marked.bio

oral SERD · small molecule

imlunestrant

1 active trials, targeting ER. 3 active approvals for a biomarker on marked.bio.

Also known as LY3484356, Inluriyo.

Counts only trials that select patients by one of the biomarkers on marked.bio, not every trial of this drug.

Approvals and pivotal results

Biomarker-selected approvals in the United States and the European Union, with the pivotal trial's results and side effects where we have them. Results from different trials are not directly comparable.

TherapyBiomarkerTumourUnited StatesEuropean Union
imlunestrant
FDA, 2025
advanced or metastatic, ESR1-mutated, after >=1 line of endocrine therapy FDA approval 25/09/2025; companion test Guardant360 CDx. Source
EU (EMA), 2026
locally advanced or metastatic, activating ESR1 mutation, after prior endocrine-based treatment EU marketing authorisation 09/01/2026. Source
Inluriyo 		ESR1 mutation breast (ER+/HER2-) Approved 2025 Approved 2026

In the FDA approval summary

EMBER-3 vs fulvestrant or exemestane, 256 with ESR1 mutation
PFS 5.5 months vs 3.8 months, HR 0.62 (0.46-0.82)

Trial details and side effects
Patients
ESR1-mutated ER+/HER2- advanced breast cancer (NCT04975308)
Most common side effects
low haemoglobin, musculoskeletal pain, raised AST, fatigue, raised ALT, diarrhoea, nausea, raised triglycerides
Notes
FDA approval summary (2025); OS immature. Side effects are those in 10% or more of patients.
Source
FDA approval summary

In the EU summary (EPAR)

EMBER-3 vs fulvestrant or exemestane, 138 vs 118 with ESR1 mutation
PFS 5.5 months vs 3.8 months, HR 0.62 (0.46-0.82)

Trial details and side effects
Patients
ESR1-mutated ER+/HER2- advanced breast cancer (NCT04975308)
Most common side effects
low haemoglobin, musculoskeletal pain, raised AST, fatigue, raised ALT, diarrhoea, nausea, raised triglycerides
Notes
EU figures from the EPAR summary; trial details and side effects from the US approval.
Source
EU summary (EPAR)
imlunestrant with abemaciclib
FDA, 2026
advanced or metastatic, ESR1-mutated, after >=1 line of endocrine therapy FDA approval 18/09/2026. Source
Inluriyoabemaciclib page 		ESR1 mutation breast (ER+/HER2-) Approved 2026 Not approved

EMBER-3 (combination arm) vs imlunestrant alone, 159 with ESR1 mutation
PFS 11.1 months vs 5.5 months, HR 0.53 (0.35-0.80), exploratory subgroupResponse 35% vs 15%

Serious side effects 21%Stopped for side effects 1% (imlunestrant)Fatal 3.8%

Trial details and side effects
Patients
ESR1-mutated ER+/HER2- advanced breast cancer (NCT04975308)
Most common side effects
diarrhoea 86%, nausea 51%, fatigue 41%, infections 36%, vomiting 32%, musculoskeletal pain 25%, abdominal pain 24%, low neutrophils 86% (208 patients)
Notes
FDA approval summary (2026); benefit was seen only in the ESR1-mutated group. Side effects: Inluriyo US label, section 6 (EMBER-3 combination arm).
Source
FDA approval summary

Biomarkers

BiomarkerActive trialsAll trialsFurthest active phase
PIK3CA activating mutation 1 1 Phase 1

Sponsors

Industry sponsors leading active biomarker-selected trials of imlunestrant.

  1. Eli Lilly 1

Trials

1 of 1 trials shown

  1. A Study of LOXO-783 in Patients With Breast Cancer/Other Solid Tumors

    Active, not recruiting Phase 1 Eli Lilly Started 2022Primary completion 2025-04 NCT05307705

    LOXO-783fulvestrant FDA EUimlunestrantabemaciclibanastrozoleletrozolepaclitaxel

    … H1047R mutation (or other Sponsor and safety review committee (SRC)-approved, activating PIK3CA mutations other than H1047R mutation)

    PIK3CA activating mutationBreast Cancer