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Daybue Stix

(Trofinetide)

Peptide

AACADIA Pharmaceuticals Inc.

0

Indications

4

Total Trials

0

Active Trials

0

Competitors

2

FDA Applications

NDA/BLA/ANDA regulatory filings

8

Patents

Clinical

Trials by Indication[1]

Rett syndrome4 trials

Open-Label Extension Study of Trofinetide for the Treatment of Girls and Women With Rett Syndrome

Completed·AACADIA Pharmaceuticals Inc.·Phase 3·NCT04279314·154 enrolled

Study of Trofinetide for the Treatment of Girls and Women With Rett Syndrome (LAVENDER™)

Completed·AACADIA Pharmaceuticals Inc.·Phase 3·NCT04181723·187 enrolled

Open-Label Extension Study of Trofinetide for Rett Syndrome

Terminated·AACADIA Pharmaceuticals Inc.·Phase 3·NCT04776746·77 enrolled

Show 1 more trial

An Open-Label Study of Trofinetide for the Treatment of Girls Two to Five Years of Age Who Have Rett Syndrome

Terminated·AACADIA Pharmaceuticals Inc.·Phase 2/3·NCT04988867·15 enrolled

Regulatory

FDA Approval Timeline[3]

Mar 10, 2023

DAYBUE

NDA NDA217026

Dec 11, 2025

DAYBUE STIX

NDA NDA219884

Sources

References

[1]
ClinicalTrials.gov — 4 trial records for Trofinetide. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — Trofinetide compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
OpenFDA — FDA approval records (NDA NDA219884). U.S. Food & Drug Administration.
[4]
FDA Orange Book — Patent and exclusivity data for Daybue Stix. U.S. Food & Drug Administration.
[5]
SEC EDGAR — ACADIA Pharmaceuticals Inc. company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Peptide[2]
Company: AACADIA Pharmaceuticals Inc.

Patent Landscape[4]

Patent Cliff

Jan 27, 2032

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9212204Jan 27, 2032

9212204*PEDJul 27, 2032

11370755Aug 3, 2040

11370755*PEDFeb 3, 2041

12492167Jul 12, 2042

3 more patents

11827600Jul 12, 2042

11827600*PEDJan 12, 2043

12492167*PEDJan 12, 2043

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