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

Mona Darwish; Amy Yamamoto; Yvonne Holmes Adegbenle; Ravi Tejwani; Yonghua Chen; Rene Nunez-Disla; James M. Youakim; Sanjeev Pathak

doi:10.1007/s12325-025-03484-1

February 12, 2026Advances in TherapyOpen Access

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

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Key Points

The study aims to evaluate the bioequivalence of trofinetide delivered as a ready-to-use oral solution compared to a constituted powder for oral solution.
Phase 1, randomized, open-label trial design
Comparison of ready-to-use oral solution and constituted powder forms of trofinetide
Assessment of bioavailability and potential adverse events
Bioequivalence between the two forms of trofinetide was demonstrated
TPOS showed no difference in bioavailability when constituted with varying water volumes
No unexpected adverse events were reported during the trial

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Implication

Phase 1 trial assesses bioequivalence of two forms of trofinetide, suggesting clinical interchangeability.

Abstract

The bioequivalence demonstrated in this study supports the clinical interchangeability of TPOS and TOS and shows that TPOS can be constituted using adjustable volumes of water without affecting bioavailability. There were no unexpected adverse events reported with trofinetide when administered as TPOS and TOS.

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Cite This Study

Darwish et al. (2026) studied this question.

synapsesocial.com/papers/699010f22ccff479cfe57533 https://doi.org/10.1007/s12325-025-03484-1

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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

Key Points

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

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

Key Points

Ask about this paper

Implication

Abstract

Discussion

Cite This Study

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