Drugs / Elacestrant
Elacestrant
also known as
RAD1901 · Elacestrant Dihydrochloride · ELACESTRANT HYDROCHLORIDE · ER-306323 · Orserdu · RAD-1901 DIHYDROCHLORIDE · RAD1901 hydrochloride · SERD/SERM RAD1901
Other / unclassified targets ESR1 via depletion
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Orserdu | — | 2023-09-15 | europa.eu ↗ |
| Approved | US (FDA) | ORSERDU | — | 2023-01-27 | fda.gov ↗ |
Trials 36 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 01 trial | ||||||
| Phase 0 | NCT04797728 | Feb 2021 → Feb 2022 | hormone receptor-positive breast cancer | SOLTI Breast Cancer Research Group | Completed | No outcome recorded |
| Phase 16 trials | ||||||
| Phase 1 | NCT06691035 | Nov 2024 → Nov 2026 expected | Her2-receptor negative breast cancer | H. Lee Moffitt Cancer Center and Research Institute | Recruiting | No outcome recorded |
| Phase 1 | NCT06638307 | Oct 2024 → Oct 2027 expected | female breast carcinoma | Stemline Therapeutics, Inc. | Recruiting | No outcome recorded |
| Phase 1 | NCT06120283 | Dec 2023 → Nov 2028 expected | hormone receptor-positive breast cancer, non-small cell lung carcinoma | BeOne Medicines | Recruiting | No outcome recorded |
| Phase 1 | NCT06126575 | Mar 2023 → Nov 2024 | — | Stemline Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02650817 | Apr 2016 → Aug 2018 | breast cancer | Stemline Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 1 | NCT02338349 | Jan 2015 → Sep 2019 | estrogen-receptor positive breast cancer | Stemline Therapeutics, Inc. | Completed | No outcome recorded |
| Phase 1/28 trials | ||||||
| Phase 1/2 | NCT07612215 | May 2026 → May 2029 expected | triple-positive breast carcinoma | NYU Langone Health | Recruiting | No outcome recorded |
| Phase 1/2 | NCT07198724 | Nov 2025 → Jun 2028 expected | Her2-receptor negative breast cancer, female breast carcinoma | Kristina A. Fanucci | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05963997 | Oct 2023 → Mar 2026 | breast cancer | Carrick Therapeutics Limited | Completed | No outcome recorded |
| Phase 1/2 | NCT06938711 | Jun → Nov 2023 | breast cancer | Context Therapeutics Inc. | Withdrawn | No outcome recorded |
| Phase 1/2 | NCT05563220 | Jan 2023 → Dec 2026 expected | breast cancer | Stemline Therapeutics, Inc. | Active not recruiting | No outcome recorded |
| Phase 1/2 | NCT05618613 | Dec 2022 → Jun 2023 | breast cancer | Context Therapeutics Inc. | Terminated | No outcome recorded |
| Phase 1/2 | NCT05386108 | Aug 2022 → Dec 2026 expected | brain neoplasm, breast neoplasm | Stemline Therapeutics, Inc. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT04791384 | Apr 2022 → Sep 2024 | breast cancer | Criterium, Inc. | Terminated | No outcome recorded |
| Phase 216 trials | ||||||
| Phase 2 | NCT07634601 | Dec 2026 → Dec 2028 expected | endometrial carcinoma | Jonsson Comprehensive Cancer Center | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07395336 | May 2026 → Dec 2028 expected | breast cancer | European Institute of Oncology | Recruiting | No outcome recorded |
| Phase 2 | NCT07467772 | Mar 2026 → Jul 2027 expected | adenosarcoma, leiomyosarcoma, neoplasm with perivascular epithelioid cell differentiation, stromal sarcoma | Dana-Farber Cancer Institute | Recruiting | No outcome recorded |
| Phase 2 | NCT07222215 | Jan 2026 → Dec 2029 expected | hormone receptor-positive breast cancer | Kristina A. Fanucci | Recruiting | No outcome recorded |
| Phase 2 | NCT07159451 | Oct 2025 → Jan 2027 expected | breast cancer | Gustave Roussy, Cancer Campus, Grand Paris | Recruiting | No outcome recorded |
| Phase 2 | NCT07209449 | Oct 2025 → Oct 2028 expected | endometrial cancer | Memorial Sloan Kettering Cancer Center | Recruiting | No outcome recorded |
| Phase 2 | NCT06923527 | Sep 2025 → Sep 2027 expected | estrogen-receptor positive breast cancer | Yale University | Recruiting | No outcome recorded |
| Phase 2 | NCT07005882 | Sep 2025 → Mar 2027 expected | female breast carcinoma, hormone receptor-positive breast cancer | Careggi University Hospital | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT06201234 | Dec 2024 → Dec 2028 expected | BRCA1-related cancer predisposition, BRCA2-related cancer predisposition, hormone receptor-positive breast cancer | GBG Forschungs GmbH | Recruiting | No outcome recorded |
| Phase 2 | NCT06075953 | Feb 2024 → Nov 2028 expected | ductal breast carcinoma in situ | QuantumLeap Healthcare Collaborative | Recruiting | No outcome recorded |
| Phase 2 | NCT06062498 | Sep 2023 → Jul 2028 expected | Her2-receptor negative breast cancer, estrogen-receptor positive breast cancer | Northwestern University | Recruiting | No outcome recorded |
| Phase 2 | NCT05826964 | Jun 2023 → Jul 2026 overdue | Her2-receptor negative breast cancer, estrogen-receptor positive breast cancer | University of Miami | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05596409 | May 2023 → Nov 2026 expected | breast cancer | Stemline Therapeutics, Inc. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT05982093 | Feb 2023 → Dec 2026 expected | hormone receptor-positive breast cancer | SOLTI Breast Cancer Research Group | Recruiting | No outcome recorded |
| Phase 2 | NCT02653417 | Dec 2015 → Dec 2016 | — | Radius Pharmaceuticals, Inc. | Terminated | No outcome recorded |
| Phase 2 | NCT00875420 | Mar 2009 → Jan 2010 | — | Radius Pharmaceuticals, Inc. | Completed | No outcome recorded |
| Phase 35 trials | ||||||
| Phase 3 | NCT07242352 | Apr 2026 → Sep 2033 expected | Her2-receptor negative breast cancer | West German Study Group | Recruiting | No outcome recorded |
| Phase 3 | NCT06382948 | Dec 2024 → Sep 2027 expected | Her2-receptor negative breast cancer, estrogen-receptor positive breast cancer | MedSIR | Recruiting | No outcome recorded |
| Phase 3 | NCT06492616 | Sep 2024 → Aug 2029 expected | breast cancer | Stemline Therapeutics, Inc. | Recruiting | No outcome recorded |
| Phase 3 | NCT05512364 | Dec 2023 → Nov 2032 expected | Her2-receptor negative breast cancer, estrogen-receptor positive breast cancer | European Organisation for Research and Treatment of Cancer - EORTC | Recruiting | No outcome recorded |
| Phase 3 | NCT03778931 | May 2019 → Aug 2021 | breast cancer | Stemline Therapeutics, Inc. | Completed | No outcome recorded |
Also used as a comparator or background therapy in 1 trial
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/2 | NCT05573126 Background | Jan 2023 → Feb 2028 expected | hormone receptor-positive breast cancer | Ellipses Pharma | Recruiting | No outcome recorded |
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 41 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Elacestrant | “Participants will receive standard of care oral SERD therapy (Elacestrant) in Step 2 Arm 2 and Step 3.” NCT05826964 ↗33 |
| Known as | Elacestrant Dihydrochloride | “Starting dose 400 mg elacestrant dihydrochloride administered orally once daily for an estimated 6 months of treatment.” NCT05596409 ↗1“Drug: Elacestrant Dihydrochloride” NCT05963997 ↗ |
| Known as | ELACESTRANT HYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297509 ↗ |
| Known as | ER-306323 | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297509 ↗ |
| Known as | Orserdu | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297509 ↗ |
| Known as | RAD-1901 DIHYDROCHLORIDE | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297509 ↗ |
| Known as | RAD1901 | “RAD1901” NCT07634601 ↗ |
| Known as | RAD1901 hydrochloride | ChEMBL registry synonym — accepted as the source's own label CHEMBL4297509 ↗ |
| Known as | SERD/SERM RAD1901 | “SERD/SERM RAD1901” NCT07634601 ↗ |
| Action | Deplete | “Estrogen receptor alpha degrader” CHEMBL4297509 ↗ |
| Action | Inhibit | “a Novel Selective Estrogen Receptor Degrader” PMID 33513026 ↗ Jan 2021 |
| Modality | Other / unclassified | “Elacestrant is a novel, nonsteroidal, orally bioavailable selective estrogen receptor degrader (SERD)” PMID 31426673 ↗ Aug 2019 |
| Route | Oral | “OBJECTIVE: The aim of the study was to assess the efficacy and safety of RAD1901, an oral estrogen receptor ligand, for the treatment of moderate-to-severe vasomotor symptoms...” PMID 27575546 ↗ Jan 2017 |
| Target | ESR1 | “Estrogen receptor alpha degrader” CHEMBL4297509 ↗ |