Drugs / RGB-14-P
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 3 | NCT05087030 | Sep 2021 → Oct 2023 | postmenopausal osteoporosis | Gedeon Richter Plc. | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2025-09-29 | Roxane Laboratories | Regulatory Hikma and Richter receive FDA approval for denosumab biosimilars EnobyTM (denosumab- qbde) and XtrenboTM (denosumab- qbde) referencing Prolia® and Xgeva® respectively hikma.com ↗ |
| 2025-09-29 | Gedeon Richter Ltd. | Regulatory Richter and Hikma receive FDA approval for denosumab biosimilars Enoby™ and Xtrenbo™, referencing Prolia® and Xgeva®, respectively gedeonrichter.com ↗
The FDA approval of Enoby TM , originally known as RGB-14-P and Xtrenbo TM , originally known as RGB-14-X, was based on a comprehensive analytical, non-clinical, and clinical data package submitted by Hikma to the FDA. |
All press releases naming this drug 2 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | RGB-14-P | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05087030 ↗ |
| Route | Subcutaneous | “subcutaneous (SC) injection of RGB-14-P” NCT05087030 ↗ |