Drugs / Romosozumab
Regulatory milestones approvals, filings & regulatory actions · 1 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Evenity | — | 2019-12-09 | europa.eu ↗ |
Trials 32 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 18 trials | ||||||
| Phase 1 | NCT05775094 | Mar 2023 → Mar 2027 expected | osteoporosis, plasma cell myeloma | Memorial Sloan Kettering Cancer Center | Active not recruiting | No outcome recorded |
| Phase 1 | NCT04545554 | Jan 2021 → Mar 2023 | osteogenesis imperfecta | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT01833754 | Apr 2013 → Feb 2014 | osteoporosis | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT01588509 | Mar → Nov 2012 | osteoporosis | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT01101061 | May → Nov 2010 | — | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT00950950 | Aug 2009 → Aug 2010 | osteoporosis | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT01825785 | Nov 2007 → Dec 2008 | — | Amgen | Completed | No outcome recorded |
| Phase 1 | NCT01059435 | Dec 2006 → Jul 2007 | osteoporosis | Amgen | Completed | No outcome recorded |
| Phase 28 trials | ||||||
| Phase 2 | NCT06973109 | Jun 2026 → Mar 2027 | postmenopausal osteoporosis | University of Pittsburgh | Withdrawn | No outcome recorded |
| Phase 2 | NCT04800367 | Mar 2021 → Mar 2027 expected | premenopausal osteoporosis | Columbia University | Active not recruiting | No outcome recorded |
| Phase 2 | NCT04708886 | Mar 2021 → Jun 2024 | osteoporosis, paraplegia, spinal cord injury | Northwestern University | Completed | No outcome recorded |
| Phase 2 | NCT04232657 | Mar 2021 → Aug 2026 overdue | disease of bone structure, spinal cord injury | VA Office of Research and Development | Active not recruiting | No outcome recorded |
| Phase 2 | NCT01992159 | Oct 2012 → Oct 2014 | postmenopausal osteoporosis | Amgen | Completed | No outcome recorded |
| Phase 2 | NCT01081678 | Jun 2010 → Jun 2012 | — | Amgen | Completed | No outcome recorded |
| Phase 2 | NCT00907296 | Sep 2009 → Mar 2012 | — | Amgen | Completed | No outcome recorded |
| Phase 2 | NCT00896532 | Jun 2009 → Feb 2011 | postmenopausal osteoporosis | Amgen | Completed | No outcome recorded |
| Phase 310 trials | ||||||
| Phase 3 | NCT06533865 | Mar 2025 → Oct 2028 expected | functional hypothalamic amenorrhea | Massachusetts General Hospital | Recruiting | No outcome recorded |
| Phase 3 | NCT05972551 | Apr 2024 → May 2027 expected | osteogenesis imperfecta | Amgen | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05067335 | Oct 2021 → Nov 2023 | osteoporosis | UCB Biopharma SRL | Completed | No outcome recorded |
| Phase 3 | NCT04779216 | Sep 2021 → Oct 2024 | anorexia nervosa, osteoporosis | Karen Klahr Miller, MD | Completed | No outcome recorded |
| Phase 3 | NCT02791516 | Jan 2017 → Feb 2018 | postmenopausal osteoporosis | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT02186171 | Jun 2014 → Feb 2016 | osteoporosis | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT02016716 | Dec 2013 → Sep 2014 | postmenopausal osteoporosis | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT01796301 | Jan 2013 → May 2015 | postmenopausal osteoporosis | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT01631214 | May 2012 → Feb 2017 | postmenopausal osteoporosis | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT01575834 | Mar 2012 → Dec 2015 | postmenopausal osteoporosis | Amgen | Completed | No outcome recorded |
| Phase 46 trials | ||||||
| Phase 4 | NCT07283887 | Dec 2025 → Jul 2026 overdue | osteoporosis | National Taiwan University Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT06079476 | Oct 2023 → Oct 2025 | postmenopausal osteoporosis | Amgen | Completed | No outcome recorded |
| Phase 4 | NCT05101018 | Nov 2021 → Jun 2026 overdue | osteoporosis, spinal cord injury | James J. Peters Veterans Affairs Medical Center | Active not recruiting | No outcome recorded |
| Phase 4 | NCT05058976 | Sep 2021 → Mar 2027 expected | postmenopausal osteoporosis | Susan L. Greenspan | Active not recruiting | No outcome recorded |
| Phase 4 | NCT04091243 | Jan 2021 → Oct 2023 | glucocorticoid-induced osteoporosis | Tuen Mun Hospital | Completed | No outcome recorded |
| Phase 4 | NCT04597931 | Nov 2020 → Nov 2023 | osteoporosis, spinal cord injury | Sheba Medical Center | Unknown | No outcome recorded |
Also used as a comparator or background therapy in 8 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT07384104 Comparator | Oct 2025 → Feb 2026 overdue | osteoporosis | Shenzhen Salubris Pharmaceuticals Co., Ltd. | Enrolling by invitation | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT03432533 Comparator | Feb 2018 → Apr 2019 | postmenopausal osteoporosis | Amgen | Completed | No outcome recorded |
| Phase 46 trials | ||||||
| Phase 4 | NCT06938152 Comparator | Apr 2025 → Apr 2029 expected | postmenopausal osteoporosis | National Taiwan University Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT06558188 Comparator | Feb 2025 → Dec 2027 expected | postmenopausal osteoporosis | Massachusetts General Hospital | Recruiting | No outcome recorded |
| Phase 4 | NCT06720350 Comparator | Jan 2025 → Oct 2026 expected | postmenopausal osteoporosis | Marmara University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06472050 Comparator | Aug 2024 → Dec 2025 | osteoporosis, poisoning | Tuen Mun Hospital | Completed | No outcome recorded |
| Phase 4 | NCT06059222 Comparator | Oct 2023 → Aug 2030 expected | osteoporosis | University of Aarhus | Recruiting | No outcome recorded |
| Phase 4 | NCT05010590 Comparator | Mar 2022 → Oct 2027 expected | postmenopausal osteoporosis | Massachusetts General Hospital | Active not recruiting | No outcome recorded |
Press releases naming this drug 25 releases
| Date | Issuer | Release |
|---|---|---|
| 2019-12-11 | Amgen | European Commission Approves EVENITY® (romosozumab) For The Treatment Of Severe Osteoporosis In Postmenopausal Women At High Risk Of Fracture amgen.com ↗ |
| 2019-10-18 | Amgen | EVENITY® (Romosozumab) Receives Positive CHMP Opinion For The Treatment Of Severe Osteoporosis In Postmenopausal Women At High Risk Of Fracture amgen.com ↗ |
| 2019-06-28 | Amgen | Amgen and UCB Provide Regulatory Update on Status of EVENITY™ (romosozumab) in the EU amgen.com ↗ |
| 2019-04-15 | Amgen | EVENITY™ (romosozumab-aqqg) Now Available In The United States For The Treatment Of Osteoporosis In Postmenopausal Women At High Risk For Fracture amgen.com ↗ |
| 2019-04-09 | Amgen | FDA Approves EVENITY™ (romosozumab-aqqg) For The Treatment Of Osteoporosis In Postmenopausal Women At High Risk For Fracture amgen.com ↗ |
| 2019-01-16 | Amgen | Amgen And UCB Receive Positive Vote From FDA Advisory Committee In Favor Of Approval For EVENITY™ (romosozumab) amgen.com ↗ |
| 2019-01-08 | Amgen | EVENITY™ (romosozumab) Receives Approval In Japan For The Treatment Of Osteoporosis In Patients At High Risk Of Fracture amgen.com ↗ |
| 2018-11-30 | Amgen | Amgen And UCB Announce FDA Advisory Committee Meeting To Review EVENITY™ (romosozumab) For The Treatment Of Osteoporosis In Postmenopausal Women At High Risk For Fracture amgen.com ↗ |
| 2018-07-12 | Amgen | Amgen And UCB Resubmit Biologics License Application (BLA) For EVENITY™ (romosozumab) To The US FDA amgen.com ↗ |
| 2018-01-08 | Amgen | European Medicines Agency Accepts Filing For EVENITY™ (Romosozumab) amgen.com ↗ |
| 2017-09-11 | Amgen | EVENITY™ (romosozumab) ARCH Study Results Published In The New England Journal Of Medicine amgen.com ↗ |
| 2017-09-08 | Amgen | Amgen Highlights The Latest EVENITY™ (Romosozumab) And Prolia® (Denosumab) Research At The American Society For Bone And Mineral Research Annual Meeting amgen.com ↗ |
| 2017-07-16 | Amgen | Amgen And UCB Provide Update On Regulatory Status Of EVENITY™ (romosozumab) In The US amgen.com ↗ |
| 2017-05-21 | Amgen | Amgen And UCB Announce Top-Line Phase 3 Data From Active-Comparator Study Of EVENITY™ (Romosozumab) In Postmenopausal Women With Osteoporosis amgen.com ↗ |
| 2017-04-01 | Amgen | Amgen And UCB Report New Data At ENDO 2017 Examining The Option Of A Second Course Of Treatment With EVENITY™ (romosozumab) amgen.com ↗ |
| 2016-12-20 | Amgen | Amgen And UCB Announce Submission Of Application For Investigational Osteoporosis Medication Romosozumab In Japan amgen.com ↗ |
| 2016-11-12 | Amgen | Results From Phase 3 BRIDGE Study Show Romosozumab Significantly Increases Bone Mineral Density In Men With Osteoporosis amgen.com ↗ |
| 2016-09-26 | Amgen | Amgen And UCB Announce U.S. FDA Acceptance Of Biologics License Application For Romosozumab amgen.com ↗ |
| 2016-09-18 | Amgen | Results From Phase 3 FRAME Study Of Romosozumab Showed Significant Reductions In Both New Vertebral And Clinical Fractures In Postmenopausal Women With Osteoporosis amgen.com ↗ |
| 2016-07-21 | Amgen | Amgen And UCB Submit Biologics License Application For Romosozumab To The FDA amgen.com ↗ |
| 2016-04-01 | Amgen | Amgen And UCB Present Positive Data At ENDO 2016 Comparing Romosozumab With Teriparatide amgen.com ↗ |
| 2016-03-21 | Amgen | Amgen And UCB Announce Positive Top-Line Results From Phase 3 Study Evaluating Romosozumab In Men With Osteoporosis amgen.com ↗ |
| 2016-02-22 | Amgen | Amgen And UCB Announce Positive Top-Line Results From The Phase 3 Study Of Romosozumab In Postmenopausal Women With Osteoporosis amgen.com ↗ |
| 2015-10-12 | Amgen | New Exploratory Analysis Showed Romosozumab Increased Estimated Bone Strength More Than Teriparatide amgen.com ↗ |
| 2015-09-01 | Amgen | Amgen And UCB Announce Positive Top-Line Results From Open-Label Phase 3 Study Of Romosozumab Compared With Teriparatide amgen.com ↗ |
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 42 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Romosozumab | “An Open-label Study to Evaluate the Effect of Treatment With Romosozumab or Teriparatide in Postmenopausal Women” NCT01796301 ↗39 |
| Known as | AMG 785 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2107874 ↗ |
| Known as | CDP-7851 | ChEMBL registry synonym — accepted as the source's own label CHEMBL2107874 ↗ |
| Known as | Evenity | “An Open-label, Single-arm, Multicenter Phase 4 Study to Evaluate Safety and Tolerability of Romosozumab (EVENITY® ) in Postmenopausal Women in India With Osteoporosis and a...” NCT06079476 ↗3“Romosozumab Prefilled Syringe [Evenity]” NCT04800367 ↗ “Romosozumab Prefilled Syringe [Evenity]” NCT06720350 ↗ “Romosozumab (Evenity)” NCT04708886 ↗ |
| Known as | ROMO | “Romosozumab (ROMO) is a humanized monoclonal antibody against sclerostin.” NCT04091243 ↗ |
| Known as | Romosozumab aqqg | ChEMBL registry synonym — accepted as the source's own label CHEMBL2107874 ↗ |
| Action | Inhibit | “Romosozumab, a sclerostin antagonist” NCT04232657 ↗1“Sclerostin inhibitor” CHEMBL2107874 ↗ |
| Modality | Monoclonal antibody | “The monoclonal antibody romosozumab binds to sclerostin and increases bone formation.” PMID 24382002 ↗ Jan 2014 |
| Route | Subcutaneous | “Participants were randomly assigned to receive subcutaneous romosozumab monthly (at a dose of 70 mg, 140 mg, or 210 mg) or every 3 months (140 mg or 210 mg), subcutaneous...” PMID 24382002 ↗ Jan 2014 |
| Target | SOST | “Sclerostin inhibitor” CHEMBL2107874 ↗ |