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DTG based ARV regimen with ABC
DTG based ARV regimen with ABC is a HIV-1 integrase inhibitor Small molecule drug developed by ViiV Healthcare. It is currently in Phase 2 development for HIV-1 infection.
Inhibits HIV-1 integrase
Inhibits HIV-1 integrase Used for HIV-1 infection.
-
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). -
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 | 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 | DTG based ARV regimen with ABC |
|---|---|
| Sponsor | ViiV Healthcare |
| Drug class | HIV-1 integrase inhibitor |
| Target | HIV-1 integrase |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | Phase 2 |
Mechanism of action
DTG (dolutegravir) is an HIV-1 integrase strand transfer inhibitor (INSTI) that blocks the integration of viral DNA into host DNA.
Approved indications
- HIV-1 infection
Common side effects
- Nausea
- Diarrhea
- Fatigue
Key clinical trials
- Study Evaluating the Efficacy, Safety, and Tolerability of Switching to Long-acting Cabotegravir Plus Long-acting Rilpivirine From Current Antiretroviral Regimen in Virologically Suppressed HIV-1-infected Adults (PHASE3)
- A Study of Switching to RPV Plus Other ARVs in HIV-1-infected Children (Aged 2 to <12 Years) Who Are Virologically Suppressed (PHASE2)
- PRJ2203: Dolutegravir Post Authorization Safety Study (PASS)
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:
- DTG based ARV regimen with ABC CI brief — competitive landscape report
- DTG based ARV regimen with ABC updates RSS · CI watch RSS
- ViiV Healthcare portfolio CI
Frequently asked questions about DTG based ARV regimen with ABC
What is DTG based ARV regimen with ABC?
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What does DTG based ARV regimen with ABC target?
Related
- Drug class: All HIV-1 integrase inhibitor drugs
- Target: All drugs targeting HIV-1 integrase
- Manufacturer: ViiV Healthcare — full pipeline
- Therapeutic area: All drugs in Infectious Disease
- Indication: Drugs for HIV-1 infection
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing