Cerebrolysin

01 / Dosing schedule

Cited dosing

Cerebrolysin has large randomized IV dosing data in acute ischaemic stroke, but no FDA approval. Both landmark trials used the same daily amount — 30 mL/day diluted in saline to 100 mL, infused intravenously — differing only in course length.

Cerebrolysin IV in acute ischaemic stroke — CASTA and CARS

Phase	Dose & frequency
CASTA daily dose	30 mL Cerebrolysin diluted in saline to a total of 100 mL, once daily
CASTA course	10 days, started within 12 h of stroke onset; median 10 doses per patient
CASTA background therapy	aspirin 100 mg orally daily in both groups
CARS daily dose	30 mL/day, diluted with physiological saline to 100 mL total
CARS infusion time	each IV infusion over 20 minutes
CARS course	once daily for 21 days, started 24-72 h after stroke onset
Dose range in earlier literature (cited by CARS)	10 to 50 mL per day, courses of 10 to 30 days

Source · Muresanu DF et al. Cerebrolysin and Recovery After Stroke (CARS): A Randomized, Placebo-Controlled, Double-Blind, Multicenter Trial. Stroke. 2016;47(1):151-159. ↗

Source indication · Acute ischaemic stroke: CASTA (treatment started within 12 h of onset) and CARS (early rehabilitation, treatment started 24-72 h after onset)

Injection frequency: Once daily. 10 consecutive days in CASTA; 21 consecutive days in CARS (93.8% of CARS patients received all 21 infusions).
Injection sites: n.a. — both trials specify intravenous infusion but do not name a venous access site.

02 / Reconstitution

Reconstitution reference

Cerebrolysin is supplied as a solution, not a lyophilised powder. In both trials the daily 30 mL was diluted with physiological saline to a total infusion volume of 100 mL; placebo was 100 mL saline.

Vial30 mL Cerebrolysin solution (daily trial amount)

BAC waterphysiological saline to 100 mL total (per trial protocol)

Concentration30 mL drug in 100 mL infusion

Example dose30 mL/day

On a U‑100 syringe100 mL IV infusion over ~20 minutes (CARS)

Open the reconstitution calculator →

03 / Overview

Protocol overview

Cerebrolysin is a porcine brain-derived preparation of low-molecular-weight peptides and amino acids. It is licensed in a number of countries in Asia, Eastern Europe and Latin America, but it has never been approved by the FDA, and its dosing evidence therefore lives entirely in trial protocols.

CASTA (Cerebrolysin Acute Stroke Treatment in Asia) randomised 1067 patients at 51 centres to 30 mL Cerebrolysin daily, diluted in saline to 100 mL, or 100 mL saline placebo, for 10 days, starting within 12 hours of onset. All patients also received aspirin 100 mg daily.

CARS (Cerebrolysin and Recovery After Stroke) used the same 30 mL/day dose but for 21 days, given as a 20-minute IV infusion starting 24-72 hours after stroke, alongside standardised rehabilitation of 2 hours a day, 5 days a week, for 21 days. Its primary endpoint was upper-extremity motor function at day 90.

The CARS report notes that prior Cerebrolysin stroke studies used 10 to 50 mL per day over 10 to 30 days, which is the honest bound on the published human dose range. No human half-life is reported in either trial, unsurprising for a multi-component peptide mixture.

04 / References