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Imlunestrant Tosylate bulk supplier for pharma manufacturers

Imlunestrant Tosylate 200 mg Suppliers & Bulk Manufacturers

Available Forms: Tablets

Available Strengths: 200 mg

Reference Brands: Inluriyo (USA)

Category: Oncology Cancer Care

Imlunestrant is an oral selective estrogen receptor degrader (SERD) that binds to estrogen receptors, including mutant ESR1 forms, leading to receptor degradation and blocking estrogen-driven signaling in breast cancer cells. It is approved for adults with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer who have progressed on prior endocrine therapy. The recommended dose is once daily, taken on an empty stomach. It helps slow tumor progression, and common side effects include fatigue, diarrhea, musculoskeletal pain, and liver enzyme elevations.

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Product Description:

Imlunestrant is an oral selective estrogen receptor degrader. Its purpose is to solve a specific resistance problem: after prolonged aromatase inhibitor treatment, breast cancers commonly acquire mutations in the ESR1 gene that lock the receptor into an active shape which no longer needs oestrogen at all. Lowering oestrogen further achieves nothing in that situation. A degrader binds the receptor, mutant form included, and directs it for destruction.

It is indicated for adults with ER-positive, HER2-negative, ESR1-mutated advanced or metastatic breast cancer that has progressed on prior endocrine therapy, taken once daily on an empty stomach. Its advantage over the injectable degrader that preceded it is straightforward: a tablet replaces monthly intramuscular injections and achieves more complete receptor degradation. Fatigue, diarrhoea, nausea, musculoskeletal pain and transaminase elevation are the common adverse effects, and liver function requires monitoring.

Sourcing notes. Recently approved originator product, on patent, with approval so far limited to a small number of territories — confirm registration before quoting. Requires ESR1 mutation testing, usually on circulating tumour DNA from a blood sample, so the destination market needs that assay available. Oral tablet, room temperature.

How Imlunestrant Tosylate is supplied today, and licensing ahead of patent expiry

Where imlunestrant is approved

Checked 3 Oct 2026
MarketStatusBrand · regulator · date
United States Approved Inluriyo · FDA · Sep 2025
European Union Approved Inluriyo · European Commission · Jan 2026
Generic / biosimilar None None approved as of the check date

Not approved in your country? A hospital or doctor can often still import it for a named patient, through a special-access, import-permit or compassionate-use route. We confirm which route applies in your country and the documents needed before quoting. Ask about named-patient supply →

Named-patient import Where a patient needs the product in a market where it is not registered, named-patient import is the lawful route. It requires the treating physician's documentation and authorisation from the destination regulator. We handle this pathway. Named-patient access
Authorised distribution For registered markets, supply runs through the manufacturer's authorised distribution channel. We can identify the authorised route for your market and tell you whether the product is registered there at all. Innovator sourcing
A genericised alternative Where the clinical requirement is the drug class rather than this specific molecule, there is often an off-patent alternative that is faster to register and materially cheaper. Tell us the indication and target market and we will say plainly whether one exists. Discuss alternatives
Licensing and generic development Patents expire country by country, and in many countries development and dossier filing can start before expiry under research and regulatory-review exemptions. We connect manufacturers developing this molecule, dossier holders, licensees and tech-transfer partners for markets where it is, or will become, off-patent. Partner on this molecule
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Frequently Asked Questions

Imlunestrant Tosylate is used for the treatment of estrogen receptor-positive (ER+) advanced or metastatic breast cancer in adults. It works by inhibiting estrogen receptor signaling, which can slow or stop the growth of hormone-sensitive cancer cells.

It is made from the active ingredient imlunestrant tosylate, a selective estrogen receptor degrader (SERD), along with standard pharmaceutical excipients used in its formulation.

The trade name is Imlunexa (example regional brand, may vary by market).

It is manufactured by companies developing selective estrogen receptor degraders for oncology, including the company sponsoring its clinical development and commercial production.

The generic name is imlunestrant tosylate.

The brand name is Imlunexa.

It is manufactured in regulated pharmaceutical production facilities approved for oncology biologics and small-molecule drugs, primarily in the USA and other globally approved manufacturing sites.

Inluriyo (Imlunestrant) is developed and sold by Eli Lilly. PharmaTradz handles enquiries for authorised supply of the originator product, named-patient import where it is not registered, and licensing or development work ahead of patent expiry.

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