Elacestrant hydrochloride
Highest phase reached
Approved
Drug type
Small molecule
First approval year
2023
- First approval year
- 2023
- Listing at source
- Listed
- Highest phase reached
- Approved
- Drug type
- Small molecule
- Drug name
- Elacestrant hydrochloride
- Molecular weight
- 531.57
- Structure (SMILES)
- CCNCCc1ccc(CN(CC)c2cc(OC)ccc2[C@@H]2CCc3cc(O)ccc3C2)cc1.Cl.Cl
- orserdu
- Orserdu
- elacestrant dihydrochloride
- Elacestrant dihydrochloride
- Elacestrant Dihydrochloride
- Elacestrant dihydrochloride [MI]
- Elacestrant dihydrochloride [USAN]
- Elacestrant dihydrochloride [WHO-DD]
- elacestrant dihydrochloride mi
- elacestrant dihydrochloride usan
- elacestrant dihydrochloride who dd
- elacestrant hydrochloride
- Elacestrant hydrochloride
- orserdu
- Orserdu
- rad 1901 dihydrochloride
- RAD-1901 DIHYDROCHLORIDE
- rad1901 dihydrochloride
- RAD1901 DIHYDROCHLORIDE
- rad1901 hydrochloride
- RAD1901 hydrochloride
- ATC classification codes
- L02BA04
Sources for recorded values
- CAS registry numbers
- 1349723-93-8
- ChEMBL ID
- CHEMBL4594273
- InChIKey
- XGFHYCAZOCBCRQ-FBHGDYMESA-N
- PubChem compound IDs
- 67479909
- RxNorm IDs (RxCUI)
- 2628469
- FDA ingredient codes (UNII)
- 8NZT0PR8AL
- Applicant
- STEMLINE THERAP
- Approval date
- 27 Jan 2023
- Application number
- NDA217639
- Patents
- 7
- Designations
- 0
- Earliest recorded loss of exclusivity
- 5 Jan 2038
- First in class
- No
- Fast track
- No
- Breakthrough designation
- No
- Orphan designation
- No
- Priority review
- No
- Orphan exclusivity
- No
- Accelerated approval
- No
- Availability
- Prescription only
- Drug name stem
- -estr-; -estrant
Administration routes
- Oral
Mechanisms of action
- Mechanism
- Estrogen receptor alpha degrader
- Action type
- DEGRADER
- Target
- Estrogen receptor
- Protein identifier
- P03372
Open Targets mechanisms
- Mechanism
- Estrogen receptor alpha degrader
- Action type
- DEGRADER
- Target
- Estrogen receptor
- Condition
- Liver Diseases
- Highest recorded phase
- 1
- Condition identifier
- EFO:0001421
- Subject identifier
- D008107
- Condition
- Breast Neoplasms
- Highest recorded phase
- 4
- Condition identifier
- EFO:0003869
- Subject identifier
- D001943
- Condition
- Breast Neoplasms, Male
- Highest recorded phase
- 4
- Condition identifier
- EFO:0006861
- Subject identifier
- D018567
- Condition identifier
- EFO_0001421
- Highest recorded phase
- 1
- Condition identifier
- EFO_0003869
- Condition identifier
- EFO_0006861
- Condition identifier
- MONDO_0004992
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0005628
- Highest recorded phase
- 4
- Condition identifier
- MONDO_0007254
- Highest recorded phase
- 1
- Condition identifier
- MONDO_0021100
- Highest recorded phase
- 4
- Event
- disease progression
- Reports
- 296
- Reporting signal score
- 1,084.31
- Event
- dizziness
- Reports
- 4
- Reporting signal score
- 6.06456
- Event
- drug intolerance
- Reports
- 15
- Reporting signal score
- 8.66871
- Event
- dyspepsia
- Reports
- 12
- Reporting signal score
- 10.2592
- Event
- dysphagia
- Reports
- 12
- Reporting signal score
- 6.3059
- Event
- dyspnoea
- Reports
- 4
- Reporting signal score
- 8.225
- Event
- foreign body in throat
- Reports
- 4
- Reporting signal score
- 17.9456
- Event
- headache
- Reports
- 4
- Reporting signal score
- 8.32088
- Event
- hospice care
- Reports
- 22
- Reporting signal score
- 78.1565
- Event
- hospitalisation
- Reports
- 16
- Reporting signal score
- 8.64124
- Event
- illness
- Reports
- 9
- Reporting signal score
- 14.908
- Event
- malignant neoplasm progression
- Reports
- 11
- Reporting signal score
- 7.49701
- Event
- metastases to bone
- Reports
- 8
- Reporting signal score
- 14.112
- Event
- nausea
- Reports
- 81
- Reporting signal score
- 41.702
- Event
- positron emission tomogram abnormal
- Reports
- 2
- Reporting signal score
- 7.61938
- Event
- pyrexia
- Reports
- 1
- Reporting signal score
- 9.83971
- Event
- salivary hyposecretion
- Reports
- 1
- Reporting signal score
- 7.36334
- Event
- tumour marker increased
- Reports
- 12
- Reporting signal score
- 40.953
- Event
- vomiting
- Reports
- 32
- Reporting signal score
- 6.10383
Trial references
- NCT06126575
- Hydrogen bond acceptors
- 4
- Hydrogen bond donors
- 2
- Polar surface area
- 44.73
- Calculated partition coefficient (ALogP)
- 5.85
- Prodrug
- No
- Chirality
- Single enantiomer
- Inorganic
- No
- Rule-of-five violations
- 1
- Rotatable bonds
- 10
- Heavy atoms
- 36
- Molecular formula
- C30H40Cl2N2O2
- Monoisotopic mass
- 530.2466839
- Natural product
- No
- Antineoplastic Agents
Related records
Trials (40)
- A First-in-Human Study of MEN2312 in Adults With Advanced Breast Cancer
- A Phase 2 Bridging Study of Elacestrant Monotherapy in Advanced or Metastatic Breast Cancer
- A Phase I, Multicenter, Open-Label, Multi-Part, Dose-escalation Study of RAD1901 in Postmenopausal Women With Advanced Estrogen Receptor Positive and HER2-Negative Breast Cancer
- A PK Study Testing Single Oral Dose of Elacestrant in Subjects With Normal or Severely Impaired Hepatic Function
- A Rollover Protocol of Elacestrant, in Combination With Onapristone, for Patients With ER+, PR+, HER2- Advanced or Metastatic Breast Cancer
- A Short-term Preoperative, Evaluating Activity and Safety of Elacestrant Monotherapy as Compared to Elacestrant + Ovarian Function Suppression (LHRH Agonist) in Premenopausal Patients With Stage I-II ER+/HER2- Breast Cancer
- A Study of Elacestrant Alone or in Combination With Abemaciclib in People With Endometrial Cancer
- A Study of Elacestrant Versus Standard Endocrine Therapy in Women and Men With ER+,HER2-, Early Breast Cancer With High Risk of Recurrence
- A Study of Samuraciclib and Elacestrant in Participants With Metastatic or Locally Advanced HR+/HER2-negative Breast Cancer
- A Study to Evaluate the Effects of RAD1901 in the Treatment of Vasomotor Symptoms in Postmenopausal Women
- BGB-43395 Alone or as Part of Combination Therapies in Participants With Breast Cancer and Other Advanced Solid Tumors
- Circulating Tumor DNA
- DCIS: RECAST Trial Ductal Carcinoma In Situ: Re-Evaluating Conditions for Active Surveillance Suitability as Treatment
- Elacestrant + Everolimus in Patients ER+/HER2-, ESR1mut, Advanced Breast Cancer Progressing to ET and CDK4/6i.
- Elacestrant and Exemestane for Patients With Pretreated HR+/HER2- Metastatic Breast Cancer and [18F] FES-avid Lesions (COMBINE)
- Elacestrant for Treating ER+/HER2- Breast Cancer Patients With ctDNA Relapse (TREAT ctDNA)
- Elacestrant in Advanced Triple Positive Breast Cancer
- Elacestrant in Patients With ER+ HER2- ESR1-mutated Locally Advanced or Metastatic Breast Cancer
- Elacestrant in Preoperative Setting, a Window of Opportunity Study
- ELACESTRANT in Women and Men With CDK4/6 Inhibitor-Naive Estrogen Receptor Positive, HER-2 Negative Metastatic Breast Cancer Study
Approved for (2)
- Breast neoplasm
- Male breast carcinoma
In development for (1)
- Liver disorder Phase 1
Targets (1)
- ESR1 Estrogen receptor alpha degrader