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 328 · started per year
today
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EU approved 2008
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Also used as a comparator or background therapy in 67 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT01537861 Background | Jun 2012 → Feb 2014 | plasma cell myeloma | Washington University School of Medicine | Terminated | No outcome recorded |
| Phase 14 trials | ||||||
| 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 1/22 trials | ||||||
| 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 |
| Phase 222 trials | ||||||
| Phase 2 | NCT07172659 Comparator | May 2026 → Jan 2027 expected | erythema nodosum | Medicines Development for Global Health | 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 2026 expected | plasma cell myeloma | University of Arkansas | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03204032 Comparator | Oct 2016 → Oct 2017 | neuroendocrine neoplasm | Chinese Academy of Medical Sciences | Unknown | No outcome recorded |
| Phase 2 | NCT03204019 Comparator | Oct 2016 → Oct 2017 | pancreatic neuroendocrine tumor | Chinese Academy of Medical Sciences | Unknown | No outcome recorded |
| 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 | 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 |
| Phase 2 | NCT00964496 Comparator | Nov 2004 → Nov 2007 | angiodysplasia, gastric antral vascular ectasia | Shanghai Jiao Tong University School of Medicine | Completed | No outcome recorded |
| 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 2/33 trials | ||||||
| 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 326 trials | ||||||
| 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 | No outcome recorded |
| 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 | No outcome recorded |
| 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 | No outcome recorded |
| 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 | No outcome recorded |
| 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 | No outcome recorded |
| Phase 3 | NCT00529633 Comparator | Sep 2007 → Dec 2008 | hypoproteinemia, hypercatabolic | George A. Kaysen, M.D. | Terminated | No outcome recorded |
| 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 | No outcome recorded |
| 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 |
| 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 44 trials | ||||||
| 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 |
| Phase not applicable5 trials | ||||||
| — | 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 |
Press releases naming this drug 5 releases
| Date | Issuer | Release |
|---|---|---|
| 2019-03-19 | Bristol-Myers Squibb | Bristol-Myers Squibb Files Investor Presentation Highlighting Significant Benefits of Pending Transaction with Celgene bms.com ↗ |
| 2019-03-06 | Bristol-Myers Squibb | Bristol-Myers Squibb Files Investor Presentation and Board of Directors Sends Letter to Shareholders Regarding Pending Transaction with Celgene bms.com ↗ |
| 2019-02-22 | Bristol-Myers Squibb | Bristol-Myers Squibb Announces Filing of Definitive Proxy Statement in Connection with Proposed Merger with Celgene bms.com ↗ |
| 2019-02-20 | Bristol-Myers Squibb | Bristol-Myers Squibb Provides Update on Pending Transaction with Celgene bms.com ↗ |
| 2019-01-03 | Bristol-Myers Squibb | Bristol-Myers Squibb to Acquire Celgene to Create a Premier Innovative Biopharma Company bms.com ↗ |
Evidence & citations 31 cited values
Every value below carries the sentence it was read from. 400 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 ↗394“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 ↗ “Thalidomide: 50mg QD during the cycle 1-6 (each cycle is 28 days)” NCT07195799 ↗ “Thalidomide,p.o,200mg/d,Continued use to the end of chemotherapy” NCT01664975 ↗ “The Drug including 6MP, AZA, infliximab and thalidomide” NCT02532738 ↗ “* Thalidomide 200 mg by mouth (PO) Days 1-7” NCT00577512 ↗ “Daily oral Thalidomide (at 3mg/kg)” NCT01858571 ↗ “Thalidomide：50-75mg, PO, qn;” NCT07309419 ↗ “Thalidomide 200 mg PO 1-6” NCT00113919 ↗ “Thalidomide (THALOMID®)” NCT00538733 ↗ “Thalidomide (Thalomid®)” NCT02128230 ↗ “Thalidomide 100mg/d” NCT04941937 ↗ “Drug: Thalidomide” NCT00222105 ↗ “Thalidomide” NCT00734877 ↗ “Thalidomide” NCT03335098 ↗ |
| 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 ↗ |