MedPath

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

Sequential Therapies After Osteoanabolic Treatment

First Posted Date
2023-12-11
Last Posted Date
2025-04-27
Lead Sponsor
424 General Military Hospital
Target Recruit Count
150
Registration Number
NCT06164795
Locations
🇬🇷

251 Airforce & VA General Hospital, Athens, Greece

🇬🇷

First Department of Propaedeutic and Internal Medicine, Medical School, National and Kapodistrian University of Athens, Athens, Greece

🇬🇷

, KAT General Hospital, Athens, Greece

and more 5 locations

Study to Evaluate the Efficacy and Safety of PBK_L2201 in Postmenopausal Women With Osteoporosis

Phase 3
Not yet recruiting
Conditions
Osteoporosis
Interventions
Drug: Placebo
First Posted Date
2023-12-04
Last Posted Date
2023-12-04
Lead Sponsor
Pharmbio Korea Co., Ltd.
Target Recruit Count
60
Registration Number
NCT06154187
Locations
🇰🇷

The Catholic University of Korea Yeouido Saint Mary's Hospital, Seoul, Korea, Republic of

Real-world Effectiveness and Cardiovascular Safety Study of Abaloparatide in Postmenopausal Women

Completed
Conditions
Osteoporosis, Postmenopausal
Interventions
First Posted Date
2021-07-23
Last Posted Date
2024-04-19
Lead Sponsor
Radius Health, Inc.
Target Recruit Count
22054
Registration Number
NCT04974723
Locations
🇺🇸

Radius Health, Boston, Massachusetts, United States

PTH Analog Type II Odontoid Fracture

Phase 2
Recruiting
Conditions
Odontoid Fracture
Interventions
Device: Hard collar immobilization
First Posted Date
2021-02-18
Last Posted Date
2023-02-15
Lead Sponsor
David Lunardini
Target Recruit Count
20
Registration Number
NCT04760782
Locations
🇺🇸

University of Vermont Medical Center, Burlington, Vermont, United States

Supracondylar Distal Femur Fractures and Abaloparatide

Phase 4
Withdrawn
Conditions
Femoral Fractures
Interventions
Drug: Placebo
First Posted Date
2020-11-12
Last Posted Date
2024-05-01
Lead Sponsor
Daniel Horwitz
Registration Number
NCT04626141
Locations
🇺🇸

Geisinger Medical Center, Danville, Pennsylvania, United States

Abaloparatide Added to Ongoing Denosumab vs Continued Denosumab Alone

Phase 4
Active, not recruiting
Conditions
Osteoporosis, Postmenopausal
Interventions
First Posted Date
2020-07-13
Last Posted Date
2025-05-02
Lead Sponsor
Hospital for Special Surgery, New York
Target Recruit Count
70
Registration Number
NCT04467983
Locations
🇺🇸

Hospital for Special Surgery, New York City, New York, United States

Abaloparatide and Pelvic Fracture Healing

Phase 2
Completed
Conditions
Fracture of Pelvis (Disorder)
Interventions
Drug: Placebo prefilled injector pen
First Posted Date
2020-01-30
Last Posted Date
2024-06-14
Lead Sponsor
Hospital for Special Surgery, New York
Target Recruit Count
48
Registration Number
NCT04249232
Locations
🇺🇸

Hospital for Special Surgery, New York, New York, United States

🇺🇸

Mount Sinai, New York, New York, United States

🇺🇸

Westchester Medical Center, Valhalla, New York, United States

Abaloparatide Before Total Knee Arthroplasty

Phase 4
Completed
Conditions
Arthroplasties, Knee Replacement
Osteoporosis
Interventions
First Posted Date
2019-11-18
Last Posted Date
2025-04-04
Lead Sponsor
University of Wisconsin, Madison
Target Recruit Count
58
Registration Number
NCT04167163
Locations
🇺🇸

University of Wisconsin, Madison, Wisconsin, United States

Abaloparatide vs. Placebo in Post-Menopausal Women and Abaloparatide in Men Receiving Initial Spinal Fusion Surgery

Phase 2
Recruiting
Conditions
Spinal Fusion
Interventions
Drug: Placebo
First Posted Date
2019-02-15
Last Posted Date
2024-06-13
Lead Sponsor
Hospital for Special Surgery, New York
Target Recruit Count
96
Registration Number
NCT03841058
Locations
🇺🇸

Hospital for Special Surgery, New York, New York, United States

A Phase I Pilot Study of Abaloparatide + Bevacizumab in Myelodysplastic Syndromes

Phase 1
Completed
Conditions
Chronic Myelomonocytic Leukemia
Myelodysplastic Syndromes
Interventions
First Posted Date
2018-11-19
Last Posted Date
2023-01-23
Lead Sponsor
University of Rochester
Target Recruit Count
20
Registration Number
NCT03746041
Locations
🇺🇸

University of Rochester, Rochester, New York, United States

© Copyright 2025. All Rights Reserved by MedPath