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 14
| 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 24 trials | ||||||
| Phase 2 | NCT07832227 | Dec 2026 → Dec 2028 expected | endometrial cancer, ovarian serous adenocarcinoma | Dana-Farber Cancer Institute | Not yet recruiting | No outcome recorded |
| 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 |
| Comparator or background therapy4 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 1/2 | NCT06590857 Background | Jul 2024 → Oct 2028 expected | hormone receptor-positive breast cancer, metastatic carcinoma in the bone | RayzeBio, Inc. | Recruiting | No outcome recorded |
| Phase 1/2 | NCT05768139 Background | Apr 2023 → Jul 2030 expected | breast cancer | Eli Lilly and Company | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2026-09-18 | Eli Lilly and Company | Regulatory U.S. FDA approves Inluriyo (imlunestrant) in combination with Verzenio (abemaciclib) for adults with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer lilly.com ↗ |
| 2025-12-12 | Eli Lilly and Company | Results Updated data for Lilly's Inluriyo™ (imlunestrant) reinforce efficacy results as monotherapy and in combination with Verzenio® (abemaciclib) in ER+, HER2- advanced breast cancer lilly.com ↗
As monotherapy, imlunestrant demonstrated a clinically meaningful 38% reduction in the risk of progression or death (median PFS 5.5 vs 3.8 months; HR=0.62 [95% CI 0.47–0.82]; nominal p=0.0007) and demonstrated an 11.4-month improvement in median OS (34.5 vs 23.1 months; HR=0.60 [95% CI 0.43–0.86]; p=0.0043; boundary for significance not met) versus endocrine therapy, in patients with ESR1-mutated disease. |
| 2025-09-25 | Eli Lilly and Company | Regulatory U.S. FDA approves Inluriyo (imlunestrant) for adults with ER+, HER2-, ESR1-mutated advanced or metastatic breast cancer lilly.com ↗ |
| 2024-12-11 | Eli Lilly and Company | Results Lilly's Imlunestrant, an Oral SERD, Significantly Improved Progression-Free Survival as Monotherapy and in Combination with Verzenio® (abemaciclib) in Patients with ER+, HER2- Advanced Breast Cancer lilly.com ↗
Imlunestrant demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) as monotherapy in patients with an ESR1 mutation versus standard of care endocrine therapy (SOC ET), reducing the risk of disease progression or death by 38%. |
| 2023-10-20 | Eli Lilly and Company | Results Landmark 5-Year monarchE Outcome Data Demonstrate Verzenio® (abemaciclib)'s Long-Term Impact on Cancer Recurrence in High-Risk Early Breast Cancer lilly.com ↗
Results demonstrated that single agent imlunestrant had a clinical benefit rate of 42% and this increased to 62% when given in combination with everolimus or alpelisib (both approved agents in the second-line setting). |
| 2021-06-04 | Eli Lilly and Company | Results Lilly Announces New Clinical Data from Verzenio and Oral SERD Programs at the American Society of Clinical Oncology Annual Meeting lilly.com ↗
The first clinical data from the ongoing Phase 1 EMBER trial of LY3484356 were also presented at ASCO. |
All press releases naming this drug 7 releases
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 20 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Imlunestrant | “Investigator's choice of endocrine therapy, such as, anastrozole, elacestrant, exemestane, fulvestrant, imlunestrant, letrozole, tamoxifen, or vepdegestrant” NCT06590857 ↗12“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 |