Thalomid, Thalidomide bms (previously thalidomide celgene)(thalidomide)
Thalidomide, Thalomid (thalidomide) is a small molecule pharmaceutical. Thalidomide was first approved as Thalomid on 1998-07-16. It is used to treat aphthous stomatitis, behcet syndrome, crohn disease, discoid lupus erythematosus, and erythema multiforme amongst others in the USA. It has been approved in Europe to treat multiple myeloma. It is known to target protein cereblon.
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Commercial
Therapeutic Areas
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Trade Name
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Thalomid (discontinued: Thalidomide)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Thalidomide
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| THALOMID | Bristol Myers Squibb | N-020785 RX | 1998-07-16 | 4 products, RLD |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| thalomid | New Drug Application | 2023-03-24 |
Indications
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EMA
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Agency Specific
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Clinical
Clinical Trials
496 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Multiple myeloma | D009101 | — | C90.0 | 20 | 87 | 59 | 3 | 16 | 171 |
| Plasma cell neoplasms | D054219 | — | — | 17 | 75 | 48 | 3 | 14 | 145 |
| Lymphoma | D008223 | — | C85.9 | 4 | 22 | 2 | 2 | 1 | 29 |
| Syndrome | D013577 | — | — | 1 | 16 | 2 | 1 | 1 | 21 |
| Myelodysplastic syndromes | D009190 | — | D46 | 3 | 13 | 2 | 1 | 2 | 20 |
| Preleukemia | D011289 | — | — | 2 | 11 | 2 | 1 | — | 16 |
| Non-small-cell lung carcinoma | D002289 | — | — | 3 | 11 | 3 | 1 | — | 16 |
| Lung neoplasms | D008175 | — | C34.90 | 2 | 9 | 3 | 1 | — | 14 |
| Thalassemia | D013789 | EFO_1001996 | D56 | 1 | 8 | 4 | 1 | 1 | 12 |
| Amyloidosis | D000686 | EFO_1001875 | E85 | 1 | 7 | 1 | 1 | 1 | 10 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | — | C80 | 9 | 17 | 4 | — | — | 28 |
| Leukemia | D007938 | — | C95 | 4 | 16 | 2 | — | 3 | 22 |
| Plasmacytoma | D010954 | — | C90.3 | — | 13 | 5 | — | 1 | 19 |
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | 3 | 14 | 6 | — | 1 | 18 |
| Hepatocellular carcinoma | D006528 | — | C22.0 | 2 | 12 | 6 | — | 1 | 15 |
| Recurrence | D012008 | — | — | — | 9 | 1 | — | 3 | 13 |
| Prostatic neoplasms | D011471 | — | C61 | 1 | 12 | 1 | — | — | 13 |
| Carcinoma | D002277 | — | C80.0 | 2 | 8 | 5 | — | 1 | 11 |
| Crohn disease | D003424 | EFO_0000384 | K50 | 1 | 2 | 3 | — | 4 | 9 |
| Colorectal neoplasms | D015179 | — | — | 1 | 6 | 1 | — | — | 8 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 5 | 11 | — | — | 1 | 14 |
| B-cell chronic lymphocytic leukemia | D015451 | — | C91.1 | 5 | 11 | — | — | 1 | 14 |
| Central nervous system neoplasms | D016543 | — | — | 2 | 10 | — | — | — | 12 |
| Melanoma | D008545 | — | — | 4 | 9 | — | — | — | 12 |
| Hiv infections | D015658 | EFO_0000764 | B20 | 2 | 7 | — | — | 3 | 12 |
| Nervous system neoplasms | D009423 | — | — | 1 | 10 | — | — | — | 11 |
| Lymphoid leukemia | D007945 | — | C91 | 2 | 8 | — | — | 1 | 9 |
| Glioma | D005910 | EFO_0000520 | — | 3 | 6 | — | — | — | 9 |
| Sarcoma | D012509 | — | — | 1 | 7 | — | — | — | 8 |
| Glioblastoma | D005909 | EFO_0000515 | — | 1 | 5 | — | — | — | 6 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Osteosarcoma | D012516 | — | — | 2 | — | — | — | — | 2 |
| Burkitt lymphoma | D002051 | — | C83.7 | 1 | — | — | — | 1 | 2 |
| Primitive neuroectodermal tumors | D018242 | — | — | 2 | — | — | — | — | 2 |
| Primitive neuroectodermal tumors peripheral | D018241 | — | — | 2 | — | — | — | — | 2 |
| Liposarcoma | D008080 | — | — | 1 | — | — | — | — | 1 |
| Salivary gland neoplasms | D012468 | EFO_0003826 | D11 | 1 | — | — | — | — | 1 |
| Precursor cell lymphoblastic leukemia-lymphoma | D054198 | — | C91.0 | 1 | — | — | — | — | 1 |
| Urinary bladder neoplasms | D001749 | — | C67 | 1 | — | — | — | — | 1 |
| Gastrointestinal stromal tumors | D046152 | EFO_0000505 | C49.A | 1 | — | — | — | — | 1 |
| Gliosarcoma | D018316 | — | — | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hematopoietic stem cell transplantation | D018380 | — | — | — | — | — | — | 3 | 3 |
| Bone marrow transplantation | D016026 | — | — | — | — | — | — | 1 | 1 |
| Adrenoleukodystrophy | D000326 | Orphanet_43 | E71.52 | — | — | — | — | 1 | 1 |
| Mothers | D009035 | — | — | — | — | — | — | 1 | 1 |
| Precancerous conditions | D011230 | — | — | — | — | — | — | 1 | 1 |
| Systemic mastocytosis | D034721 | — | C96.21 | — | — | — | — | 1 | 1 |
| Carpal tunnel syndrome | D002349 | EFO_0004143 | G56.0 | — | — | — | — | 1 | 1 |
| Leukapheresis | D007937 | — | — | — | — | — | — | 1 | 1 |
| Acute-phase reaction | D000210 | — | — | — | — | — | — | 1 | 1 |
| Survivorship | D000073859 | — | — | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Thalidomide |
| INN | thalidomide |
| Description | 2-(2,6-dioxopiperidin-3-yl)-1H-isoindole-1,3(2H)-dione is a dicarboximide that is isoindole-1,3(2H)-dione in which the hydrogen attached to the nitrogen is substituted by a 2,6-dioxopiperidin-3-yl group. It is a member of piperidones and a member of phthalimides. |
| Classification | Small molecule |
| Drug class | thalidomide derivatives |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | O=C1CCC(N2C(=O)c3ccccc3C2=O)C(=O)N1 |
Identifiers
| PDB | — |
| CAS-ID | 1012310-87-0 |
| RxCUI | — |
| ChEMBL ID | CHEMBL468 |
| ChEBI ID | 74947 |
| PubChem CID | 5426 |
| DrugBank | DB01041 |
| UNII ID | 4Z8R6ORS6L (ChemIDplus, GSRS) |
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Thalomid – Celgene
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Safety
Black-box Warning
Black-box warning for: Thalomid
Adverse Events
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38,520 adverse events reported
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