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Inluriyo

imlunestrant
Selective Estrogen Receptor DegraderFDA Approved 2025Eli Lilly
Route
Oral
Half-Life
~14 hrs
FDA Approved
2025
Manufacturer
Eli Lilly
1. Indications and Usage

Adults with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer with progression on endocrine therapy.

2. Dosage and Administration

400 mg orally once daily with or without food.

3. Dosage Forms and Strengths

Tablets: 200 mg, 400 mg

4. Contraindications

None listed in the prescribing information.

5. Warnings and Precautions
  • Hepatotoxicity: Monitor LFTs at baseline and periodically.
  • Embryo-Fetal Toxicity: Can cause fetal harm.
6. Adverse Reactions
Most Common Adverse Reactions

Nausea (34%), Fatigue (28%), Arthralgia (24%), Diarrhea (22%), Vomiting (18%), Decreased Appetite (16%), Hot Flush (14%), Increased ALT (12%)

Nausea
34%
Fatigue
28%
Arthralgia
24%
Diarrhea
22%
Vomiting
18%
Decreased Appetite
16%
Hot Flush
14%
Increased ALT
12%

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

7. Drug Interactions

Strong CYP3A4 Inducers: Avoid.

8. Use in Specific Populations
Pregnancy

Consult the full prescribing information for pregnancy-related considerations.

Lactation

Refer to prescribing information for lactation guidance.

Pediatric Use

Pediatric safety and efficacy information is detailed in the full label.

Hepatic/Renal Impairment

Dose modifications for organ impairment are specified in the complete prescribing information.

12. Clinical Pharmacology
Mechanism of Action

Imlunestrant is an oral SERD that degrades the estrogen receptor, with activity against both wild-type ER and common ESR1 mutations (Y537S, D538G) conferring resistance to prior endocrine therapies.

Pharmacokinetics

Tmax: 4 hours. Protein binding: ~99%. Half-life: ~29 hours. Steady state within 7 days.

14. Clinical Studies

Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.

Pivotal Clinical Trials
  • EMBER-3 — Imlunestrant vs standard endocrine therapy in ESR1-mutant breast cancer. Phase III, n=874.
    🔬 NCT04975308 ↗
Additional Resources
📋 All Imlunestrant Trials on ClinicalTrials.gov ↗ 📚 PubMed: Imlunestrant Clinical Trials ↗
FDA-Approved Tumor Types

Inluriyo has FDA-approved indications across the following cancer types covered on CancerDrugEvidence:

Breast Cancer
External Resources
📋 DailyMed Label ↗🏛️ FDA Drugs@FDA ↗🔬 ClinicalTrials.gov ↗📚 PubMed Pivotal Trials ↗
Important Notice: This page is intended as a navigational reference to the FDA-approved prescribing information for Inluriyo. It does not replace the full prescribing information. Healthcare professionals should consult the complete package insert available at DailyMed before making prescribing decisions. Patient-specific factors should always guide clinical decision-making.

Frequently Asked Questions

What is Inluriyo (imlunestrant) approved for?

Inluriyo (imlunestrant) is an FDA-approved oncology agent. Refer to the full prescribing information for complete indication details.

How is Inluriyo (imlunestrant) administered?

Refer to the full prescribing information for dosing schedules, administration instructions, and dose modifications.

How does Inluriyo (imlunestrant) work?

Imlunestrant is an oral SERD that degrades the estrogen receptor, with activity against both wild-type ER and common ESR1 mutations (Y537S, D538G) conferring resistance to prior endocrine therapies.

What are the most common side effects?

Nausea (34%), Fatigue (28%), Arthralgia (24%), Diarrhea (22%), Vomiting (18%), Decreased Appetite (16%), Hot Flush (14%), Increased ALT (12%) Nausea 34% Fatigue 28% Arthralgia 24% Diarrhea 22% Vomiting 18% Decreased Appetite 16% Hot Flush 14% Increased ALT 12%

← All TherapiesFull Prescribing Information ↗