Source: European Medicines Agency (EU) Revision Year: 2026 Publisher: Acadia Pharmaceuticals (Netherlands) B.V., Strawinskylaan 3051, 1077 ZX Amsterdam, Netherlands
Daybu 200 mg/mL oral solution.
| Pharmaceutical Form |
|---|
|
Oral solution. Pink to red oral solution, pH 4. |
Each mL of oral solution contains 200 mg of trofinetide.
Excipient(s) with known effect:
Each mL of oral solution contains 30 mg maltitol, 1.12 mg sodium methyl parahydroxybenzoate, 0.25 mg sodium propyl parahydroxybenzoate, 4.9 mg propylene glycol, and 0.02 mg Allura Red AC.
For the full list of excipients, see section 6.1.
| Active Ingredient |
|---|
|
Trofinetide is a synthetic analogue of the N-terminal tripeptide of insulin-like growth factor 1. The precise molecular mechanism of trofinetide activity in the treatment of neurobehavioural symptoms of Rett syndrome is not known. |
| List of Excipients |
|---|
|
Maltitol (E965) |
Translucent high-density polyethylene (HDPE) multi-dose bottle containing 450 mL oral solution with a white polypropylene child-resistant closure.
Each pack includes 1 bottle of 450 mL Daybu oral solution and 2 dosing cups (30 mL and 110 mL).
The 30 mL dosing cup is graduated from 5 mL to 30 mL by increments of 2.5 mL.
The 110 mL dosing cup is graduated from 10 mL to 110 mL by increments of 10 mL.
Acadia Pharmaceuticals (Netherlands) B.V., Strawinskylaan 3051, 1077 ZX Amsterdam, Netherlands
EU/1/26/2045/001
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