Wednesday, July 8, 2026

Drug profile · INN

dolutegravir

dolutegravir (TIVICAY) is an FDA-listed pharmaceutical active ingredient. Associated with ViiV Healthcare Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

FDA: approved EMA: approved TGA: approved Antiinfectives for systemic use (J05) J05AR
US status approved
Patents linked 0
Pipeline programs 17
News articles 0
Drug details — dolutegravir
US status
approved
Class
Antiinfectives for systemic use (J05)
Route
ORAL
Patents
0
Programs
17
Data quality
0.89

Quick answer

dolutegravir (TIVICAY) is an FDA-listed pharmaceutical active ingredient. Associated with ViiV Healthcare Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN dolutegravir
Brand TIVICAY
Therapeutic class Antiinfectives for systemic use (J05)
Route ORAL
Formulation FILM
ATC code J05AR

Approval history

Authority Status Date
FDA approved
EMA approved
TGA approved

Pipeline programs

  1. CVAY736F12301 Phase 3 · Novartis India · Systemic Lupus Erythematosus
  2. Dolutegravir/abacavir/lamivudine FDC Phase 3 · ViiV Healthcare · Infection, Human Immunodeficiency Virus
  3. GS-US-528-6727 Phase 3 · Gilead Sciences · Human Immunodeficiency Virus (HIV-1) infection
  4. GS-US-563-5926 Phase 3 · Gilead Sciences · HIV-1 Infection
  5. MK-8527-011 Phase 3 · MSD Merck Sharp · HIV-1 prevention
  6. Tenofovir DF Phase 3 · Gilead Sciences Ireland · Chronic Hepatitis B
  7. Tenofovir gel Phase 3 · United Therapeutics Europe · HIV Prevention
  8. 222638 Phase 2 · ViiV Healthcare Pty · HIV Infections

Related & competitor drugs

  1. atazanavir sulfate Antiinfectives for systemic use (J05)
  2. colistimethate sodium Antiinfectives for systemic use (J01)
  3. covid-19 mrna vaccine Antiinfectives for systemic use (J07)
  4. daptomycin Antiinfectives for systemic use (J01)
  5. darunavir Antiinfectives for systemic use (J05)
  6. dengue tetravalent vaccine (live, attenuated) Antiinfectives for systemic use (J07)

Frequently asked questions

What is dolutegravir?

dolutegravir (TIVICAY) is an FDA-listed pharmaceutical active ingredient. Associated with ViiV Healthcare Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for dolutegravir?

TIVICAY is a marketed brand name for dolutegravir. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of dolutegravir?

dolutegravir has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.