Tamoxifen
Soltamox, Tamoxifen (tamoxifen) is a small molecule pharmaceutical. Tamoxifen was first approved as Nolvadex on 1982-01-01. It is used to treat breast neoplasms, gynecomastia, pancreatic neoplasms, and precocious puberty in the USA. The pharmaceutical is active against estrogen receptor. In addition, it is known to target G-protein coupled estrogen receptor 1 and estrogen receptor beta.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Soltamox, Tamoxifen (discontinued: Nolvadex, Tamoxifen)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Tamoxifen citrate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| SOLTAMOX | Mayne Group | N-021807 RX | 2005-10-29 | 1 products, RLD, RS |
Show 1 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| soltamox | New Drug Application | 2021-11-29 |
| tamoxifen citrate | ANDA | 2024-07-17 |
Indications
FDA
EMA
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| S0187 | Tamoxifen citrate, oral, 10 mg |
Clinical
Clinical Trials
564 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 33 | 160 | 149 | 15 | 104 | 450 |
| Triple negative breast neoplasms | D064726 | — | — | 2 | 9 | 2 | 1 | 1 | 15 |
| Breast carcinoma in situ | D000071960 | — | D05 | 1 | 8 | 1 | 1 | 1 | 12 |
| Hot flashes | D019584 | — | — | 1 | 3 | 2 | 1 | 3 | 10 |
| Invasive hydatidiform mole | D002820 | — | D39.2 | 1 | 1 | 2 | 1 | 1 | 6 |
| Postmenopause | D017698 | — | — | — | 2 | — | 1 | 3 | 6 |
| Infertility | D007246 | HP_0000789 | — | — | 1 | 1 | 1 | 1 | 4 |
| Mastodynia | D059373 | EFO_1001366 | N64.4 | — | 2 | 1 | 1 | — | 4 |
| Hemorrhage | D006470 | MP_0001914 | R58 | — | — | — | 4 | — | 4 |
| Breast diseases | D001941 | — | N60-N65 | — | 1 | 1 | 1 | — | 2 |
Show 11 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Carcinoma | D002277 | — | C80.0 | 3 | 22 | 6 | — | 2 | 32 |
| Carcinoma in situ | D002278 | — | D09.9 | 2 | 15 | 5 | — | 3 | 24 |
| Male breast neoplasms | D018567 | — | — | 1 | 9 | 7 | — | 6 | 23 |
| Intraductal carcinoma noninfiltrating | D002285 | — | D05.1 | 2 | 14 | 4 | — | 3 | 22 |
| Neoplasms | D009369 | — | C80 | 5 | 7 | 3 | — | 4 | 19 |
| Ductal carcinoma | D044584 | — | — | 2 | 10 | 3 | — | 2 | 16 |
| Recurrence | D012008 | — | — | — | 8 | 5 | — | 2 | 14 |
| Endometrial neoplasms | D016889 | EFO_0004230 | — | — | 2 | 2 | — | 7 | 11 |
| Ductal carcinoma breast | D018270 | — | — | 1 | 7 | 2 | — | 1 | 11 |
| Ovarian neoplasms | D010051 | EFO_0003893 | C56 | 2 | 7 | 1 | — | — | 10 |
Show 39 more
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Lobular carcinoma | D018275 | EFO_0000570 | — | 1 | 5 | — | — | 1 | 7 |
| Central nervous system neoplasms | D016543 | — | — | — | 5 | — | — | — | 5 |
| Nervous system neoplasms | D009423 | — | — | — | 5 | — | — | — | 5 |
| Urinary bladder neoplasms | D001749 | — | C67 | — | 3 | — | — | — | 3 |
| Glioma | D005910 | EFO_0000520 | — | — | 3 | — | — | — | 3 |
| Amyotrophic lateral sclerosis | D000690 | HP_0007354 | G12.21 | 1 | 3 | — | — | — | 3 |
| Motor neuron disease | D016472 | EFO_0003782 | G12.2 | 1 | 3 | — | — | — | 3 |
| Sclerosis | D012598 | — | — | 1 | 3 | — | — | — | 3 |
| Glioblastoma | D005909 | EFO_0000515 | — | 1 | 2 | — | — | — | 3 |
| Sarcoma | D012509 | — | — | — | 2 | — | — | 1 | 3 |
Show 51 more
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | 2 | 3 |
| Hepatitis c | D006526 | — | B19.2 | 1 | — | — | — | — | 1 |
| Chronic hepatitis c | D019698 | EFO_0004220 | B18.2 | 1 | — | — | — | — | 1 |
| Hepatitis | D006505 | HP_0012115 | K75.9 | 1 | — | — | — | — | 1 |
| Chronic hepatitis | D006521 | — | K73.9 | 1 | — | — | — | — | 1 |
| Hepatitis a | D006506 | EFO_0007305 | B15 | 1 | — | — | — | — | 1 |
| Brain neoplasms | D001932 | EFO_0003833 | C71 | 1 | — | — | — | — | 1 |
| Gastrointestinal neoplasms | D005770 | — | C26.9 | 1 | — | — | — | — | 1 |
| Digestive system neoplasms | D004067 | — | — | 1 | — | — | — | — | 1 |
| Barrett esophagus | D001471 | EFO_0000280 | K22.7 | 1 | — | — | — | — | 1 |
Show 4 more
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Endometrial hyperplasia | D004714 | — | N85.0 | — | — | — | — | 4 | 4 |
| Hodgkin disease | D006689 | — | C81 | — | — | — | — | 2 | 2 |
| Menopause | D008593 | EFO_0003922 | N95 | — | — | — | — | 2 | 2 |
| Acupuncture therapy | D015670 | — | — | — | — | — | — | 2 | 2 |
| Disease progression | D018450 | — | — | — | — | — | — | 1 | 1 |
| Systemic mastocytosis | D034721 | — | C96.21 | — | — | — | — | 1 | 1 |
| Mastocytosis | D008415 | — | D47.09 | — | — | — | — | 1 | 1 |
| Non-small-cell lung carcinoma | D002289 | — | — | — | — | — | — | 1 | 1 |
| Multiple myeloma | D009101 | — | C90.0 | — | — | — | — | 1 | 1 |
| Depression | D003863 | — | F33.9 | — | — | — | — | 1 | 1 |
Show 23 more
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Tamoxifen |
| INN | tamoxifen |
| Description | Tamoxifen is a tertiary amino compound and a stilbenoid. It has a role as an estrogen receptor antagonist, a bone density conservation agent, an estrogen receptor modulator, an estrogen antagonist, an angiogenesis inhibitor, an EC 2.7.11.13 (protein kinase C) inhibitor, an EC 1.2.3.1 (aldehyde oxidase) inhibitor and an antineoplastic agent. It derives from a hydride of a stilbene. |
| Classification | Small molecule |
| Drug class | Selective estrogen receptor modulator |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CC/C(=C(\c1ccccc1)c1ccc(OCCN(C)C)cc1)c1ccccc1 |
Identifiers
| PDB | — |
| CAS-ID | 10540-29-1 |
| RxCUI | — |
| ChEMBL ID | CHEMBL83 |
| ChEBI ID | 41774 |
| PubChem CID | 2733526 |
| DrugBank | DB00675 |
| UNII ID | 094ZI81Y45 (ChemIDplus, GSRS) |
Target
Agency Approved
No data
Alternate
ESR2
ESR2
CES1
CES1
Organism
Homo sapiens
Gene name
ESR2
Gene synonyms
ESTRB, NR3A2
NCBI Gene ID
Protein name
estrogen receptor beta
Protein synonyms
estrogen receptor beta 2, estrogen receptor beta 4, Nuclear receptor subfamily 3 group A member 2, oestrogen receptor beta
Uniprot ID
Mouse ortholog
Esr2 (13983)
estrogen receptor beta (O08537)
Variants
No data
Financial
Revenue by drug
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Estimated US medical usage
Tamoxifen
Total medical expenditures per year (USD, in millions)
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Number of persons purchased
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Number of purchases
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Trends
PubMed Central
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Additional graphs summarizing 98,946 documents
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Safety
Black-box Warning
Black-box warning for: Soltamox, Tamoxifen citrate
Adverse Events
Top Adverse Reactions
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12,552 adverse events reported
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