Orserdu(elacestrant)
Orserdu (elacestrant) is a small molecule pharmaceutical. Elacestrant was first approved as Orserdu on 2023-01-27. It has been approved in Europe to treat breast neoplasms.
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Commercial
Therapeutic Areas
Therapeutic Area | MeSH |
|---|---|
| neoplasms | D009369 |
| skin and connective tissue diseases | D017437 |
Trade Name
FDA
EMA
Orserdu
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Elacestrant dihydrochloride
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ORSERDU | Stemline Therapeutics | N-217639 RX | 2023-01-27 | 2 products, RLD, RS |
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| elacestrant | New Drug Application | 2023-01-27 |
| orserdu | New Drug Application | 2024-08-02 |
Indications
FDA
EMA
No data
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
ELACESTRANT DIHYDROCHLORIDE, ORSERDU, STEMLINE THERAP | |||
| 2028-01-27 | NCE | ||
Patent Expiration
ATC Codes
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HCPCS
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Clinical
Clinical Trials
25 clinical trials
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Indications Phases 4
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 10 | 10 | 4 | — | 1 | 20 |
| Triple negative breast neoplasms | D064726 | — | — | 2 | 2 | 2 | — | — | 6 |
| Recurrence | D012008 | — | — | — | — | 1 | — | — | 1 |
Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Brain neoplasms | D001932 | EFO_0003833 | C71 | 2 | 2 | — | — | — | 2 |
| Hot flashes | D019584 | — | — | — | 2 | — | — | — | 2 |
| Neoplasms | D009369 | — | C80 | 1 | 1 | — | — | — | 1 |
| Central nervous system neoplasms | D016543 | — | — | 1 | 1 | — | — | — | 1 |
| Central nervous system diseases | D002493 | HP_0002011 | G96.9 | 1 | 1 | — | — | — | 1 |
| Brain diseases | D001927 | HP_0001298 | G93.40 | 1 | 1 | — | — | — | 1 |
| Nervous system diseases | D009422 | — | G00-G99 | 1 | 1 | — | — | — | 1 |
| Neoplasms by site | D009371 | — | — | 1 | 1 | — | — | — | 1 |
| Nervous system neoplasms | D009423 | — | — | 1 | 1 | — | — | — | 1 |
| Breast diseases | D001941 | — | N60-N65 | 1 | 1 | — | — | — | 1 |
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Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Liver diseases | D008107 | HP_0002910 | K70-K77 | 1 | — | — | — | — | 1 |
| Hepatic insufficiency | D048550 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Ventricular tachycardia | D017180 | — | I47.2 | — | — | — | — | 1 | 1 |
| Tachycardia | D013610 | HP_0001649 | R00.0 | — | — | — | — | 1 | 1 |
| Healthy volunteers/patients | — | — | — | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Elacestrant |
| INN | elacestrant |
| Description | Elacestrant is a member of the class of tetralins that is 1,2,3,4-tetrahydronaphthalene which is substituted by hydroxy group at position 2 and by a 2-(ethyl{4-[2-(ethylamino)ethyl]benzyl}amino)-4-methoxyphenyl group at position 6R. It is a is an estrogen receptor degrader indicated for the treatment of postmenopausal women or adult men, with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. It has a role as an antineoplastic agent, an estrogen receptor antagonist and an anti-estrogen. It is a monomethoxybenzene, a member of tetralins, a tertiary amino compound, a secondary amino compound, a substituted aniline and an organic hydroxy compound. |
| Classification | Small molecule |
| Drug class | estrogens; estrogen antagonists |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | CCNCCc1ccc(CN(CC)c2cc(OC)ccc2[C@@H]2CCc3cc(O)ccc3C2)cc1 |
Identifiers
| PDB | — |
| CAS-ID | 722533-56-4 |
| RxCUI | — |
| ChEMBL ID | CHEMBL4297509 |
| ChEBI ID | — |
| PubChem CID | 23642301 |
| DrugBank | DB06374 |
| UNII ID | FM6A2627A8 (ChemIDplus, GSRS) |
Target
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Variants
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Financial
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Trends
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Safety
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Adverse Events
Top Adverse Reactions
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4,197 adverse events reported
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