CDEK
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elacestrant

Trade name: Orserdu

Small moleculeapprovedFast Track FDA

Approved

Jan 27, 2023

Elacestrant, sold under the brand name Orserdu, is a selective estrogen receptor degrader (SERD) used in the treatment of breast cancer. It is taken by mouth. — Wikipedia

Clinical trial activity

31 trials · 31 clinical orgs · 2 marketing orgs

Phase 1
13
Phase 2
25
Phase 3
5
Phase 4
0

Earliest trial started Mar 1, 2009 (NCT00875420)

Timeline

2000s

  1. Jan 1, 2009

    Earliest Phase 2 Sponsor(trial)

2010s

  1. Jan 1, 2015

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2018

    Earliest Phase 3 Sponsor(trial)

2020s

  1. Jan 27, 2023

    Menarini Group — Earliest FDA Approval

  2. Jan 27, 2023

    Stemline Therapeutics, Inc. — Marketing Organization

  3. Jan 27, 2023

    Menarini Group — NDA Secondary Org

  4. Jan 27, 2023

    Menarini Group — NDA Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedPriority reviewFast trackJan 27, 2023

Chemistry & pharmacology

Loading structure…

SMILES

CCNCCc1ccc(CN(CC)c2cc(OC)ccc2[C@@H]2CCc3cc(O)ccc3C2)cc1
Mol. weight
458.65 g/mol
Lipinski Ro5
1 violation(s)
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Availability
Prescription Only

Oral

No

Parenteral

No

Topical

No

Sources

Also known as

  • rad1901
  • rad1901
  • rad-1901
  • rad-1901

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07198724Phase 1/Phase 2 (Phase 2)Mar 31, 2026Harvard University, Pipeline Therapeutics, Inc.
NCT07242352Phase 3Jan 31, 2026Ev. Hospital Bethesda, Moenchengladbach, Kliniken Essen-Mitte, Germany, Ludwig Maximilians University, Menarini Group, Ruhr University Bochum, West German Study Group
NCT07222215Phase 2Dec 31, 2025Harvard University, Johns Hopkins University, Menarini Group, Pipeline Therapeutics, Inc., Translational Breast Cancer Research Consortium
NCT07209449Phase 2Oct 1, 2025Memorial Sloan-Kettering Cancer Center
NCT06923527Phase 2Sep 30, 2025Johns Hopkins University, Pipeline Therapeutics, Inc., Yale University
NCT07159451Phase 2Sep 23, 2025Institut Gustave Roussy, Menarini Group
NCT07005882Phase 2Sep 1, 2025University of Florence
NCT06201234Phase 2Nov 30, 2024German Breast Group Forschungs GmbH, Pipeline Therapeutics, Inc.
NCT06691035Phase 1Nov 4, 2024University of South Florida, V Foundation
NCT06638307Phase 1Oct 31, 2024Pipeline Therapeutics, Inc.
NCT06492616Phase 3Sep 27, 2024Pipeline Therapeutics, Inc.
NCT06382948Phase 3Sep 1, 2024MedSIR, Pipeline Therapeutics, Inc., University of Barcelona
NCT06126575Phase 1Jan 24, 2024Pipeline Therapeutics, Inc.
NCT06075953Phase 2Nov 30, 2023QuantumLeap Healthcare Collaborative
NCT05963997Phase 1/Phase 2 (Phase 2)Oct 9, 2023Carrick Therapeutics Limited, Menarini Group
NCT06062498Phase 2Sep 30, 2023National Cancer Institute (NCI), Northwestern University
NCT05982093Phase 2Aug 31, 2023SOLTI Breast Cancer Research Group
NCT06938711Phase 1/Phase 2 (Phase 2)Jun 30, 2023Context Therapeutics
NCT05826964Phase 2Jun 12, 2023University of Miami
NCT05512364Phase 3May 1, 2023European Organisation for Research and Treatment of Cancer, Menarini Group, University of Milan
Showing 20 of 31 trials
Page 1 / 2

Organizations

Research & Development (31)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Pipeline Therapeutics, Inc.For profit11632022
Radius HealthFor profit6532009
Menarini GroupFor profit5022023
Context TherapeuticsFor profit2212022
Harvard UniversityAcademic/Hospital2212025
Johns Hopkins UniversityAcademic/Hospital2012025
SOLTI Breast Cancer Research GroupAcademic/Hospital2222021
Carrick Therapeutics LimitedFor profit1112023
Criterium, Inc.For profit1112021
European Organisation for Research and Treatment of CancerAcademic/Hospital1112023
Ev. Hospital Bethesda, MoenchengladbachAcademic/Hospital1012026
German Breast Group Forschungs GmbHFor profit1112024
Institut Gustave RoussyAcademic/Hospital1112025
Kliniken Essen-Mitte, GermanyAcademic/Hospital1012026
Ludwig Maximilians UniversityAcademic/Hospital1012026
MedSIRAcademic/Hospital1112024
Memorial Sloan-Kettering Cancer CenterAcademic/Hospital1112025
National Cancer Institute (NCI)Government1012023
Northwestern UniversityAcademic/Hospital1112023
QuantumLeap Healthcare CollaborativeAcademic/Hospital1112023
31 organizations
Page 1 / 2

Marketing (4)

OrganizationOrg typeRelationshipDate
Menarini GroupFor profitNDA2Jan 27, 2023
Menarini GroupFor profitNDAJan 27, 2023
Stemline Therapeutics, Inc.For profitMKTGJan 27, 2023
Stemline Therapeutics, Inc.For profitSYNJan 27, 2023