Dapivirine Vaginal Ring

Drug

Drug Profile

Dapivirine Vaginal Ring 25 mg is a silicone vaginal ring for HIV-1 prevention in women, designed to release dapivirine over one month. It is intended for women aged 16+ in combination with safer-sex practices when oral PrEP is not feasible. The product received a positive EMA opinion under the EU-M4all pathway for use outside the EU.

Drug Class
Antiviral vaginal ring; NNRTI-based anti-HIV product
Approval Status
EMA positive opinion under EU-M4all (outside EU) dated 23 July 2020; opinion status remains positive on page updated 21 August 2025
Mechanism of Action
Locally releases dapivirine in the vagina; dapivirine blocks HIV reverse transcriptase to stop viral replication and spread
Indications
  • \Reducing risk of HIV-1 infection via vaginal intercourse in HIV-uninfected women aged 16 years and older when oral PrEP is not/cannot be used or not available\

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Related Clinical Trials

NCT ID Title Status Phase
NCT02010593

Safety and Pharmacokinetics of Dapivirine Vaginal Ring in Post-menopausal Women

COMPLETED PHASE2
NCT01363037

Safety and Pharmacokinetics of Dapivirine/Maraviroc Vaginal Ring

COMPLETED PHASE1