Source: European Medicines Agency (EU) Revision Year: 2025 Publisher: Gilead Sciences Ireland UC, Carrigtohill, County Cork, T45 DP77, Ireland
Seladelpar Gilead 10 mg hard capsules.
| Pharmaceutical Form |
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Hard capsules. Size 1 (26.1 mm x 9.4 mm) hard capsules with dark blue opaque cap and light grey opaque body imprinted with “CBAY” in white ink on the cap and “10” in black ink on the body. |
Each hard capsule contains seladelpar lysine dihydrate equivalent to 10 mg seladelpar.
For the full list of excipients, see section 6.1.
| Active Ingredient |
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Seladelpar is a peroxisome proliferator-activated receptor delta (PPARδ) agonist, or delpar. PPARδ is a nuclear receptor expressed in the liver and other tissues. PPARδ activation reduces bile acid synthesis in the liver through Fibroblast Growth Factor 21 (FGF21)-dependent downregulation of CYP7A1, the key enzyme for the synthesis of bile acids from cholesterol and by decreasing cholesterol synthesis and absorption. These actions result in lower bile acid exposure in the liver and reduced circulating bile acid levels. |
| List of Excipients |
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Capsule contents: Microcrystalline cellulose Capsule shell: Gelatin Black ink used to imprint “10” (on the body of the capsule shell contains): Shellac (E904) White ink used to imprint “CBAY” (on the cap of the capsule contains): Shellac (E904) |
Seladelpar Gilead hard capsules are packaged in a high density polyethylene bottle closed with a polypropylene child resistant cap containing an induction seal. Each bottle contains 30 capsules.
Gilead Sciences Ireland UC, Carrigtohill, County Cork, T45 DP77, Ireland
EU/1/24/1898/001
Date of first authorisation: 20 February 2025
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