Drugs / HLX14
Trials 2 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT04534582 | Nov 2020 → Sep 2023 | — | Shanghai Henlius Biotech | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT05352516 | Jun 2022 → Dec 2023 | postmenopausal osteoporosis | Shanghai Henlius Biotech | Completed | No outcome recorded |
Press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2024-10-30 | Organon and Co | US FDA Accepts Biologics License Application (BLA) for HLX14, Biosimilar Candidate of PROLIA/XGEVA (denosumab) organon.com ↗ |
| 2024-05-24 | Organon and Co | European Medicines Agency (EMA) Validates Henlius and Organon Filings for Prolia® and Xgeva® (denosumab) Biosimilar Candidate HLX14 organon.com ↗ |
| 2024-04-08 | Organon and Co | Phase 3 Comparative Clinical Study of Prolia® and Xgeva® (denosumab) Biosimilar Candidate HLX14 Met Primary Endpoints organon.com ↗ |
Evidence & citations 3 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | HLX14 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT05352516 ↗ |
| Modality | Monoclonal antibody | “Denosumab is a human IgG2 monoclonal antibody against receptor activator of nuclear factor kappa-B ligand (RANKL) for the treatment of osteoporosis and bone loss. HLX14 is a...” PMID 39700054 ↗ Dec 2024 |
| Route | Subcutaneous | “All study drugs were administered via subcutaneous injection at a single dose of 60 mg.” PMID 39700054 ↗ Dec 2024 |