Product Description
Abaloparatide is used to treat osteoporosis in postmenopausal women who are at high risk for bone fracture. It reduces the risk of having bone and spine fracture in postmenopausal women with osteoporosis. (Sourced from: https://www.mayoclinic.org/drugs-supplements/abaloparatide-subcutaneous-route/side-effects/drg-20406221?p=1)
Mechanisms of Action: PTH Agonist
Novel Mechanism: No
Modality: Peptide/Protein
Route of Administration: Subcutaneous, Transdermal
FDA Designation: *
Approval Status: Approved
Approved Countries: Austria | Belgium | Croatia | Czech | European Medicines Agency | Finland | Iceland | Ireland | Italy | Japan | Lithuania | Poland | Portugal | Slovakia | Sweden | United States
Approved Indications: None
Known Adverse Events: None
Company: Radius Health
Company Location:
Company CEO: G. Kelly Martin
Additional Commercial Interests: None
Clinical Description
Countries in Clinic:
Active Clinical Trial Count:
Recent & Upcoming Milestones
Highest Development Phases
Phase 4: Femoral Fractures|Osteoporosis, Postmenopausal|Osteoporosis
Phase 3: Osteoporosis|Osteoporosis, Postmenopausal|Osteoporotic Fractures
Phase 2: Osteoporosis|Osteoporosis, Postmenopausal|Intervertebral Disc Degeneration|Hip Fracture|Neck Pain|Acute Pain|Pain, Referred|Low Back Pain|Hypercalcemia|Kyphosis
Phase 1: Myelodysplastic Syndrome|Juvenile Myelomonocytic Leukemia,|Osteoporosis|Chronic Myelomonocytic Leukemia|Preleukemia|Bone Diseases, Metabolic|Osteoporosis, Postmenopausal
Trial ID |
Trial |
Phase |
Trial Status |
Disease |
Primary Completion Date |
Probability of Success |
Latest Trial Update Date |
Data Updated |
|---|---|---|---|---|---|---|---|---|
NCT06164795 |
START | N/A |
Recruiting |
Osteoporosis, Postmenopausal |
2026-12-01 |
2025-04-30 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
|
NCT04974723 |
BA058-05-028 | N/A |
Completed |
Osteoporosis, Postmenopausal |
2021-09-30 |
2025-02-07 |
Primary Endpoints|Treatments |
|
NCT03746041 |
NCT03746041 | P1 |
Completed |
Preleukemia|Myelodysplastic Syndrome|Juvenile Myelomonocytic Leukemia,|Chronic Myelomonocytic Leukemia |
2022-04-01 |
2025-02-07 |
Primary Endpoints|Treatments |
|
NCT04663464 |
BA058-05-024 | P1 |
Completed |
Osteoporosis |
2021-03-27 |
50% |
2025-02-07 |
Primary Endpoints |
NCT04936984 |
BA058-05-023 | P1 |
Completed |
Osteoporosis |
2021-02-09 |
2025-02-07 |
||
NCT04366726 |
BA058-05-022 | P1 |
Completed |
Bone Diseases, Metabolic|Osteoporosis, Postmenopausal |
2019-05-14 |
2025-02-07 |
Primary Endpoints|Treatments |
|
NCT03841058 |
FAST-Healing | P2 |
Recruiting |
Kyphosis|Low Back Pain |
2026-09-01 |
2025-02-07 |
Patient Enrollment|Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments |
|
NCT04249232 |
NCT04249232 | P2 |
Completed |
Hip Fracture |
2024-04-25 |
2025-02-07 |
Primary Endpoints |
|
NCT04760782 |
STUDY00001025 | P2 |
Terminated |
Neck Pain|Acute Pain|Pain, Referred|Hypercalcemia|Hip Fracture |
2023-08-14 |
2025-02-07 |
Primary Endpoints|Treatments |
|
NCT03708926 |
IRB00185784 | P2 |
Withdrawn |
Intervertebral Disc Degeneration |
2023-08-01 |
2025-02-07 |
Primary Endpoints |
|
JapicCTI-132381 |
JapicCTI-132381 | P2 |
Completed |
Osteoporosis |
2015-10-31 |
|||
2012-001921-29 |
Not Applicable | P2 |
Completed |
Osteoporosis, Postmenopausal |
2013-08-02 |
2022-03-13 |
Treatments |
|
NCT01674621 |
BA058-05-007 | P2 |
Completed |
Osteoporosis, Postmenopausal |
2013-08-02 |
2025-02-07 |
Primary Endpoints |
|
2019-004807-11 |
2019-004807-11 | P3 |
Completed |
Osteoporosis, Postmenopausal |
2021-10-11 |
2025-07-09 |
Treatments |
|
NCT04064411 |
the wearABLe Study | P3 |
Completed |
Osteoporosis, Postmenopausal |
2021-10-05 |
38% |
2025-02-07 |
Primary Endpoints |
2017-004220-30 |
2017-004220-30 | P3 |
Completed |
Osteoporosis |
2021-09-08 |
2022-03-13 |
Treatments |
|
NCT03512262 |
ATOM | P3 |
Completed |
Osteoporosis |
2021-08-17 |
38% |
2025-02-07 |
Primary Endpoints|Treatments |
NCT03710889 |
BA058-05-020 | P3 |
Completed |
Osteoporosis, Postmenopausal|Osteoporotic Fractures |
2020-07-15 |
23% |
2025-02-07 |
Primary Endpoints |
JapicCTI-173575 |
JapicCTI-173575 | P3 |
Unknown |
Osteoporosis |
2020-03-31 |
|||
2012-002216-10 |
2012-002216-10 | P3 |
Completed |
Osteoporosis, Postmenopausal |
2016-10-03 |
2022-03-13 |
Treatments |
|
2010-022576-30 |
2010-022576-30 | P3 |
Completed |
Osteoporosis, Postmenopausal |
2014-10-07 |
2022-03-13 |
Treatments |
|
NCT01343004 |
ACTIVE | P3 |
Completed |
Osteoporosis, Postmenopausal |
2014-10-01 |
2025-02-07 |
Primary Endpoints |
|
NCT04467983 |
NCT04467983 | P4 |
Active, not recruiting |
Osteoporosis, Postmenopausal |
2026-09-01 |
2025-08-27 |
||
NCT04626141 |
NCT04626141 | P4 |
Withdrawn |
Femoral Fractures |
2025-06-01 |
2025-02-07 |
Primary Endpoints|Treatments |
|
NCT04167163 |
A534255 | P4 |
Completed |
Osteoporosis |
2025-04-03 |
2025-04-05 |
Primary Completion Date|Primary Endpoints|Study Completion Date|Treatments|Trial Status |
Recent News Events
Date |
Type |
Title |
|---|---|---|
|
01/12/2026 |
News Article |
B-FLEXION Life Sciences to Acquire Remaining 57% Interest in Radius Health |
|
10/08/2025 |
News Article |
Could Oral Osteoporosis Treatment Become the Next GLP-1-Style Blockbuster? |
|
09/18/2025 |
News Article |
Formation Bio Expands Leadership Team With Top Biotech and Pharma Executives to Accelerate AI-Driven Drug Development |
|
09/08/2025 |
News Article |
Entera Bio Presents Positive Effects of EB613 on Both Trabecular and Cortical Bone in Postmenopausal Women with Osteoporosis at ASBMR 2025 |