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Comparator: efavirenz
Comparator: efavirenz is a Non-nucleoside reverse transcriptase inhibitor (NNRTI) Small molecule drug developed by Merck Sharp & Dohme LLC. It is currently in Phase 3 development for HIV-1 infection (as part of combination antiretroviral therapy). Also known as: Sustiva®.
Efavirenz is a non-nucleoside reverse transcriptase inhibitor (NNRTI) that blocks HIV reverse transcriptase to prevent viral replication.
Efavirenz is a non-nucleoside reverse transcriptase inhibitor (NNRTI) that blocks HIV reverse transcriptase to prevent viral replication. Used for HIV-1 infection (as part of combination antiretroviral therapy).
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Anti-infectives pathway favourability
+2.0pp
Microbiological endpoints + non-inferiority designs raise approval rates above baseline. -
Big-pharma sponsor
+3.0pp
Merck Sharp & Dohme LLC is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Comparator: efavirenz |
|---|---|
| Also known as | Sustiva® |
| Sponsor | Merck Sharp & Dohme LLC |
| Drug class | Non-nucleoside reverse transcriptase inhibitor (NNRTI) |
| Target | HIV reverse transcriptase |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease / Virology |
| Phase | Phase 3 |
Mechanism of action
Efavirenz binds directly to HIV reverse transcriptase and inhibits its enzymatic activity, preventing the conversion of viral RNA into DNA. This blocks an essential step in HIV replication and integration into the host genome. It is commonly used as part of combination antiretroviral therapy (cART) for HIV-1 infection.
Approved indications
- HIV-1 infection (as part of combination antiretroviral therapy)
Common side effects
- Dizziness
- Rash
- Nausea
- Headache
- CNS effects (impaired concentration, abnormal dreams)
- Elevated liver enzymes
Key clinical trials
- Safety and Pharmacokinetics of Dolutegravir in Pregnant HIV Mothers and Their Neonates: A Pilot Study (PHASE2, PHASE3)
- Kuwa Free! - Live Free! (NA)
- Comparison of Doravirine, Tenofovir, Lamivudine (MK-1439A) and ATRIPLA™ in Treatment-Naive Human Immunodeficiency Virus Type 1 (HIV-1)-Infected Participants (MK-1439A-021) (PHASE3)
- Efficacy of Efavirenz 400mg vs. 600mg Combined With Lamivudine and Tenofovir in Treatment Naive HIV Infection (NA)
- Switching TDF/FTC/EFV to TDF/FTC/RPV VS Continuing TDF/FTC/EFV in HIV Patients With Complete Virological Suppression (NA)
- Human Immunodeficiency Virus (HIV) Postexposure Prophylaxis (PEP) With Darunavir/Ritonavir (DRV/r) (PHASE3)
- A Study to Evaluate the Safety and Antiretroviral Activity of MK-0518 Versus Efavirenz in Treatment Naive HIV-Infected Patients, Each in Combination With TRUVADA (0518-021 EXT) (PHASE3)
- A Study to Evaluate the Safety and Efficacy of an Investigational Drug in HIV Infected Patients (0518-004)(COMPLETED) (PHASE2)
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 |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Comparator: efavirenz CI brief — competitive landscape report
- Comparator: efavirenz updates RSS · CI watch RSS
- Merck Sharp & Dohme LLC portfolio CI
Frequently asked questions about Comparator: efavirenz
What is Comparator: efavirenz?
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Is Comparator: efavirenz also known as anything else?
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What does Comparator: efavirenz target?
Related
- Drug class: All Non-nucleoside reverse transcriptase inhibitor (NNRTI) drugs
- Target: All drugs targeting HIV reverse transcriptase
- Manufacturer: Merck Sharp & Dohme LLC — full pipeline
- Therapeutic area: All drugs in Infectious Disease / Virology
- Indication: Drugs for HIV-1 infection (as part of combination antiretroviral therapy)
- Also known as: Sustiva®
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing