Last reviewed · How we verify
Atazanavir (immediate switch)
Atazanavir (immediate switch) 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-naive and treatment-experienced adults, HIV-1 infection in combination antiretroviral therapy. Also known as: Reyataz.
Atazanavir is a protease inhibitor that blocks HIV protease, preventing the cleavage of viral polyproteins and inhibiting viral replication.
Atazanavir is a small molecule inhibitor of the human immunodeficiency virus type 1 protease. It is used to treat HIV-1 infection, typically as part of a regimen that includes other antiretroviral medications such as doravirine, tenofovir, and lamivudine.
-
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 (immediate switch) |
|---|---|
| Also known as | Reyataz |
| 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 binds to the active site of HIV protease, a viral enzyme essential for processing precursor proteins into functional viral components. By preventing this proteolytic cleavage, the drug blocks the maturation of infectious HIV virions, reducing viral load in infected individuals. The immediate-switch formulation refers to a dosing strategy allowing rapid transition from other antiretroviral regimens.
Approved indications
- HIV-1 infection in treatment-naive and treatment-experienced adults
- HIV-1 infection in combination antiretroviral therapy
Common side effects
- Hyperbilirubinemia
- Jaundice
- Nausea
- Diarrhea
- Headache
- Rash
- Nephrolithiasis
Key clinical trials
- Safety and Efficacy of a Switch to Doravirine, Tenofovir, Lamivudine (MK-1439A) in Human Immunodeficiency Virus (HIV-1)-Infected Participants Virologically Suppressed on an Anti-retroviral Regimen in Combination With Two Nucleoside Reverse Transcriptase Inhibitors (MK-1439A-024) (PHASE3)
- A Phase IIIB Study Evaluating the Effect on Serum Lipids Following a Switch to Atazanavir in HIV Infected Subjects Evidencing Virologic Suppression on Their First PI-Based Antiretroviral Therapy (PHASE3)
- Study of HIV Patients With Undetectable Viral Load and Abnormal Lipids Switching to Atazanavir/Ritonavir (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 (immediate switch) CI brief — competitive landscape report
- Atazanavir (immediate switch) updates RSS · CI watch RSS
- Bristol-Myers Squibb portfolio CI
Frequently asked questions about Atazanavir (immediate switch)
What is Atazanavir (immediate switch)?
How does Atazanavir (immediate switch) work?
What is Atazanavir (immediate switch) used for?
Who makes Atazanavir (immediate switch)?
Is Atazanavir (immediate switch) also known as anything else?
What drug class is Atazanavir (immediate switch) in?
What development phase is Atazanavir (immediate switch) in?
What are the side effects of Atazanavir (immediate switch)?
What does Atazanavir (immediate switch) 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-naive and treatment-experienced adults
- Indication: Drugs for HIV-1 infection in combination antiretroviral therapy
- Also known as: Reyataz
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing