Drugs / Imlunestrant
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Approved | EU (EMA) | Inluriyo | — | 2026-01-09 | europa.eu ↗ |
| Approved | US (FDA) | INLURIYO | — | 2025-09-25 | fda.gov ↗ |
Trials 13 · a red edge is where a trial was stopped
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 18 trials | ||||||
| Phase 1 | NCT05509790 | Oct 2022 → Feb 2024 overdue | breast neoplasm | Eli Lilly and Company | Active not recruiting | No outcome recorded |
| Phase 1 | NCT05509816 | Sep → Nov 2022 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT05444556 | Jul → Nov 2022 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT05440344 | Jul 2022 → Feb 2024 | liver disorder | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT04991766 | Aug 2021 → Apr 2022 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT04840888 | Apr 2021 → Apr 2022 | — | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT04647487 | Apr 2021 → Nov 2022 | breast cancer | Eli Lilly and Company | Completed | No outcome recorded |
| Phase 1 | NCT04188548 | Dec 2019 → Jun 2020 overdue | breast cancer, endometrial cancer | Eli Lilly and Company | Active not recruiting | No outcome recorded |
| Phase 23 trials | ||||||
| Phase 2 | NCT07410559 | Jul 2026 → Apr 2029 expected | female breast carcinoma | Fudan University | Not yet recruiting | No outcome recorded |
| Phase 2 | NCT07287098 | May 2026 → Jan 2029 expected | breast neoplasm | Eli Lilly and Company | Recruiting | No outcome recorded |
| Phase 2 | NCT07191717 | Apr 2026 → Apr 2030 expected | Her2-receptor negative breast cancer, estrogen-receptor positive breast cancer, female breast carcinoma, invasive breast carcinoma | Jonsson Comprehensive Cancer Center | Not yet recruiting | No outcome recorded |
| Phase 32 trials | ||||||
| Phase 3 | NCT05514054 | Oct 2022 → Oct 2027 expected | breast neoplasm | Eli Lilly and Company | Active not recruiting | No outcome recorded |
| Phase 3 | NCT04975308 | Oct 2021 → Jun 2024 overdue | breast cancer, metastatic malignant neoplasm | Eli Lilly and Company | Active not recruiting | No outcome recorded |
Also used as a comparator or background therapy in 3 trials
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT07114601 Background | Aug 2025 → Apr 2030 expected | breast neoplasm, colorectal neoplasm, endometrium neoplasm, gastric neoplasm +3 | Eli Lilly and Company | Recruiting | No outcome recorded |
| Phase 1 | NCT05307705 Background | May 2022 → Dec 2026 expected | breast cancer | Eli Lilly and Company | Recruiting | No outcome recorded |
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT05768139 Background | Apr 2023 → Jul 2030 expected | breast cancer | Eli Lilly and Company | Recruiting | No outcome recorded |
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 18 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Imlunestrant | “Fulvestrant, Imlunestrant, Aromatase Inhibitors, Capecitabine, Abemaciclib” NCT07114601 ↗ |
| Known as | LY3484356 | “effect of imlunestrant (LY3484356) when administered orally” NCT05509816 ↗ |
| Action | Inhibit | “Imlunestrant is a next-generation, brain-penetrant, oral selective estrogen-receptor (ER) degrader that delivers continuous ER inhibition, even in cancers with mutations in the...” PMID 39660834 ↗ Dec 2024 |
| Modality | Small molecule | — CHEMBL5095183 ↗ |
| Route | Oral | “LY3484356 given orally.” NCT04188548 ↗ |
| Target | ESR1 | “Imlunestrant is a next-generation, brain-penetrant, oral selective estrogen-receptor (ER) degrader that delivers continuous ER inhibition, even in cancers with mutations in the...” PMID 39660834 ↗ Dec 2024 |