Asset profile
Ulonivirine
Small molecule
Evidence outlook · registrational
HIV: registrational readout pending
Entered Phase 3 on partial signal mid-stage evidence. Registrational readout expected around 2029-02-01.
NCT04564547: Randomized, triple-masked phase 2b switch study of once-weekly islatravir plus ulonivirine in virologically suppressed HIV-1 infection (161 participants). All three primary endpoints are adverse-event rates reported descriptively; no efficacy comparison was posted as primary.
How the evidence outlook works ↗
Featured trials
The studies most instrumental to this drug's clinical progression, individually graded on design and result. Pick an indication; Research unlocks the trials, endpoints, key results and grades.
Competitive landscape
60 competitors in this universe: 11 direct rivals (same mechanism and indication), 0 same-class, 49 same-indication; 31 further along in development.
| Drug | Stage | Modality | Mechanism | Evidence signal | Reported efficacygraded featured trials |
|---|---|---|---|---|---|
| Ulonivirine: this drug | Phase 2/3 | Small molecule | HIV reverse transcriptase | ||
| Doravirine (Pifeltro) | Approved | Small molecule | HIV reverse transcriptase | ||
| Elsulfavirine (Elpida) | Approved | Small molecule | HIV reverse transcriptase | ||
| Emtricitabine / Tenofovir Disoproxil Fumarate (Truvada) | Approved | Small molecule | HIV reverse transcriptase | ||
| Etravirine (Intelence) | Approved | Small molecule | HIV reverse transcriptase | ||
| Rilpivirine (Edurant) | Approved | Small molecule | HIV reverse transcriptase | ||
| Tenofovir Alafenamide / Emtricitabine (Descovy) | Approved | Small molecule | HIV reverse transcriptase | ||
| Alimatravir | Phase 3 | Small molecule | HIV reverse transcriptase | ||
| Azvudine (FNC) | Phase 3 | Small molecule | HIV reverse transcriptase | ||
| Dapivirine (Dapivirine Vaginal Ring) | Phase 3 | Small molecule | HIV reverse transcriptase | ||
| CL-197 | Phase 2 | Small molecule | HIV reverse transcriptase | ||
| Ainuovirine | Phase 1 | Small molecule | HIV reverse transcriptase | ||
| Bictegravir (Biktarvy) | Approved | Small molecule | HIV integrase | ||
| Cabotegravir (Vocabria / Cabenuva / Apretude) | Approved | Small molecule | HIV integrase | ||
| Crofelemer (Mytesi) | Approved | Small molecule | Chloride channel (intestinal epithelium) | ||
| Darunavir (Prezista) | Approved | Small molecule | HIV protease |
…and 45 more. Research shows the complete landscape.
Unlock the full comparison
Research adds each competitor's evidence grade and sourced trial results, aligned per race, so you can see who actually has the data.
Compare head-to-head
5 further head-to-head pairs are tracked; the rosters on each shared mechanism and indication page list every rival in the race.
Upcoming events
(4 total)
Estimated primary-completion dates from ClinicalTrials.gov. These are registry estimates, never confirmed readout dates; they can move as trials progress.
2027 (3)
January 2027 (1)
June 2027 (1)
What to watch
August 2027 (1)
What to watch
2029 (1)
February 2029 (1)
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.