Also known as: PIFELTRO
Doravirine is an oral non-nucleoside reverse transcriptase inhibitor (NNRTI) developed by Merck for HIV treatment. It is marketed as Pifeltro and is also used in fixed-dose combinations such as Delstrigo. The drug was approved in the U.S. in August 2018.
The FDA is set to make decisions on four drug applications in April 2026, including Orca-T for hematological malignancies, orforglipron for obesity, sparsentan for kidney disease, and a doravirine/islatravir combination for HIV-1.
Merck announced Phase 3 trial results for its investigational once-daily, two-drug HIV regimen doravirine/islatravir at CROI 2026, demonstrating non-inferiority to standard treatment in treatment-naïve adults with viral suppression rates of 91.8% at Week 48.
Merck stock reached a 52-week high at $122.69, rising 46.25% over 12 months and 7.4% in the past month following strong Q4 results and improved long-term pipeline outlook beyond Keytruda's 2028 patent expiration.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT05761509 |
"Observational Study on Tolerability and Observance of Post-exposure Prophylaxis With Doravirine in HIV Viral Risk" |
COMPLETED | |
| NCT05630638 |
Doravirine Dose Optimisation in Pregnancy |
RECRUITING | PHASE4 |
| NCT05322083 |
HIV A6 Genome In ART Unsuccessful Patients On DOR |
UNKNOWN | |
| NCT05202613 |
Non-Interventional Observational Retrospective Study to Evaluate Doravirine Based-regimens in HIV Infected Aged Patients (DORAge). |
UNKNOWN | |
| NCT04900974 |
Single Dose Pharmacokinetics of Doravirine in HIV-infected Pregnant Women |
COMPLETED | PHASE1 |
| NCT04892654 |
Efficacy of Doravirine + Dolutegravir Dual Therapy in the Context of Antiretroviral Therapy Switch |
RECRUITING | PHASE3 |
| NCT04689737 |
Removal of Doravirine by Hemodialysis in HIV-Infected Patients With End-stage Renal Disease (ESRD) |
COMPLETED | PHASE4 |
| NCT04495348 |
Explorations Into the Mechanism for INSTI-associated Weight Gain: a Focus on Energy Balance |
COMPLETED | |
| NCT04375800 |
Doravirine (DOR) in Human Immunodeficiency Virus (HIV)-Infected Children Aged 4 Weeks to <12 Years and <45 kg (MK-1439-066) |
RECRUITING | PHASE2 |
| NCT04334551 |
HIV Switch Trial in Experienced Patients With Multiple Class Resistance Including NNRTI Resistance |
UNKNOWN | PHASE4 |
