ZANVASTRO Solution for injection Ref.[116918] Active ingredients: Zilganersen

Zilganersen sodium is a glial fibrillary acidic protein (GFAP)-directed antisense oligonucleotide.

Zilganersen sodium is a white to yellow solid that is freely soluble in water and in artificial cerebrospinal fluid (aCSF). The molecular formula of zilganersen sodium is C230H301N67O127P19S13Na19 and the molecular weight is 7478.4 daltons. The chemical name of zilganersen sodium is DNA, d([2′-O-(2-methoxyethyl)]m5rC-sp-[2′-O-(2-methoxyethyl)]rA-[2′-O-(2-methoxyethyl)]rG-[2′-O-(2-methoxyethyl)]m5rU-[2′-O-(2-methoxyethyl)]rA-[2′-O-(2-methoxyethyl)]m5rU-T-sp-A-sp-m5C-sp-m5C-sp-T-sp-m5C-sp-T-sp-A-sp-m5C-sp-T-sp-[2′-O-(2-methoxyethyl)]rA-[2′-O-(2-methoxyethyl)]rG-sp-[2′-O-(2-methoxyethyl)]m5rU-sp-[2′-O-(2-methoxyethyl)]m5rC), sodium salt (1:19).

The structure of zilganersen sodium is presented in Figure 1.

Figure 1. Zilganersen Sodium Structural Formula:

ZANVASTRO is a sterile, preservative-free, parenteral solution for intrathecal (IT) administration. Each vial of ZANVASTRO solution contains 56 mg zilganersen in 2.8 mL at a concentration of 20 mg/mL (equivalent to 21.2 mg of zilganersen sodium) and the following inactive ingredients: calcium chloride (0.58 mg), disodium hydrogen phosphate (0.27 mg), magnesium chloride (0.46 mg), potassium chloride (0.63 mg), sodium chloride (for tonicity), sodium dihydrogen phosphate (0.14 mg), water for injection, and may include sodium hydroxide (q.s.) and/or hydrochloric acid (q.s.) for pH adjustment to a target pH of 7.2. The formulation is intended to be diluted with the provided aCSF Diluent prior to administration by IT injection.

Artificial cerebrospinal fluid Diluent is a sterile, preservative-free, parenteral solution for dilution of ZANVASTRO. The formulation does not contain any active ingredients. Each vial of the artificial cerebrospinal fluid Diluent contains 21 mL solution with the following inactive ingredients: calcium chloride (4.33 mg), disodium hydrogen phosphate (2.04 mg), magnesium chloride (3.42 mg), potassium chloride (4.70 mg), sodium chloride (for tonicity), sodium dihydrogen phosphate (1.05 mg), water for injection, and may include sodium hydroxide (q.s.) and/or hydrochloric acid (q.s.) for pH adjustment to a target pH of 7.2.