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Raltegravir/3TC
Raltegravir/3TC is a Integrase strand transfer inhibitor (INSTI) and Nucleoside reverse transcriptase inhibitor (NRTI) combination Small molecule drug developed by Juan A. Arnaiz. It is currently in Phase 3 development for Treatment of HIV-1 infection in adults and pediatric patients 4 weeks of age and older without antiretroviral treatment experience and with a viral load of 100,000 copies/mL or greater.
Raltegravir/3TC is an integrase strand transfer inhibitor (INSTI) and a nucleoside reverse transcriptase inhibitor (NRTI) combination used to treat HIV-1 infection.
Raltegravir, in combination with 3TC (lamivudine or emtricitabine), is used to treat HIV infections. Raltegravir is a small molecule that works by inhibiting the integrase enzyme of the HIV virus.
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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.
| 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 | Raltegravir/3TC |
|---|---|
| Sponsor | Juan A. Arnaiz |
| Drug class | Integrase strand transfer inhibitor (INSTI) and Nucleoside reverse transcriptase inhibitor (NRTI) combination |
| Target | Integrase enzyme |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
This combination works by inhibiting the integrase enzyme, which is essential for the replication of HIV-1, and also by incorporating nucleoside analogs into the viral DNA, thereby terminating its replication. The combination of these two mechanisms provides a synergistic effect, making it more effective in suppressing HIV-1 replication.
Approved indications
- Treatment of HIV-1 infection in adults and pediatric patients 4 weeks of age and older without antiretroviral treatment experience and with a viral load of 100,000 copies/mL or greater
Common side effects
- Nausea
- Diarrhea
- Fatigue
Key clinical trials
- Study of Cobicistat-Boosted Atazanavir (ATV/co), Cobicistat-Boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in Children With HIV (PHASE2, PHASE3)
- A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments (PHASE4)
- Study to Compare an Oral Weekly Islatravir/Lenacapavir Regimen With Standard of Care in Virologically Suppressed People With HIV-1 (PHASE3)
- Study to Compare Bictegravir/Lenacapavir Versus Current Therapy in People With HIV-1 Who Are Successfully Treated With a Complicated Regimen (PHASE2, PHASE3)
- Research on the Psychological Status of Patients With HIV-1 Infection
- Safety & Efficacy of Dual Therapy With Raltegravir/Lamivudine (PHASE3)
- Simplification Study of HIV-1 Infected Patients With Virological Suppression Under the Combination of Lamivudine (150 mg BID) Plus Raltegravir (400 mg BID) Switching to Lamivudine (300 mg QD) Plus Raltegravir (1200 mg QD) : Roll-over Study of the RALAM (PHASE3)
- Study With Dual Therapy Including Lamivudine (300 mg QD) Plus Raltegravir (1200 mg QD) in Virologically Suppressed HIV-1 Infected Patients Experiencing Inconvenience, Toxicity, Negative Impact on Co-morbidities or Risk of Drug-drug Interactions With Their Current Regimen (PHASE3)
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:
- Raltegravir/3TC CI brief — competitive landscape report
- Raltegravir/3TC updates RSS · CI watch RSS
- Juan A. Arnaiz portfolio CI
Frequently asked questions about Raltegravir/3TC
What is Raltegravir/3TC?
How does Raltegravir/3TC work?
What is Raltegravir/3TC used for?
Who makes Raltegravir/3TC?
What drug class is Raltegravir/3TC in?
What development phase is Raltegravir/3TC in?
What are the side effects of Raltegravir/3TC?
What does Raltegravir/3TC target?
Related
- Drug class: All Integrase strand transfer inhibitor (INSTI) and Nucleoside reverse transcriptase inhibitor (NRTI) combination drugs
- Target: All drugs targeting Integrase enzyme
- Manufacturer: Juan A. Arnaiz — full pipeline
- Therapeutic area: All drugs in Infectious Disease
- Indication: Drugs for Treatment of HIV-1 infection in adults and pediatric patients 4 weeks of age and older without antiretroviral treatment experience and with a viral load of 100,000 copies/mL or greater
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing