Drug

Doravirine

Approved · EMA

Emerging researchLate-stage development

Also known as Delstrigo, Idvynso, Pifeltro, Doravirinum.

RxNorm2055755 ChEMBLCHEMBL2364608UNII913P6LK81M

Research papers

Active clinical trials

Regulatory events

Latest activity

beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Phase 2 Clinical Study to Evaluate the Pharmacokinetics, Safety, and Efficacy of Doravirine and Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate in Participants With HIV-1, Who Are 4 Weeks to Less Than 12 Years of Age and Weigh Less Than 45 kg

Clinical trial2026-07-08Results expected Q4 2028 · ClinicalTrials.gov

Single Dose Pharmacokinetics of Doravirine in HIV-infected Pregnant Women

Clinical trial2026-04-16Results posted · ClinicalTrials.gov

Study on PhArmacokinetics of First liNe Antiretrovirals in Healthy Breastfeeding Volunteers

Clinical trial2026-04-16Results posted · ClinicalTrials.gov

Doravirine Dose Optimisation in Pregnancy

Clinical trial2026-02-19Results expected Q3 2028 · ClinicalTrials.gov

A Switch Clinical Trial of Antiretrovirals to Compare the Impact of Doravirine Versus Integrase Inhibitors With Backbone of Emtricitabine and Tenofovir Alafenamide on Instigators of Atherosclerosis in Persons With Chronic Treated HIV.

Clinical trial2025-12-01Completed · ClinicalTrials.gov

A Randomized Comparative Phase II Trial Evaluating the Capacity of the Dual Combination Doravirine/Raltegravir to Maintain Virological Success in HIV-1 Infected Patients With an HIV-RNA Plasma Viremia Below 50 Copies/mL Under a Current Antiretroviral Regimen

Clinical trial2025-10-30Primary completion · ClinicalTrials.gov

Doravirine for Obese Persons on Integrase Inhibitors and Tenofovir Alafenamide (The Do IT Study)

Clinical trial2025-07-02Results posted · ClinicalTrials.gov

Open-label, Single-arm, Unicenter and Pilot Study of a Switch Strategy From Etravirine (ETR) to Doravirine (DOR) in Virologically-Suppressed HIV-1 Infected Adults With ETR-Resistance

Clinical trial2024-12-01Primary completion · ClinicalTrials.gov

A Phase 3 Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Evaluate the Safety and Efficacy of Doravirine (MK-1439) 100 mg Once Daily Versus Darunavir 800 mg Once Daily Plus Ritonavir 100 mg Once Daily, Each in Combination With TRUVADA™ or EPZICOM™/KIVEXA™, in Treatment-Naïve HIV-1 Infected Subjects

Clinical trial2024-10-01Results posted · ClinicalTrials.gov

Pharmacokinetics of Plasma Doravirine Once Daily Over 72 Hours Following Drug Intake Cessation in Healthy Volunteers

Clinical trial2024-09-19Results posted · ClinicalTrials.gov

Approval: Pifeltro (EMA)

Regulatory2018-11-22EMA

Moderate Hepatic Impairment Does Not Affect Doravirine Pharmacokinetics.

Research2016-12-27Journal of clinical pharmacology

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name

Doravirine

Aliases & brands

DelstrigoIdvynsoPifeltroDoravirinum

RxNorm CUI

2055755

ChEMBL ID

CHEMBL2364608

UNII

913P6LK81M

Regulatory jurisdictions

ema

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval

2018-11-22

Latest approval

2018-11-22

Authorities

EMA

Total events

emaEuropean Medicines Agency· 1 event

2018-11-22Approval

Approval: Pifeltro (EMA)

Indication: Pifeltro is indicated, in combination with other antiretroviral medicinal products, for the treatment of adults, and adolescents aged 12 years and older weighing at least 35 kg… Show full indication

Pifeltro is indicated, in combination with other antiretroviral medicinal products, for the treatment of adults, and adolescents aged 12 years and older weighing at least 35 kg infected with HIV 1 without past or present evidence of resistance to the NNRTI class.

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.