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Sebetralstat bulk supplier for pharma manufacturers

Sebetralstat 300mg Suppliers & Bulk Manufacturers

Available Forms: Tablets

Available Strengths: 300mg

Reference Brands: Ekterly (USA)

Category: Immune Disorder

Sebetralstat is an oral plasma kallikrein inhibitor used for the on-demand treatment of hereditary angioedema (HAE) attacks in adults and adolescents. It reduces bradykinin production, which helps control swelling episodes caused by HAE.

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Product Description:

Sebetralstat is an oral inhibitor of plasma kallikrein. In hereditary angioedema, deficient C1 esterase inhibitor lets kallikrein generate bradykinin unchecked, and bradykinin makes blood vessels leak, producing attacks of swelling in the skin, abdomen and airway. Sebetralstat blocks the enzyme directly, stopping bradykinin production and halting the attack.

It is used for acute attacks in patients aged twelve and over. Its significance is the route: until its approval, every on-demand HAE treatment was an injection or infusion, which meant patients delayed treatment — carrying a syringe, finding a private place, managing needles during an abdominal attack — and delay makes attacks longer and more dangerous. An oral tablet taken at the first symptom removes that barrier, and trials showed faster symptom relief than placebo with a second dose permitted if needed. It does not prevent attacks; patients on prophylaxis still need it for breakthrough episodes. It is well tolerated, with headache the most reported effect.

Sourcing notes. Originator product, approved in 2025, on patent, no generic. As a tablet it needs no cold chain — unusual in this therapeutic area and a genuine distribution advantage in hot climates and for patients who travel. Supply is through authorised distribution.

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

Where sebetralstat is approved

Checked 3 Oct 2026
MarketStatusBrand · regulator · date
United States Approved Ekterly · FDA · Jul 2025
European Union Approved Ekterly · European Commission · Sep 2025
Japan Approved Ekterly · MHLW · Dec 2025
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

Ekterly (Sebetralstat) is developed and sold by KalVista Pharmaceuticals. 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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