> Trialight public data. Index of pages: https://trialight.com/llms.txt
> Web page: https://trialight.com/data/asset/elacestrant-hydrochloride-13959fda-16a0-4471-b7ed-8c2cda471800
> Record changed: 2026-10-13

# Elacestrant hydrochloride

Highest phase reached

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4594273)

Drug type

Small molecule

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4594273)

First approval year

2023

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4594273)

## Development status

**First approval year**

2023

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4594273)

**Listing at source**

Listed

**Highest phase reached**

Approved

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4594273)

## Names and chemistry

**Drug type**

Small molecule

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4594273)

**Drug name**

Elacestrant hydrochloride

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4594273)

**Molecular weight**

531.57

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4594273)

**Structure (SMILES)**

CCNCCc1ccc(CN(CC)c2cc(OC)ccc2\[C@@H\]2CCc3cc(O)ccc3C2)cc1.Cl.Cl

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4594273)

### Brand names (2)

- orserdu
- Orserdu

### Other names (19)

- 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

## Identifiers

**ATC classification codes**

- L02BA04

Sources for recorded values

Source: [mor.nlm.nih.gov](https://mor.nlm.nih.gov/RxNav/search?searchBy=RXCUI&searchTerm=2628469)

**CAS registry numbers**

- 1349723-93-8

**ChEMBL ID**

CHEMBL4594273

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4594273)

**InChIKey**

XGFHYCAZOCBCRQ-FBHGDYMESA-N

Source: [www.ebi.ac.uk](https://www.ebi.ac.uk/chembl/explore/compound/CHEMBL4594273)

**PubChem compound IDs**

- 67479909

**RxNorm IDs (RxCUI)**

- 2628469

**FDA ingredient codes (UNII)**

- 8NZT0PR8AL

## Regulatory information

### United States

**Applicant**

STEMLINE THERAP

**Approval date**

27 Jan 2023

**Application number**

NDA217639

### Other regulatory facts

**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

## Pharmacology

### Drug classification

**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

### Investigated indications (3)

- **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

### Open Targets indications (7)

- **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

### Reported adverse events (19)

- **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  
Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT06126575)

## Chemical properties

**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

## Pharmacologic actions

- Antineoplastic Agents  
Source: [id.nlm.nih.gov](https://id.nlm.nih.gov/mesh/D000970.html)

## Related records

### Trials (40)

- [A First-in-Human Study of MEN2312 in Adults With Advanced Breast Cancer](https://trialight.com/data/trial/a-first-in-human-study-of-men2312-in-adults-with-advanced-ecce3c33-363a-4306-8ff1-80b47cb0ac54.md)
- 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](https://trialight.com/data/trial/a-study-of-elacestrant-versus-standard-endocrine-therapy-in-dff6c6aa-c4b1-4a1b-95e0-992970dd2c2f.md)
- 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](https://trialight.com/data/trial/bgb-43395-alone-or-as-part-of-combination-therapies-in-7911d36e-b7ad-48e1-98d0-ccaa83a2f342.md)
- 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](https://trialight.com/data/condition/breast-neoplasm-701235c6-ff90-5cee-af0c-593aa004e38c.md)
- Male breast carcinoma

### In development for (1)

- [Liver disorder](https://trialight.com/data/condition/liver-disorder-8388d30a-2581-5015-9ddf-adc5f6a331d7.md) Phase 1

### Targets (1)

- [ESR1](https://trialight.com/data/target/esr1-e58c882c-75fc-5507-bf76-2d7a172c0a28.md) Estrogen receptor alpha degrader

---

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