Elafibranor bulk supplier for pharma manufacturers

Elafibranor 80 mg Suppliers & Bulk Manufacturers

Available Forms: Tablets

Available Strengths: 80 mg

Reference Brands: Iqirvo (USA/EU)

Elafibranor is an oral dual PPAR-α and PPAR-δ agonist used for the treatment of primary biliary cholangitis. It helps improve liver function, reduce bile acid accumulation, and lower inflammation, supporting better long-term liver health.

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Product Description:

Elafibranor is an oral dual agonist of peroxisome proliferator-activated receptors alpha and delta. In primary biliary cholangitis, an autoimmune disease that gradually destroys the small bile ducts, PPAR activation reduces bile acid synthesis and toxicity, increases bile acid detoxification and export, and has anti-inflammatory effects. The measurable result is a fall in alkaline phosphatase, the marker used to judge whether treatment is controlling the disease.

It is used with ursodeoxycholic acid in patients who respond inadequately to it, or alone in those who cannot tolerate it, at 80 mg once daily. In the pivotal trial about half of patients reached the biochemical response threshold, against very few on placebo, and itch improved in some. Myalgia, raised creatine kinase and rhabdomyolysis are recognised, particularly with statins. Fractures, liver injury and effects on hormonal contraception are also noted. It is not recommended in decompensated cirrhosis.

Sourcing notes. Originator product, on patent, no generic. Approved in the US in 2024 under accelerated approval and in the EU with conditional authorisation, both pending confirmation of clinical outcomes. It competes with another PPAR agonist and with obeticholic acid, whose position has changed in several markets. Supply is through authorised distribution, and hepatology centres drive demand.

How Elafibranor is supplied today, and licensing ahead of patent expiry

Elafibranor is a patented innovator medicine. Where its patents are in force, which today includes most major markets, it can only be supplied by the originator or its licensees, through the routes below. Patents do expire, though, and generic development and licensing deals for post-patent markets start years in advance. If you are developing Elafibranor, hold a dossier for it or want to license it, talk to us.

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

Elafibranor is used for treating primary biliary cholangitis in adults who do not respond adequately to ursodeoxycholic acid or cannot tolerate it. It works as a dual PPAR-α/δ agonist that helps reduce liver inflammation and improve bile flow.

Elafibranor is made from the active ingredient elafibranor, a synthetic peroxisome proliferator-activated receptor (PPAR) agonist that targets metabolic and inflammatory pathways involved in cholestatic liver disease.

The trade name is Iqirvo.

Iqirvo is manufactured and marketed by Ipsen in collaboration with Genfit, the company that originally developed the drug.

The generic name is elafibranor.

The brand name is Iqirvo.

Elafibranor is manufactured in Europe and the United States through Ipsen’s and Genfit’s regulated pharmaceutical production facilities.

Iqirvo (Elafibranor) is developed and sold by Ipsen (developed by Genfit). 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.