Trial Profile

An Actual Use Trial (AUT) to support the Rx-to-OTC switch for Cialis (tadalafil)

Status: Suspended

Phase of Trial: Phase IV

Latest Information Update: 31 May 2022

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At a glance

Drugs Tadalafil (Primary)
Indications Erectile dysfunction
Focus Therapeutic Use

Most Recent Events

31 May 2022 New trial record
30 May 2022 According to Sanofi media release, U.S. Food and Drug Administration has informed Sanofi that its planned Actual Use Trial (AUT) to support the Rx-to-OTC switch for Cialis (tadalafil) has been placed on clinical hold due to matters surrounding the protocol design.

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