ORSERDU

Peak

elacestrant

NDAORALTABLETPriority Review
Approved
Jan 2023
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
13

Mechanism of Action

Estrogen Receptor Antagonists

Pharmacologic Class:

Estrogen Receptor Antagonist

Clinical Trials (5)

NCT07198724Phase 1/2Not Yet Recruiting

ERADICATE: A Phase Ib/II Study of Elacestrant Plus Trastuzumab Deruxtecan in Patients With CDK4/6 Inhibitor and Endocrine-resistant HR+/HER2-low or HER2-ultralow Metastatic Breast Cancer

Started Mar 2026
65 enrolled
Metastatic Breast CancerHER2 Low Breast CarcinomaHER2-negative Breast Cancer+2 more
NCT07467772Phase 2Not Yet Recruiting

Ph 2 Elacestrant in ER Positive Uterine Sarcomas

Started Feb 2026
30 enrolled
Uterine SarcomaUterine LeiomyosarcomaEndometrial Stromal Sarcoma+6 more
NCT07222215Phase 2Recruiting

PhII Randomized CAPecitabine + ELAcestrant vs. Capecitabine Alone in ER+ Breast Cancer (CAPELA)

Started Jan 2026
297 enrolled
Estrogen-receptor-positive Breast CancerMetastatic Breast CancerBreast Cancer+6 more
NCT06201234Phase 2Recruiting

Evaluating the Addition of Elacestrant (Oral SERD) to Olaparib (PARP-inhibitor) in Patients With Advanced/Metastatic HR+/HER2- Breast Cancer

Started Dec 2024
176 enrolled
Hormone Receptor Positive HER-2 Negative Breast CancerAdvanced or Metastatic Breast CancerBRCA1 Mutation+1 more
NCT06382948Phase 3Recruiting

Elacestrant + Everolimus in Patients ER+/HER2-, ESR1mut, Advanced Breast Cancer Progressing to ET and CDK4/6i.

Started Dec 2024
240 enrolled
Advanced Breast CancerER-positive Breast CancerHER2-negative Breast Cancer+1 more

Loss of Exclusivity

LOE Date
Jan 5, 2038
144 months away
Patent Expiry
Jan 5, 2038
Exclusivity Expiry
Jan 27, 2028

Patent Records (5)

Patent #ExpiryTypeUse Code
7612114
Aug 18, 2026
SubstanceProduct
U-3523
10071066
Oct 10, 2034
U-3524
11779552
Oct 10, 2034
U-3524
10420734
Oct 3, 2036
U-3524
11819480
Feb 28, 2037
U-3523