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A Phase 1, Randomized, Open-Label Study to Assess the Bioequivalence of Trofinetide as a Ready-to-Use Oral Solution and Constituted Powder for Oral Solution in Healthy Adults

Crossref DOI link: https://doi.org/10.1007/s12325-025-03484-1

Published Online: 2026-02-12

Update policy: https://doi.org/10.1007/springer_crossmark_policy

Authors

Darwish, Mona

Yamamoto, Amy

Adegbenle, Yvonne

Tejwani, Ravi

Chen, Yonghua

Nunez-Disla, Rene

Youakim, James M.

Pathak, Sanjeev
Funding

Funding for this research was provided by:

ACADIA Pharmaceuticals
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Text and Data Mining valid from 2026-02-12

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Article History

Received: 1 October 2025

Accepted: 18 December 2025

First Online: 12 February 2026

Declarations

:

: Mona Darwish, Amy Yamamoto, Yvonne Adegbenle, Ravi Tejwani, Yonghua Chen, Rene Nunez-Disla, James M. Youakim, and Sanjeev Pathak are employees and stakeholders of Acadia Pharmaceuticals Inc.

: All requisite study-related material, including the protocol, was reviewed by an institutional review board/ethics committee (Advarra #Pro00079521, IRB approval May 17, 2024). All subjects provided written informed consent for participation in the study. The study was performed in full conformity with the current Declaration of Helsinki, the International Council for Harmonisation Guideline for Good Clinical Practice, and all other applicable regulations.

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