What's the most recent regulatory action in Human immunodeficiency virus infection?

Most recent: Pifeltro — FDA approved.

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Last reviewed 2026-06-10 · How we verify

Human immunodeficiency virus infection — Treatment Landscape & Competitive Intelligence

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Human immunodeficiency virus infection (disease) competitive landscape: 10 marketed treatments tracked, 0 Phase 3 candidates, 0 Phase 2 candidates. Recent regulatory actions and upcoming PDUFA dates across the entire treatment set.

10 marketed 0 Phase 3 0 Phase 2 Live · 30-min refresh

Marketed treatment landscape

Approved drugs treating Human immunodeficiency virus infection, deduplicated by molecule. See the full disease page for line-of-therapy detail.

Drug	Generic	Sponsor	Class	Target	First approval
Trogarzo	IBALIZUMAB	Taimed Biologics Usa	CD4-directed Blocking Antibody [EPC]	T-cell surface glycoprotein CD4	2018-01-01
Pifeltro	DORAVIRINE	Merck & Co.	Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]		2018-01-01
Biktarvy	BICTEGRAVIR	Gilead Sciences	Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]		2018-01-01
Vemlidy	TENOFOVIR ALAFENAMIDE	Gilead Sciences	Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]		2015-01-01
Tivicay	DOLUTEGRAVIR	GSK	Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]	Transmembrane protein 97	2013-01-01
Tybost	COBICISTAT	Gilead Sciences	Cytochrome P450 3A Inhibitor [EPC]	Cytochrome P450 3A	2012-01-01
Vitekta	ELVITEGRAVIR	Gilead Sciences	Cytochrome P450 3A Inhibitor [EPC]		2012-01-01
Intelence	ETRAVIRINE	Janssen R And D	Human Immunodeficiency Virus 1 Non-Nucleoside Analog Reverse Transcriptase Inhibitor [EPC]	Canalicular multispecific organic anion transporter 2	2008-01-01
Prezista	DARUNAVIR	Janssen Prods	Protease Inhibitor [EPC]	Multidrug resistance protein 1	2006-01-01
Lexiva	FOSAMPRENAVIR	GSK	Protease Inhibitor		2003-01-01

Phase 3 pipeline

No Phase 3 pipeline candidates tracked.

Phase 2 pipeline

No Phase 2 pipeline candidates tracked.

Recent regulatory actions (last 90 days)

2026-04-20 — Pifeltro · FDA · approved · US

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this treatment set.

Sponsor landscape

GSK · 7 drugs in Human immunodeficiency virus infection
Gilead Sciences · 5 drugs in Human immunodeficiency virus infection
Bristol-Myers Squibb · 4 drugs in Human immunodeficiency virus infection
Boehringer Ingelheim · 2 drugs in Human immunodeficiency virus infection
Saint Michael's Medical Center · 2 drugs in Human immunodeficiency virus infection
Merck & Co. · 2 drugs in Human immunodeficiency virus infection
Pfizer · 1 drug in Human immunodeficiency virus infection
Replicor Inc. · 1 drug in Human immunodeficiency virus infection
Roche · 1 drug in Human immunodeficiency virus infection
St Stephens Aids Trust · 1 drug in Human immunodeficiency virus infection
Taimed Biologics Usa · 1 drug in Human immunodeficiency virus infection
AbbVie · 1 drug in Human immunodeficiency virus infection

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Every new regulatory action, PDUFA date, or trial completion in Human immunodeficiency virus infection:

Cite this brief

Drug Landscape (2026). Human immunodeficiency virus infection — Treatment Landscape & Competitive Intelligence Brief. https://druglandscape.com/ci/disease/human-immunodeficiency-virus-infection. Accessed 2026-06-10.

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