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Orserdu (ELACESTRANT)
Orserdu works by blocking the estrogen receptor, a protein that helps cancer cells grow.
Orserdu (ELACESTRANT) is a small molecule estrogen receptor antagonist developed by STEMLINE THERAPEUTICS INC and currently owned by Stemline Therap. It targets the estrogen receptor and is approved for the treatment of ESR1-mutated advanced or metastatic breast cancer, estrogen receptor-positive advanced or metastatic breast cancer, and HER2-negative advanced or metastatic breast cancer. Orserdu was FDA-approved in 2023 and has a half-life of 30 to 50 hours. The commercial status of Orserdu is patented, with no generic manufacturers available. Key safety considerations include its mechanism of action as an estrogen receptor antagonist.
At a glance
| Generic name | ELACESTRANT |
|---|---|
| Sponsor | Stemline Therap |
| Drug class | Estrogen Receptor Antagonist [EPC] |
| Target | Estrogen receptor |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2023 |
Mechanism of action
Elacestrant is an estrogen receptor antagonist that binds to estrogen receptor-alpha (ER). In ER-positive (ER+) HER2-negative (HER2-) breast cancer cells, elacestrant inhibited 17-estradiol mediated cell proliferation at concentrations inducing degradation of ER protein mediated through proteasomal pathway. Elacestrant demonstrated in vitro and in vivo antitumor activity including in ER+ HER2- breast cancer models resistant to fulvestrant and cyclin-dependent kinase 4/6 inhibitors and those harboring estrogen receptor gene (ESR1) mutations.
Approved indications
- ESR1-mutated advanced or metastatic breast cancer
- Estrogen receptor positive advanced or metastatic breast cancer
- HER2-negative advanced or metastatic breast cancer
Common side effects
- Musculoskeletal pain
- Nausea
- Increased cholesterol
- Increased AST
- Increased triglycerides
- Fatigue
- Decreased hemoglobin
- Vomiting
- Increased ALT
- Decreased sodium
- Increased creatinine
- Decreased appetite
Key clinical trials
- A Study of Elacestrant Versus Standard Endocrine Therapy in Women and Men With ER+,HER2-, Early Breast Cancer With High Risk of Recurrence (PHASE3)
- Circulating Tumor DNA (PHASE2)
- A Study of Samuraciclib and Elacestrant in Participants With Metastatic or Locally Advanced HR+/HER2-negative Breast Cancer (PHASE1,PHASE2)
- Phase 1/2 Study to Evaluate EP0062 as Monotherapy and in Combination in Patients With Advanced or Metastatic AR+/HER-2-/ER+ Breast Cancer (PHASE1,PHASE2)
- A Study of Elacestrant Alone or in Combination With Abemaciclib in People With Endometrial Cancer (PHASE2)
- BGB-43395 Alone or as Part of Combination Therapies in Participants With Breast Cancer and Other Advanced Solid Tumors (PHASE1)
- DCIS: RECAST Trial Ductal Carcinoma In Situ: Re-Evaluating Conditions for Active Surveillance Suitability as Treatment (PHASE2)
- Elacestrant + Everolimus in Patients ER+/HER2-, ESR1mut, Advanced Breast Cancer Progressing to ET and CDK4/6i. (PHASE3)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Orserdu CI brief — competitive landscape report
- Orserdu updates RSS · CI watch RSS
- Stemline Therap portfolio CI