Drug · Small Molecule
Fulvestrant
CI-DRUG-00000253Explore in graph →NCIt C1379 CHEMBL1358 CIViC Approved
Regulatory
Approvals (37)
Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.
- Source
- openFDA — Drugs@FDA applications and drug labels (SPL)
- Dataset
- Drugs@FDA via openFDA
- Version
- drugsfda-2026-09-04
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Evidence
- regulatory
- License
- CC0 1.0 Universal (public domain; https://open.fda.gov/license/)
- Run
- ING-OPENFDA-20260908-000001
| Jurisdiction · authority | Cancer | Indication | Status | Approval date | Source |
|---|---|---|---|---|---|
| US FDA | — | Efficacy supplement 2021-05-12 (see label) | approved | May 12, 2021 | openfda |
| US FDA | — | Efficacy supplement 2020-07-28 (see label) | approved | Jul 28, 2020 | openfda |
| US FDA | — | Efficacy supplement 2020-05-13 (see label) | approved | May 13, 2020 | openfda |
| US FDA | — | Efficacy supplement 2019-11-21 (see label) | approved | Nov 21, 2019 | openfda |
| US |
Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.
Data updated 13 hours agoSource updated unknown
Derived
Development pipeline
Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.
| Scope | Stage | Max phase | Active | Recruiting | Phase 3 | Trials | Approvals | Jurisdictions | First approval | First trial |
|---|---|---|---|---|---|---|---|---|---|---|
| All cancers | Approved | Phase 4 | 138 | 65 | 67 | 371 | 37 | CA, EU, US | Apr 25, 2002 | 1997-05 |
| Malignant Breast Neoplasm | Approved | Phase 4 | 82 | 41 | 48 | 241 | 12 | EU, US | Apr 25, 2002 | 1997-05 |
| Malignant Ovarian Neoplasm | Phase2 | Phase 2 | 8 | 6 | 0 | 17 | 0 | — | — | 2007-06 |
| Malignant Lung Neoplasm | Phase2 | Phase 2 | 7 | 5 | 0 | 15 | 0 |
Curated evidence
Clinical evidence (58)
CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.
- Source
- CIViC — Clinical Interpretation of Variants in Cancer
- Dataset
- CIViC evidence items
- Version
- civic-2026-09-08
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Evidence
- expert curation
- License
- CC0 1.0
- PMID
- 37256976
- Run
- ING-CIVIC-20260908-000001
| Therapy | Cancer | Type | Level | Direction · significance | Rating (1–5) | Status | Evidence | Source |
|---|---|---|---|---|---|---|---|---|
| PIK3CA H1047Y1 | ||||||||
| Capivasertib + Fulvestrant | ||||||||
Clinical trials
Trials with this intervention (384)
Most recently updated first, 50 per page.
- Source
- ClinicalTrials.gov
- Dataset
- ClinicalTrials.gov API v2 studies
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
| NCT | Title | Status | Phase | Enrollment (n) | Sponsor | Countries | Last update | Source |
|---|---|---|---|---|---|---|---|---|
| NCT03344536 | A Study of Debio 1347 Plus Fulvestrant in Patients With Metastatic Breast Cancer | completed | Phase 1 / Phase 2 | 10 | Memorial Sloan Kettering Cancer CenterOTHER | 1 | Nov 25, 2022 | clinicaltrials |
| NCT05577923 | Exploring Whether Disease-free Intervals Can Guide Endocrine Combined Targeted Therapy for ER+/HER2+ Advanced Breast Cancer (T-sunflower) | unknown |