (PMID 38164073).

A 2023 article in Pediatric Discovery examined the impact of growth hormone on scoliosis, reviewing whether growth hormone exposure relates to spinal curve development or progression in children (PMID 40626081). Elsewhere in the endocrine literature, a review of gynecomastia set out the etiology, diagnosis and treatment of male breast tissue enlargement and catalogued the hormonal and drug-related causes considered during assessment (PMID 25905330). None of these sources is presented here as a safety verdict on any product; each describes an association examined in the literature (PMID 38164073, PMID 40626081).

Publication and regulatory timeline as published

How to read this timeline

Three cautions apply when reading any growth hormone chronology. First, publication year and approval year are different things: a first-approval profile published in 2022 summarises a regulatory decision reported in that article, as in the lonapegsomatropin profile (PMID 34709591). Second, regulatory decisions are jurisdiction-specific; a product approved in one country is not automatically available elsewhere, a point reflected in the way first-approval reports are structured (PMID 35041176). Third, historical comparison of patient populations is limited by changing diagnostic thresholds, which the 2023 diagnostic review described as variable across settings and ages (PMID 37052176).

Open questions in the current literature

• How diagnostic cut-offs should be harmonised across ages and assays, as raised in the 2023 global diagnostic review (PMID 37052176).
• How bone quality rather than density should be assessed in states of growth hormone excess, per the 2023 acromegaly and bone update (PMID 38164073).
• What relationship, if any, exists between growth hormone exposure and scoliosis in children, as examined in 2023 (PMID 40626081).
• What roles growth hormone-releasing hormone signalling plays outside the pituitary, including in endothelial inflammation (PMID 36503995).
• How biosimilar comparability standards continue to evolve for recombinant proteins (PMID 40739434, PMID 22108957).

References

• Gynecomastia: Etiology, Diagnosis, and Treatment (2000)
• Growth hormone secretagogues (Combinatorial Chemistry & High Throughput Screening, 2006)
• Biosimilar growth hormone (Indian Journal of Pediatrics, 2012)
• The History of Acromegaly (Neuroendocrinology, 2016)
• Lonapegsomatropin: Pediatric First Approval (Paediatric Drugs, 2022)
• Somatrogon: First Approval (Drugs, 2022)
• Growth Hormone-Releasing Hormone in Endothelial Inflammation (Endocrinology, 2022)
• Diagnosis and testing for growth hormone deficiency across the ages (Endocrine Connections, 2023)
• Acromegaly and Bone: An Update (Endocrinology and Metabolism, 2023)
• Impact of growth hormone on scoliosis (Pediatric Discovery, 2023)
• Gigantism and Acromegaly Through History (Acta Clinica Croatica, 2024)
• Developing Biosimilars: Challenges and Opportunities (Pharmaceutical Medicine, 2025)