Data updated: Jun 28, 2026
CLIGAVYX (fulvestrant) · AVYXA HOLDINGS
Approved 2019-08-19
CLIGAVYX is FDA-approved to treat 1 condition (same as FULVESTRANT).
1
Indication
--
Phase 3 Trials
6
Years on Market
Details
- Status
- Discontinued
- First Approved
- 2019-08-19
- Routes
- INTRAMUSCULAR
- Dosage Forms
- SOLUTION
CLIGAVYX Approval History
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
4 FDA actions from 2019 to 2025
What CLIGAVYX Treats
1 indicationsCLIGAVYX is approved for 1 conditions since its original approval in 2019. These indications span multiple therapeutic areas including oncology, immunology, and more.
Same approved indications as FULVESTRANT (same active ingredient).
Source: FDA Label
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Clinical Trial Registry
270 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 | active not 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 | withdrawn | 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 | active not 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 | active not 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 results posted | 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 270 trials
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Pro Active Pipeline
Ongoing clinical trials by development phase
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Pro Key Completed Trials
Completed studies with published results, ranked by significance
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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.
CLIGAVYX FDA Label Details
Indications & Usage
FDA Label (PDF)CLIGAVYX is FDA-approved to treat 1 condition — same approved indications as FULVESTRANT.
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Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.