Table 1.
A summary of long-acting growth hormones categorized by development approach.
| Approach | Company | Product | Pediatric GHD development status |
|---|---|---|---|
| Unmodified GH – Half-life extension achieved by the slow-release of somatropin from polymeric depot, crystal, or prodrug | Genentech, Inc. | Nutropin Depot GH encapsulated in polylactide-coglycolic acid microparticles |
Approved in the U.S; later withdrawn |
| LG Life Sciences, Ltd. | LB03002 GH encapsulated in sodium hyaluronate microparticles |
Approved but not marketed in Europe; available in South Korea | |
| Altus Pharmaceuticals, Inc. | ALTU-238 GH crystallization |
Discontinued | |
| Ascendis Pharma A/S | TransCon GH Transiently PEGylated GH prodrug |
Phase 3 | |
| Modified GH – Half-life achieved by increasing molecular size (except NNCO195-0092, which is modified with a small albumin affinity tag) | |||
| GeneScience Pharmaceuticals Co., Ltd. | Jintrolong Permanently PEGylated GH |
Available in China | |
| Pfizer, Inc. | PHA-794428 Permanently PEGylated GH |
Discontinued | |
| Novo Nordisk A/S | NNCl126-0083 Permanently PEGylated GH |
Discontinued | |
| Ambrx, Inc. | ARX201 Permanently PEGylated and mutated GH |
Discontinued | |
| Teva Pharmaceutical Industries, Ltd. | TV-1106 GH fused to albumin |
Discontinued | |
| Versartis, Inc. | VRS-317 GH fused to half-life extension technology polypeptides |
Phase 3 | |
| OPKO Health, Inc. | MOD-4023 GH fused to carboxyterminal peptides |
Phase 3 | |
| Novo Nordisk A/S | NNCO195-0092 Mutated GH attached to an albumin affinity tag |
Phase 2 | |
| Genexine, Inc., and Handok, Inc. | GX-H9 GH fused to an Fc fragment |
Phase 2 | |
| Hanmi Pharmaceutical Co., Ltd. | LAPS-rhGH/HM10560A GH fused to an Fc fragment |
Phase 2 |
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