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
FDA
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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
538 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 | 27 | 94 | 61 | 4 | 17 | 186 |
| Plasma cell neoplasms | D054219 | — | — | 26 | 87 | 58 | 4 | 16 | 175 |
| Lymphoma | D008223 | — | C85.9 | 4 | 25 | 3 | 2 | 2 | 34 |
| Syndrome | D013577 | — | — | 2 | 19 | 2 | 1 | 1 | 24 |
| Myelodysplastic syndromes | D009190 | — | D46 | 3 | 14 | 2 | 1 | 2 | 21 |
| Preleukemia | D011289 | — | — | 3 | 14 | 2 | 1 | — | 19 |
| Non-small-cell lung carcinoma | D002289 | — | — | 2 | 11 | 3 | 1 | — | 15 |
| 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 | 15 | 5 | — | — | 27 |
| Leukemia | D007938 | — | C95 | 4 | 18 | 2 | — | 3 | 24 |
| Plasmacytoma | D010954 | — | C90.3 | 1 | 14 | 5 | — | 1 | 21 |
| Carcinoma | D002277 | — | C80.0 | 3 | 14 | 6 | — | 1 | 17 |
| Liver neoplasms | D008113 | EFO_1001513 | C22.0 | 2 | 14 | 6 | — | 1 | 17 |
| Hepatocellular carcinoma | D006528 | — | C22.0 | 2 | 11 | 6 | — | 1 | 14 |
| Prostatic neoplasms | D011471 | — | C61 | 1 | 12 | 1 | — | — | 13 |
| Crohn disease | D003424 | EFO_0000384 | K50 | 1 | 2 | 3 | — | 4 | 9 |
| Primary myelofibrosis | D055728 | — | D47.4 | — | 6 | 2 | — | — | 8 |
| 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 |
|---|---|---|---|---|---|---|---|---|---|
| B-cell chronic lymphocytic leukemia | D015451 | — | C91.1 | 4 | 11 | — | — | 1 | 13 |
| Central nervous system neoplasms | D016543 | — | — | 2 | 11 | — | — | — | 13 |
| Nervous system neoplasms | D009423 | — | — | 1 | 11 | — | — | — | 12 |
| Hiv infections | D015658 | EFO_0000764 | B20 | 2 | 7 | — | — | 3 | 12 |
| Recurrence | D012008 | — | — | — | 10 | — | — | 1 | 11 |
| Non-hodgkin lymphoma | D008228 | — | C85.9 | 4 | 9 | — | — | 1 | 11 |
| Melanoma | D008545 | — | — | 3 | 9 | — | — | — | 11 |
| Lymphoid leukemia | D007945 | — | C91 | 2 | 8 | — | — | 1 | 9 |
| Sarcoma | D012509 | — | — | — | 8 | — | — | — | 8 |
| Glioma | D005910 | EFO_0000520 | — | 2 | 6 | — | — | — | 8 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 5 | — | — | — | — | 5 |
| Therapeutic equivalency | D013810 | — | — | 2 | — | — | — | — | 2 |
| Liposarcoma | D008080 | — | — | 1 | — | — | — | — | 1 |
| Intestinal neoplasms | D007414 | — | C26.0 | 1 | — | — | — | — | 1 |
| Pulmonary sarcoidosis | D017565 | DOID_13406 | D86.0 | 1 | — | — | — | — | 1 |
| Osteosarcoma | D012516 | — | — | 1 | — | — | — | — | 1 |
| Retinoblastoma | D012175 | — | — | 1 | — | — | — | — | 1 |
| Ewing sarcoma | D012512 | EFO_0000173 | — | 1 | — | — | — | — | 1 |
| Rhabdomyosarcoma | D012208 | — | — | 1 | — | — | — | — | 1 |
| Primitive neuroectodermal tumors | D018242 | — | — | 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 |
| Carpal tunnel syndrome | D002349 | EFO_0004143 | G56.0 | — | — | — | — | 1 | 1 |
| Leukapheresis | D007937 | — | — | — | — | — | — | 1 | 1 |
| Acute-phase reaction | D000210 | — | — | — | — | — | — | 1 | 1 |
| Survivorship | D000073859 | — | — | — | — | — | — | 1 | 1 |
| Chronic pain | D059350 | — | — | — | — | — | — | 1 | 1 |
| Tendinopathy | D052256 | EFO_1001434 | M77.9 | — | — | — | — | 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
Top Adverse Reactions
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37,831 adverse events reported
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