Sanofi reaches study milestone for Cialis

21 January 2025

French pharma major Sanofi’s (Euronext; SAN) consumer healthcare business, Opella, has announced that the US Food and Drug Administration (FDA) has lifted a clinical hold on its planned actual use trial (AUT) to support the switch of Cialis (tadalafil), for erectile dysfunction (ED), from a prescription to an over-the-counter medicine.

This decision allows for the initiation of the AUT and makes Cialis the first PDE-5 inhibitor to achieve this milestone.

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