Drugs / Romiplostim
Romiplostim
Regulatory milestones approvals, filings & regulatory actions · 5 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (3) | US (FDA) | NPLATE | — | 2018-12-14 – 2021-01-28 | fda.gov ↗ |
| Approved | EU (EMA) | Nplate | — | 2009-02-04 | europa.eu ↗ |
| Approved | US (FDA) | NPLATE | — | 2008-08-22 | fda.gov ↗ |
Trials 70 · started per year
today
US approved 2008
EU approved 2009
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 02 trials | ||||||
| Phase 0 | NCT07048249 | Jan 2024 → Jan 2027 expected | Ewing sarcoma, thrombocytopenia | Children's Hospital Medical Center, Cincinnati | Recruiting | No outcome recorded |
| Phase 0 | NCT04478227 | Aug 2020 → Jan 2024 | aplastic anemia, bone marrow failure syndrome, refractory cytopenia of childhood, thrombocytopenia | Anjali Sharathkumar | Completed | No outcome recorded |
| Phase 13 trials | ||||||
| Phase 1 | NCT07595133 | Jun 2026 → Dec 2027 expected | infectious disease with sepsis | Shanghai 10th People's Hospital | Not yet recruiting | No outcome recorded |
| Phase 1 | NCT05652595 | Jun 2022 → Jun 2024 | — | Geropharm | Unknown | No outcome recorded |
| Phase 1 | NCT02046291 | Apr 2015 → Dec 2020 | hematopoietic and lymphoid cell neoplasm | Masonic Cancer Center, University of Minnesota | Completed | No outcome recorded |
| Phase 1/27 trials | ||||||
| Phase 1/2 | NCT02868060 | Sep 2015 → Aug 2017 | autoimmune thrombocytopenia | Kyowa Kirin Co., Ltd. | Completed | No outcome recorded |
| Phase 1/2 | NCT01980030 | Nov 2013 → Dec 2015 | disease related to hematopoietic stem cell transplant | Assistance Publique - Hôpitaux de Paris | Completed | No outcome recorded |
| Phase 1/2 | NCT00515203 | Jul 2007 → Mar 2009 | autoimmune thrombocytopenic purpura | Amgen | Completed | No outcome recorded |
| Phase 1/2 | NCT00299182 | Mar 2006 → Apr 2012 | lymphoma | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 1/2 | NCT00283439 | Oct 2005 → May 2008 | Hodgkins lymphoma, cancer, non-Hodgkin lymphoma, thrombocytopenia | Amgen | Completed | No outcome recorded |
| Phase 1/2 | NCT00147225 | Aug 2005 → Mar 2013 | cancer | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 1/2 | NCT00117143 | Dec 2002 → Jul 2004 | thrombocytopenic purpura | Amgen | Completed | No outcome recorded |
| Phase 227 trials | ||||||
| Phase 2 | NCT07278661 | Sep 2026 → Dec 2028 expected | thrombocytopenia | Nantes University Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT07001254 | Aug 2026 → Dec 2031 expected | aplastic anemia | Anjali Sharathkumar | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07400341 | Jan 2026 → Jan 2028 expected | aplastic anemia, myelodysplastic syndrome | The First Affiliated Hospital of Soochow University | Recruiting | No outcome recorded |
| Phase 2 | NCT06898983 | Jul 2025 → Jun 2026 overdue | chemotherapy-induced toxicity | Anhui Provincial Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT06693791 | Dec 2024 → Nov 2026 expected | transient neonatal thrombocytopenia | Anhui Provincial Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT05323617 | Aug 2023 → Feb 2025 | aplastic anemia | Amgen | Withdrawn | No outcome recorded |
| Phase 2 | NCT04933942 | Sep → Dec 2022 | high grade astrocytic tumor | European Organisation for Research and Treatment of Cancer - EORTC | Withdrawn | No outcome recorded |
| Phase 2 | NCT04673266 | Dec 2020 → Apr 2026 | lymphoma, thrombocytopenia | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT04671901 | Dec 2020 → Mar 2023 | carcinoma, childhood malignant neoplasm | Memorial Sloan Kettering Cancer Center | Terminated | No outcome recorded |
| Phase 2 | NCT04588194 | Nov 2020 → Nov 2021 | autoimmune thrombocytopenia, thrombotic thrombocytopenic purpura | David Gomez Almaguer | Unknown | No outcome recorded |
| Phase 2 | NCT04478123 | Jul 2020 → Jun 2023 | Hodgkins lymphoma, non-Hodgkin lymphoma, plasma cell myeloma | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT04371939 | Nov 2019 → Dec 2022 | Wiskott-Aldrich syndrome | Federal Research Institute of Pediatric Hematology, Oncology and Immunology | Unknown | No outcome recorded |
| Phase 2 | NCT02335268 | May 2015 → Jul 2021 | myelodysplastic syndrome | Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH | Completed | No outcome recorded |
| Phase 2 | NCT02338414 | Jan → Dec 2015 | autoimmune thrombocytopenia | Samsung Medical Center | Unknown | No outcome recorded |
| Phase 2 | NCT02227576 | Jul 2014 → Dec 2017 | glioblastoma, thrombocytopenia | University Hospital, Lille | Terminated | No outcome recorded |
| Phase 2 | NCT02094417 | Apr 2014 → Apr 2017 | aplastic anemia | Kyowa Kirin Co., Ltd. | Completed | No outcome recorded |
| Phase 2 | NCT03622931 | Feb 2014 → Jan 2019 | ovarian cancer | Gesellschaft fur Medizinische Innovation - Hamatologie und Onkologie mbH | Terminated | No outcome recorded |
| Phase 2 | NCT02052882 | Jan 2014 → Nov 2023 | thrombocytopenia | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT01676961 | Jan 2013 → Nov 2015 | plasma cell myeloma, thrombocytopenia | NYU Langone Health | Terminated | No outcome recorded |
| Phase 2 | NCT01516619 | Nov 2011 → Nov 2012 | non-Hodgkin lymphoma | Andres J. M. Ferreri | Completed | No outcome recorded |
| Phase 2 | NCT01143038 | Nov 2010 → Sep 2013 | autoimmune thrombocytopenic purpura | Amgen | Completed | No outcome recorded |
| Phase 2 | NCT00902018 | Jan 2009 → Sep 2015 | thrombocytopenia due to immune destruction | Weill Medical College of Cornell University | Completed | No outcome recorded |
| Phase 2 | NCT00614523 | Jul 2008 → Mar 2011 | myelodysplastic syndrome, thrombocytopenia | Amgen | Completed | No outcome recorded |
| Phase 2 | NCT00413283 | Dec 2006 → Dec 2008 | non-small cell lung carcinoma, thrombocytopenia | Amgen | Completed | No outcome recorded |
| Phase 2 | NCT00303472 | Feb 2006 → May 2008 | myelodysplastic syndrome, thrombocytopenia | Amgen | Completed | No outcome recorded |
| Phase 2 | NCT00305435 | Feb → Nov 2006 | autoimmune thrombocytopenic purpura | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00111475 | Jul 2002 → Jun 2004 | autoimmune thrombocytopenic purpura | Amgen | Completed | No outcome recorded |
| Phase 2/34 trials | ||||||
| Phase 2/3 | NCT04095936 | Dec 2019 → Oct 2021 | aplastic anemia | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 2/3 | NCT03957694 | Apr 2019 → Nov 2020 | aplastic anemia | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 2/3 | NCT02773290 | May 2016 → Nov 2017 | aplastic anemia | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 2/3 | NCT00440037 | Nov 2006 → Jul 2011 | autoimmune thrombocytopenic purpura | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 316 trials | ||||||
| Phase 3 | NCT07700238 | Jul 2026 → Sep 2029 expected | autoimmune thrombocytopenia | Amgen | Not yet recruiting | No outcome recorded |
| Phase 3 | NCT06759636 | Feb 2025 → Apr 2026 overdue | chemotherapy-induced toxicity | The First Affiliated Hospital with Nanjing Medical University | Recruiting | No outcome recorded |
| Phase 3 | NCT06201663 | Dec 2023 → May 2025 | cancer, thrombocytopenia | Ain Shams University | Unknown | No outcome recorded |
| Phase 3 | NCT05325593 | Dec 2022 → Oct 2026 expected | autoimmune thrombocytopenia | Andalusian Public Foundation for Health Research in Seville | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03937154 | Feb 2020 → Mar 2026 overdue | thrombocytopenia | Amgen | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03362177 | Sep 2019 → Jan 2024 | thrombocytopenia | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT03343847 | Jan 2018 → Jul 2021 | thrombocytopenia | Amgen | Withdrawn | No outcome recorded |
| Phase 3 | NCT02868099 | Sep 2015 → Feb 2017 | autoimmune thrombocytopenia | Kyowa Kirin Co., Ltd. | Completed | No outcome recorded |
| Phase 3 | NCT02279173 | Dec 2014 → Aug 2018 | autoimmune thrombocytopenia | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT01444417 | Jan 2012 → Feb 2015 | autoimmune thrombocytopenic purpura | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT01071954 | Dec 2009 → Jan 2017 | autoimmune thrombocytopenic purpura | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT00415532 | Dec 2006 → Nov 2008 | autoimmune thrombocytopenic purpura | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT00102336 | Apr 2005 → Dec 2006 | autoimmune thrombocytopenic purpura | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT00102323 | Mar 2005 → Sep 2006 | autoimmune thrombocytopenic purpura | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT00508820 | Feb 2005 → Jan 2011 | autoimmune thrombocytopenic purpura | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT00116688 | Aug 2004 → Jan 2010 | autoimmune thrombocytopenic purpura | Amgen | Completed | No outcome recorded |
| Phase 47 trials | ||||||
| Phase 4 | NCT06535685 | Aug 2024 → Mar 2025 overdue | aplastic anemia | Peking Union Medical College Hospital | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06516484 | Jul 2024 → Jul 2025 overdue | aplastic anemia | Peking Union Medical College Hospital | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06009497 | Aug 2023 → Dec 2024 | aplastic anemia | Peking Union Medical College Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT05861297 | May 2020 → Jan 2024 | autoimmune thrombocytopenic purpura | Nahda University | Unknown | No outcome recorded |
| Phase 4 | NCT03119974 | Sep 2017 → Aug 2020 | autoimmune thrombocytopenic purpura | Assistance Publique - Hôpitaux de Paris | Completed | No outcome recorded |
| Phase 4 | NCT02760251 | Apr 2016 → Jul 2019 | autoimmune thrombocytopenia | University Hospital, Basel, Switzerland | Completed | No outcome recorded |
| Phase 4 | NCT00907478 | Aug 2009 → Jan 2014 | autoimmune thrombocytopenic purpura | Amgen | Completed | No outcome recorded |
| Phase not applicable4 trials | ||||||
| — | NCT07662525 | Jun 2026 → Dec 2027 expected | autoimmune thrombocytopenic purpura | Peking University People's Hospital | Not yet recruiting | No outcome recorded |
| — | NCT07612319 | Mar 2026 → Sep 2027 expected | autoimmune thrombocytopenic purpura | The First Affiliated Hospital of Soochow University | Recruiting | No outcome recorded |
| — | NCT07162519 | Sep 2025 → Aug 2026 overdue | breast cancer, chemotherapy-induced toxicity | Tianjin Medical University Cancer Institute and Hospital | Not yet recruiting | No outcome recorded |
| — | NCT00472290 | Apr 2007 → Jul 2011 | myelodysplastic syndrome, thrombocytopenia | Amgen | Completed | No outcome recorded |
Also used as a comparator or background therapy in 9 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 26 trials | ||||||
| Phase 2 | NCT07421167 Background | Jun 2026 → Apr 2028 expected | Evans syndrome | Novartis Pharmaceuticals | Recruiting | No outcome recorded |
| Phase 2 | NCT06345495 Background | Oct 2024 → Jan 2027 expected | myelofibrosis, splenic disorder | M.D. Anderson Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT04289207 Background | Mar → Sep 2020 | autoimmune thrombocytopenia | Seoul National University Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT01153919 Comparator | Jun 2010 → Jul 2014 | hepatitis C virus infection, thrombocytopenia | University of Southern California | Terminated | No outcome recorded |
| Phase 2 | NCT00418665 Comparator | Dec 2006 → Mar 2009 | myelodysplastic syndrome, thrombocytopenia | Amgen | Completed | No outcome recorded |
| Phase 2 | NCT00321711 Comparator | Oct 2006 → Oct 2009 | myelodysplastic syndrome, thrombocytopenia | Amgen | Completed | No outcome recorded |
| Phase 33 trials | ||||||
| Phase 3 | NCT06497036 Comparator | Apr 2023 → Mar 2028 expected | — | Geropharm | Active not recruiting | No outcome recorded |
| Phase 3 | NCT05220878 Comparator | Sep 2021 → Aug 2023 | autoimmune thrombocytopenic purpura | AO GENERIUM | Completed | No outcome recorded |
| Phase 3 | NCT00603642 Comparator | Oct 2007 → Apr 2009 | autoimmune thrombocytopenic purpura | Amgen | Completed | No outcome recorded |
Press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2019-10-18 | Amgen | Nplate® (romiplostim) Now Approved For Earlier Use In Adults With Immune Thrombocytopenia amgen.com ↗ |
| 2018-12-19 | Amgen | Amgen Submits Supplemental Biologics License Application For Nplate® (romiplostim) amgen.com ↗ |
| 2018-12-14 | Amgen | FDA Approves Nplate® (Romiplostim) For Use In Pediatric Patients With Immune Thrombocytopenia amgen.com ↗ |
| 2017-11-10 | Amgen | Amgen Receives Positive CHMP Opinion To Expand Use Of Nplate® (romiplostim) In Pediatric Patients With Chronic Immune Thrombocytopenic Purpura amgen.com ↗ |
| 2016-04-19 | Amgen | Nplate® (Romiplostim) Study In The Lancet Shows Significant Increase In Durable Platelet Response Among Children With Immune Thrombocytopenia amgen.com ↗ |
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 81 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Romiplostim | “AMG 531 (Romiplostim) will be administered weekly by subcutaneous injection at a dose of 500 or 750 μg during Part A and 750 μg during Part B for the 4 cycle treatment period,...” NCT00321711 ↗64“The investigators developed, in this study, a standardized procedure to discontinue Eltrombopag and Romiplostim, wherein the dose will be slowly tapered to limit the risk of bleeding.” NCT03119974 ↗ “romiplostim” NCT07421167 ↗ |
| Known as | AMG-531 | “This is a Phase 2, multicenter, randomized, double blind, placebo controlled study designed to assess the efficacy and safety of romiplostim (formerly, AMG 531) treatment in...” NCT00614523 ↗15“Study of Romiplostim(AMG531) in Subjects With Aplastic Anemia” NCT02773290 ↗ “Romiplostim (formerly AMG 531)” NCT00472290 ↗ “Romiplostim (AMG-531)” NCT07048249 ↗ “Romiplostim (AMG-531)” NCT00305435 ↗ |
| Known as | N-Plate | “N-Plate / romiplostim” NCT02335268 ↗ |
| Known as | N01 | “To evaluate the efficacy of romiplostim (N01) in the treatment of chemotherapy-induced thrombocytopenia (CIT) in breast cancer patients by assessing the proportion of patients...” NCT07162519 ↗1“Romiplostim for injection N01 (specification: 250 μg per vial) is administered subcutaneously, 250 μg, once a week” NCT07595133 ↗ |
| Known as | Romiplate | ChEMBL registry synonym — accepted as the source's own label CHEMBL1201832 ↗ |
| Known as | Romiplostim N01 | “Romiplostim N01 will be administered via subcutaneous injection once weekly when patients develop Grade 3 thrombocytopenia” NCT06898983 ↗ |
| Action | Activate | “Romiplostim is a thrombopoietin receptor agonist that increases platelet counts” PMID 19671919 ↗ Aug 20091“Thrombopoietin receptor agonist” CHEMBL1201832 ↗ |
| Modality | Peptide | “a novel thrombopoiesis-stimulating peptibody” NCT00117143 ↗ |
| Route | Subcutaneous | “Administered by subcutaneous injection” NCT00111475 ↗ |
| Target | MPL | “Thrombopoietin receptor agonist” CHEMBL1201832 ↗ |