Elexacaftor + Tezacaftor + Ivacaftor Tablets Suppliers & Bulk Manufacturers

Available Forms: Film-coated tablets, oral granules

Available Strengths: 100 mg/50 mg/75 mg + ivacaftor 150 mg; 50/25/37.5 mg + ivacaftor 75 mg; granules for children

Pack Sizes: 28-day pack (84 tablets)

Reference Brands: Trikafta (US), Kaftrio (EU) (Vertex)

Category: Orphan Drugs

Elexacaftor, tezacaftor and ivacaftor (Trikafta in the US, Kaftrio in Europe; Vertex) is the triple CFTR modulator therapy for cystic fibrosis in people with at least one F508del mutation or another responsive mutation. PharmaTradz handles enquiries for authorised supply of the originator product (named-patient and import-permit orders), and connects developers and licensees preparing for patent and exclusivity expiry.

Product Description:

Cystic fibrosis is caused by faulty CFTR protein, a channel that moves salt and water across the surfaces of the lungs, gut and pancreas. Elexacaftor and tezacaftor help the faulty protein fold properly and reach the cell surface, and ivacaftor helps the channel open. Together they restore much of the protein's function in people with the common F508del mutation and a number of other mutations.

For many patients this has transformed the disease, with large gains in lung function, weight and quality of life and far fewer hospital stays. The usual adult regimen is two triple-combination tablets in the morning and one ivacaftor tablet in the evening, with fat-containing food. Lower-strength tablets and granules are available for children from two years. Liver tests are checked during treatment.

Sourcing notes. The combination is patented and supplied by the originator; there is no generic. Access in many countries depends on named-patient import or special funding, and treatment is lifelong, so continuity of supply is the main concern. Ivacaftor, lumacaftor-ivacaftor and the newer once-daily vanzacaftor combination are also listed on PharmaTradz.