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Abaloparatide

Generic Name
Abaloparatide
Brand Names
Tymlos, Eladynos
Drug Type
Biotech
CAS Number
247062-33-5
Unique Ingredient Identifier
AVK0I6HY2U
Background

Abaloparatide is an N-terminal analog of parathyroid hormone-related protein (PTHrP) and an agonist at the parathyroid hormone type 1 (PTH1) receptor. It is a synthetic 34 amino acid peptide with 41% homology to human parathyroid hormone 1-34 and human PTHrP 1-34. Abaloparatide and PTHrP share the first 21 amino acids and the receptor-activating domain.

Abaloparatide is an osteoanabolic agent that stimulates bone formation. It was first approved by the FDA on April 28, 2017, for the treatment of osteoporosis in postmenopausal women and is also used to increase bone density in men with osteoporosis. In October 2022, the EMA's Committee for Medicinal Products for Human Use (CHMP) recommended abaloparatide be granted marketing authorization in Europe and the drug was fully authorized by the European Commission on December 19, 2022.

Indication

Abaloparatide is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture (defined as a history of osteoporotic fracture or multiple risk factors for fracture) or patients who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis, abaloparatide reduces the risk of vertebral and nonvertebral fractures.

Abaloparatide is also indicated to increase bone density in men with osteoporosis at high risk for fracture (defined as a history of osteoporotic fracture or multiple risk factors for fracture) or patients who have failed or are intolerant to other available osteoporosis therapy.

Associated Conditions
Osteoporosis

Early Effects of Abaloparatide on Tissue-Based Indices of Bone Formation and Resorption

Phase 3
Completed
Conditions
Osteoporosis
Osteoporosis, Postmenopausal
Osteoporosis Vertebral
Osteoporosis Risk
Osteoporosis Fracture
Osteoporosis Localized to Spine
Osteoporosis, Age-Related
Osteoporosis Senile
Osteoporosis of Vertebrae
Interventions
First Posted Date
2018-10-18
Last Posted Date
2021-10-15
Lead Sponsor
Radius Health, Inc.
Target Recruit Count
23
Registration Number
NCT03710889
Locations
🇺🇸

Panorama Orthopedics & Spine Center, Golden, Colorado, United States

🇺🇸

Center for Advanced Research & Education, Gainesville, Georgia, United States

🇺🇸

Harvard Medical School, Boston, Massachusetts, United States

and more 1 locations

Effect of Abaloparatide on Lumbar Disc Degeneration

Phase 2
Withdrawn
Conditions
Degeneration Disc Intervertebral
Interventions
Drug: Placebo
First Posted Date
2018-10-17
Last Posted Date
2021-04-12
Lead Sponsor
Johns Hopkins University
Registration Number
NCT03708926
Locations
🇺🇸

Johns Hopkins University, Baltimore, Maryland, United States

Safety and Efficacy of Abaloparatide-SC in Men With Osteoporosis (ATOM)

Phase 3
Completed
Conditions
Osteoporosis
Osteoporosis, Age-Related
Osteoporosis Localized to Spine
Osteoporosis Senile
Age Related Osteoporosis
Osteoporosis of Vertebrae
Interventions
Drug: Placebo
First Posted Date
2018-04-30
Last Posted Date
2023-04-07
Lead Sponsor
Radius Health, Inc.
Target Recruit Count
228
Registration Number
NCT03512262
Locations
🇺🇸

Meridian Clinical Research, Savannah, Georgia, United States

🇺🇸

The University of Chicago, Chicago, Illinois, United States

🇺🇸

SUNY Upstate Medical University, Syracuse, New York, United States

and more 31 locations
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