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Seladelpar bulk supplier for pharma manufacturers

Seladelpar 10 mg Suppliers & Bulk Manufacturers

Available Forms: Capsules

Available Strengths: 10 mg

Reference Brands: Livdelzi (USA/EU)

Category: Medical Aid

Seladelpar (Livdelzi) is used to treat Primary Biliary Cholangitis (PBC) in adults who did not respond adequately to or cannot tolerate Ursodeoxycholic acid (UDCA). It activates PPAR‑delta receptors to reduce bile acid production, inflammation, and liver fibrosis — helping improve liver function tests and relieve symptoms such as chronic itch (pruritus).

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Product Description:

Seladelpar is a selective agonist at PPAR-delta, a nuclear receptor that regulates genes controlling bile acid synthesis and inflammation in the liver. Activating it suppresses the enzyme that makes bile acids from cholesterol, so the toxic bile acid load falls, while also damping hepatic inflammatory signalling. Primary biliary cholangitis destroys small bile ducts through an autoimmune process, and the resulting bile acid retention drives much of the ongoing injury.

It is used for primary biliary cholangitis in adults who have responded inadequately to ursodeoxycholic acid or cannot tolerate it — historically a group with few options. Alkaline phosphatase falls substantially on treatment, and, importantly to patients, so does pruritus, the relentless itch that dominates life with this disease and which some earlier treatments made worse. Headache, abdominal pain, nausea and transaminase elevation occur, and liver function requires monitoring.

Sourcing notes. Recently approved originator product, on patent, with accelerated approval in some markets pending confirmatory outcome data — registration and reimbursement status should be checked per destination. The patient population is small, predominantly middle-aged women, and treatment is lifelong, so demand is low-volume but durable. Oral capsules, room temperature.

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

Where seladelpar is approved

Checked 3 Oct 2026
MarketStatusBrand · regulator · date
United States Approved Livdelzi · FDA · Aug 2024 (accelerated)
European Union Approved Lyvdelzi · European Commission · Feb 2025 (conditional)
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

Seladelpar is used to treat Primary Biliary Cholangitis (PBC), a chronic autoimmune liver disease, for patients who have an inadequate response to first‑line therapy or cannot tolerate it.

Seladelpar is a small-molecule drug that acts as a selective agonist of the Peroxisome proliferator-activated receptor delta (PPAR‑δ), affecting bile acid synthesis, inflammation, lipid metabolism, and fibrosis.

The trade name is Livdelzi.

Livdelzi is manufactured by Gilead Sciences.

The generic name is seladelpar.

The brand name is Livdelzi.

It is manufactured in the United States by Gilead Sciences.

Seladelpar is sold as Livdelzi and Lyvdelzi. It is developed and sold by Gilead. 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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