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# Saniona Delaying Tesomet Phase 2b Trial to Answer FDA
- URL: https://www.fdaweb.com/saniona-delaying-tesomet-phase-2b-trial-to-answer-fda/
- Published: 2021-04-27T12:00:00.000Z
- Updated: 2026-09-14T16:56:31.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149199

Saniona says its efforts to gather information to respond to an FDA request will delay the start of a Phase 2b clinical trial of its Tesomet for Prader-Willi syndrome and hypothalamic obesity into the second half of 2021\. The company [says](https://www.globenewswire.com/news-release/2021/04/21/2214643/0/en/Saniona-Updates-Tesomet-Clinical-Development-Timelines-Based-on-Manufacturing-Feedback-from-U-S-FDA.html?ref=fdaweb.com) it requested FDA feedback on its proposed chemistry, manufacturing, and controls plans for Tesomet.

“FDA agreed with the company’s proposal but requested additional information regarding Tesomet manufacturing,” the company statement says.

Tesomet is described as an investigational fixed-dose combination of tesofensine (a triple monoamine reuptake inhibitor) and metropolol (a beta-1 selective blocker).