Description
Indication & Scope
Inluriyo’s active ingredient is imlunestrant tosylate. An oral selective estrogen receptor degrader (SERD) approved in 2025 for adults with ER‑positive, HER2‑negative, ESR1‑mutated advanced or metastatic breast cancer.
- Mechanism: Selective estrogen receptor degrader (SERD), binds and degrades wild-type and mutated ESR1 receptors to block estrogen-driven tumor proliferation.
- Drug class: Oral selective estrogen receptor degrader.
- Clinical use: Treatment of ER-positive, HER2-negative, ESR1-mutated locally advanced or metastatic breast cancer in adults with prior endocrine therapy failure.
| Generic Name | Imlunestrant Tosylate |
| Brand Name | Inluriyo® |
| Ingredient | Each film-coated tablet contains imlunestrant tosylate equivalent to 200 mg imlunestrant |
| Dosage Form | Film-coated Tablets |
| Package | 28 tablets per carton |
| Conditions Treated | ER-positive, HER2-negative, ESR1-mutated locally advanced or metastatic breast cancer in adults with prior endocrine therapy failure |
| Taboos | Hypersensitivity to any component of the product |
| Place of origin | USA |
| Prescription type | Prescription Drug (Rx) |
| Storage Conditions | Store below 30°C, protect from moisture |
| Manufacturer | Eli Lilly and Company |
| Registration Authority | National Medical Products Administration (NMPA) |
| Approval number | 218881 |
| Date of Revision | 2025/9/25 |
| Shelf Life | 24 months |
How to use ?
Recommended Dose: 400 mg orally once daily, continue treatment until disease progression or unacceptable toxicity develops.
Time: Administer at a consistent time each day on an empty stomach (at least 2 hours before meals or 1 hour after meals).
Instructions for use: Swallow film-coated tablets whole; do not split, crush or chew. Premenopausal women and male patients should receive concomitant GnRH agonist therapy. Skip the missed dose if more than 6 hours have passed or vomiting occurs after dosing; resume the regular daily dose the following day without extra supplementation.
Interaction: Strong CYP3A4 inducers will lower systemic drug exposure; concomitant use with rifampicin, carbamazepine is contraindicated.
Side effects: Hot flushes, fatigue, musculoskeletal pain, nausea, elevated liver transaminases, diarrhea.
Important Notice
This product should be administered only by qualified healthcare professionals in accordance with the approved prescribing information and local clinical guidelines. Dosage and administration may vary depending on patient condition, indication, and regional regulatory requirements.
Packaging & Shipping
Packaging
Original manufacturer’s packaging with secure export carton. Customized export packaging is available upon request.
Shipping Methods
Express Courier (EMS, DHL, FedEx, UPS), Air Freight, and Sea Freight. Cold-chain transportation is available for products requiring temperature-controlled logistics.
Export Support
Certificate of Analysis
GMP Certificate
Commercial Invoice
Packing List & CPP
Cold Chain Logistics
Customs Documentation
Scientific and regulatory sources
FAQ
What are the side effects of imlunestrant?
Other less frequent adverse reactions (incidence <10%) observed in Inluriyo-treated patients are vomiting, headache, cough, reduced appetite, hot flushes, pruritus, indigestion and stomatitis.
What is Inluriyo?
Inluriyo’s active ingredient is imlunestrant tosylate, an oral SERD tablet for ESR1-mutated advanced breast cancer.
Is imlunestrant approved by the FDA for breast cancer?
Absolutely. Imlunestrant (Inluriyo), an oral SERD hormonal therapy, received FDA approval in September 2025 for ESR1-mutated advanced breast cancer, supported by clinical outcomes of the EMBER-3 trial.
Is inluriyo effective?
Definitely. Clinical data from the EMBER-3 trial proved Inluriyo’s notable efficacy for ESR1-mutated breast cancer.
For the 256 patients with ESR1 mutations, the median time to cancer progression was 5.5 months with Inluriyo, longer than the 3.8 months seen in patients treated with fulvestrant or exemestane.
Inluriyo® Imlunestrant Tosylate | Estrogen Receptor Positive Breast Cancer | DengYueRX
INN: Imlunestrant tosylate
Indications: ER+, HER2-, ESR1-mutated advanced/metastatic breast cancer
Dosage Form: Film-coated Tablets
Strength: 200 mg x 28 tablets
