Overview
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
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2023/12/11 | N/A | Recruiting | |||
2023/12/04 | Phase 3 | Not yet recruiting | |||
2021/07/23 | N/A | Completed | |||
2021/02/18 | Phase 2 | Recruiting | David Lunardini | ||
2020/11/12 | Phase 4 | Withdrawn | Daniel Horwitz | ||
2020/07/13 | Phase 4 | Active, not recruiting | Hospital for Special Surgery, New York | ||
2020/01/30 | Phase 2 | Completed | Hospital for Special Surgery, New York | ||
2019/11/18 | Phase 4 | Completed | |||
2019/02/15 | Phase 2 | Recruiting | Hospital for Special Surgery, New York | ||
2018/11/19 | Phase 1 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Radius Health, Inc. | 70539-001 | SUBCUTANEOUS | 3.12 mg in 1.56 mL | 12/31/2023 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 12/12/2022 |
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| ELADYNOS abaloparatide 2 mg/mL solution for injection cartridge in a pre-filled pen | 430937 | Medicine | A | 11/28/2024 |
Help Us Improve
Your feedback helps us provide better drug information and insights.