| Depot Formulations |
| |
Genentech (South San Francisco, USA) Alkermes (Dublin, Ireland) |
Nutropin Depot |
Encapsulated in Polylactide-Coglycolide Microspheres |
FDA approved, but removed from the market in 2004. |
| |
BioPartners (Los Angeles, USA) LG Life Sciences (Seoul, South Korea) |
Declage LB03002 |
Growth hormone incorporated into sodum hyaluronate and suspended in MCT for injection |
Approved for pediatric growth hormone deficiency in South Korea |
| PEGylated Formulations |
| |
Ambrx (La Jolla, USA) |
ARX201 |
30-kDa PEG incorporated into recombinant human growth hormone |
Drug development stopped due to PEG accumulation in ependymal cells of choroid plexus |
| |
Novo Nordisk (Bagsvaerd, Denmark) |
NNCI126-0083 |
43-kDa PEG linked to recombinant human growth hormone |
Drug development stopped |
| |
Pfizer (New York City, USA) |
PHA-794428 |
Branched 40-kDa PEG linked to amino end of recombinant human growth hormone |
Drug development stopped |
| |
GeneScience Pharmaceuticals (Changchun, China) |
Jintrolong |
40-kDa PEG linked to growth hormone |
Approved for pediatric growth hormone deficiency in China |
| Pro-drug Formulations |
| |
Ascendis Pharma (Hellerup, Denmark) |
TransCon Growth Hormone |
Recombinant human growth hormone transiently bound to mPEG |
Phase 3 testing concluding. Seeking regulatory approval in 2020 |
| Non-Covalent Albumin Binding Growth Hormone |
| |
Novo Nordisk (Bagsvaerd, Denmark) |
Somapacitan |
Recombinant human growth hormone with a single point mutation attached to a terminal fatty acid that reversibly binds albumin |
Ongoing pediatric phase 3 testing |
| Growth Hormone Fusion Proteins |
| |
Genexine (Seongnam, South Korea) Handok (Seoul, South Korea) |
HyTropin GX-H9 |
Recombinant human growth hormone fused to hybrid Fc |
Pending phase 3 trial |
| |
OPKO Health (Miami, USA) Pfizer (New York City, USA) |
Somatrogon Lagova MOD-4023 |
Recombinant human growth hormone fused to 3 copies of carboxy-terminal of hCG’s beta subunit |
Phase 3 testing in children underway. |
| |
Teva (Petah Tikva, Israel) |
TV-1106 |
Recombinant human growth hormone fused to albumin |
Blocking/inactivating antibodies developed, drug abandoned. |
| |
Versartis (Menlo Park, USA) |
Somavaratan VRS-317 |
Recombinant human growth hormone fused to hydrophilic strings of amino acids |
Discontinued due to inferiority to daily recombinant human growth hormone in increasing adult height |
