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# FDA, ARCA Reach Gencaro SPA Agreement
- URL: https://www.fdaweb.com/fda-arca-reach-gencaro-spa-agreement/
- Published: 2019-02-20T12:00:00.000Z
- Updated: 2026-09-15T01:06:06.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143428

FDA and Arca Biopharma have reached agreement on a special protocol assessment (SPA) for the PRECISION-AF Phase 3 clinical trial to assess the safety and efficacy of Gencaro (bucindolol HCl) as a genetically-targeted treatment for atrial fibrillation in patients with a specific type of heart failure (those with mid-range ejection fraction). The company [says](https://www.marketwatch.com/press-release/arca-biopharma-announces-fda-agreement-for-a-single-phase-3-clinical-trial-to-support-approval-for-the-first-genetically-targeted-cardiovascular-drug-2019-02-20?ref=fdaweb.com) the target population for the planned trial, partially identified by precision therapeutic genotyping, currently has no FDA approved drug therapies.

The SPA provides agreement that the trial protocol design, clinical endpoints, trial population, and statistical analyses adequately address objectives that, if met, would support a regulatory submission seeking approval of Gencaro for preventing atrial fibrillation recurrence in a genotype-defined heart failure population, Arca says.

The company says PRECISION-AF is designed as a single, adequate, and well-controlled Phase 3 trial that may be sufficient to support an NDA submission for the indication. It will enroll about 400 patients and will compare Gencaro with Aralez’ Toprol-XL (metroprolol succinate). It says it plans to initiate the trial in the last quarter of this year.