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# Clinical Hold on Sanofi OTC Cialis Trial
- URL: https://www.fdaweb.com/clinical-hold-on-sanofi-otc-cialis-trial/
- Published: 2022-05-31T12:00:00.000Z
- Updated: 2026-09-14T17:46:53.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151947

FDA has placed a clinical hold on a Sanofi actual use trial to support its planned Rx-to-OTC switch for Cialis (tadalafil), which it licensed from Eli Lilly. The agency said the hold is related to issues surrounding the trial’s protocol design, according to the company. Sanofi’s says the trial has not yet recruited any patients and it will meet with the agency to determine next steps.

Lilly’s Cialis is currently approved as a prescription treatment for erectile dysfunction, the signs and symptoms of benign prostatic hyperplasia (BPH), and both ED and the signs and symptoms of BPH.