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Pifeltro FDA Approval History

FDA Approved: Yes (First approved August 30, 2018)
Brand name: Pifeltro
Generic name: doravirine
Dosage form: Tablets
Company: Merck
Treatment for: HIV Infection

Pifeltro (doravirine) is a non-nucleoside reverse transcriptase inhibitor (NNRTI) indicated for the treatment of HIV-1 infection.

Pifeltro is indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in adult patients:

  • with no prior antiretroviral treatment history, OR
  • to replace the current antiretroviral regimen in those who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) on a stable antiretroviral regimen with no history of treatment failure and no known substitutions associated with resistance to doravirine.

Development Timeline for Pifeltro

Sep 20, 2019ApprovalMerck’s Pifeltro (doravirine) and Delstrigo (doravirine/lamivudine/tenofovir disoproxil fumarate) Receive FDA Approval for Use in Appropriate Adults Living with HIV-1 Who Are Virologically Suppressed
Aug 30, 2018ApprovalFDA Approves Merck’s Pifeltro (doravirine) for the Treatment of HIV-1 in Appropriate Patients
Jul 24, 2018Merck Announces Week 96 Data from Pivotal Phase 3 DRIVE-FORWARD Study of Its Investigational HIV Therapy Doravirine
Jan  8, 2018FDA Accepts New Drug Applications for Merck’s Doravirine, the Company’s Investigational Non-Nucleoside Reverse Transcriptase Inhibitor (NNRTI), for Treatment of HIV-1 Infection

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.