Drugs / Romiplostim
Romiplostim
Regulatory milestones approvals, filings & regulatory actions · 6 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed primary thrombocytopenia 1 milestone | |||||
| Filed | US (FDA) | Nplate | primary thrombocytopenia | 2018-12-19 | “submission of a Supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration ( FDA ) for Nplate ® (romiplostim)” amgen.com ↗ |
| Approved Indication not stated 3 milestones | |||||
| 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 71 · started per year
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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 · 1 met primary | ||||||
| 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 | Met primary |
| 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 · 1 missed | ||||||
| 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 | Missed primary |
| 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 228 trials · 2 met primary · 1 missed | ||||||
| Phase 2 | NCT07278661 | Sep 2026 → Dec 2028 expected | thrombocytopenia | Nantes University Hospital | Recruiting | No outcome recorded |
| Phase 2 | NCT07854561 | Aug 2026 → Feb 2027 expected | anemia due to chronic disorder | Chinese University of Hong Kong | 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 Stop: Business |
| 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 Stop: Enrollment |
| 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 | Met primary |
| 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 Stop: Enrollment |
| Phase 2 | NCT02052882 | Jan 2014 → Nov 2023 | thrombocytopenia | Memorial Sloan Kettering Cancer Center | Completed | Met primary |
| 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 | Missed primary |
| Phase 2 | NCT00413283 | Dec 2006 → Dec 2008 | non-small cell lung carcinoma, thrombocytopenia | Amgen | Completed | No outcome recorded |
| Phase 2 | NCT00305435 | Feb → Nov 2006 | autoimmune thrombocytopenic purpura | Kyowa Kirin, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00303472 | Feb 2006 → May 2008 | myelodysplastic syndrome, thrombocytopenia | Amgen | 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 · 6 met primary | ||||||
| Phase 3 | NCT07700238 | Aug 2026 → Sep 2029 expected | autoimmune thrombocytopenia | Amgen | 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 | Met primary |
| 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 | Met primary |
| 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 | Met primary |
| 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 | Met primary |
| Phase 3 | NCT00102336 | Apr 2005 → Dec 2006 | autoimmune thrombocytopenic purpura | Amgen | Completed | Met primary |
| Phase 3 | NCT00102323 | Mar 2005 → Sep 2006 | autoimmune thrombocytopenic purpura | Amgen | Completed | Met primary |
| 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 |
| Comparator or background therapy9 trials | ||||||
| Phase 2 | NCT07421167 Background | Aug 2026 → Jan 2029 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 3 | NCT06497036 Comparator | Apr 2023 → Mar 2028 expected | — | Geropharm | Active not recruiting | Met primary |
| 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 |
News releases announcing trial results or a regulatory action · 9
| Date | Issuer | Release |
|---|---|---|
| 2023-09-25 | Kyowa Kirin, Inc. | Regulatory Kyowa Kirin Received Approval for Partial Change Approval of Romiplate® for Aplastic Anemia in Japan kyowakirin.com ↗
the company has received approval from the Japanese Ministry of Health, Labour and Welfare for hematopoietic stimulating agent Romiplate® (AMG531, generic name: romiplostim (genetical recombination)) |
| 2019-10-18 | Amgen | Regulatory Nplate® (romiplostim) Now Approved For Earlier Use In Adults With Immune Thrombocytopenia amgen.com ↗
The updated indication expands treatment with Nplate to newly diagnosed and persistent adult ITP patients who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy. |
| 2019-06-18 | Kyowa Kirin, Inc. | Regulatory Kyowa Hakko Kirin Receives the Partial Change Approval of Romiplate® for Aplastic Anemia in Japan kyowakirin.com ↗
Kyowa Hakko Kirin Co., Ltd. (Tokyo: 4151, President and CEO: Masashi Miyamoto, "Kyowa Hakko Kirin") announced today that it has received the partial change approval of Romiplate® (code name: AMG531, generic name: romiplostim (recombinant), "the drug") for an additional indication of treatment of aplastic anemia (AA) in patients who have had an inadequate response to conventional therapy from Japan's Ministry of Health, Labour and Welfare (MHLW). |
| 2018-12-19 | Amgen | Regulatory Amgen Submits Supplemental Biologics License Application For Nplate® (romiplostim) amgen.com ↗
today announced the submission of a Supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration ( FDA ) |
| 2018-12-14 | Amgen | Regulatory FDA Approves Nplate® (Romiplostim) For Use In Pediatric Patients With Immune Thrombocytopenia amgen.com ↗ |
| 2018-12-02 | Novartis Pharmaceuticals | Results Real-world data show Novartis drug Revolade® improves outcomes for ITP patients compared to other second-line therapies novartis.com ↗
Revolade (eltrombopag) showed lower rate of bleeding-related episodes and similar rate of thrombotic events vs. romiplostim, rituximab and splenectomy, in a retrospective analysis of US electronic health records |
| 2018-07-31 | Kyowa Kirin, Inc. | Regulatory Kyowa Hakko Kirin Submits Application for Additional Indication for Romiplostim (Recombinant) for Aplastic Anemia in Japan kyowakirin.com ↗
Kyowa Hakko Kirin Co., Ltd. (Tokyo: 4151, President and COO: Masashi Miyamoto, "Kyowa Hakko Kirin") announced today that an application seeking approval of an additional indication for romiplostim (code name: AMG531, "the drug") for aplastic anemia (AA) has been filed with Japan's Ministry of Health, Labour and Welfare (MHLW). |
| 2017-11-10 | Amgen | Regulatory 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 | Results Nplate® (Romiplostim) Study In The Lancet Shows Significant Increase In Durable Platelet Response Among Children With Immune Thrombocytopenia amgen.com ↗
The study showed that 52 percent of Nplate patients achieved a durable platelet response, compared with 10 percent of placebo-treated patients ( p =0.002, odds ratio 9.1, 95 percent CI: 1.9, 43.2). |
All press releases naming this drug 10 releases
Evidence & citations 10 cited values
Every value below carries the sentence it was read from. 82 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 ↗65“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)” NCT00305435 ↗ “Romiplostim (AMG-531)” NCT07048249 ↗ |
| 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 ↗ |