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# FDA, Acer Agree on Edsivo Pivotal Clinical Trial
- URL: https://www.fdaweb.com/fda-acer-agree-on-edsivo-pivotal-clinical-trial/
- Published: 2021-06-10T12:00:00.000Z
- Updated: 2026-09-14T17:02:35.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149507

Acer Therapeutics says it is planning a pivotal clinical trial of its Edsivo (celiprolol) in patients with COL3A1+ vascular Ehlers-Danlos syndrome (vEDS). The company says the agency agreed with its submission of a proposed protocol under a special protocol assessment with a possible breakthrough designation.

Minutes from a recent Type B meeting with the agency indicate that FDA accepted the proposal for a decentralized (virtual) clinical trial design and use of an independent centralized adjudication committee; acceptability of a primary endpoint based on clinical events associated with disease outcome; agreement with modest safety data collection and no pharmacokinetic data needed to be collected; and a statistical plan that considers the rare disease classification of vEDS.

Acer says it will submit an IND and a protocol for the planned study in the second half of the year. It will request a breakthrough therapy designation at the same time, it says.