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 · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed female breast nipple and areola cancer 1 milestone | |||||
| Filed | US (FDA) | — | female breast nipple and areola cancer | 2022-06-22 | “has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for elacestrant” menarini.com ↗ |
| Filed progesterone-receptor positive breast cancer 1 milestone | |||||
| Filed | Other | ORSERDU | progesterone-receptor positive breast cancer | — | “已于2023年12月向中国澳门特别行政区药物监督管理局递交ORSERDU ® （艾拉司群 Elacestrant) 的进口药品预先许可申请，用于治疗晚期或转移性乳腺癌。” sciclone.com ↗ |
| Approved Indication not stated 2 milestones | |||||
| Approved | EU (EMA) | Orserdu | — | 2023-09-15 | europa.eu ↗ |
| Approved | US (FDA) | ORSERDU | — | 2023-01-27 | fda.gov ↗ |
Trials 37
| 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 → Dec 2029 expected | hormone receptor-positive breast cancer | 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 Stop: Business |
| 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 Stop: Business |
| 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 Stop: Enrollment |
| Phase 217 trials | ||||||
| Phase 2 | NCT07634601 | Dec 2026 → Dec 2028 expected | endometrial carcinoma | Jonsson Comprehensive Cancer Center | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07766018 | Aug 2026 → Oct 2028 expected | breast cancer | Stemline Therapeutics, Inc. | 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 · 1 met primary | ||||||
| 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 | Met primary |
| Comparator or background therapy2 trials | ||||||
| Phase 1/2 | NCT06590857 Background | Jul 2024 → Oct 2028 expected | hormone receptor-positive breast cancer, metastatic carcinoma in the bone | RayzeBio, Inc. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05573126 Background | Jan 2023 → Feb 2028 expected | hormone receptor-positive breast cancer | Ellipses Pharma | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 22
| Date | Issuer | Release |
|---|---|---|
| 2026-05-28 | Menarini Group | Results Menarini Group Presents New Data from the Phase 1b/2 ELEVATE Study of Elacestrant in Combination with Capivasertib in Patients with ER+, HER2- Metastatic Breast Cancer (mBC) at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting menarini.com ↗
ELEVATE results reported at ASCO 2026 (abstract 1098)¹ include safety and preliminary efficacy data from the phase 1b elacestrant (258-345 mg) plus capivasertib (320-400 mg) cohorts (n=31), which demonstrate preliminary median progression-free survival (mPFS) benefit in the recommended phase 2 dose (RP2D) cohort. |
| 2025-05-22 | Menarini Group | Results Menarini Group Presents Updated Data Underscoring the Combinability of Elacestrant (ORSERDU®) in Patients with ER+, HER2- Metastatic Breast Cancer (mBC) at the ASCO 2025 Annual Meeting menarini.com ↗
ELEVATE results reported at ASCO 2025 (abstract 1070/49) include updated efficacy data which demonstrate favorable preliminary progression-free survival (PFS) from the elacestrant plus ribociclib and the elacestrant plus everolimus cohorts. |
| 2024-11-26 | Menarini Group | Results Menarini Group Presents New and Expanded Data at the 2024 San Antonio Breast Cancer Symposium Reinforcing the Role of ORSERDU® (Elacestrant) for Patients with ER+, HER2- Advanced or Metastatic Breast Cancer (mBC) menarini.com ↗
Updated results of elacestrant in combination with abemaciclib show favorable efficacy regardless of the ESR1 mutation status, with a manageable and predictable safety profile in patients with ER+/HER2- mBC. |
| 2024-05-24 | Menarini Group | Results Menarini Group Presents Updated Data from ELECTRA and ELEVATE Combination Studies of Elacestrant (ORSERDU®) in Patients with ER+, HER2- Metastatic Breast Cancer (mBC) at the ASCO 2024 Annual Meeting menarini.com ↗
Updated results from the ELECTRA study, evaluating elacestrant in combination with abemaciclib regardless of metastatic site, show a safety profile consistent with previous results. |
| 2024-01-16 | SciClone Pharmaceuticals | Regulatory 赛生药业合作伙伴美纳里尼在中国澳门递交ORSERDU®（艾拉司群 Elacestrant）的进口药品预先许可申请 sciclone.com ↗ |
| 2023-12-11 | Menarini Group | Results Menarini Group Presented Initial Safety and Efficacy Data from Phase 1b/2 ELEVATE and ELECTRA Combination Studies of ORSERDU® (Elacestrant) in Patients with ER+, HER2- Metastatic Breast Cancer (mBC) at the 2023 San Antonio Breast Cancer Symposium menarini.com ↗
A preliminary analysis of data in the phase 1b part of the ELEVATE trial demonstrates antitumor activity of the combination evaluating ORSERDU with inhibitors of the PI3K/AKT/mTOR pathway and CDK 4/6 inhibitors. |
| 2023-12-08 | Menarini Group | Results Menarini Group Presents New Progression-Free Survival Data from EMERALD Clinical Study of ORSERDU® (Elacestrant) in Clinically Relevant Subgroups of Patients with ER+, HER2- Metastatic Breast Cancer (mBC) with ESR1 Mutations at SABCS 2023 menarini.com ↗
The data show favorable PFS for single-agent ORSERDU® (elacestrant) compared to standard-of-care (SOC) for patients with ER+, HER2- advanced or metastatic breast cancer (mBC) with tumors that are endocrine sensitive and which harbor ESR1 mutations, when prior treatment duration with CDK4/6 inhibitors was at least 12 months. |
| 2023-09-20 | Menarini Group | Regulatory European Commission Approves Menarini Group’s ORSERDU® (Elacestrant) for the Treatment of Patients with ER+, HER2- Locally Advanced or Metastatic Breast Cancer with an Activating ESR1 Mutation menarini.com ↗
The Menarini Group (“Menarini”), a leading international pharmaceutical and diagnostics company, and Stemline Therapeutics Inc. (“Stemline”), a wholly-owned subsidiary of the Menarini Group, announced today that the European Commission has approved ORSERDU® (elacestrant) as a monotherapy for the treatment of postmenopausal women, and men, with estrogen receptor (ER)‑positive, HER2-negative, locally advanced or metastatic breast cancer (mBC) with an activating ESR1 mutation who have disease progression following at least one line of endocrine therapy including a CDK 4/6 inhibitor. |
| 2023-07-21 | Menarini Group | Regulatory Menarini Group Receives Positive CHMP Opinion Recommending EC Approval of ORSERDU® (Elacestrant) for the Treatment of Patients with ER+, HER2- Locally Advanced or Metastatic Breast Cancer with an Activating ESR1 Mutation menarini.com ↗ |
| 2023-05-26 | Menarini Group | Results Menarini Group Shares New Analysis from EMERALD Clinical Study of ORSERDU® (Elacestrant) in Metastatic Breast Cancer at ASCO 2023 menarini.com ↗
Patients who progressed within six months of CDK4/6i therapy achieved a median PFS of 5.32 months with elacestrant vs. 1.87 months with SOC. |
| 2023-01-30 | Menarini Group | Regulatory Stemline Therapeutics, a subsidiary of Menarini Group, Receives U.S. FDA Approval for ORSERDU™ (elacestrant) as the First and Only Treatment Specifically Indicated for Patients with ESR1 Mutations in ER+, HER2- Advanced or Metastatic Breast Cancer menarini.com ↗
The Menarini Group (“Menarini”), a leading Italian pharmaceutical and diagnostics company, announced today that the U.S. Food and Drug Administration (FDA) has approved ORSERDU for the treatment of postmenopausal women or adult men, with ER+, HER2-, ESR1 -mutated advanced or metastatic breast cancer with disease progression following at least one line of endocrine therapy. |
| 2023-01-30 | Radius Health, Inc. | Regulatory Stemline Therapeutics Inc., a wholly owned subsidiary of Menarini Group, Receives Approval from U.S. FDA for ORSERDU™ (elacestrant) as the First and Only Treatment Specifically Indicated for Patients with ESR1 Mutations in ER+, HER2- Advanced or Metastatic Breast Cancer radiuspharm.com ↗
The FDA approval of ORSERDU marks the first ever therapy for ER+, HER2- advanced or metastatic breast cancer patients with ESR1 mutations and we are very proud to offer a targeted therapy addressing this huge unmet need, |
| 2023-01-30 | Berlin-Chemie Menarini | Regulatory Stemline Therapeutics, a subsidiary of Menarini Group, Receives U.S. FDA Approval for ORSERDUTM (elacestrant) as the First and Only Treatment Specifically Indicated for Patients with ESR1 Mutations in berlin-chemie.de ↗
“The FDA approval of ORSERDU marks the first ever therapy for ER+, HER2- advanced or metastatic breast cancer patients with ESR1 mutations and we are very proud to offer a targeted therapy addressing this huge unmet need,” |
| 2022-11-30 | Menarini Group | Results Menarini Group Presents Updated Results from Pivotal Phase 3 EMERALD Trial at the 2022 San Antonio Breast Cancer Symposium (SABCS) that Demonstrate Elacestrant’s PFS Increases with Duration of Prior CDK4/6i in ER+, HER2- in Metastatic Setting menarini.com ↗
A post-hoc analysis of the PFS results in the EMERALD trial based on the duration of prior CDK4/6i usage shows clinically meaningful results which favor monotherapy elacestrant, both in the total patient population as well as in patients with ESR1-mut. |
| 2022-08-19 | Menarini Group | Regulatory Menarini Group’s Elacestrant Marketing Authorization Application Accepted for Review by the European Medicines Agency (EMA) for the Treatment of ER+/HER2- Advanced or Metastatic Breast Cancer menarini.com ↗
The Menarini Group (“Menarini”), a privately held Italian pharmaceutical and diagnostics company, and Stemline Therapeutics (“Stemline”), a wholly-owned subsidiary of the Menarini Group, today announced that EMA has validated the Marketing Authorization Application (MAA) for elacestrant, a selective estrogen receptor degrader (SERD), for patients with ER+/HER2- advanced or metastatic breast cancer. |
| 2022-08-11 | Menarini Group | Regulatory Menarini Group’s Elacestrant Granted Priority Review by the U.S. FDA for Patients with ER+/HER2- Advanced or Metastatic Breast Cancer menarini.com ↗
The FDA has granted the application Priority Review and assigned a PDUFA date of February 17, 2023. |
| 2022-06-22 | Menarini Group | Regulatory Menarini Group and Radius Health Submit New Drug Application to the U.S. FDA for Elacestrant menarini.com ↗
The Menarini Group (“Menarini”) and Radius Health, Inc. (“Radius”) (NASDAQ: RDUS) (collectively, the “Companies”) announced that Menarini, with support from Radius, has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for elacestrant in patients with ER+/HER2- advanced or metastatic breast cancer. |
| 2022-06-06 | Menarini Group | Results Menarini Group and Radius Health, Inc. present a subgroup analysis from the elacestrant pivotal phase 3 EMERALD clinical trial at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting menarini.com ↗
In a non-pre-specified subgroup analysis of patients with ER+/HER2− metastatic breast cancer (mBC) without prior chemotherapy in the metastatic setting, elacestrant significantly prolonged progression-free survival (PFS) compared to standard of care (SOC) endocrine therapy. |
| 2022-05-20 | Menarini Group | Results Menarini Group and Radius Health, Inc. announce publication of elacestrant pivotal Phase 3 EMERALD clinical trial data in the Journal of Clinical Oncology menarini.com ↗
Data demonstrated elacestrant significantly reduced the risk of disease progression or death by 30% in all patients and by 45% in patients with ESR1 mutation |
| 2021-12-08 | Menarini Group | Results Positive EMERALD Trial Results for Elacestrant Presented at San Antonio Breast Cancer Symposium 2021 menarini.com ↗
Trial met both primary endpoints demonstrating statistically significant and clinically meaningful extension of progression free survival (PFS) as monotherapy vs. standard of care (SoC) endocrine therapy in overall population and estrogen receptor mutation (mESR1) population |
| 2021-10-20 | Menarini Group | Results Menarini Group and Radius Health Announce Positive Phase 3 Topline Results from the EMERALD Trial Evaluating Elacestrant in Breast Cancer menarini.com ↗
EMERALD met both primary endpoints, showing statistically significant PFS in the overall population and ESR1 mutation subgroup. |
| 2021-10-20 | Berlin-Chemie Menarini | Results Menarini Group and Radius Health Announce Positive Phase 3 Topline Results from the EMERALD Trial Evaluating Elacestrant in Breast Cancer berlin-chemie.de ↗
EMERALD met both primary endpoints, showing statistically significant PFS in the overall population and ESR1 mutation subgroup. |
All press releases naming this drug 35 releases
Evidence & citations 14 cited values
Every value below carries the sentence it was read from. 43 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Elacestrant | “Investigator's choice of endocrine therapy, such as, anastrozole, elacestrant, exemestane, fulvestrant, imlunestrant, letrozole, tamoxifen, or vepdegestrant” NCT06590857 ↗35“Participants will receive standard of care oral SERD therapy (Elacestrant) in Step 2 Arm 2 and Step 3.” NCT05826964 ↗ |
| 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 ↗ |