Drugs / GX-H9
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 2 | NCT03309891 | Jan 2016 → Oct 2017 | pituitary deficiency | Genexine, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT02946606 | Jan 2015 → Dec 2016 | pituitary deficiency | Genexine, Inc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2023-08-30 | Genexine, Inc. | Results Genexine’s long-acting growth hormone meets Phase 3 primary endpoint genexine.com ↗
The study being conducted by Genexine’s partner in China, I-Mab, met its primary endpoint of annualized height velocity (AHV) at week 52 and demonstrated that eftansomatropin alfa was non-inferior to Norditropin®. |
| 2018-10-28 | Genexine, Inc. | Results Genexine Presents 12-month PGHD Phase 2 height velocity data of GX-H9 at ESPE 2018 genexine.com ↗
The annualized height velocity after 12 months of treatment was comparable between all doses of GX-H9 and Genotropin®. |
| 2017-09-18 | Genexine, Inc. | Results Genexine Presents P2 Interim Results of GX-H9, A Long-Acting rhGH, at IMPE genexine.com ↗
Compared to 10.8cm mean annualized height velocity of Genotropin®, two weekly dosing groups of 0.8mg/kg and 1.2mg/kg showed height velocity of 11.7cm and 13.1cm at 6 months, respectively. |
| 2017-04-03 | Genexine, Inc. | Results Genexine Releases Positive Interim Phase 2 Clinical Data from PGHD Trial with long-acting growth hormone, GX-H9 at ENDO 2017 genexine.com ↗
In multi-national, open label, randomized phase 2 pediatric growth hormone deficiency (GHD) trial, GX-H9 demonstrated annualized height velocities comparable to that of active comparator, daily recombinant human growth hormone (rhGH) at 3 months. |
| 2016-11-21 | Genexine, Inc. | Results Genexine Presents Phase 2 Interim Data of GX-H9 at JSPE genexine.com ↗
Based on the current results, GX-H9 demonstrated it was safe and well tolerated in pediatric GHD patients and the adverse events were comparable to those found in daily growth hormone control. |
| 2016-11-16 | Genexine, Inc. | Regulatory Genexine Granted FDA Orphan Drug Designation for GX-H9 in Growth Hormone Deficiency genexine.com ↗
Genexine Inc. (KOSDAQ: 095700), an innovative biotechnology company focused on immuno-oncology, metabolic and orphan diseases, announced today that US FDA Office of Orphan Products Development (OOPD) has granted GX-H9 an orphan drug designation for the treatment of growth hormone deficiency. |
All press releases naming this drug 9 releases
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | GX-H9 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT03309891 ↗ |
| Modality | Protein / enzyme biologic | “Long-acting Antibody-fused Recombinant Human Growth Hormone (GX-H9)” NCT02946606 ↗ |
| Route | Subcutaneous | “GX-H9 subcutaneous injections (weekly)” NCT03309891 ↗ |