Drugs / Thalidomide
Thalidomide
also known as
Thalomid · Thado · thal · NSC # 66847 · .alpha.-phthalimidoglutarimide · Celgene · Contergan · Distaval · +18 more
Other / unclassified targets DLL4, GATA1, IKZF1, IKZF3, KLF1, NOTCH1, TNF via inhibition
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | THALOMID | — | 2012-02-03 | fda.gov ↗ |
| Approved | EU (EMA) | Thalidomide BMS (previously Thalidomide Celgene) | — | 2008-04-16 | europa.eu ↗ |
| Approved | US (FDA) | THALOMID | — | 1998-07-16 | fda.gov ↗ |
Trials 327 · started per year
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EU approved 2008
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| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT02956538 | Oct 2016 → Oct 2018 | Crohn disease | Sixth Affiliated Hospital, Sun Yat-sen University | Unknown | No outcome recorded |
| Phase 113 trials | ||||||
| Phase 1 | NCT02870036 | Oct 2016 → Dec 2020 | colorectal cancer | Haihe Biopharma Co., Ltd. | Unknown | No outcome recorded |
| Phase 1 | NCT02467647 | Jan 2015 → Dec 2018 | plasma cell myeloma | Wuhan University | Unknown | No outcome recorded |
| Phase 1 | NCT01937442 | Nov 2013 → Sep 2015 | plasma cell myeloma | Celgene Corporation | Completed | No outcome recorded |
| Phase 1 | NCT01661400 | Oct 2012 → Dec 2023 | Ewing sarcoma, Wilms tumor, glioma, osteosarcoma +3 | Washington University School of Medicine | Completed | No outcome recorded |
| Phase 1 | NCT01028781 | Oct 2006 → Aug 2009 | endometriosis | University of North Carolina, Chapel Hill | Terminated | No outcome recorded Stop: Business |
| Phase 1 | NCT00527657 | Feb 2006 → Feb 2012 | brain neoplasm, melanoma | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT00062127 | Apr 2003 → May 2006 | cancer of unknown primary site | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 1 | NCT00052416 | Oct 2002 → Jan 2003 | leukemia, lymphoma | Beth Israel Deaconess Medical Center | Completed | No outcome recorded |
| Phase 1 | NCT00049296 | Jul 2002 → Dec 2004 | cancer | Case Comprehensive Cancer Center | Completed | No outcome recorded |
| Phase 1 | NCT00418132 | Aug 2000 → Oct 2007 | systemic sclerosis | NYU Langone Health | Terminated | No outcome recorded Stop: Enrollment |
| Phase 1 | NCT00251797 | Mar 2000 → Jun 2006 | cancer, nervous system disorder | University of New Mexico | Completed | No outcome recorded |
| Phase 1 | NCT00002104 | — | HIV infectious disease, Mycobacterium avium complex disease, tuberculosis | Aaron Diamond AIDS Research Center | Completed | No outcome recorded |
| Phase 1 | NCT00000812 | ? → Jul 2000 | HIV infectious disease | National Institute of Allergy and Infectious Diseases (NIAID) | Completed | No outcome recorded |
| Phase 1/215 trials · 1 met primary | ||||||
| Phase 1/2 | NCT05198856 | Mar 2022 → Mar 2024 | gastric cancer | Qilu Hospital of Shandong University | Unknown | No outcome recorded |
| Phase 1/2 | NCT04891744 | Jul 2021 → Dec 2024 | plasma cell myeloma | Li Zheng | Unknown | No outcome recorded |
| Phase 1/2 | NCT02545907 | Sep 2017 → Sep 2019 | amyloidosis | University College, London | Completed | No outcome recorded |
| Phase 1/2 | NCT02145715 | Jan 2013 → Jul 2015 | plasma cell myeloma | Prof Jamie Cavenagh | Unknown | Met primary |
| Phase 1/2 | NCT01242267 | May 2010 → Jan 2016 | plasma cell myeloma | Hackensack Meridian Health | Completed | No outcome recorded |
| Phase 1/2 | NCT00966693 | Aug 2009 → Jul 2018 | plasma cell myeloma | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 1/2 | NCT00971126 | Jul 2009 → Jan 2010 | hepatocellular carcinoma | National Health Research Institutes, Taiwan | Terminated | No outcome recorded |
| Phase 1/2 | NCT01061866 | Jun 2006 → Jun 2007 | epilepsy | National Institute of Neurology and Neurosurgery, Mexico | Completed | No outcome recorded |
| Phase 1/2 | NCT00406978 | Feb 2006 → Sep 2010 | plasma cell myeloma | Silvio Aime | Completed | No outcome recorded |
| Phase 1/2 | NCT00155272 | Mar → Aug 2005 | hepatocellular carcinoma | National Taiwan University Hospital | Unknown | No outcome recorded |
| Phase 1/2 | NCT00096018 | May 2002 → Nov 2010 | leukemia | Roswell Park Cancer Institute | Completed | No outcome recorded |
| Phase 1/2 | NCT00038246 | Oct 2000 → Feb 2004 | prostate cancer | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 1/2 | NCT00277017 | Sep 2000 → Aug 2005 | cancer, kidney disorder | New Mexico Cancer Research Alliance | Completed | No outcome recorded |
| Phase 1/2 | NCT00005815 | Dec 1999 → Aug 2004 | cutaneous melanoma, ocular melanoma | Memorial Sloan Kettering Cancer Center | Completed | No outcome recorded |
| Phase 1/2 | NCT00081757 | Sep 1998 → May 2005 | plasma cell myeloma | University of Arkansas | Completed | No outcome recorded |
| Phase 2204 trials · 2 met primary · 2 missed | ||||||
| Phase 2 | NCT07671534 | Jun 2026 → Jun 2029 expected | — | Sarcoma Oncology Research Center, LLC | Recruiting | No outcome recorded |
| Phase 2 | NCT07338344 | Feb 2026 → Dec 2027 expected | beta-thalassemia major | Rongrong Liu | Recruiting | No outcome recorded |
| Phase 2 | NCT07204041 | Aug 2025 → Aug 2027 expected | Langerhans cell histiocytosis | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Active not recruiting | No outcome recorded |
| Phase 2 | NCT07187193 | Apr 2025 → Apr 2027 expected | Langerhans cell histiocytosis | Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Recruiting | No outcome recorded |
| Phase 2 | NCT07195799 | Dec 2024 → Dec 2027 expected | non-Hodgkin lymphoma | The First Affiliated Hospital with Nanjing Medical University | Recruiting | No outcome recorded |
| Phase 2 | NCT06617182 | Sep 2024 → Oct 2028 expected | enteritis | Yongquan Shi | Recruiting | No outcome recorded |
| Phase 2 | NCT06279351 | Aug 2024 → Dec 2025 overdue | — | Xinqiao Hospital of Chongqing | Recruiting | No outcome recorded |
| Phase 2 | NCT06530576 | Aug 2024 → Jun 2026 overdue | T-cell large granular lymphocyte leukemia, chronic lymphoproliferative disorder of NK-cells | Institute of Hematology & Blood Diseases Hospital, China | Recruiting | No outcome recorded |
| Phase 2 | NCT06268093 | Feb 2024 → Feb 2027 expected | syringomyelia, thalidomide embryopathy | Xuanwu Hospital, Beijing | Recruiting | No outcome recorded |
| Phase 2 | NCT06231680 | Jan → Jun 2024 | carcinoma of esophagus, non-small cell lung carcinoma | Henan Cancer Hospital | Unknown | No outcome recorded |
| Show all 204 trials opens the full record — a long page | ||||||
| Phase 2/313 trials · 2 met primary | ||||||
| Phase 2/3 | NCT07309419 | Dec 2025 → Jun 2030 expected | hepatocellular carcinoma | Shanghai Zhongshan Hospital | Not yet recruiting | No outcome recorded |
| Phase 2/3 | NCT03759093 | Sep 2023 → Sep 2025 | plasma cell myeloma | National University Hospital, Singapore | Unknown | No outcome recorded |
| Phase 2/3 | NCT06153784 | Jul 2020 → Jul 2023 | beta thalassemia | Children's Hospital Karachi | Completed | No outcome recorded |
| Phase 2/3 | NCT05132270 | Jan → Dec 2020 | beta thalassemia | Children's Hospital Karachi | Completed | Met primary |
| Phase 2/3 | NCT03651102 | Jan 2018 → Nov 2021 | thalassemia | Blood Diseases Clinic | Completed | No outcome recorded |
| Phase 2/3 | NCT02387086 | May 2015 → May 2017 | non-small cell lung carcinoma | Bai Jun | Unknown | No outcome recorded |
| Phase 2/3 | NCT04453345 | May 2013 → May 2023 | T-cell large granular lymphocyte leukemia, chronic lymphoproliferative disorder of NK-cells | Institute of Hematology & Blood Diseases Hospital, China | Unknown | No outcome recorded |
| Phase 2/3 | NCT01094340 | Mar 2010 → Dec 2012 | Alzheimer disease | Banner Health | Unknown | No outcome recorded |
| Phase 2/3 | NCT00728078 | Jul 2008 → Jul 2009 | hepatocellular carcinoma | Sun Yat-sen University | Unknown | No outcome recorded |
| Phase 2/3 | NCT00934739 | Jun 2007 → Dec 2012 | oral cavity cancer | National Health Research Institutes, Taiwan | Terminated | No outcome recorded |
| Phase 2/3 | NCT00657488 | Dec 2001 → Oct 2005 | plasma cell myeloma | Celgene Corporation | Completed | No outcome recorded |
| Phase 2/3 | NCT00205751 | Aug 2001 → Oct 2009 | plasma cell myeloma | Austrian Forum Against Cancer | Completed | Met primary |
| Phase 2/3 | NCT00038090 | Jun 2000 → May 2005 | plasma cell myeloma | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 350 trials · 10 met primary · 7 missed | ||||||
| Phase 3 | NCT06017284 | Nov 2023 → Nov 2025 overdue | chemotherapy-induced toxicity, pancreatic neoplasm | Fudan University | Recruiting | No outcome recorded |
| Phase 3 | NCT06031012 | Sep 2023 → Oct 2025 | mucositis | Air Force Military Medical University, China | Completed | No outcome recorded |
| Phase 3 | NCT06146478 | Jan 2022 → Jul 2023 | beta thalassemia | Blood Care Clinic | Completed | No outcome recorded |
| Phase 3 | NCT03221166 | Feb 2018 → Jul 2020 | Crohn disease | IRCCS Burlo Garofolo | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT03318835 | Aug 2017 → Aug 2020 | — | Fudan University | Unknown | No outcome recorded |
| Phase 3 | NCT03016000 | Jul 2017 → Dec 2019 | diffuse large B-cell lymphoma | Nanfang Hospital, Southern Medical University | Unknown | No outcome recorded |
| Phase 3 | NCT03562169 | Mar 2017 → Mar 2026 overdue | plasma cell myeloma | University of Leeds | Recruiting | No outcome recorded |
| Phase 3 | NCT06985134 | Jan 2017 → Dec 2018 | spondyloarthropathy | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh | Completed | No outcome recorded |
| Phase 3 | NCT02707484 | Apr 2016 → Dec 2020 | vascular malformation | Shanghai Jiao Tong University School of Medicine | Completed | Met primary |
| Phase 3 | NCT01858571 | Oct 2013 → Jul 2016 | childhood malignant neoplasm | All India Institute of Medical Sciences | Completed | Missed primary |
| Phase 3 | NCT02085655 | Apr 2013 → Dec 2022 | extranodal nasal NK/T cell lymphoma | Huiqiang Huang | Unknown | No outcome recorded |
| Phase 3 | NCT00921531 | Jun 2009 → Dec 2012 | hepatocellular carcinoma | Fudan University | Unknown | No outcome recorded |
| Phase 3 | NCT00720538 | Aug 2008 → Sep 2011 | Crohn disease, ulcerative colitis | IRCCS Burlo Garofolo | Completed | Mixed |
| Phase 3 | NCT00600028 | Dec 2007 → Sep 2011 | idiopathic pulmonary fibrosis | Johns Hopkins University | Completed | Met primary |
| Phase 3 | NCT00602511 | Oct 2007 → Sep 2010 | plasma cell myeloma | Nordic Myeloma Study Group | Completed | No outcome recorded |
| Phase 3 | NCT00507416 | Jun 2007 → Mar 2013 | plasma cell myeloma | Millennium Pharmaceuticals, Inc. | Completed | Missed primary |
| Phase 3 | NCT00572169 | Nov 2006 → Aug 2027 expected | plasma cell myeloma | University of Arkansas | Active not recruiting | No outcome recorded |
| Phase 3 | NCT00573391 | Aug 2006 → Jul 2008 | plasma cell myeloma | University of Arkansas | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT00574080 | Jul 2006 → Mar 2011 | plasma cell myeloma | University of Arkansas | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT01134484 | May 2006 → Aug 2008 | plasma cell myeloma | Michele Cavo | Unknown | Met primary |
| Phase 3 | NCT01063179 | May 2006 → Jul 2014 | plasma cell myeloma | Fondazione EMN Italy Onlus | Completed | Met primary |
| Phase 3 | NCT00934154 | Mar 2006 → Sep 2009 | plasma cell myeloma | Cigdem Sahinbas YILMAZ | Completed | Mixed |
| Phase 3 | NCT00461747 | Mar 2006 → Dec 2008 | plasma cell myeloma | PETHEMA Foundation | Completed | Met primary |
| Phase 3 | NCT00452569 | Feb 2006 → Dec 2008 | plasma cell myeloma | Celgene Corporation | Completed | No outcome recorded |
| Phase 3 | NCT00256776 | Jul 2005 → Dec 2013 | plasma cell myeloma | European Society for Blood and Marrow Transplantation | Terminated | No outcome recorded |
| Phase 3 | NCT00443235 | Mar 2005 → Mar 2007 | plasma cell myeloma | PETHEMA Foundation | Completed | No outcome recorded |
| Phase 3 | NCT00305552 | Feb 2005 → Nov 2007 | sarcoidosis | Assistance Publique - Hôpitaux de Paris | Completed | Missed primary |
| Phase 3 | NCT00098475 | Nov 2004 → Nov 2008 overdue | plasma cell myeloma | National Cancer Institute (NCI) | Active not recruiting | No outcome recorded |
| Phase 3 | NCT01296503 | Oct 2003 → Jul 2008 | plasma cell myeloma | Grupo de Estudos Multicentricos em Onco-Hematologia | Completed | No outcome recorded |
| Phase 3 | NCT00432458 | Jul 2003 → Jun 2011 | plasma cell myeloma | Mayo Clinic | Completed | Met primary |
| Phase 3 | NCT00633542 | Jun 2003 → Sep 2007 | plasma cell myeloma | Marche Polytechnic University | Completed | No outcome recorded |
| Phase 3 | NCT01070862 | May 2003 → Dec 2009 | — | University Hospital, Caen | Completed | No outcome recorded |
| Phase 3 | NCT00061919 | Apr 2003 → Feb 2007 | lung cancer | University College, London | Completed | Missed primary |
| Phase 3 | NCT00041080 | Feb 2003 → Jan 2011 | fallopian tube cancer, malignant epithelial tumor of ovary, peritoneum cancer | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 3 | NCT00057564 | Feb 2003 → Apr 2006 | plasma cell myeloma | Celgene Corporation | Completed | Met primary |
| Phase 3 | NCT00225290 | Feb 2003 → ? | hepatocellular carcinoma | TTY Biopharm | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT00049673 | Oct 2002 → Oct 2011 | plasma cell myeloma | NCIC Clinical Trials Group | Completed | Missed primary |
| Phase 3 | NCT00033332 | Apr 2002 → Mar 2006 | plasma cell myeloma | National Cancer Institute (NCI) | Completed | Met primary |
| Phase 3 | NCT00033254 | Mar 2002 → May 2006 | metastatic malignant neoplasm in the brain | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 3 | NCT00232934 | Jan 2002 → Jan 2005 | plasma cell myeloma | Gruppo Italiano per lo Studio del Mieloma Multiplo | Completed | Met primary |
| Phase 3 | NCT00050843 | Aug 2001 → Feb 2004 | myelodysplastic syndrome | Celgene Corporation | Completed | No outcome recorded |
| Phase 3 | NCT00028886 | Mar 2001 → ? | plasma cell myeloma | Commissie Voor Klinisch Toegepast Onderzoek | Unknown | No outcome recorded |
| Phase 3 | NCT00005966 | Oct 2000 → Mar 2006 | renal cell carcinoma | Eastern Cooperative Oncology Group | Completed | No outcome recorded |
| Phase 3 | NCT00367185 | May 2000 → Oct 2005 | plasma cell myeloma | University Hospital, Lille | Completed | Met primary |
| Phase 3 | NCT00222053 | Apr 2000 → Sep 2009 | plasma cell myeloma | University Hospital, Toulouse | Completed | No outcome recorded |
| Phase 3 | NCT00005834 | Apr 2000 → Nov 2003 | plasma cell myeloma | SWOG Cancer Research Network | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT00004635 | Mar 2000 → Jan 2005 | prostate cancer | National Cancer Institute (NCI) | Completed | Missed primary |
| Phase 3 | NCT00004859 | Jan 2000 → Dec 2009 | lung cancer | National Cancer Institute (NCI) | Terminated | Missed primary |
| Phase 3 | NCT00038233 | May 1999 → Apr 2005 | plasma cell myeloma | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 3 | NCT00083876 | Sep 1998 → Nov 2007 | plasma cell myeloma | University of Arkansas | Completed | No outcome recorded |
| Phase 417 trials | ||||||
| Phase 4 | NCT07264894 | Dec 2025 → Dec 2027 expected | mantle cell lymphoma | Zhengzhou University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06438679 | Mar → Sep 2024 overdue | dermatomyositis | Second Affiliated Hospital, School of Medicine, Zhejiang University | Enrolling by invitation | No outcome recorded |
| Phase 4 | NCT06276933 | Feb 2024 → Nov 2025 overdue | lung cancer | Tongji University | Not yet recruiting | No outcome recorded |
| Phase 4 | NCT06299670 | Nov 2023 → Jan 2026 | beta thalassemia | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh | Completed | No outcome recorded |
| Phase 4 | NCT05525234 | Sep → Dec 2022 | — | RenJi Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT04612582 | Jan 2020 → Jan 2023 | AL amyloidosis | Guangdong Provincial People's Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT03777930 | Dec 2018 → Oct 2020 | cancer-related condition | Shenzhen Fifth People's Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT03122431 | Jun 2017 → Dec 2020 | cutaneous lupus erythematosus, pediatric systemic lupus erythematosus | University of Sao Paulo General Hospital | Completed | No outcome recorded |
| Phase 4 | NCT02844309 | May 2016 → Nov 2019 | Waldenstrom macroglobulinemia | Institute of Hematology & Blood Diseases Hospital, China | Completed | No outcome recorded |
| Phase 4 | NCT02778893 | Mar 2016 → Mar 2017 | non-small cell lung carcinoma | Henan Provincial People's Hospital | Unknown | No outcome recorded |
| Phase 4 | NCT02858804 | Jan 2016 → Dec 2019 | mantle cell lymphoma | Institute of Hematology & Blood Diseases Hospital, China | Completed | No outcome recorded |
| Phase 4 | NCT02401971 | Aug 2014 → Aug 2016 | gastric cancer | Wang Jufeng | Unknown | No outcome recorded |
| Phase 4 | NCT01664975 | Aug 2011 → Apr 2016 | peripheral T-cell lymphoma, not otherwise specified | Mingzhi Zhang | Completed | No outcome recorded |
| Phase 4 | NCT01249690 | Jun 2010 → Jun 2012 | plasma cell myeloma | Second Military Medical University | Unknown | No outcome recorded |
| Phase 4 | NCT00390247 | Jan 2007 → Dec 2008 | protein-energy malnutrition | Chinese University of Hong Kong | Withdrawn | No outcome recorded Stop: Business |
| Phase 4 | NCT00652041 | Jan 2007 → Jan 2010 | plasma cell myeloma | PETHEMA Foundation | Completed | No outcome recorded |
| Phase 4 | NCT00314665 | Jan 2004 → Aug 2006 | uveitis | University of Cincinnati | Terminated | No outcome recorded |
| Phase not applicable13 trials | ||||||
| — | NCT07673302 | Jun 2026 → Jun 2027 expected | beta thalassemia | Riphah International University | Not yet recruiting | No outcome recorded |
| — | NCT07476625 | Apr 2026 → Mar 2027 expected | PFAPA syndrome | Wenjie Zheng | Not yet recruiting | No outcome recorded |
| — | NCT06772480 | Jan 2025 → Jan 2026 overdue | cirrhosis of liver, gastric antral vascular ectasia | Institute of Liver and Biliary Sciences, India | Not yet recruiting | No outcome recorded |
| — | NCT06888232 | Aug 2023 → Dec 2024 | thalassemia | Muhammad Aamir Latif | Completed | No outcome recorded |
| — | NCT03601871 | Jul 2018 → Jun 2020 | chemotherapy-induced toxicity | Yunpeng Liu | Unknown | No outcome recorded |
| — | NCT02998827 | Nov 2016 → Nov 2017 | Crohn disease | Sixth Affiliated Hospital, Sun Yat-sen University | Unknown | No outcome recorded |
| — | NCT01927718 | Jan 2014 → Nov 2016 | plasma cell myeloma | M.D. Anderson Cancer Center | Terminated | No outcome recorded |
| — | NCT01924624 | Jul 2013 → Aug 2015 | hepatocellular carcinoma | The First Affiliated Hospital of Xiamen University | Unknown | No outcome recorded |
| — | NCT00023530 | Sep 2001 → Aug 2006 | graft versus host disease, leukemia, myelodysplastic syndrome, plasma cell myeloma | National Heart, Lung, and Blood Institute (NHLBI) | Completed | No outcome recorded |
| — | NCT00004450 | Aug 1998 → Nov 2000 | adrenoleukodystrophy | FDA Office of Orphan Products Development | Completed | No outcome recorded |
| — | NCT00002392 | — | HIV infectious disease | Rockefeller University | Completed | No outcome recorded |
| — | NCT00002174 | — | HIV infectious disease | Louisiana State University Health Sciences Center in New Orleans | Completed | No outcome recorded |
| — | NCT00002157 | — | HIV wasting syndrome | Celgene Corporation | Completed | No outcome recorded |
| Phase not stated1 trial | ||||||
| — | NCT00769587 | Jun 2007 → May 2011 | — | Centre Hospitalier Universitaire, Amiens | Completed | No outcome recorded |
| Comparator or background therapy69 trials | ||||||
| Phase 0 | NCT01537861 Background | Jun 2012 → Feb 2014 | plasma cell myeloma | Washington University School of Medicine | Terminated | No outcome recorded |
| Phase 1 | NCT06098014 Comparator | Mar 2023 → Feb 2024 | inherited hemoglobinopathy | Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh | Completed | No outcome recorded |
| Phase 1 | NCT01998971 Background | Feb 2014 → Jan 2019 | plasma cell myeloma | Janssen Research & Development, LLC | Completed | No outcome recorded |
| Phase 1 | NCT00258245 Background | May 2005 → Apr 2008 | plasma cell myeloma | Barbara Ann Karmanos Cancer Institute | Completed | No outcome recorded |
| Phase 1 | NCT00083460 Comparator | Dec 2001 → Nov 2007 | plasma cell myeloma | University of Arkansas | Completed | No outcome recorded |
| Phase 1/2 | NCT01057225 Background | Mar 2010 → Mar 2014 | plasma cell myeloma | Mayo Clinic | Completed | No outcome recorded |
| Phase 1/2 | NCT00113919 Background | Jun 2004 → Oct 2009 | plasma cell myeloma | University of Arkansas | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT07172659 Comparator | Sep 2026 → Jan 2027 expected | erythema nodosum | Medicines Development for Global Health | Recruiting | No outcome recorded |
| Phase 2 | NCT07828015 Comparator | May 2025 → Sep 2029 expected | hereditary hemorrhagic telangiectasia | Second Affiliated Hospital, Zhejiang University, School of Medicine | Recruiting | No outcome recorded |
| Phase 2 | NCT06490627 Comparator | Apr 2024 → Apr 2025 overdue | beta-thalassemia major | National Institute of Blood and Marrow Transplant (NIBMT), Pakistan | Recruiting | No outcome recorded |
| Phase 2 | NCT06490601 Comparator | Apr 2022 → Apr 2024 overdue | beta thalassemia | National Institute of Blood and Marrow Transplant (NIBMT), Pakistan | Active not recruiting | No outcome recorded |
| Phase 2 | NCT06239389 Comparator | Sep → Dec 2021 | beta thalassemia | National Institute of Blood and Marrow Transplant (NIBMT), Pakistan | Completed | No outcome recorded |
| Phase 2 | NCT03896737 Comparator | Apr 2019 → Jun 2026 overdue | plasma cell myeloma | European Myeloma Network B.V. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03004287 Background | Jul 2017 → Oct 2027 expected | plasma cell myeloma | University of Arkansas | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03204019 Comparator | Oct 2016 → Oct 2017 | pancreatic neuroendocrine tumor | Chinese Academy of Medical Sciences | Unknown | Missed primary |
| Phase 2 | NCT03204032 Comparator | Oct 2016 → Oct 2017 | neuroendocrine neoplasm | Chinese Academy of Medical Sciences | Unknown | Missed primary |
| Phase 2 | NCT02733380 Background | May 2016 → May 2020 | diffuse large B-cell lymphoma | Henan Cancer Hospital | Unknown | No outcome recorded |
| Phase 2 | NCT02301949 Comparator | Dec 2015 | vascular malformation | Zhizheng Ge | Withdrawn | No outcome recorded |
| Phase 2 | NCT02424851 Comparator | Nov 2014 → Apr 2020 | chronic kidney disease, plasma cell myeloma | Oxford University Hospitals NHS Trust | Completed | No outcome recorded |
| Phase 2 | NCT01356290 Background | Apr 2014 → Apr 2030 expected | atypical teratoid rhabdoid tumor, ependymoma, medulloblastoma | Medical University of Vienna | Recruiting | No outcome recorded |
| Phase 2 | NCT02201043 Comparator | Feb 2013 → Feb 2015 | ankylosing spondylitis | Shanghai Pharmaceuticals Holding Co., Ltd | Completed | No outcome recorded |
| Phase 2 | NCT01632150 Background | May 2012 → Oct 2013 | refractory plasma cell neoplasm | Bristol-Myers Squibb | Completed | No outcome recorded |
| Phase 2 | NCT02754960 Comparator | Mar 2010 → Mar 2014 | vascular malformation | Shanghai Jiao Tong University School of Medicine | Withdrawn | No outcome recorded |
| Phase 2 | NCT00531453 Background | Oct 2007 → Apr 2009 | plasma cell myeloma | Millennium Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 2 | NCT00379353 Comparator | Sep 2006 → Jan 2013 | — | M.D. Anderson Cancer Center | Completed | No outcome recorded |
| Phase 2 | NCT00301405 Comparator | Mar → Nov 2006 | chronic prostatitis, pelvis syndrome | Kenneth Peters, MD | Terminated | No outcome recorded Stop: Enrollment |
| Phase 2 | NCT00964496 Comparator | Nov 2004 → Nov 2007 | angiodysplasia, gastric antral vascular ectasia | Shanghai Jiao Tong University School of Medicine | Completed | Met primary |
| Phase 2 | NCT00064337 Background | Jan 2004 → May 2012 | plasma cell myeloma | SWOG Cancer Research Network | Completed | No outcome recorded |
| Phase 2 | NCT00083538 Background | Feb 2001 → Dec 2007 | plasma cell myeloma | University of Arkansas | Completed | No outcome recorded |
| Phase 2 | NCT00250796 Comparator | Sep 2000 → Jan 2006 | cancer, liver disorder | University of New Mexico | Completed | No outcome recorded |
| Phase 2 | NCT00019539 Background | Nov 1998 → Nov 2004 | renal cell carcinoma | National Cancer Institute (NCI) | Completed | No outcome recorded |
| Phase 2/3 | NCT02532738 Background | Jan 2016 → Nov 2018 | Crohn disease | Sixth Affiliated Hospital, Sun Yat-sen University | Unknown | No outcome recorded |
| Phase 2/3 | NCT01438450 Comparator | Oct 2007 → Aug 2013 | hepatocellular carcinoma | All India Institute of Medical Sciences | Unknown | No outcome recorded |
| Phase 2/3 | NCT02240771 Comparator | Jan 2006 → Dec 2014 | hepatocellular carcinoma | All India Institute of Medical Sciences | Unknown | No outcome recorded |
| Phase 3 | NCT04576156 Comparator | Apr 2021 → Jun 2028 expected | myelofibrosis | Geron Corporation | Active not recruiting | No outcome recorded |
| Phase 3 | NCT03792620 Background | Nov 2018 → May 2020 | plasma cell myeloma | Grupo de Estudos Multicentricos em Onco-Hematologia | Unknown | No outcome recorded |
| Phase 3 | NCT02748772 Comparator | Jan 2016 → Dec 2017 | colorectal neoplasm | The First People's Hospital of Hefei | Unknown | No outcome recorded |
| Phase 3 | NCT02541383 Background | Sep 2015 → Aug 2020 | plasma cell myeloma | Intergroupe Francophone du Myelome | Completed | Met primary |
| Phase 3 | NCT02203253 Comparator | Jul 2014 → Jul 2016 | neoplasm | China Medical University, China | Completed | No outcome recorded |
| Phase 3 | NCT01971658 Comparator | Oct 2013 → Aug 2015 | plasma cell myeloma | Nantes University Hospital | Completed | No outcome recorded |
| Phase 3 | NCT01659658 Comparator | Dec 2012 → Jul 2022 | AL amyloidosis | Millennium Pharmaceuticals, Inc. | Terminated | Missed primary |
| Phase 3 | NCT02248428 Background | Apr 2012 → Sep 2019 | plasma cell myeloma | Jinling Hospital, China | Unknown | No outcome recorded |
| Phase 3 | NCT01539083 Background | Jan 2012 → Dec 2015 | plasma cell myeloma | Janssen Scientific Affairs, LLC | Completed | Missed primary |
| Phase 3 | NCT01554852 Comparator | May 2010 → Dec 2021 | plasma cell myeloma | University of Leeds | Unknown | No outcome recorded |
| Phase 3 | NCT03402295 Comparator | Jun 2009 → Jun 2014 | chemotherapy-induced toxicity, plasma cell myeloma | Grupo de Estudos Multicentricos em Onco-Hematologia | Completed | No outcome recorded |
| Phase 3 | NCT00689936 Comparator | Aug 2008 → Jul 2016 | plasma cell myeloma | Celgene Corporation | Completed | Met primary |
| Phase 3 | NCT00734877 Comparator | Jul 2008 → Sep 2027 expected | plasma cell myeloma | University of Arkansas | Active not recruiting | No outcome recorded |
| Phase 3 | NCT00910897 Comparator | Mar 2008 → Aug 2009 | plasma cell myeloma | Intergroupe Francophone du Myelome | Unknown | No outcome recorded |
| Phase 3 | NCT00602641 Comparator | Feb 2008 → Jan 2014 overdue | plasma cell myeloma | National Cancer Institute (NCI) | Active not recruiting | Missed primary |
| Phase 3 | NCT00529633 Comparator | Sep 2007 → Dec 2008 | hypoproteinemia, hypercatabolic | George A. Kaysen, M.D. | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT01532856 Comparator | Jan 2007 → Dec 2011 | plasma cell myeloma | Grupo de Estudos Multicentricos em Onco-Hematologia | Unknown | No outcome recorded |
| Phase 3 | NCT00787436 Comparator | May 2006 → Jan 2010 | portal hypertension | The Cleveland Clinic | Withdrawn | No outcome recorded |
| Phase 3 | NCT00111748 Comparator | Feb 2005 → Sep 2006 | plasma cell myeloma | University of Arkansas | Completed | No outcome recorded |
| Phase 3 | NCT00097981 Background | Jan 2005 → Oct 2007 | plasma cell myeloma | Johnson & Johnson Pharmaceutical Research & Development, L.L.C. | Completed | Missed primary |
| Phase 3 | NCT00075829 Comparator | Dec 2003 → Jun 2012 | plasma cell myeloma | National Heart, Lung, and Blood Institute (NHLBI) | Completed | No outcome recorded |
| Phase 3 | NCT00215943 Comparator | Jun 2003 → Aug 2012 | plasma cell myeloma | H. Lee Moffitt Cancer Center and Research Institute | Terminated | No outcome recorded Stop: Enrollment |
| Phase 3 | NCT00644306 Comparator | Apr 2002 → May 2007 | plasma cell myeloma | Central Hospital, Nancy, France | Terminated | No outcome recorded |
| Phase 3 | NCT00218855 Comparator | Jan 2002 → Apr 2007 | plasma cell myeloma | Norwegian University of Science and Technology | Completed | No outcome recorded |
| Phase 3 | NCT00083915 Comparator | Jun 2001 → Jun 2010 | plasma cell myeloma | University of Arkansas | Completed | No outcome recorded |
| Phase 3 | NCT00083551 Comparator | Aug 1998 → Aug 2014 | plasma cell myeloma | University of Arkansas | Completed | No outcome recorded |
| Phase 4 | NCT05527444 Background | Mar 2022 → Dec 2024 | ankylosing spondylitis | Qilu Hospital of Shandong University | Unknown | No outcome recorded |
| Phase 4 | NCT01638078 Comparator | Jan 2014 → Jun 2015 | coronary artery disorder | University of Roma La Sapienza | Unknown | No outcome recorded |
| Phase 4 | NCT01640639 Comparator | Jul 2012 → Dec 2013 | congestive heart failure | University of Roma La Sapienza | Unknown | No outcome recorded |
| Phase 4 | NCT02559154 Background | Jul 2010 → Oct 2018 | plasma cell myeloma | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | Unknown | No outcome recorded |
| — | NCT06793475 Background | Apr 2025 → Jun 2026 overdue | plasma cell myeloma | Institute of Hematology & Blood Diseases Hospital, China | Recruiting | No outcome recorded |
| — | NCT06256627 Comparator | Jul 2023 → Mar 2025 overdue | acute myeloid leukemia | Henan Cancer Hospital | Recruiting | No outcome recorded |
| — | NCT05321758 Comparator | Mar 2020 → Jun 2027 expected | Crohn disease | Tongji Hospital | Recruiting | No outcome recorded |
| — | NCT00907452 Comparator | Jul 2009 → Dec 2010 | plasma cell myeloma | Intergroupe Francophone du Myelome | Completed | No outcome recorded |
| — | NCT00577096 Comparator | Oct 2001 → Jun 2004 | plasma cell myeloma | University of Arkansas | Completed | No outcome recorded |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2024-05-23 | Janssen Research & Development, LLC | Results Johnson & Johnson advances leadership in oncology innovation with more than 75 clinical study and real-world presentations at ASCO and EHA jnj.com ↗ |
| 2024-05-23 | Janssen Research & Development, LLC | Results Johnson & Johnson advances leadership in oncology innovation with more than 75 clinical study and real-world presentations at ASCO and EHA jnj.com ↗
Six-year follow-up data from the Phase 3 CASSIOPEIA study evaluating DARZALEX® in combination with bortezomib, thalidomide and dexamethasone (D-VTd) followed by an every 8 week DARZALEX® maintenance regimen in transplant-eligible, newly diagnosed multiple myeloma (Oral Abstract #S204) |
| 2020-01-20 | Janssen Research & Development, LLC | Regulatory European Commission Approves Darzalex®▼ (daratumumab) in Combination with Bortezomib, Thalidomide and Dexamethasone (VTd) for Patients with Newly Diagnosed Multiple Myeloma Who Are Transplant Eligible jnj.com ↗
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the European Commission (EC) ha s granted marketing authorisation for Darzalex® (daratumumab) in combination with bortezomib, thalidomide and dexamethasone (VTd) for the treatment of patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant (ASCT). |
| 2019-09-26 | Janssen Research & Development, LLC | Regulatory Janssen Announces U.S. FDA Approval of DARZALEX® (daratumumab) Combination Regimen for Newly Diagnosed, Transplant-Eligible Patients with Multiple Myeloma jnj.com ↗
announced today the U.S. Food and Drug Administration (FDA) approval of DARZALEX®(daratumumab) in combination with bortezomib, thalidomide and dexamethasone (VTd) |
| 2019-09-26 | Janssen Research & Development, LLC | Regulatory Janssen Announces U.S. FDA Approval of DARZALEX® (daratumumab) Combination Regimen for Newly Diagnosed, Transplant-Eligible Patients with Multiple Myeloma jnj.com ↗
Janssen Announces U.S. FDA Approval of DARZALEX® (daratumumab) Combination Regimen for Newly Diagnosed, Transplant-Eligible Patients with Multiple Myeloma |
| 2019-06-02 | Janssen Research & Development, LLC | Results DARZALEX® (daratumumab) Investigational Study Shows Increased Depth of Response and Longer Progression-Free Survival in Patients with Newly Diagnosed Multiple Myeloma Who are Eligible for a Transplant jnj.com ↗
DARZALEX® (daratumumab) Investigational Study Shows Increased Depth of Response and Longer Progression-Free Survival in Patients with Newly Diagnosed Multiple Myeloma Who are Eligible for a Transplant |
All press releases naming this drug 41 releases
Evidence & citations 31 cited values
Every value below carries the sentence it was read from. 401 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Thalidomide | “The purpose of this study is to find out what the response is and the side effects are with chemotherapy using a combination of drugs called D.T. PACE (Dexamethasone,...” NCT00107614 ↗395“For relapsed refractory MCL patients who had received BTK inhibitors: selinexor 60mg once daily on days 1 and 8, zuberitamab 375 mg/m² on day 0, Dexamethasone 20 mg on days 1-3...” NCT07264894 ↗ “which may include but is not limited to hydroxyurea, thalidomide or an analog of thalidomide, interferon, danazol, hypomethylating agents, chemotherapy or radiotherapy.” NCT04576156 ↗ “After cycle 4, patients in complete remission will take oral thalidomide until progression of disease.” NCT00450801 ↗ “oral thalidomide in combination with tegafur-uracil will be applied to prevent tumor recurrence” NCT02447679 ↗ “Chidamide 30mg ，twice a week Prednisone 20mg qd Cyclophosphamide 50mg qd Thalidomide 100mg qd” NCT02879526 ↗ “Thalidomide: 50 mg OD x 1 week 100 mg OD x 1 week 200 mg OD x 1 week, 300 mg OD x 1 week” NCT01438450 ↗ “cyclophosphamide 500mg D1-8-15 + thalidomide 100-200mg D1-28 + dexamethasone 40mg/week” NCT03792620 ↗ “Treatment on this study combines two drugs: Thalomid™ (thalidomide) and carboplatin.” NCT00179881 ↗ “Drugs used would be Thalidomide and Capecitabine in the following dosage schedule-” NCT02240771 ↗ “Tofacitinib 5mg BID+thalidomide 50mg BID+tacrolimus 0.1mg/kg QD per oral” NCT06438679 ↗ |
| Known as | .alpha.-phthalimidoglutarimide | ChEMBL registry synonym — accepted as the source's own label CHEMBL468 ↗ |
| Known as | Celgene | ChEMBL registry synonym — accepted as the source's own label CHEMBL468 ↗ |
| Known as | Contergan | ChEMBL registry synonym — accepted as the source's own label CHEMBL468 ↗ |
| Known as | Distaval | ChEMBL registry synonym — accepted as the source's own label CHEMBL468 ↗ |
| Known as | Kevadon | ChEMBL registry synonym — accepted as the source's own label CHEMBL468 ↗ |
| Known as | Myrin | ChEMBL registry synonym — accepted as the source's own label CHEMBL468 ↗ |
| Known as | N-phthalylglutamic acid imide | ChEMBL registry synonym — accepted as the source's own label CHEMBL468 ↗ |
| Known as | Neurosedyn | ChEMBL registry synonym — accepted as the source's own label CHEMBL468 ↗ |
| Known as | NSC # 66847 | “A Randomized Phase III Trial Of Thalidomide (NSC # 66847) Plus Dexamethasone Versus Dexamethasone In Newly Diagnosed Multiple Myeloma” NCT00033332 ↗2“A Phase II Evaluation of Thalidomide (NSC #66847) in the Treatment of Recurrent or Persistent Leiomyosarcoma of the Uterus” NCT00025220 ↗ “Escalating Doses of Thalidomide (NSC #66847) Administered Orally Once a Day” NCT00017316 ↗ |
| Known as | NSC-527179 | ChEMBL registry synonym — accepted as the source's own label CHEMBL468 ↗ |
| Known as | Pantosediv | ChEMBL registry synonym — accepted as the source's own label CHEMBL468 ↗ |
| Known as | Pharmion | ChEMBL registry synonym — accepted as the source's own label CHEMBL468 ↗ |
| Known as | Softenon | ChEMBL registry synonym — accepted as the source's own label CHEMBL468 ↗ |
| Known as | Talidex | ChEMBL registry synonym — accepted as the source's own label CHEMBL468 ↗ |
| Known as | Talidomida | ChEMBL registry synonym — accepted as the source's own label CHEMBL468 ↗ |
| Known as | Thado | “Medication and Dose: Thalidomide (THADO 50mg/cap.) 100mg, BID.” NCT00201357 ↗3“sorafenib (Nexavar®), thalidomide (Thado®)” NCT00971126 ↗ “Thalidomide(THADO), Tegafur/Uracil(UFUR)” NCT00384800 ↗ “Thalidomide(Thado)” NCT00225290 ↗ |
| Known as | thal | “The marked activity of thalidomide (thal) and dexamethasone (dex) in relapsed and refractory multiple myeloma (MM) provided the basis for this phase 2 clinical study” NCT01341262 ↗3“adjuvant dexamethasone (dex) and thalidomide (thal) in an attempt to reduce TRM and improve response rates.” NCT01527032 ↗ “the immunomodulatory agent thalidomide (Thal) has proven effectiveness in active MM” PMID 22902362 ↗ Aug 2012 “combining thalidomide (THAL, 200 mg/d) with monthly pamidronate” PMID 18669874 ↗ Jul 2008 |
| Known as | Thaled | ChEMBL registry synonym — accepted as the source's own label CHEMBL468 ↗ |
| Known as | Thalidomide (Thalomid) | “Thalidomide (Thalomid®)” NCT02128230 ↗ |
| Known as | Thalidomide bms (previously thalidomide celgene) | ChEMBL registry synonym — accepted as the source's own label CHEMBL468 ↗ |
| Known as | Thalidomide lipomed | ChEMBL registry synonym — accepted as the source's own label CHEMBL468 ↗ |
| Known as | Thalidomide Oral Product | “Thalidomide (Thalidomide Oral Product)100 mg by mouth twice a day on days 1-5 after chemotherapy .” NCT03601871 ↗ |
| Known as | Thalomid | “A Phase II Study on the Effectiveness of Thalomid (Thalidomide) Combined With Procrit (Erythropoietin) for the Treatment of Anemia in Patients With Low and Intermediate Risk-1...” NCT00053001 ↗8“A Randomized, Multi-Center, Double-Blind, Placebo-Controlled Trial Assessing The Safety And Efficacy Of Thalidomide (THALOMID) For The Treatment Of Anemia In Red Blood Cell...” NCT00030550 ↗ “Both epirubicin (Ellence); Pfizer Pharmaceuticals, New York, NY, http://www.pfizer.com) and thalidomide (Thalomid); Celgene Corporation, Warren, NJ, http://www.celgene.com)...” PMID 15967833 ↗ Jun 2005 “A Phase II Study of Dexamethasone (DECADRON®), Thalidomide (THALOMID®), and Lenalidomide (REVLIMID®) for Subjects With Relapsed or Refractory Multiple Myeloma” NCT00538824 ↗ “The purpose of this study is to determine if Thalidomide (Thalomid) is effective in treating patients with chronic pancreatitis.” NCT00469703 ↗ “A Pilot Study Of Hycamtin (Topotecan) And Thalomid (Thalidomide) In Patients With Recurrent Malignant Gliomas” NCT00014443 ↗ “Thalidomide (THALOMID®)” NCT00538733 ↗ |
| Known as | Thalomid(R) | “Thalomid(R) (thalidomide) is an approved medication for Hansen's disease (leprosy).” NCT00162760 ↗ |
| Known as | THD | “Thalidomide (THD) is currently widely used in the treatment of immune rheumatic diseases, blood tumors and solid tumors.” NCT06470464 ↗ |
| Known as | THL | “Thalidomide (THL) shows potent anti-inflammatory properties and increased the lifespan in ALS transgenic mice.” PMID 18425621 ↗ Apr 2008 |
| Action | Inhibit | “thalidomide reduces TNF-alpha levels and inhibits production of HIV” NCT00000812 ↗ |
| Modality | Other / unclassified | “old, well established first line immunomodulatory imide drugs (IMiD)” NCT02891811 ↗ |
| Route | Oral | “Patients are randomized to receive 4 weeks of either thalidomide or placebo orally, administered once daily.” NCT00000790 ↗ |
| Target | TNF | “thalidomide reduces TNF-alpha levels” NCT00000812 ↗ |