Last reviewed · How we verify
Pifeltro (DORAVIRINE)
Pifeltro works by blocking the reverse transcriptase enzyme, which is essential for the replication of the HIV virus.
At a glance
| Generic name | DORAVIRINE |
|---|---|
| Sponsor | Merck & Co. |
| Drug class | Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC] |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
| First approval | 2018 |
Mechanism of action
Doravirine is an antiretroviral drug [see Microbiology (12.4)].
Approved indications
- Human immunodeficiency virus infection
Common side effects
- Dizziness
- Fatigue
- Nausea
- Diarrhea
- Abdominal Pain
- Headache
- Rash
- Abnormal Dreams
- Insomnia
- Somnolence
- Sleep disorders and disturbances
- Altered sensorium
Key clinical trials
- Switch to Doravirine/Islatravir (DOR/ISL) in Human Immunodeficiency Virus 1 (HIV-1) Participants Treated With Bictegravir/Emtricitabine/Tenofovir Alafenamide (BIC/FTC/TAF) (MK-8591A-018) (PHASE3)
- Doravirine (DOR) in Human Immunodeficiency Virus (HIV)-Infected Children Aged 4 Weeks to <12 Years and <45 kg (MK-1439-066) (PHASE2)
- A Study of Doravirine/Islatravir in Healthy Lactating Females (MK-8591A-061) (PHASE1)
- Doravirine Dose Optimisation in Pregnancy (PHASE4)
- Safety and Efficacy of a Switch to Doravirine/Islatravir in Participants With HIV-1 (MK-8591A-017) (PHASE3)
- Doravirine Versus Integrase Inhibitors on Backbone of Emtricitabine and Tenofovir Alafenamide in HIV (EARLY_PHASE1)
- Study of Doravirine/Islatravir (DOR/ISL 100 mg/0.75 mg) to Evaluate the Antiretroviral Activity, Safety, and Tolerability in Treatment-Naïve Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Infection (MK-8591A-020) (PHASE3)
- Efficacy and Safety of Doravirine in the Rapid Initiation (PHASE4)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Pifeltro CI brief — competitive landscape report
- Pifeltro updates RSS · CI watch RSS
- Merck & Co. portfolio CI