TRYNGOLZA Solution for injection Ref.[115519] Active ingredients: Olezarsen

Olezarsen is an ASO directed inhibitor of Apolipoprotein C-III (apoC-III) mRNA, conjugated to a ligand containing three N-acetyl galactosamine (GalNAc) residues to enable delivery of the ASO to hepatocytes.

TRYNGOLZA contains olezarsen sodium as the active ingredient. Olezarsen sodium is a white to yellow solid and it is freely soluble in water and in phosphate buffer. The molecular formula of olezarsen sodium is C₂₉₆H₄₁₉N₇₁O₁₅₄P₂₀S₁₉Na₂₀ and the molecular weight is 9124.48 daltons. The chemical name of olezarsen sodium is DNA, d(P-thio) ([2'-O(2-methoxyethyl)] rA-[2'O(2-methoxyethyl)]rG-[2'O(2-methoxyethyl)]m5rC-[2'O(2-methoxyethyl)]m5rU-[2'O(2-methoxyethyl)]m5rU-m5C-T-T-G-T-m5C-m5C-A-G-m5C-[2'O(2-methoxyethyl)]m5rU-[2'O(2-methoxyethyl)] m5rU-[2'O(2-methoxyethyl)]m5rU-[2'O(2-methoxyethyl)]rA-[2'O-(2-methoxyethyl)]m5rU),5'-[26-[[2-(acetylamino)-2-deoxy-β-D-galactopyranosyl]oxy]-14,14-bis[[3-[[6-[[2-(acetylamino)-2-deoxy-β-D-galactopyranosyl]oxy]hexyl]amino]-3-oxopropoxy]methyl]-8,12,19-trioxo-16-oxa-7,13,20-triazahexacos-1-yl hydrogen phosphate], sodium salt (1:20).

The structure of olezarsen sodium is presented below:

TRYNGOLZA is a sterile, preservative-free solution for subcutaneous injection. Each single-dose autoinjector contains 80 mg olezarsen (equivalent to 84 mg of olezarsen sodium) in 0.8 mL of solution. The solution also contains the following inactive ingredients: disodium hydrogen phosphate, sodium chloride, sodium dihydrogen phosphate to maintain pH and provide tonicity, and water for injection. The solution may include hydrochloric acid and/or sodium hydroxide for pH adjustment between 6.9 to 7.9. Each dose of TRYNGOLZA injection contains 6 mg of phosphorous and 5 mg of sodium.