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.
Download report
Favorite
Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
Mock data
Subscribe for the real data
Subscribe for the real data
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 hydrochloride
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
No data
HCPCS
No data
Clinical
Clinical Trials
34 clinical trials
View more details
Mock data
Subscribe for the real data
Subscribe for the real data
Indications Phases 4
No data
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Breast neoplasms | D001943 | EFO_0003869 | C50 | 5 | 5 | 3 | — | — | 11 |
| Triple negative breast neoplasms | D064726 | — | — | 1 | — | 1 | — | — | 2 |
| Male breast neoplasms | D018567 | — | — | — | — | 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 | 1 | 1 | — | — | — | 1 |
| Neoplasms | D009369 | — | C80 | 1 | 1 | — | — | — | 1 |
| Central nervous system neoplasms | D016543 | — | — | 1 | 1 | — | — | — | 1 |
| Central nervous system diseases | D002493 | — | G96.9 | 1 | 1 | — | — | — | 1 |
| Brain diseases | D001927 | — | 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 |
| Hereditary breast and ovarian cancer syndrome | D061325 | — | — | — | 1 | — | — | — | 1 |
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
View more details
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
No data
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
Subscribe for the real data
Subscribe for the real data
Additional graphs summarizing 599 documents
View more details
Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
Subscribe for the real data
Subscribe for the real data
7,828 adverse events reported
View more details
© 2020-2025 Collaborative Drug Discovery Inc. (CDD) | Terms of Use