Depot Formulations |
|
Genentech / Alkermes |
Nutropin Depot |
Encapsulated in Polylactide-Coglycolide Microspheres |
FDA Approved. Removed from market in 2004. |
|
BioPartners / LG Life Sciences |
Declage LB03002 |
rhGH incorporated into sodum hyaluronate and suspended in MCT for injection |
Available for use by children in South Korea. Approved in Europe but not marketed. |
PEGylated Formulations |
|
Ambrx |
ARX201 |
30-kDa PEG incorporated into rhGH |
Drug development stopped due to PEG accumulation in ependymal cells of choroid plexus. |
|
Novo Nordisk |
NNCI126–0083 |
43-kDa PEG attached to rhGH |
Drug development stopped. |
|
Pfizer |
PHA-794428 |
Branched 40-kDa PEG attached to amino end of GH |
Drug development stopped. |
|
GeneScience Pharmaceuticals |
Jintrolong |
40-kDa PEG attached to rhGH |
Available for use by children in China. |
Pro-drug Formulations |
|
Ascendis Pharma |
TransCon Growth Hormone |
rhGH transiently bound to mPEG |
In phase 3 testing. |
Non-Covalent Albumin Binding GH |
|
Novo Nordisk |
Somapacitan NNC0195–0092 |
rhGH with a single po int mutation attached to a terminal fatty acid |
In phase 3 testing. |
GH Fusion Proteins |
|
Genexine / Handok |
HyTropin GX-H9 |
rhGH fused to IgD and IgG4 |
Pending phase 3 testing. |
|
Teva |
TV-1106 |
rhGH fused to albumin |
Blocking/inactivating antibodies developed, drug abandoned. |
|
OPKO Health / Pfizer |
MOD-4023 |
rhGH fused to 3 copies of carboxy-terminal of hCG’s beta subunit |
Phase 3 studies in adults completed at end of 2016, phase 3 testing in children underway. |
|
Versartis |
Somavaratan VRS-317 |
rhGH fused to hydrophilic strings of amino acids |
Discontinued due to inferiority to daily rhGH in increasing height in children |