HIV-1 protease Inhibitors
2 drugsAbout HIV-1 protease
HIV-1 protease is an essential retroviral aspartyl protease required for HIV replication. It cleaves viral precursor polyproteins into functional proteins, enabling viral assembly and infectivity. Inhibiting HIV-1 protease prevents the maturation of new viral particles, halting further infection.
HIV-1 protease is a well-validated drug target due to its crucial role in the HIV lifecycle. Although there is currently no genetic evidence linking HIV-1 protease to specific diseases, its essential function makes it a significant target for drug development.
Two FDA-approved drugs target HIV-1 protease: VIRACEPT and PAXLOVID. Both are small molecule inhibitors developed by AGOURON PHARMS and Pfizer, respectively, for infectious disease indications.
Top HIV-1 protease Drugs
The competitive landscape includes AGOURON PHARMS and Pfizer, each with an approved drug.
Low market concentration suggests opportunity for new entrants, but high entry barriers due to established players.
HIV-1 protease Drug Modality Landscape
Modalities
Routes of Administration
Only one approved drug targets HIV-1 protease, using small molecule modality.
Explore alternative modalities like antibodies or PROTACs to differentiate from existing therapies.
HIV-1 protease Clinical Trials 60 trials
Phase 1-4 trials started in 2008 or later that test an FDA-approved drug acting on HIV-1 protease. Source: ClinicalTrials.gov. How we count
Completion by Phase
| Phase | Total | Completed | Stopped | Active | Completion |
|---|---|---|---|---|---|
| Phase 1 | 24 | 13 | 8 | 3 | 62% |
| Phase 2 | 22 | 13 | 6 | 3 | 68% |
| Phase 3 | 10 | 4 | 0 | 6 | 100% |
| Phase 4 | 4 | 2 | 0 | 2 | 100% |
Top Sponsors
By Modality
Top Conditions
Top Drugs
HIV-1 protease Drug Approval Timeline (2023 - 2023)
The first drug, VIRACEPT, was approved in 1997, and the most recent, PAXLOVID, in 2023, spanning 27 years.
Recent approval of PAXLOVID indicates continued interest in this target, but potential market saturation warrants careful consideration.
Pro Intelligence Preview
Deep insights for drug target analysis
Competitive Landscape
- • 2 companies competing
- • Market share by company
Full Drug Portfolio
- • All 2 approved drugs
- • Approval dates & indications
Genetic Validation
- • Full genetic evidence table
- • Effect sizes & directions
Approval Timeline
- • Full 2-drug timeline
- • First-of-modality markers
Clinical Trials Analysis
- • Sponsors: 39 (4 companies)
- • Completion rates by condition
Full summary • All drugs • Genetic evidence • Trials • Timeline
How We Count Trials
- Trials: phase 1-4 interventional trials on ClinicalTrials.gov that started in 2008 or later and test an FDA-approved drug acting on HIV-1 protease. A trial counts if an approved drug acting on HIV-1 protease is in any arm, including as a comparator, and a trial that tests two such drugs counts once. Trials that test only unapproved drugs are not counted. A trial listed as phase 1/2 counts as phase 1, and phase 2/3 as phase 2.
- Active: recruiting, not yet recruiting, enrolling by invitation, or active and no longer recruiting.
- Completion rate: of the trials that have ended, the share marked Completed rather than Terminated or Withdrawn. Completed means the trial ended as planned; it does not mean the drug worked. Suspended trials are not counted as ended.
- Stopped: terminated or withdrawn. Trials stop for many reasons, including slow enrolment and business decisions, not only safety or efficacy.
- Sponsors: the lead sponsor of each trial. Companies are the sponsors ClinicalTrials.gov classes as industry; the rest are universities, hospitals, cooperative groups, government bodies and individuals.