Last reviewed · How we verify
RITONAVIR
RITONAVIR is a Cytochrome P450 3A Inhibitor [EPC] drug. It is currently FDA-approved (first approved 1996) for HIV-1 Infection Treatment.
Lopinavir and ritonavir tablets increase lopinavir plasma levels by inhibiting its CYP3A-mediated metabolism.
Ritonavir, in combination with lopinavir, is a marketed antiretroviral therapy primarily indicated for the treatment of HIV-1 infection. The drug's key strength lies in its mechanism of action, which increases lopinavir plasma levels by inhibiting CYP3A-mediated metabolism, enhancing therapeutic efficacy. The primary risk is the key composition patent expiry in 2028, which could lead to increased competition from generics.
At a glance
| Generic name | RITONAVIR |
|---|---|
| Drug class | Cytochrome P450 3A Inhibitor [EPC] |
| Target | CYP3A |
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 1996 |
Mechanism of action
Lopinavir and ritonavir tablets are a combination of two HIV-1 antiviral drugs. Ritonavir inhibits the enzyme CYP3A, which normally breaks down lopinavir, leading to higher levels of lopinavir in the bloodstream.
Approved indications
- HIV-1 Infection Treatment
Common side effects
- diarrhea
- nausea
- vomiting
- abdominal pain (upper and lower)
- gastroenteritis and colitis
- dyspepsia
- pancreatitis
- Gastroesophageal Reflux Disease (GERD)
- hemorrhoids
- flatulence
- abdominal distension
- constipation
Drug interactions
- CYP3A substrates
- OATP1B1 substrates
- CYP3A inducers
- CYP3A inhibitors
- fosamprenavir/ritonavir
- indinavir
Key clinical trials
- RECOVER-VITAL: Platform Protocol, Appendix to Measure the Effects of Paxlovid on Long COVID Symptoms (PHASE2)
- A Trial of 2 Options for Second Line Combination Antiretroviral Therapy Following Virological Failure of a Standard Non-nucleoside Reverse Transcriptase Inhibitor (NNRTI)+2N(t)RTI First Line Regimen (PHASE4)
- Study of Cobicistat-Boosted Atazanavir (ATV/co), Cobicistat-Boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in Children With HIV (PHASE2, PHASE3)
- A Study to Provide Continued Access to Study Drug to Children and Adolescents Who Have Completed Clinical Studies Involving Gilead HIV Treatments (PHASE4)
- Pharmacokinetics Safety and Acceptability of DRV/r for Children Living With HIV (PHASE1, PHASE2)
- Early Infant HIV Treatment in Botswana (PHASE2, PHASE3)
- OPtimisation of Antiviral Therapy in Immunocompromised COVID-19 Patients: a Randomized Factorial Controlled Strategy Trial (PHASE2)
- Finding Treatments for COVID-19: A Trial of Antiviral Pharmacodynamics in Early Symptomatic COVID-19 (PLATCOV) (PHASE2)
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 |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| 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:
- RITONAVIR CI brief — competitive landscape report
- RITONAVIR updates RSS · CI watch RSS
Frequently asked questions about RITONAVIR
What is RITONAVIR?
How does RITONAVIR work?
What is RITONAVIR used for?
What drug class is RITONAVIR in?
When was RITONAVIR approved?
What development phase is RITONAVIR in?
What are the side effects of RITONAVIR?
What does RITONAVIR target?
Related
- Drug class: All Cytochrome P450 3A Inhibitor [EPC] drugs
- Target: All drugs targeting CYP3A
- Indication: Drugs for HIV-1 Infection Treatment
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing