Uses
DAYBUE and DAYBUE STIX are indicated for the treatment of Rett syndrome in adults and pediatric patients 2 years of age and older.
Source: US FDA prescribing information
- Presentations
- 4
- Brands
- 2
- Manufacturers
- 1
- Available from stock
- 0
Trofinetide is a prescription medicine indicated for the treatment of Rett syndrome in adults and pediatric patients 2 years of age and older. It is available as powder for oral solution and oral solution. MedsAcross supplies Trofinetide for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Key facts
- Pharmacological class
- Cytochrome P450 3A4 Inhibitors, Organic Anion Transporting Polypeptide 1B1 Inhibitors, Organic Anion Transporting Polypeptide 1B3 Inhibitors
- ATC classification
- N07XX24 Trofinetide · Other nervous system medicines, subgroup N07X, subgroup N07XX
- US FDA first approval
- 10 March 2023
- EU status
- Authorised
- Orphan designation
- Yes
- WHO essential medicine
- Not recorded
- India (CDSCO)
- Not yet confirmed against CDSCO approval lists
- Routes
- Oral
- Dosage forms
- Powder for oral solution, Oral solution
- Identifiers
- UNII Z2ME8F52QLCAS 853400-76-7DrugBank DB06045Q27294917
Clinical information
From the regulator-approved product information. Each section names its source.
How it works
The mechanism by which trofinetide exerts therapeutic effects in patients with Rett syndrome is unknown.
Source: US FDA prescribing information
Dosing overview
Recommended dosage is twice daily, morning and evening, according to patient weight. DAYBUE or DAYBUE STIX can be given with or without food. Patient Weight Recommended Dosage 9 kg to less than 12 kg 5,000 mg twice daily 12 kg to less than 20 kg 6,000 mg twice daily 20 kg to less than 35 kg 8,000 mg twice daily 35 kg to less than 50 kg 10,000 mg twice daily 50 kg or more 12,000 mg twice daily Can be given orally or via gastrostomy (G) tube, doses administered via gastrojejunal (GJ) tubes must be administered through the G-port. See Full Prescribing Information for instruction on dissolving DAYBUE STIX for oral solution powder. See Full Prescribing Information for dosage recommendations in patients with renal impairment.
Source: US FDA prescribing information
Contraindications
None. None.
Source: US FDA prescribing information
Warnings and precautions
Diarrhea: Most patients experience diarrhea during treatment with DAYBUE. Advise patients to stop laxatives before starting DAYBUE or DAYBUE STIX. If diarrhea occurs, patients should start antidiarrheal treatment, increase oral fluids, and notify their healthcare provider. Interrupt, reduce dose, or discontinue DAYBUE or DAYBUE STIX if severe diarrhea occurs or if dehydration is suspected. Weight Loss: Weight loss may occur in patients treated with DAYBUE or DAYBUE STIX. Monitor weight and interrupt, reduce dose, or discontinue DAYBUE or DAYBUE STIX if significant weight loss occurs. Vomiting: Aspiration and aspiration pneumonia have occurred after vomiting in patients treated with DAYBUE. Interrupt, reduce dose, or discontinue DAYBUE or DAYBUE STIX if vomiting is severe or occurs despite medical management.
Source: US FDA prescribing information
Side effects
The following clinically significant adverse reactions are described elsewhere in labeling: Diarrhea Weight Loss Vomiting The most common adverse reactions (that occurred in at least 10% of DAYBUE-treated patients and at least 2% greater than in placebo) were diarrhea and vomiting.
Source: US FDA prescribing information
Interactions
Orally administered CYP3A and/or P-gp sensitive substrates for which a small change in substrate plasma concentration may lead to serious adverse reactions: closely monitor for adverse reactions with concomitant use.
Source: US FDA prescribing information
Storage
Store DAYBUE in an upright position refrigerated at 2°C to 8°C (36°F to 46°F). Do not freeze. DAYBUE STIX for Oral Solution Store DAYBUE STIX packets at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
All presentations
4 presentations of Trofinetide, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Daybue 200 mg/mL oral solutionOral Cold chain | Acadia Pharmaceuticals | US FDA | Available on request |
| Daybue Stix 5000 mg powder for oral solutionOral Cold chain | Acadia Pharmaceuticals | US FDA | Available on request |
| Daybue Stix 6000 mg powder for oral solutionOral Cold chain | Acadia Pharmaceuticals | US FDA | Available on request |
| Daybue Stix 8000 mg powder for oral solutionOral Cold chain | Acadia Pharmaceuticals | US FDA | Available on request |
Brands by market
2 brand names across 1 markets.
United States
Manufacturers
Regulatory status
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
Questions and answers
Is Trofinetide available for export from India?
Yes, on request. MedsAcross lists 4 presentations of Trofinetide and sources them for licensed hospitals, importers and physicians against valid import documents.
What brand names does Trofinetide have?
The catalogue lists 2 brand names for Trofinetide, including Daybue, Daybue Stix.
Is Trofinetide approved by the US FDA?
Yes. The US FDA first approved Trofinetide on 10 March 2023, according to Drugs@FDA.
Is Trofinetide authorised in the European Union?
Yes. Trofinetide has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
Does Trofinetide need cold chain shipping?
At least one listed presentation of Trofinetide must be kept cold, so it is shipped in temperature-controlled packaging. Check the storage line on each presentation.
Which ATC class is Trofinetide in?
Trofinetide is classified under ATC code N07XX24 (Trofinetide).
References
- Daybue prescribing information (Acadia Pharmaceuticals). U.S. National Library of Medicine, DailyMed. Retrieved 4 September 2026
- Daybu: European public assessment report (EPAR). European Medicines Agency. Retrieved 12 October 2026
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