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ABC-3TC-EFV once a day
ABC-3TC-EFV once a day is a Antiretroviral combination therapy Small molecule drug developed by ANRS, Emerging Infectious Diseases. It is currently in Phase 2 development.
Combines two nucleoside reverse transcriptase inhibitors (abacavir, lamivudine) with one non-nucleoside reverse transcriptase inhibitor (efavirenz) to block HIV replication.
ABC-3TC-EFV is a once-daily antiretroviral treatment for HIV infections. It is a small molecule combination of the drugs Abacavir, Lamivudine, and Efavirenz.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | ABC-3TC-EFV once a day |
|---|---|
| Sponsor | ANRS, Emerging Infectious Diseases |
| Drug class | Antiretroviral combination therapy |
| Modality | Small molecule |
| Phase | Phase 2 |
Mechanism of action
Abacavir and lamivudine are converted to active metabolites that compete with natural substrates and terminate viral DNA chain elongation. Efavirenz binds directly to reverse transcriptase, causing disruption of the enzyme's catalytic site. Together, they provide complementary inhibition of HIV-1 replication.
Approved indications
Common side effects
Key clinical trials
- Evaluation of Simplified Antiretroviral Treatment Strategies in HIV Infected Children Treated by Antiretroviral (ARV) Before One Year of Age (PHASE2, 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:
- ABC-3TC-EFV once a day CI brief — competitive landscape report
- ABC-3TC-EFV once a day updates RSS · CI watch RSS
- ANRS, Emerging Infectious Diseases portfolio CI
Frequently asked questions about ABC-3TC-EFV once a day
What is ABC-3TC-EFV once a day?
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Related
- Drug class: All Antiretroviral combination therapy drugs
- Manufacturer: ANRS, Emerging Infectious Diseases — full pipeline
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing