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
| 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 · 2 met primary | ||||||
| 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 Stop: Enrollment |
| Phase 2 | NCT03708926 | Mar 2021 → Aug 2023 | intervertebral disk degenerative disorder | Johns Hopkins University | Withdrawn | No outcome recorded |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 | Met primary |
| Phase 2 | NCT00542425 | Apr 2007 → Jun 2009 | osteoporosis | Radius Health, Inc. | Completed | Met primary |
| Phase 35 trials · 2 met primary · 1 missed | ||||||
| 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 | Missed primary |
| 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 | Met primary |
| Phase 3 | NCT01343004 | Apr 2011 → Oct 2014 | postmenopausal osteoporosis | Radius Health, Inc. | Completed | Met primary |
| Phase 41 trial | ||||||
| Phase 4 | NCT04626141 | Jun 2024 → Jun 2025 | — | Daniel Horwitz | Withdrawn | No outcome recorded Stop: Enrollment |
| Comparator or background therapy3 trials | ||||||
| Phase 2 | NCT04249232 Comparator | Sep 2020 → Apr 2024 | — | Hospital for Special Surgery, New York | Completed | No outcome recorded |
| Phase 4 | NCT04467983 Comparator | Feb 2021 → Sep 2026 overdue | 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 |
News releases announcing trial results or a regulatory action · 5
| Date | Issuer | Release |
|---|---|---|
| 2024-04-16 | Radius Health, Inc. | Results Radius Announces Presentation of Data on TYMLOS (abaloparatide) at the World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases radiuspharm.com ↗
In this analysis of over 18-months of treatment, abaloparatide demonstrated a lower incidence of hip fracture and non-vertebral fracture compared to teriparatide. |
| 2022-12-20 | Radius Health, Inc. | Regulatory Radius Health’s TYMLOS® (abaloparatide) Receives U.S. FDA Approval as a Treatment to Increase Bone Density in Men with Osteoporosis at High Risk for Fracture radiuspharm.com ↗ |
| 2022-12-19 | Radius Health, Inc. | Regulatory European Commission Approves ELADYNOS (Abaloparatide) for the Treatment of Osteoporosis in Postmenopausal Women at Increased Risk of Fracture radiuspharm.com ↗
Radius Health, Inc. (“Radius” or the “Company”) announced that the European Commission has granted marketing authorization for abaloparatide under the tradename of ELADYNOS to treat osteoporosis in postmenopausal women at increased risk of fracture. |
| 2022-10-14 | Radius Health, Inc. | Regulatory Radius’ Abaloparatide Receives Positive CHMP Opinion for the Treatment of Osteoporosis in Postmenopausal Women at Increased Risk of Fracture radiuspharm.com ↗ |
| 2022-10-13 | Radius Health, Inc. | Results Radius Announces Publication of Abaloparatide Phase 3 ATOM Trial Data in the Journal of Bone and Mineral Research radiuspharm.com ↗
Radius Health, Inc. (“Radius” or the “Company”), today announced that data from the Phase 3 Abaloparatide for the Treatment of Men with Osteoporosis (ATOM) clinical trial (NCT03512262) evaluating abaloparatide compared to placebo were published in the Journal of Bone and Mineral Research (JBMR). |
All press releases naming this drug 11 releases
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 201416“Abaloparatide Injection (QLG2128)” NCT06898060 ↗ |
| 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 ↗ |