Drugs / CT-P41
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | EU (EMA) | — | — | — | “CT-P41 was filed for regulatory approval with the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) in November 2023” celltrion.com ↗ |
| Filed | US (FDA) | — | — | — | “CT-P41 was filed for regulatory approval with the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) in November 2023” celltrion.com ↗ |
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials · 1 met primary | ||||||
| Phase 1 | NCT06037395 | Oct 2021 → Oct 2022 | — | Celltrion | Completed | Met primary |
| Phase 1 | NCT04512872 | Oct 2020 → May 2021 | — | Celltrion | Completed | No outcome recorded |
| Phase 31 trial · 1 met primary | ||||||
| Phase 3 | NCT04757376 | Jun 2021 → May 2023 | postmenopausal osteoporosis | Celltrion | Completed | Met primary |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2025-10-30 | Celltrion | Regulatory U.S. FDA grants interchangeability designation to Celltrion's denosumab biosimilars, STOBOCLO® (denosumab-bmwo) and OSENVELT® (denosumab-bmwo) celltrion.com ↗
The U.S. FDA approved STOBOCLO® (denosumab-bmwo) and OSENVELT® (denosumab-bmwo) as interchangeable with the reference products PROLIA® (denosumab) and XGEVA® (denosumab), respectively, for all approved indications, effective as of October 29, 2025 |
| 2025-03-04 | Celltrion | Regulatory Celltrion receives U.S. FDA approval for STOBOCLO® (denosumab-bmwo) and OSENVELT® (denosumab-bmwo) biosimilars referencing PROLIA® and XGEVA® celltrion.com ↗
Celltrion today announced that the U.S. Food and Drug Administration (FDA) has approved STOBOCLO® (CT-P41, denosumab-bmwo) and OSENVELT® (CT-P41, denosumab-bmwo), biosimilars referencing PROLIA® (denosumab) and XGEVA® (denosumab) respectively for all indications of reference products. |
| 2025-02-19 | Celltrion | Regulatory Celltrion Expands Biosimilar Portfolio in the European Union Following European Commission Approval of Two Biosimilars celltrion.com ↗
Celltrion gains simultaneous regulatory approval of two monoclonal antibody biosimilars across three treatments – Eydenzelt® (aflibercept), Stoboclo® and Osenvelt® (denosumab) in the EU market |
| 2024-12-16 | Celltrion | Regulatory Celltrion Receives Positive CHMP Opinion for Three Biosimilars in the European Union celltrion.com ↗
Stoboclo (60 mg solution for injection in pre-filled syringe) and Osenvelt (120 mg solution for injection in vial) have been recommended for approval for all indications of the reference products Prolia® and Xgeva®, respectively. |
| 2024-11-19 | Celltrion | Results Celltrion presents additional data from phase III randomized controlled trials to further support biosimilarity for CT-41 (biosimilar candidate of denosumab) and CT-P47 (biosimilar candidate of tocilizumab) at ACR Convergence 2024 celltrion.com ↗
The results further support the biosimilarity between CT-P41 and reference denosumab in treating women with PMO. |
All press releases naming this drug 5 releases
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | CT-P41 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04512872 ↗ |
| Route | Subcutaneous | “by subcutaneous injection” NCT04512872 ↗ |