abaloparatide
Trade name: tymlos
Approved
Apr 28, 2017
Abaloparatide (brand name Tymlos) is a human parathyroid hormone related peptide [PTHrP(1-34)] analog indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture. Abaloparatide is a PTHrP(1-34) analog which acts as an agonist at the PTH1 receptor (PTH1R). This results in activation of the cAMP signaling pathway in target cells. In rats and monkeys, abaloparatide had an anabolic effect on bone, demonstrated by increases in BMD and bone mineral content (BMC) that correlated with increases in bone strength at vertebral and/or nonvertebral sites. Abaloparatide was approved in April 28, 2017 by the FDA (as Tymlos) for the treatment of postmenopausal women with osteoporosis at high risk for fracture. — NCATS
Clinical trial activity
17 trials · 14 clinical orgs · 2 marketing orgs
Earliest trial started Apr 1, 2007 (NCT00542425)
Timeline
2000s
- Dec 9, 2005
Ipsen — IND Organization
- Dec 9, 2005
Ipsen — IND Organization
- Jan 1, 2007
Radius Health — Earliest Phase 2 Sponsor(trial)
2010s
- Jan 1, 2011
Radius Health — Earliest Phase 3 Sponsor(trial)
- Apr 28, 2017
Radius Health — Earliest FDA Approval
- Apr 28, 2017
Radius Health — NDA Organization
- Jan 1, 2019
Earliest Phase 1 Sponsor(trial)
Indications
Approved for
Studied for
- Arthroplasty, Replacement, Knee · Phase 4
- Femoral Fractures · Phase 4
- Fractures, Bone · Phase 2
- Healthy Volunteers · Phase 1
- Intervertebral Disc Degeneration · Phase 2
- Leukemia, Myelomonocytic, Chronic · Phase 1
- Myelodysplastic Syndromes · Phase 1
- Osteoporosis, Postmenopausal · Phase 4
- Spinal Fusion · Phase 2
Mechanism of action
Approval history
- approvedApr 28, 2017
Chemistry & pharmacology
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Prescription Only
- Multi-specific
- No
Oral
No
Parenteral
Yes
Topical
No
Sources
- WikipediaAbaloparatide ↗
- NCATSAVK0I6HY2U ↗
- ChEMBLCHEMBL3301581 ↗
Also known as
- abaloparatide
- abaloparatide
- abaloparatide
- abaloparatide
- abaloparatide
- abaloparatide
- ba058
- ba058
- ba058
- ba-058
- bim-44058
- tymlos
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT04760782 | Phase 2 | Feb 28, 2021 | University of Vermont |
| NCT04626141 | Phase 4 | Jan 31, 2021 | Geisinger Clinic, Radius Health |
| NCT04663464 | Phase 1 | Nov 16, 2020 | Medpace, Inc., Radius Health |
| NCT04936984 | Phase 1 | Nov 16, 2020 | Medpace, Inc., Radius Health |
| NCT04467983 | Phase 4 | Aug 1, 2020 | Crozer Chester Medical Center, Pennsylvania, Osteoporosis Center of Delaware County, Radius Health |
| NCT04249232 | Phase 2 | Mar 31, 2020 | Cornell University, Lenox Hill Hospital, New York Hospital Queens, Rockefeller University |
| NCT04167163 | Phase 4 | Dec 31, 2019 | University of Wisconsin |
| NCT04064411 | Phase 3 | Aug 5, 2019 | Radius Health |
| NCT03708926 | Phase 2 | Jun 30, 2019 | Johns Hopkins University |
| NCT03841058 | Phase 2 | May 31, 2019 | Rockefeller University |
| NCT04366726 | Phase 1 | Apr 9, 2019 | Radius Health |
| NCT03746041 | Phase 1 | Feb 14, 2019 | University of Rochester |
| NCT03710889 | Phase 3 | Sep 20, 2018 | Radius Health |
| NCT03512262 | Phase 3 | Mar 30, 2018 | Radius Health |
| NCT01674621 | Phase 2 | Aug 1, 2012 | Nordic Bioscience, Radius Health |
| NCT01343004 | Phase 3 | Apr 1, 2011 | Radius Health |
| NCT00542425 | Phase 2 | Apr 1, 2007 | Radius Health |
Organizations
Research & Development (14)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Radius Health | For profit | 11 | 9 | 4 | 2007 |
| Medpace, Inc. | For profit | 2 | 0 | 1 | 2020 |
| Rockefeller University | Academic/Hospital | 2 | 2 | 1 | 2019 |
| Cornell University | Academic/Hospital | 1 | 0 | 1 | 2020 |
| Crozer Chester Medical Center, Pennsylvania | Academic/Hospital | 1 | 0 | 1 | 2020 |
| Geisinger Clinic | Academic/Hospital | 1 | 1 | 1 | 2021 |
| Johns Hopkins University | Academic/Hospital | 1 | 1 | 1 | 2019 |
| Lenox Hill Hospital | Academic/Hospital | 1 | 0 | 1 | 2020 |
| New York Hospital Queens | Academic/Hospital | 1 | 0 | 1 | 2020 |
| Nordic Bioscience | For profit | 1 | 0 | 1 | 2012 |
| Osteoporosis Center of Delaware County | Academic/Hospital | 1 | 1 | 1 | 2020 |
| University of Rochester | Academic/Hospital | 1 | 1 | 1 | 2019 |
| University of Vermont | Academic/Hospital | 1 | 1 | 1 | 2021 |
| University of Wisconsin | Academic/Hospital | 1 | 1 | 1 | 2019 |
Marketing (2)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Ipsen | For profit | IND | Dec 9, 2005 |
| Radius Health | For profit | NDA | Apr 28, 2017 |