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Atazanavir capsules
Atazanavir capsules is a HIV protease inhibitor Small molecule drug developed by Bristol-Myers Squibb. It is currently in Phase 3 development for HIV-1 infection in treatment-naïve and treatment-experienced patients (as part of combination antiretroviral therapy).
Atazanavir inhibits HIV protease, preventing the cleavage of viral polyproteins and blocking the maturation of infectious HIV particles.
Atazanavir inhibits HIV protease, preventing the cleavage of viral polyproteins and blocking the maturation of infectious HIV particles. Used for HIV-1 infection in treatment-naïve and treatment-experienced patients (as part of combination antiretroviral therapy).
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Anti-infectives pathway favourability
+2.0pp
Microbiological endpoints + non-inferiority designs raise approval rates above baseline. -
Big-pharma sponsor
+3.0pp
Bristol-Myers Squibb is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Atazanavir capsules |
|---|---|
| Sponsor | Bristol-Myers Squibb |
| Drug class | HIV protease inhibitor |
| Target | HIV protease |
| Modality | Small molecule |
| Therapeutic area | Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
Atazanavir is a protease inhibitor that binds to the active site of HIV protease, an enzyme essential for processing viral precursor proteins into functional components. By blocking this enzymatic activity, the drug prevents the formation of mature, infectious viral particles, thereby reducing viral replication and slowing disease progression. It is typically used as part of combination antiretroviral therapy (cART) in HIV-infected patients.
Approved indications
- HIV-1 infection in treatment-naïve and treatment-experienced patients (as part of combination antiretroviral therapy)
Common side effects
- Hyperbilirubinemia
- Jaundice
- Nausea
- Diarrhea
- Headache
- Rash
- Nephrolithiasis
Key clinical trials
- Study of Cobicistat-Boosted Atazanavir (ATV/co), Cobicistat-Boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in Children With HIV (PHASE2, PHASE3)
- Antiviral Agents Against COVID-19 Infection (PHASE2, PHASE3)
- A Study to Determine Safety and Efficacy of Dolutegravir/Abacavir/Lamivudine (DTG/ABC/3TC) in Human Immunodeficiency Virus (HIV)-1 Infected Antiretroviral Therapy (ART) Naïve Women (ARIA) (PHASE3)
- Open-Label Study Comparing Efficacy and Safety of ATV/RTV+3TC With ATV/RTV+TDF/FTC in HIV-Infected, Treatment Naïve Subjects, Followed by Treatment With ATV/RTV+3TC (PHASE3)
- Second-line Treatment of HIV-1 With Ritonavir Boosted Atazanavir or Darunavir With an Optimized NRTI Backbone (PHASE3)
- NA-831, Atazanavir and Dexamethasone Combination Therapy for the Treatment of COVID-19 Infection (PHASE2, PHASE3)
- Atazanavir Used in Combination With Other Anti-HIV Drugs in HIV-Infected Infants, Children, and Adolescents (PHASE1, PHASE2)
- Study to Evaluate Switching From a TDF-Containing Combination Regimen to a TAF-Containing Fixed Dose Combination (FDC) in Virologically-Suppressed, HIV-1 Positive Participants (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Atazanavir capsules CI brief — competitive landscape report
- Atazanavir capsules updates RSS · CI watch RSS
- Bristol-Myers Squibb portfolio CI
Frequently asked questions about Atazanavir capsules
What is Atazanavir capsules?
How does Atazanavir capsules work?
What is Atazanavir capsules used for?
Who makes Atazanavir capsules?
What drug class is Atazanavir capsules in?
What development phase is Atazanavir capsules in?
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What does Atazanavir capsules target?
Related
- Drug class: All HIV protease inhibitor drugs
- Target: All drugs targeting HIV protease
- Manufacturer: Bristol-Myers Squibb — full pipeline
- Therapeutic area: All drugs in Infectious Disease
- Indication: Drugs for HIV-1 infection in treatment-naïve and treatment-experienced patients (as part of combination antiretroviral therapy)
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing