Lead Product(s) : Denosumab
Therapeutic Area : Musculoskeletal
Study Phase : Phase I
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
GlycoNex Successfully Completes Phase 1 Study of Denosumab Biosimilar, SPD8
Details : SPD8 (denosumab) is a biosimilar of Prolia and Xgeva, designed for use in postmenopausal women with osteoporosis. This medication is administered subcutaneously and functions as a RANKL inhibitor.
Product Name : SPD8
Product Type : Antibody
Upfront Cash : Inapplicable
August 19, 2024
Lead Product(s) : Denosumab
Therapeutic Area : Musculoskeletal
Highest Development Status : Phase I
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Cilostazol
Therapeutic Area : Musculoskeletal
Study Phase : Phase I
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Genovate Plans NDA Submission for PMR to FDA in Second Half of 2025
Details : PMR, a novel extended-release formulation of cilostazol is being evaluated in the early-stage clinical trial studies for the treatment of Intermittent Claudication.
Product Name : PMR
Product Type : Other Small Molecule
Upfront Cash : Inapplicable
May 28, 2024
Lead Product(s) : Cilostazol
Therapeutic Area : Musculoskeletal
Highest Development Status : Phase I
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Denosumab
Therapeutic Area : Musculoskeletal
Study Phase : Phase I
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Eden Biologics’ Leading Biosimilar Program Receives Phase 3 Approval in Europe
Details : EB-CLIN-1001-03 phase 3 clinical trial for the leading biosimilar program EB1001, a Denosumab biosimilar, for the future treatment of osteoporosis, giant cell tumors of bone, and other skeletal-related events from metastatic solid tumors.
Product Name : EB1001
Product Type : Antibody
Upfront Cash : Inapplicable
August 31, 2021
Lead Product(s) : Denosumab
Therapeutic Area : Musculoskeletal
Highest Development Status : Phase I
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Denosumab
Therapeutic Area : Musculoskeletal
Study Phase : Phase I
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
First Subjects Dosed in JHL's Phase I Clinical Study of a Denosumab Biosimilar
Details : The Three-Arm Study is randomized, double-blinded, parallel-grouped, and single-dosed and will compare the pharmacokinetic similarity of JHL1266 versus Prolia® sourced from the EU and the US in healthy human subjects.
Product Name : EB1001
Product Type : Antibody
Upfront Cash : Inapplicable
May 18, 2020
Lead Product(s) : Denosumab
Therapeutic Area : Musculoskeletal
Highest Development Status : Phase I
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
Lead Product(s) : Denosumab
Therapeutic Area : Musculoskeletal
Study Phase : Phase I
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable
First Subjects Dosed in Australian Phase I Clinical Study of a Denosumab Biosimilar
Details : JHL1266, a proposed biosimilar to denosumab, is a monoclonal antibody targeting RANKL and works by inhibiting the development of osteoclasts and then preventing break down of bones in the human body.
Product Name : EB1001
Product Type : Antibody
Upfront Cash : Inapplicable
May 18, 2020
Lead Product(s) : Denosumab
Therapeutic Area : Musculoskeletal
Highest Development Status : Phase I
Sponsor : Inapplicable
Deal Size : Inapplicable
Deal Type : Inapplicable