US-licensed Prolia

BIOLOGICAL2 trials

Sponsors

Celltrion

Conditions

Healthy SubjectPostmenopausal Women With Osteoporosis

Phase 1

Phase I Study to Compare the Pharmacokinetics, Pharmacodynamics, and Safety Between CT-P41 and US-licensed Prolia in Healthy Male Subjects

CompletedNCT06037395

CelltrionHealthy Subject

Start: 2021-10-06End: 2022-10-20Updated: 2023-09-14

Phase 3

A Phase 3 Study to Compare Between CT-P41 and US-licensed Prolia in Postmenopausal Women With Osteoporosis

CompletedNCT04757376

CelltrionPostmenopausal Women With Osteoporosis

Start: 2021-06-17End: 2023-11-16Updated: 2024-06-14

Related Papers

Efficacy and safety of candidate biosimilar CT-P41 versus reference denosumab: a double-blind, randomized, active-controlled, Phase 3 trial in postmenopausal women with osteoporosis.

2024-07-237 citations

A randomized, double-blind, single-dose, phase 1 study comparing the pharmacokinetics, pharmacodynamics, safety, and immunogenicity of denosumab biosimilar CT‑P41 and reference denosumab in healthy males

Expert Opinion on Biological Therapy2024-02-134 citations