Last reviewed 2026-04-23 · How we verify

DTG based ARV regimen without ABC

ViiV Healthcare · Phase 2 active Small molecule

DTG based ARV regimen without ABC is a Integrase strand transfer inhibitor (INSTI) Small molecule drug developed by ViiV Healthcare. It is currently in Phase 2 development for HIV-1 infection (treatment-naive or treatment-experienced patients).

DTG (dolutegravir) is an integrase strand transfer inhibitor that blocks HIV integrase, preventing the virus from inserting its genetic material into host cell DNA.

DTG (dolutegravir) is an integrase strand transfer inhibitor that blocks HIV integrase, preventing the virus from inserting its genetic material into host cell DNA. Used for HIV-1 infection (treatment-naive or treatment-experienced patients).

Likelihood of approval

17.3% vs 15.3% industry baseline

If approved by FDA: likely 2031–2034

Steps remaining: Phase 3 → NDA/BLA submission

Confidence: Medium

Why this estimate

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.

Predicted approval windows by jurisdiction (conditional on FDA approval)

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 without ABC
Sponsor	ViiV Healthcare
Drug class	Integrase strand transfer inhibitor (INSTI)
Target	HIV integrase
Modality	Small molecule
Therapeutic area	Infectious Disease / Virology
Phase	Phase 2

Mechanism of action

Dolutegravir binds to the HIV integrase enzyme and inhibits its catalytic activity, blocking the strand transfer step of viral integration. This prevents HIV from establishing persistent infection in CD4+ T cells. The regimen formulation without abacavir (ABC) is designed to avoid potential hypersensitivity reactions while maintaining potent antiretroviral activity.

Approved indications

HIV-1 infection (treatment-naive or treatment-experienced patients)

Common side effects

Insomnia
Headache
Diarrhea
Nausea
Fatigue

Key clinical trials

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 without ABC CI brief — competitive landscape report
DTG based ARV regimen without ABC updates RSS · CI watch RSS
ViiV Healthcare portfolio CI

Frequently asked questions about DTG based ARV regimen without ABC

What is DTG based ARV regimen without ABC?

DTG based ARV regimen without ABC is a Integrase strand transfer inhibitor (INSTI) drug developed by ViiV Healthcare, indicated for HIV-1 infection (treatment-naive or treatment-experienced patients).

How does DTG based ARV regimen without ABC work?

DTG (dolutegravir) is an integrase strand transfer inhibitor that blocks HIV integrase, preventing the virus from inserting its genetic material into host cell DNA.

What is DTG based ARV regimen without ABC used for?

DTG based ARV regimen without ABC is indicated for HIV-1 infection (treatment-naive or treatment-experienced patients).

Who makes DTG based ARV regimen without ABC?

DTG based ARV regimen without ABC is developed by ViiV Healthcare (see full ViiV Healthcare pipeline at /company/viiv-healthcare).

What drug class is DTG based ARV regimen without ABC in?

DTG based ARV regimen without ABC belongs to the Integrase strand transfer inhibitor (INSTI) class. See all Integrase strand transfer inhibitor (INSTI) drugs at /class/integrase-strand-transfer-inhibitor-insti.

What development phase is DTG based ARV regimen without ABC in?

DTG based ARV regimen without ABC is in Phase 2.

What are the side effects of DTG based ARV regimen without ABC?

Common side effects of DTG based ARV regimen without ABC include Insomnia, Headache, Diarrhea, Nausea, Fatigue.

What does DTG based ARV regimen without ABC target?

DTG based ARV regimen without ABC targets HIV integrase and is a Integrase strand transfer inhibitor (INSTI).

Drug class: All Integrase strand transfer inhibitor (INSTI) drugs
Target: All drugs targeting HIV integrase
Manufacturer: ViiV Healthcare — full pipeline
Therapeutic area: All drugs in Infectious Disease / Virology
Indication: Drugs for HIV-1 infection (treatment-naive or treatment-experienced patients)

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing