Is Elacestrant registered with the SFDA?

The SFDA human drug list (edition 4-2026, as published by the Council of Health Insurance) lists 2 valid registrations of Elacestrant, including ORSERDU (345 mg, Film-coated tablet, SAR 44126.90); ORSERDU (86 mg, Film-coated tablet, SAR 10999.75).

Is Elacestrant approved by the US FDA?

Drugs@FDA lists 1 application product line for Elacestrant, including ORSERDU (Prescription).

Is Elacestrant authorised in the European Union?

EMA lists 1 centrally authorised medicine containing Elacestrant: Orserdu.

Active substance

Elacestrant

SFDA 2
US FDA 1
EMA 1

Open in the medicines table

SFDA Saudi Arabia — SFDA human drug list

Trade name	Strength	Form · route	Pack	Public price	Type	Company	Status
ORSERDU	345 mg	Film-coated tablet · Oral use	30 Bottle	SAR 44126.90	NCE · Prescription	Stemline Therapeutics, Inc	Valid
ORSERDU	86 mg	Film-coated tablet · Oral use	30 Bottle	SAR 10999.75	NCE · Prescription	Stemline Therapeutics, Inc	Valid

Indications — CHI Daman Drug Formulary

BREAST CANCER MET.HORMONAL

US FDA United States — FDA approvals (Drugs@FDA)

Product	Strength	Form · route	Applicant	Status	First approved
ORSERDU	EQ 86MG BASE; EQ 345MG BASE	tablet · oral	STEMLINE THERAP	Prescription	27 Jan 2023

EMA European Union — centrally authorised medicines

Orserdu Stemline Therapeutics B.V. · Authorised · authorised 15 Sep 2023 · ATC L02BA

Therapeutic indication (EMA)

Orserdu monotherapy is indicated for the treatment of postmenopausal women, and men, with estrogen receptor (ER) positive, HER2-negative, locally advanced or metastatic breast cancer with an activating ESR1 mutation who have disease progression following at least one line of endocrine therapy including a CDK 4/6 inhibitor.

Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.