Drug

Fluoroestradiol

As of the edition of 20 October 2026, Fluoroestradiol is a small molecule: marketed, first approved in 2016 (FR); acts on ESR1.

Sources: FDA Orange Book and Purple Book, other approval registers, ClinicalTrials.gov, ChEMBL.

The drug

Status
Marketed; latest approval 2020
Kind
Small molecule
Brand name
Cerianna
First approved
21 July 2016 (FR)
Approvals on record
2 in 2 regions
Holder of the most recent approval
GE Healthcare
Registered trials
20, 7 stopped early
Disease areas
Cancer; Skin and connective tissue; Pregnancy and women's health; Urinary and reproductive; Lungs and airways; Digestive system

US protection

No US approval on record.

With no US approval on record there are no listed US patents or exclusivities.

This is the US only.

Companies that need a new molecule because of this drug

1 company on route B because of this drug.

Companies on route B for this drug

In the product

1 company is on route B because of Fluoroestradiol.

Target

GeneProteinUniProt
ESR1Estrogen receptorP03372

Registered trials

PhaseTrialsCompletedActiveStopped early
Phase not stated6204
Phase 13111
Phase 29252
Phase 31100
Phase 41010
All trials20

Who has held its approvals

CompanyRoleYears
GE HealthcareAcquired holder and Lead sponsor of trials2022 to now