Asset profile

Semzuvolimab

Monoclonal antibody

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Phase 3underway

Evidence outlook · registrational

HIV: registrational readout pending

Entered Phase 3 on partial signal mid-stage evidence. The registry's posted readout date (2026-06-30) has passed without a status update. Check News for topline announcements.

NCT04404049: This is a small, open-label randomized study comparing two dosing schedules of add-on Semzuvolimab against standard therapy alone in people already on antiretroviral therapy. The primary measure is treatment-related side effects rather than a virologic or clinical outcome, and results are not yet available, so the evidence for Semzuvolimab's clinical benefit cannot yet be assessed.

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Competitive landscape

60 competitors in this universe: 1 direct rival (same mechanism and indication), 0 same-class, 59 same-indication; 21 further along in development.

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DrugStageModalityMechanismEvidence signalReported efficacygraded featured trials
Semzuvolimab: this drugPhase 3Monoclonal antibodyCD4 receptor
Ibalizumab (Trogarzo)ApprovedMonoclonal antibodyCD4 receptor
Bictegravir (Biktarvy)ApprovedSmall moleculeHIV integrase
Cabotegravir (Vocabria / Cabenuva / Apretude)ApprovedSmall moleculeHIV integrase
Crofelemer (Mytesi)ApprovedSmall moleculeChloride channel (intestinal epithelium)
Darunavir (Prezista)ApprovedSmall moleculeHIV protease
Dolutegravir (Tivicay / Triumeq / Dovato / Juluca (component))ApprovedSmall moleculeHIV integrase
Doravirine (Pifeltro)ApprovedSmall moleculeHIV reverse transcriptase
Elsulfavirine (Elpida)ApprovedSmall moleculeHIV reverse transcriptase
Elvitegravir (Stribild / Genvoya (component))ApprovedSmall moleculeHIV integrase
Emtricitabine / Tenofovir Disoproxil Fumarate (Truvada)ApprovedSmall moleculeHIV reverse transcriptase
Etravirine (Intelence)ApprovedSmall moleculeHIV reverse transcriptase
Fosamprenavir (Lexiva / Telzir)ApprovedSmall moleculeHIV protease
Fostemsavir (Rukobia)ApprovedSmall moleculeHIV gp120
Lenacapavir (Sunlenca / Yeztugo)ApprovedSmall moleculeHIV capsid
Maraviroc (Selzentry / Celsentri)ApprovedSmall moleculeCCR5 co-receptor

…and 45 more. Research shows the complete landscape.

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Research adds each competitor's evidence grade and sourced trial results, aligned per race, so you can see who actually has the data.

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Upcoming events

(1 total)

Estimated primary-completion dates from ClinicalTrials.gov. These are registry estimates, never confirmed readout dates; they can move as trials progress.

2026 (1)
December 2026 (1)
Phase 2HIVNot yet recruiting
Est. primary completion 2026-12 · NCT04985890 · CT.gov ↗
What to watch
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All registered studies

Every ClinicalTrials.gov study of this drug's own program, grouped by indication and phase. Research unlocks the studies themselves: titles, statuses, dates and featured-trial cross-links.