Drug

Fulvestrant

Approved · EMA

ClassEstrogen receptor alpha antagonistEmerging researchLate-stage developmentSteady momentum

Also known as Faslodex.

RxNorm282357 ChEMBLCHEMBL1358 ATCL02BA03UNII22X328QOC4

Research papers

Active clinical trials

Estrogen receptor

Primary target

Regulatory events

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Dose-confirming Study of CFI-402257 as a Single Agent in Advanced Solid Tumors and in Combination With Fulvestrant in Patients With ER+/HER2- Advanced Breast Cancer After Disease Progression on Prior CDK4/6 and Endocrine Therapy

Clinical trial2026-08-01Primary completion · ClinicalTrials.gov

A Phase 2, Randomized, Open-Label Dose Optimization and Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of LY4064809 Combined With a CDK4/6 Inhibitor and Endocrine Therapy in Adults With HR+, HER2-Advanced Breast Cancer With a PIK3CA Mutation Who Received No Prior Treatment for Advanced Breast Cancer (PIKALO-2)

Clinical trial2026-07-30Results expected Q2 2029 · ClinicalTrials.gov

Reversing InGuinal Hernia Trial (RIGHT Trial): The Evaluation of Sex Hormones to Reverse Inguinal Hernias in Males

Clinical trial2026-07-28Results expected Q2 2028 · ClinicalTrials.gov

A Phase 1b/2 Trial Investigating the Safety and Efficacy of Oral AMXT 1501 and Oral DFMO in Combination With Standard of Care in Patients With Advanced Solid Tumors Who Progressed After Prior Therapies

Clinical trial2026-07-15Results expected Q1 2028 · ClinicalTrials.gov

A Phase 1 First-in-human Study of BMS-986500 as Monotherapy in Advanced Solid Tumors and as Combination Therapy in CDK4/6 Inhibitor Pre-treated Advanced Breast Cancer

Clinical trial2026-07-10Results expected Q4 2028 · ClinicalTrials.gov

A Phase 1a/1b, Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Preliminary Antitumor Activity of BG-75098 Alone and in Combination With Other Agents in Patients With Advanced Solid Tumors

Clinical trial2026-07-10Results expected Q4 2028 · ClinicalTrials.gov

Inhibition of lysine acetyltransferase KAT6 in ER+HER2- metastatic breast cancer: a phase 1 trial.

Research2024-06-01Nature medicine

Endocrine and Targeted Therapy for Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Metastatic Breast Cancer-Capivasertib-Fulvestrant: ASCO Rapid Recommendation Update.

Research2024-03-13Journal of clinical oncology : official journal of the American Society of Clinical Oncology

Lasofoxifene versus fulvestrant for ER+/HER2- metastatic breast cancer with an ESR1 mutation: results from the randomized, phase II ELAINE 1 trial.

Research2023-12-01Annals of oncology : official journal of the European Society for Medical Oncology

Capivasertib in Hormone Receptor-Positive Advanced Breast Cancer.

Research2023-06-01The New England journal of medicine

Approval: Fulvestrant Mylan (EMA)

Regulatory2018-01-08EMA

Approval: Faslodex (EMA)

Regulatory2004-03-09EMA

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Fulvestrant

Aliases & brands

Faslodex

RxNorm CUI

282357

ChEMBL ID

CHEMBL1358

ATC codes

L02BA03

UNII

22X328QOC4

Primary mechanism

Estrogen receptor alpha antagonist

Regulatory jurisdictions

ema

Pharmacology & targets

1 target

Known molecular targets and mechanisms supported by curated pharmacology databases.

Estrogen receptor

ESR1 · P03372

ANTAGONISTEstrogen receptor alpha antagonist

Regulatory timeline

2 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval

2004-03-09

Latest approval

2018-01-08

Authorities

EMA

Total events

emaEuropean Medicines Agency· 2 events

2018-01-08Approval

Approval: Fulvestrant Mylan (EMA)

Indication: Fulvestrant is indicated for the treatment of estrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women: not previously treated with… Show full indication

Fulvestrant is indicated for the treatment of estrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women: not previously treated with endocrine therapy, or with disease relapse on or after adjuvant anti-estrogen therapy, or disease progression on antiestrogen therapy.

Evidence ↗

2004-03-09Approval

Approval: Faslodex (EMA)

Indication: Faslodex is indicated as monotherapy for the treatment of estrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women: not previously… Show full indication

Faslodex is indicated as monotherapy for the treatment of estrogen receptor positive, locally advanced or metastatic breast cancer in postmenopausal women: not previously treated with endocrine therapy, or with disease relapse on or after adjuvant antiestrogen therapy, or disease progression on antiestrogen therapy. in combination with palbociclib for the treatment of hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative locally advanced or metastatic breast cancer in women who have received prior endocrine therapy. In pre- or perimenopausal women, the combination treatment with palbociclib should be combined with a luteinizing hormone releasing hormone (LHRH) agonist.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

197 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme

CLINICALTRIALS.GOV · LIVE REGISTRY

197

registered trials across all phases

LATEST COMPLETION 2026

Active studies

Recruiting

Late-stage (III+)

Completed

Discontinued

PHASE DISTRIBUTIONn = 197

Phase 147Phase 1 / 227Phase 283Phase 2 / 31Phase 334Phase 44Phase N / A1

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

A Post-trial Access Roll-over Study to Allow Access to Ribociclib (LEE011) for Patients Who Are on Ribociclib Treatment in Novartis-sponsored Study

Active, not recruitingPH IVNovartis Pharmaceuticalsn=1342030

ALPelisib INdia Safety STudy (ALPINIST): A Phase IV, Prospective, Multicenter, Open-label, Non-comparative, Interventional Study to Assess the Safety of Alpelisib Plus Fulvestrant, in Men and Post-menopausal Women With HR Positive, HER2-negative, Advanced Breast Cancer (aBC) With a PIK3CA Mutation, Whose Disease Has Progressed on or After Endocrine Based Treatment.

CompletedPH IVNovartis Pharmaceuticalsn=402025

PRECYCLE: Multicenter, Randomized Phase IV Intergroup Trial to Evaluate the Impact of eHealth-based Patient Reported Outcome (PRO) Assessment on Quality of Life in Patients With Hormone Receptor Positive, HER2 Negative Locally Advanced or Metastatic Breast Cancer Treated With Palbociclib and an Aromatase Inhibitor- or Palbociclib and Fulvestrant

TerminatedPH IVPalleos Healthcare GmbHn=5322021

A Multicenter, Open-Label, Randomized-Controlled Study of Abemaciclib, a CDK4 and 6 Inhibitor, in Combination With Fulvestrant Compared to Chemotherapy in Women With HR Positive, HER2 Negative Metastatic Breast Cancer With Visceral Metastases

TerminatedPH IVEli Lilly and Companyn=42020

RecruitingPH IIIEli Lilly and Companyn=8002033

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Randomised, Double-blind, Parallel-group, Multicentre, Phase III Study to Compare the Efficacy and Tolerability of Fulvestrant (FASLODEX) 500 mg With Anastrozole (ARIMIDEX) 1 mg as Hormonal Treatment for Postmenopausal Women With Hormone Receptor-Positive Locally Advanced or Metastatic Breast Cancer Who Have Not Previously Been Treated With Any Hormonal Therapy.

CompletedPH IIIAstraZenecan=4622026

A Phase I, Open-label, Multicentre, Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of AZD2014 Administered Orally in Combination With Intramuscular (IM) Fulvestrant to Patients With Estrogen Receptor Positive (ER+) Advanced, Metastatic Breast Cancer

CompletedPH IAstraZenecan=992026

Phase 2a Study of ZW25 in Combination With Palbociclib Plus Fulvestrant

CompletedPH IIJazz Pharmaceuticalsn=512025

CompletedPH IVNovartis Pharmaceuticalsn=402025

An Open Label, Dose Escalation, Safety, and Pharmacokinetic Study of CFI-402257 Administered Orally to Patients With Advanced Solid Tumors

CompletedPH IUniversity Health Network, Toronton=522025

A Phase I Trial of Palbociclib and Bosutinib With Fulvestrant in Patients With Metastatic Hormone Receptor Positive and HER2 Negative (HR+ HER2-) Breast Cancer Refractory to an Aromatase Inhibitor and a CDK4/6 Inhibitor (ASPIRE - WI231696)

CompletedPH IGeorgetown Universityn=192025

Research activity

12 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time

20092024

Most influential

Alpelisib for PIK3CA-Mutated, Hormone Receptor-Positive Advanced Breast Cancer.

The New England journal of medicine · 2019 · 1,948 cites

Overall Survival with Palbociclib and Fulvestrant in Advanced Breast Cancer.

The New England journal of medicine · 2018 · 885 cites

The Effect of Abemaciclib Plus Fulvestrant on Overall Survival in Hormone Receptor-Positive, ERBB2-Negative Breast Cancer That Progressed on Endocrine Therapy-MONARCH 2: A Randomized Clinical Trial.

JAMA oncology · 2020 · 754 cites

Overall Survival with Ribociclib plus Fulvestrant in Advanced Breast Cancer.

The New England journal of medicine · 2020 · 597 cites

Capivasertib in Hormone Receptor-Positive Advanced Breast Cancer.

The New England journal of medicine · 2023 · 539 cites

Alpelisib plus fulvestrant for PIK3CA-mutated, hormone receptor-positive, human epidermal growth factor receptor-2-negative advanced breast cancer: final overall survival results from SOLAR-1.

Annals of oncology : official journal of the European Society for Medical Oncology · 2021 · 447 cites

Related diseases

1 conditions

Regulator-approved indications and conditions co-mentioned with this drug across the research literature. Number shows shared papers.

Active research areas

Breast Neoplasms10

Related drugs

8 matches

Drugs sharing diseases, protein targets and literature with this one. Ranked by graph evidence (shared targets + diseases weighted above co-mentions).

Estradiol

Acts on the same molecular target as Fulvestrant, with 2 overlapping disease areas.

Shared target2 shared diseases1 shared paper

Lasofoxifene

Acts on the same molecular target as Fulvestrant, with 2 overlapping disease areas.

Shared target2 shared diseases1 shared paper

Capivasertib

Studied across 4 of the same disease areas as Fulvestrant in the shared literature.

4 shared diseases3 shared papers

Alpelisib

Studied across 2 of the same disease areas as Fulvestrant in the shared literature.

2 shared diseases2 shared papers

Abemaciclib

Studied across 3 of the same disease areas as Fulvestrant in the shared literature.

3 shared diseases1 shared paper

Neratinib

Studied across the same disease area as Fulvestrant in the shared literature.

1 shared disease1 shared paper

Palbociclib

Studied across the same disease area as Fulvestrant in the shared literature.

1 shared disease1 shared paper

Ribociclib

Studied across the same disease area as Fulvestrant in the shared literature.

1 shared disease1 shared paper

References & data sources

RxNorm (U.S. National Library of Medicine) — drug identity
ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
Europe PMC — research literature
ClinicalTrials.gov — clinical trials
Regulatory event sources are credited in the Regulatory Timeline above.