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Imlunestrant is Lilly's oral oestrogen-receptor degrader, approved in 2025 for ESR1-mutant breast cancer and shown to work with abemaciclib regardless of mutation.
EMBER-3: monotherapy PFS benefit confined to ESR1-mutant tumours (HR 0.62; OS 34.5 vs 23.1 months in update); imlunestrant + abemaciclib beat imlunestrant alone in all patients (PFS 10.9 vs 5.5 months, HR 0.59). FDA approved 25 September 2025 for ESR1-mutant disease after ≥1 endocrine line. EMBER-4 tests it as adjuvant therapy.
Brain-penetrant oral SERD; pure antagonist that degrades ER. Connects to Estrogen receptor (ERα).
1.Imlunestrant acts on Estrogen receptor (ERα), the hormone receptor or the enzyme that makes the hormone.
Oral, self-administered, so it is a Part D drug: covered through a stand-alone Part D plan or Medicare Advantage drug benefit, usually on the specialty tier with 25 to 33% coinsurance until the annual cap ($2,000 in 2025, $2,100 in 2026). FDA-approved 2025.
Covered for FDA-labelled and NCCN-listed uses, but almost always behind prior authorisation confirming diagnosis, biomarker and line of therapy; dispensed through a specialty pharmacy. ESR1 mutation documentation required; plan policies are still being written.
Part D out-of-pocket capped at $2,000 (2025) / $2,100 (2026). Medicare patients cannot use manufacturer co-pay cards; charity funds (PAN, HealthWell, CancerCare) and the Extra Help subsidy are the routes.
Sources: Medicare.gov: Drug coverage (Part D) · Medicare.gov: Costs for Medicare drug coverage (annual out-of-pocket cap). Not medical or financial advice; verify with your plan.
Sources: NICE TA1168. Funding decisions are indication-specific and change monthly; verify with NICE and your treating team.
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Approved as Inluriyo source
With abemaciclib, for ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer source
| Region | Year | Indication |
|---|---|---|
| US | 2025 | ER+/HER2- ESR1-mutated advanced breast cancer after ≥1 line of endocrine therapy |
| EU | 2026 | ESR1-mutant ER+/HER2- mBC; 9 Jan 2026 |
| Adverse event | Any grade | Grade 3+ |
|---|---|---|
| Diarrhoea (with abemaciclib) | 86% | 8% |
| Nausea (monotherapy) | 17% | - |
| Fatigue | 23% | - |
Events listed without rates were not read from a primary source; see the label. Blank cells mean the figure was not sourced, not that it is zero.
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Query for this drug: (TITLE:"Imlunestrant" OR ABSTRACT:"Imlunestrant" OR TITLE:"Inluriyo" OR ABSTRACT:"Inluriyo" OR TITLE:"LY3484356" OR ABSTRACT:"LY3484356") AND (cancer OR tumor OR tumour OR oncology OR carcinoma OR lymphoma OR leukemia OR leukaemia OR myeloma OR sarcoma OR melanoma OR glioma). Results are unfiltered search hits about Imlunestrant, not a curated reading list.
Shares Oral SERDs, Oral SERD, Oral SERD + CDK4/6 inhibitor after ESR1 emergence, ESR1 mutation (ligand-binding domain, usually in ctDNA).
Shares Oral SERDs, Oral SERD, ESR1 mutation (ligand-binding domain, usually in ctDNA), ESR1 mutation.
Shares ESR1 mutation, HR-positive metastatic breast cancer after CDK4/6 inhibitors, Estrogen receptor (ERα), Hormonal therapy roadmap: removing the ovaries → tamoxifen → oral degraders switched by a blood test.
Shares Oral SERDs, Oral SERD, HR-positive metastatic breast cancer after CDK4/6 inhibitors, Estrogen receptor (ERα).
Shares HR-positive metastatic breast cancer after CDK4/6 inhibitors, Estrogen receptor (ERα), Hormonal therapy roadmap: removing the ovaries → tamoxifen → oral degraders switched by a blood test, Endocrine therapy (SERMs, AIs, SERDs).
Shares Oral SERDs, ESR1 mutation, HR-positive metastatic breast cancer after CDK4/6 inhibitors, Estrogen receptor (ERα).
Shares Oral SERD + CDK4/6 inhibitor after ESR1 emergence, ESR1 mutation, HR-positive metastatic breast cancer after CDK4/6 inhibitors, Estrogen receptor (ERα).
Shares HR-positive metastatic breast cancer after CDK4/6 inhibitors, Hormonal therapy roadmap: removing the ovaries → tamoxifen → oral degraders switched by a blood test, Eli Lilly (incl. Loxo), HR-positive / HER2-negative breast cancer.