Drugs / Abaloparatide
Abaloparatide
Regulatory milestones approvals, filings & regulatory actions · 7 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (4) | US (FDA) | TYMLOS | — | 2018-10-17 – 2022-12-19 | fda.gov ↗ |
| Approved | EU (EMA) | Eladynos | — | 2022-12-12 | europa.eu ↗ |
| Refused (EMA) | EU (EMA) | Eladynos | — | 2019-01-07 | europa.eu ↗ |
| Approved | US (FDA) | TYMLOS | — | 2017-04-28 | fda.gov ↗ |
Trials 15 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 13 trials | ||||||
| Phase 1 | NCT04663464 | Nov 2020 → Mar 2021 | — | Radius Health, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT04366726 | Apr → May 2019 | postmenopausal osteoporosis | Radius Health, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT03746041 | Feb 2019 → Apr 2022 | chronic myelomonocytic leukemia, myelodysplastic syndrome | University of Rochester | Completed | No outcome recorded |
| Phase 26 trials | ||||||
| Phase 2 | NCT07587775 | Jun 2026 → Jun 2028 expected | lumbar disk degenerative disorder | State University of New York at Buffalo | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT04760782 | May 2022 → Aug 2023 | — | David Lunardini | Terminated | No outcome recorded |
| Phase 2 | NCT03708926 | Mar 2021 → Aug 2023 | intervertebral disk degenerative disorder | Johns Hopkins University | Withdrawn | No outcome recorded |
| Phase 2 | NCT03841058 | Aug 2019 → Feb 2027 expected | — | Hospital for Special Surgery, New York | Active not recruiting | No outcome recorded |
| Phase 2 | NCT01674621 | Sep 2012 → Aug 2013 | postmenopausal osteoporosis | Radius Health, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00542425 | Apr 2007 → Jun 2009 | osteoporosis | Radius Health, Inc. | Completed | No outcome recorded |
| Phase 35 trials | ||||||
| Phase 3 | NCT06898060 | Jun 2025 → May 2027 expected | postmenopausal osteoporosis | Qilu Pharmaceutical Co., Ltd. | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT04064411 | Aug 2019 → Oct 2021 | postmenopausal osteoporosis | Radius Health, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT03710889 | Sep 2018 → Jul 2020 | postmenopausal osteoporosis | Radius Health, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT03512262 | May 2018 → Aug 2021 | osteoporosis | Radius Health, Inc. | Completed | No outcome recorded |
| Phase 3 | NCT01343004 | Apr 2011 → Oct 2014 | postmenopausal osteoporosis | Radius Health, Inc. | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT04626141 | Jun 2024 → Jun 2025 | — | Daniel Horwitz | Withdrawn | No outcome recorded |
Also used as a comparator or background therapy in 3 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 21 trial | ||||||
| Phase 2 | NCT04249232 Comparator | Sep 2020 → Apr 2024 | — | Hospital for Special Surgery, New York | Completed | No outcome recorded |
| Phase 42 trials | ||||||
| Phase 4 | NCT04467983 Comparator | Feb 2021 → Sep 2026 expected | postmenopausal osteoporosis | Hospital for Special Surgery, New York | Active not recruiting | No outcome recorded |
| Phase 4 | NCT04167163 Comparator | Jan 2020 → Apr 2025 | osteoarthritis, knee, osteoporosis | University of Wisconsin, Madison | Completed | No outcome recorded |
Evidence & citations 11 cited values
Every value below carries the sentence it was read from. 19 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Abaloparatide | “Effects of abaloparatide, a human parathyroid hormone-related peptide analog, on bone mineral density in postmenopausal women with osteoporosis.” PMID 25393645 ↗ Nov 2014 |
| Known as | Abaloparatida | ChEMBL registry synonym — accepted as the source's own label CHEMBL3301581 ↗ |
| Known as | BA058 | “Phase 2 Study of BA058 (Abaloparatide) Transdermal Delivery in Postmenopausal Women With Osteoporosis” NCT01674621 ↗ |
| Known as | BIM-44058 | ChEMBL registry synonym — accepted as the source's own label CHEMBL3301581 ↗ |
| Known as | Eladynos | ChEMBL registry synonym — accepted as the source's own label CHEMBL3301581 ↗ |
| Known as | QLG2128 | “Abaloparatide Injection (QLG2128)” NCT06898060 ↗ |
| Known as | Tymlos | ChEMBL registry synonym — accepted as the source's own label CHEMBL3301581 ↗ |
| Action | Activate | “a potent and selective activator of the parathyroid hormone 1 receptor signaling pathway” NCT03512262 ↗1“Parathyroid hormone receptor agonist” CHEMBL3301581 ↗ |
| Modality | Peptide | “Abaloparatide is a novel synthetic peptide analog of parathyroid hormone-related protein (PTHrP)” PMID 25393645 ↗ Nov 2014 |
| Route | Subcutaneous | “daily sc injections of placebo, abaloparatide, 20, 40, or 80 μg, or teriparatide, 20 μg” PMID 25393645 ↗ Nov 2014 |
| Target | PTH1R | “Parathyroid hormone receptor agonist” CHEMBL3301581 ↗ |