Explore

Companies

Drugs

About·Data Management·Terms·Privacy

Stay informed

© 2026 VivoSeq. All rights reserved.

Orserdu

(Elacestrant Dihydrochloride)

Small molecule

SStemline Therapeutics, Inc.

0

Indications

2

Total Trials

0

Active Trials

0

Competitors

1

FDA Application

NDA/BLA/ANDA regulatory filings

Clinical

Trials by Indication[1]

Hepatic Function1 trial

A PK Study Testing Single Oral Dose of Elacestrant in Subjects With Normal or Severely Impaired Hepatic Function

Completed·SStemline Therapeutics, Inc.·Phase 1·NCT06126575·16 enrolled

Breast Cancer1 trial

A Study of Samuraciclib and Elacestrant in Participants With Metastatic or Locally Advanced HR+/HER2-negative Breast Cancer

Completed·CCarrick Therapeutics Limited·Phase 1/2·NCT05963997·49 enrolled

Regulatory

FDA Approval Timeline[3]

Jan 27, 2023

ORSERDU

NDA NDA217639

Sources

References

[1]
ClinicalTrials.gov — 2 trial records for Elacestrant Dihydrochloride. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Elacestrant Dihydrochloride compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
OpenFDA — FDA approval records (NDA NDA217639). U.S. Food & Drug Administration.
[4]
SEC EDGAR — Stemline Therapeutics, Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Small molecule[2]
Company: SStemline Therapeutics, Inc.

Related News