Data updated: May 26, 2026
FULVESTRANT
Estrogen Receptor Antagonists
Oncology
Approved 2019-03-04
Fulvestrant helps postmenopausal women with hormone receptor-positive advanced breast cancer, including those who have not yet received endocrine therapy or those whose disease has progressed after such treatments. It is also used for patients with advanced or metastatic breast cancer that is HER2-negative, often in combination with other therapies like ribociclib, palbociclib, or abemaciclib. This medication provides a treatment option for both initial therapy and cases where previous hormonal treatments have stopped working.
How FULVESTRANT Works
This drug works by binding to estrogen receptors in breast cancer cells, competing with natural estradiol to block the signals that stimulate tumor growth. Once bound, it downregulates the estrogen receptor protein, effectively inhibiting the growth of both estrogen-sensitive and tamoxifen-resistant cancer cells. Because it lacks agonist effects, it targets the cancer cells without triggering peripheral steroidal responses in the body.
16
Indications
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Phase 3 Trials
7
Years on Market
Details
- Status
- Prescription
- First Approved
- 2019-03-04
- Patent Cliff
- 2034
- Routes
- INTRAMUSCULAR
- Dosage Forms
- SOLUTION
Companies
SAGENT PHARMS INC Dr. Reddy's AMNEAL JIANGSU HANSOH PHARM GLENMARK PHARMS XIROMED EUGIA PHARMA HBT LABS INC Apotex Fresenius Kabi ZYDUS PHARMS CHIA TAI TIANQING ACCORD HLTHCARE ALEMBIC Novartis
Active Ingredient: FULVESTRANT
Website: ↗
FULVESTRANT Approval History
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
41 FDA actions from 2019 to 2025 · 1 indication expansions
Sep 2025 SUPPL
Label · Labeling
Dec 2024 SUPPL
Label · Labeling
Mar 2024 SUPPL
Label · Labeling
Oct 2023 SUPPL
Label
Jun 2023 ORIGINAL
Update
May 2023 SUPPL
Label
Dec 2022 ORIGINAL
Update
Feb 2022 ORIGINAL
Update
Aug 2021 ORIGINAL
Update
Jul 2021 ORIGINAL
Update
Jun 2021 ORIGINAL
Update
May 2021 SUPPL
Label
Mar 2021 SUPPL
Label
Nov 2020 ORIGINAL
Update
Aug 2020 ORIGINAL
Update
Feb 2020 ORIGINAL
Update
Nov 2019 ORIGINAL
Update
Aug 2019 ORIGINAL
Update
Jul 2019 ORIGINAL
Update
May 2019 ORIGINAL
Update
What FULVESTRANT Treats
1 indicationsFULVESTRANT is approved for 1 conditions since its original approval in 2019. These indications span multiple therapeutic areas including oncology, immunology, and more.
- Breast Cancer
Source: FDA Label
FULVESTRANT Competitive Set
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Direct competitors
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Same target(s) AND same indication — head-to-head.
MoA expansion candidates
8
Same target(s), different indications — where else is this mechanism being explored?
Indication competitors
10
Same indication, different mechanism — what else might this patient receive?
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What's emerging in FULVESTRANT's indications
See all emerging drugs →Phase 3 candidates targeting molecules with no FDA-approved drug, in indications FULVESTRANT treats. First-in-class if their pivotal trials read out positive.
Drugs Similar to FULVESTRANT
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
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Clinical Trial Registry
266 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT06110793 | 23-274 | Ph 1, Ph 2 | recruiting | A Study of Lenvatinib, Pembrolizumab, and Fulvestrant in People With Breast Cancer |
| NCT06979596 | 5684-015 2024-519563-18-00, U1111-1315-5430 | Ph 2 | recruiting | A Study of MK-5684 in People With Certain Solid Tumors (MK-5684-015/OMAHA-015) |
| NCT05564377 | NCI-2022-06842 NCI-2022-06842, EAY191 | Ph 2 | recruiting | Targeted Therapy Directed by Genetic Testing in Treating Patients With Locally Advanced or Advanced Solid Tumors, The ComboMATCH Screening Trial |
| NCT07287917 | AMXT1501-103 | Ph 1, Ph 2 | recruiting | Study of AMXT 1501 and DFMO in Combination With Standard Therapies in Advanced Solid Tumors |
| NCT07288359 | CGVV858A12101 2025-521911-38 | Ph 1, Ph 2 | recruiting | Study of GVV858 as a Single Agent or in Combination With Endocrine Therapy in Patients With HR+/HER2- Breast Cancer and Other Advanced Solid Tumors |
| NCT07368998 optINAVO | WO46063 2025-522805-39-00 | Ph 2 | recruiting | To Study the Effect of Inavolisib in Combination With Fulvestrant in Participants With Breast Cancer |
| NCT07226349 | BG-75098-101 2025-523165-19-00 | Ph 1 | recruiting | A Study of BG-75098 Alone and in Combination With Other Agents in Adults With Advanced Solid Tumors |
| NCT05319873 | 21-001819 NCI-2021-11707 | Ph 1, Ph 2 | active not recruiting | Ribociclib, Tucatinib, and Trastuzumab for the Treatment of HER2 Positive Breast Cancer |
| NCT06257264 | BG-68501-101 CTR20243059, 2024-517324-19-00 | Ph 1 | recruiting | A Study to Examine the Safety of Different Doses of BG-68501 Given to Participants With Advanced-Stage Tumors |
| NCT07318805 | C6321001 2025-524387-38-00 | Ph 1 | recruiting | A Study to Learn About the Study Medicine Called PF-08032562 in People With Advanced or Metastatic Solid Tumors |
| NCT06982521 ReDiscover-2 | RLY-2608-102 | Ph 3 | recruiting | Phase 3 Study of RLY-2608 + Fulvestrant vs Capivasertib + Fulvestrant as Treatment for Locally Advanced or Metastatic PIK3CA-mutant HR+/HER2- Breast Cancer |
| NCT05601440 | I241 | Ph 2 | recruiting | Liquid-biopsy Informed Platform Trial to Evaluate CDK4/6-inhibitor Resistant ER+/HER2- Metastatic Breast Cancer |
| NCT05646862 INAVO121 | WO43919 2022-502322-41-00 | Ph 3 | active not recruiting | A Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy |
| NCT07062965 | C4551002 2025-520566-22-00 | Ph 3 | recruiting | A Study to Learn About the Study Medicine Called PF-07248144 in Combination With Fulvestrant in People With HR-positive, HER2-negative Advanced or Metastatic Breast Cancer Who Progressed After a Prior Line of Treatment. |
| NCT07570966 | CERW316A12101 2025-521913-16 | Ph 1, Ph 2 | not yet recruiting | Study of ERW316 as a Single Agent or in Combination With Endocrine Therapy in Patients With HR+/HER2- Breast Cancer and Other Advanced Solid Tumors |
| NCT06065748 | CO44657 2022-502980-39-00 | Ph 3 | recruiting | A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer) |
| NCT03179904 results posted | MC1633 W81XWH-16-1-0269, W81XWH-16-1-0268 | Ph 2 | active not recruiting | TVB-2640 and Trastuzumab With Paclitaxel or Endocrine Therapy for Treatment of HER2 Positive Metastatic Breast Cancer |
| NCT06998407 AVZO-023-1001 | AVZO-023-1001 | Ph 1, Ph 2 | recruiting | ORION-1: Study of AVZO-023 as a Single Agent and in Combination With AVZO-021, and/or Endocrine Therapy in Advanced Solid Tumors |
| NCT04305496 CAPItello-291 results posted | D3615C00001 2023-505042-25-00, 2019-003629-78 | Ph 3 | active not recruiting | Capivasertib+Fulvestrant vs Placebo+Fulvestrant as Treatment for Locally Advanced (Inoperable) or Metastatic HR+/HER2- Breast Cancer |
| NCT05306340 | ML43171 2022-000199-20, 2023-506821-12-00 | Ph 3 | active not recruiting | A Study Evaluating the Efficacy and Safety of Giredestrant Plus Everolimus Compared With the Physician's Choice of Endocrine Therapy Plus Everolimus in Participants With Estrogen Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer (evERA Breast Cancer) |
| NCT05608252 | 22-490 | Ph 1, Ph 2 | recruiting | VS-6766+Abema+Fulv in Met HR+/HER- BC |
| NCT07558733 | FTH-PIK-101 | Ph 1, Ph 2 | recruiting | Sapanisertib and Serabelisib (PIKTOR) in Various Combinations in Patients With HR+/HER2- Advanced/Metastatic Breast Cancer |
| NCT05870579 | CAAA603B12101 2022-502465-18-00 | Ph 1 | recruiting | [177Lu]Lu-NeoB in Combination With Ribociclib and Fulvestrant in Participants With ER+, HER2- and GRPR+ Advanced Breast Cancer |
| NCT03633331 results posted | A171601 NCI-2017-01596 | Ph 2 | completed | Palbociclib and Letrozole or Fulvestrant in Treating Patients With Estrogen Receptor Positive, HER2 Negative Metastatic Breast Cancer |
| NCT07174336 | 27726 J6M-MC-JSGD, 2025-522791-92-00 | Ph 3 | recruiting | A Study of Tersolisib (LY4064809/STX-478) With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA) |
| NCT03939897 results posted | NCI-2019-02752 NCI-2019-02752, 201911082 | Ph 1 | active not recruiting | Testing the Addition of Copanlisib to Usual Treatment (Fulvestrant and Abemaciclib) in Metastatic Breast Cancer |
| NCT06726148 | CECI830A12101 2024-517281-42 | Ph 1, Ph 2 | recruiting | Study of ECI830 Single Agent or in Combination in Patients With Advanced HR+/HER2- Breast Cancer and Other Advanced Solid Tumors |
| NCT06428396 | 6482-029 MK-6482-029, LITESPARK-029 | Ph 2 | recruiting | Study of Belzutifan (MK-6482) Plus Fulvestrant for ER+/HER2- Metastatic Breast Cancer (MK-6482-029/LITESPARK-029) |
| NCT05768139 PIKALO-1 | 27691 2023-504807-94-00, 2023-000442-41 | Ph 1, Ph 2 | recruiting | First-in-Human Study of Tersolisib (STX-478) as Monotherapy and in Combination With Other Antineoplastic Agents in Participants With Advanced Solid Tumors |
| NCT05683418 | TOS-358-001 2023-505346-26-01 | Ph 1 | recruiting | A Study to Evaluate the Safety and Tolerability of TOS-358 in Women With HR+ HER2- Breast Cancer |
| NCT06997029 | CA243-0001 2025-524334-26-00, U1111-1330-3304 | Ph 1 | recruiting | A Phase 1 Study of BMS-986500 as Monotherapy or Combination Therapy in Advanced Solid Tumors |
| NCT05307705 PIKASSO-01 | 18394 2022-000175-40, J4C-OX-JZUA | Ph 1 | active not recruiting | A Study of LOXO-783 in Patients With Breast Cancer/Other Solid Tumors |
| NCT04862663 CAPItello-292 | D361DC00001 2020-004637-20 | Ph 3 | recruiting | Capivasertib + CDK4/6i + Fulvestrant for Advanced/Metastatic HR+/HER2- Breast Cancer (CAPItello-292) |
| NCT07405801 | CO46274 2025-523013-28-00 | Ph 2 | recruiting | A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus Ribociclib Plus Fulvestrant in Participants With Advanced Breast Cancer |
| NCT06179303 | RG1122019 NCI-2022-06409, FHIRB0020029 | Ph 2 | recruiting | Functional Imaging in Prediction of Response to Abemaciclib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer |
| NCT04606446 KAT6 | C4551001 NCT04606446 | Ph 2 | recruiting | Study of PF-07248144 in Advanced or Metastatic Solid Tumors |
| NCT06120283 | BGB-43395-101 2023-506888-34-00, CTR20243370 | Ph 1 | recruiting | BGB-43395 Alone or as Part of Combination Therapies in Participants With Breast Cancer and Other Advanced Solid Tumors |
| NCT05238922 | INCB 123667-101 2021-005357-91 | Ph 1 | recruiting | Study of INCB123667 in Subjects With Advanced Solid Tumors |
| NCT06380751 EvoPAR-BR01 | D9722C00001 | Ph 3 | recruiting | Saruparib (AZD5305) Plus Camizestrant Compared With CDK4/6 Inhibitor Plus Endocrine Therapy or Plus Camizestrant in HR-Positive, HER2-Negative (IHC 0, 1+, 2+/ ISH Non-amplified), BRCA1, BRCA2, or PALB2m Advanced Breast Cancer |
| NCT07408089 KOMODO-1 | BBI-940-101 | Ph 1 | recruiting | Study of the Kinesin Oral Molecular Degrader BBI-940 in Subjects With Advanced or Metastatic Breast Cancer |
| NCT06625775 | TBBO10203-101 2024-519445-29-00, BREAKER-101 | Ph 1 | recruiting | Open-Label Study of BBO-10203 in Subjects With Advanced Solid Tumors |
| NCT04650581 FINER results posted | MA40 2101, M041883 | Ph 3 | active not recruiting | Fulvestrant and Ipatasertib for Advanced HER-2 Negative and Estrogen Receptor Positive (ER+) Breast Cancer Following Progression on First Line CDK 4/6 Inhibitor and Aromatase Inhibitor |
| NCT05467891 RaPhLRR | HCRN BRE20-468 | Ph 2 | recruiting | Ribociclib And Endocrine Treatment of Physician's Choice for Locoregional Recurrent, Resected Hormone Receptor Positive HER2 Negative Breast Cancer |
| NCT04524000 | CBYL719C1201 | Ph 2 | active not recruiting | Study Assessing the Efficacy and Safety of Treatment With Alpelisib Plus Fulvestrant in Japanese Men and Postmenopausal Women With Advanced Breast Cancer |
| NCT06764186 CAPItana | D3612L00005 | Ph 3 | active not recruiting | A Phase IIIB Study to Evaluate the Use of Capivasertib in Combination With Fulvestrant in Patients With Advanced Breast Cancer Who Have Relapsed/Progressed on ET and CDK4/6 Inhibitor Reflecting Real World Clinical Practice in Spain |
| NCT05038735 EPIK-B5 | CBYL719C2303 2023-509133-39-00 | Ph 3 | active not recruiting | Study to Assess the Efficacy and Safety of Alpelisib Plus Fulvestrant in Participants With HR-positive (HR+), HER2-negative, Advanced Breast Cancer After Treatment With a CDK4/6 Inhibitor and an Aromatase Inhibitor. |
| NCT05631795 ALPINIST | CBYL719CIN01 | Ph 4 | completed | 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 PIK3CA Mutation, Whose Disease Progressed on or After Endocrine Treatment |
| NCT04544189 | CBYL719C2201 | Ph 2 | active not recruiting | Study Assessing the Efficacy and Safety of Treatment With Alpelisib Plus Fulvestrant Versus Placebo Plus Fulvestrant in Chinese Men and Postmenopausal Women With Advanced Breast Cancer |
| NCT05161195 | CLEE011A2412B 2024-514891-41-00 | Ph 4 | active not recruiting | Roll-over Study to Allow Continued Access to Ribociclib |
| NCT05735080 INX-315-01 | INX-315-01 | Ph 1, Ph 2 | recruiting | Open-Label Study to Evaluate the Safety, Tolerability, PK, and Efficacy of INX-315 in Patients With Advanced Cancer |
Showing 50 of 266 trials
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Trial Timeline
Full development history with FDA approval milestones
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Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
FULVESTRANT FDA Label Details
Indications & Usage
FDA Label (PDF)FULVESTRANT is indicated for the treatment of Breast Cancer.
View full patent landscape →
3 OB patents · 1 families ·
10 international docs across 1 countries
FULVESTRANT Patents & Exclusivity
Latest Patent: May 2034
Patents (3 active)
Source: FDA Orange Book
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Revenue Insights
- • Quarterly revenue tracking
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Patent Timeline
- • Cliff: 2034
- • 3 active patents
Trial Analysis
- • Clinical trial tracking
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Competitive Landscape
- • 20 similar drugs
- • Same target/indication analysis
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Data Sources
FDA Approval: ANDA205871 → Label: DailyMed → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →
Data sourced from official FDA and NIH databases. Click links to verify on original sources.