Growth Hormone Receptor (GHR) Agonist Market: Competitive Landscape, Pipeline, and Market Analysis 2024

Growth hormone receptor (GHR) is a transmembrane protein of 620 amino acids. The receptor is part of the Type I cytokine receptor family of receptors. This gene encodes a protein that is a transmembrane receptor for growth hormone. The binding of growth hormone to the receptor leads to the reorientation of a pre-assembled receptor dimer dimerization and the activation of an intra- and intercellular signal transduction pathway leading to growth.GHR agonist mimics the action as performed by the growth hormone in the body. The mechanism of action (MOA) of the GHR Agonist is by binding GHR, which dimerizes and interacts with Janus kinase 2 (JAK2), subsequently leading to tyrosine phosphorylation of JAK2 and the GH receptor. The signal transducer activator of the transcription (STAT) pathway is initiated, where transcription factors such as STAT1, STAT3, and STAT5 are translocated into the nucleus to stimulate target gene transcription. At the epiphysis or growth plate, growth hormone increases linear growth by promoting differentiation of prechondrocytes and expansion of osteoblasts and binding to its receptor in the liver and cartilage promotes the production of IGF-1, which acts on type 1 IGF receptors to also stimulate linear growth.

GHR Agonists are used in treating bone diseases, dwarfism, endocrine system diseases, brain diseases, pituitary diseases, growth diseases, heart diseases, gonadal disorders, infertility, obesity, etc. Increased prevalence of bone and endocrine disorders and increased R&D investment are the key drivers for the GHR Agonist market. For instance, according to the National Organization for Rare Disorders 2021, it has been estimated that achondroplasia is the most commonly occurring abnormality of bone growth (skeletal dysplasia), occurring in approximately 1 in 20,000-30,000 live births. For instance, Novo Nordisk launched Norditropin (Somatropin) for the treatment of growth hormone deficiencies in children and adults. Moreover, numerous market participants are developing innovative compounds to address the difficulties in therapy. For instance, Lateral Pharma’s LAT8881 for the indication of neuropathic pain is under the various stages of clinical studies.

Key Market Developments:

• In February 2018, Ferring Pharma received the FDA approval for Zomacton (Somatropin) injection for the replacement of growth hormone (GH) in adults with GH deficiency.
• In August 2021, Ascendis Pharma received the FDA approval for Skytrofa (Lonapegsomatropin-Tcgd) for pediatric patients having growth failure due to inadequate secretion of endogenous growth hormone.
• In June 2023, Pfizer in global collaboration with OPKO Health has received FDA approval for Ngenla (Somatrogon-Ghla) for the treatment of growth hormone deficiency.

Approved Drug Molecules and Brand Names for GHR Agonist:

   Norditropin (Somatropin)

   Zorbtive (Somatropin)

   Nutropin AQ (Somatropin)

   Genotropin (Somatropin)

   Ngenla (Somatrogon-Ghla)

   Skytrofa (Lonapegsomatropin-Tcgd)

   Egrifta (Tesamorelin Acetate)

   Jintropin (Recombinant Human Growth Hormone)

   Omnitrope (Somatotropin)

   Zomacton (Somatropin)

Drugs under the Pipeline for GHR Agonist:

 Sogroya (Somapacitan)

 Tev-Tropin (JR-401S)

 Macrilen (Macimorelin)

 Somavaratan (VRS-317)

 LAT8881

 Eutropin Plus (Somatropin SR)

 Growtropin-II (Somatropin Biosimilar)

 Pegylated Somatropin (LA Growth Hormone)

 Alutropin (TV-1106)

 Valtropin (Somatropin Biosimilar)

 Efpegsomatropin (HM10560A)

 Eftansomatropin Alfa (GX-H9)

 Accretropin (Somatropin)

 Maxomat (Somatropin)

ALRN-5281

 ALT-P1 (Somatropin Biosimilar)

 PEG-Somatropin (ARX201)

 Syntropin (Somatropin Biosimilar)

 Viador-Hpth (1-34)

Vitatropin (HL032)

hGH-DepoFoam (Somatropin)

 rhGH-Emisphere (Somatropin Oral, Oral Recombinant Human Growth Hormone)

Clinical Activity and Developments of GHR Agonist:

Up until July 2023, there will be about 41 companies with over 34 compounds that focus on various forms of bone diseases and CNS disorder. For these molecules, more than 60 clinical trials are being conducted and majority are in phase-2, phase-3 clinical trials by the players across the globe. For instance,

• In September 2020, Lateral Pharma has completed phase 2a of oral LAT8881 clinical trial study to evaluate safety and efficacy in Neuropathic pain.
• In April 2023, AEterna Zentaris has completed phase 2, a pilot clinical trial of repeated doses of Macimorelin to evaluate safety and efficacy in patients with cancer cachexia.