RITONAVIR
Ritonavir helps patients with HIV-1 infection when used in combination with other antiretroviral medications. It is prescribed as part of a multi-drug regimen to manage the virus and support the immune system. This medication belongs to a class of drugs that targets specific viral proteins to control the progression of the infection.
How RITONAVIR Works
This medication works by inhibiting the HIV protease enzyme, which is essential for the virus to function. As an antiretroviral agent, it also acts as a Cytochrome P450 3A inhibitor to assist in the treatment of the infection. By blocking these specific pathways, the drug helps limit the activity of the HIV-1 virus within the body.
Details
- Status
- Prescription
- First Approved
- 2015-01-15
- Routes
- ORAL
- Dosage Forms
- CAPSULE, TABLET
RITONAVIR Approval History
What RITONAVIR Treats
1 indicationsRITONAVIR is approved for 1 conditions since its original approval in 2015. These indications span multiple therapeutic areas including oncology, immunology, and more.
- HIV-1 Infection
RITONAVIR Boxed Warning
DRUG-DRUG INTERACTIONS LEADING TO POTENTIALLY SERIOUS AND/OR LIFE THREATENING REACTIONS Co-administration of ritonavir with several classes of drugs including sedative hypnotics, antiarrhythmics, or ergot alkaloid preparations may result in potentially serious and/or life-threatening adverse events due to possible effects of ritonavir on the hepatic metabolism of certain drugs. Review medications taken by patients prior to prescribing ritonavir or when prescribing other medications to patients a...
WARNING: DRUG-DRUG INTERACTIONS LEADING TO POTENTIALLY SERIOUS AND/OR LIFE THREATENING REACTIONS Co-administration of ritonavir with several classes of drugs including sedative hypnotics, antiarrhythmics, or ergot alkaloid preparations may result in potentially serious and/or life-threatening adverse events due to possible effects of ritonavir on the hepatic metabolism of certain drugs. Review medications taken by patients prior to prescribing ritonavir or when prescribing other medications to patients already taking ritonavir [see Contraindications (4) , Warnings and Precautions (5.1) ]. WARNING: DRUG-DRUG INTERACTIONS LEADING TO POTENTIALLY SERIOUS AND/OR LIFE THREATENING REACTIONS See full prescribing information for complete boxed warning Co-administration of ritonavir with several classes of drugs including sedative hypnotics, antiarrhythmics, or ergot alkaloid preparations may result in potentially serious and/or life-threatening adverse events due to possible effects of ritonavir on the hepatic metabolism of certain drugs. Review medications taken by patients prior to prescribing ritonavir or when prescribing other medications to patients already taking ritonavir. ( 4 , 5.1 )
RITONAVIR Competitive Set
ProThree rings of competition based on shared molecular targets and treated indications.
Indication competitors
Same indication, different mechanism — what else might this patient receive?
Filters applied: drops same-active-ingredient (505(b)(2) reformulations), route-mismatch (topical vs systemic), and cross-therapeutic-area matches in same-indication rings.
Drugs Similar to RITONAVIR
3 of 20FDA-approved drugs for similar conditions. Compare mechanisms and indications to understand treatment alternatives.
Clinical Trial Registry
155 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT05441215 results posted | C4671039 2022-001020-15 | Ph 1 | completed | A Study to Learn About the Medicine (PF-07321332 or Nirmatrelvir/Ritonavir) in Healthy Lactating Women |
| NCT05229991 LOWR6 | SOR-0527-20-CTIL SCRC20042 | Ph 3 | completed | Once Daily Dosing of Lonafarnib Co-administered With Ritonavir for Treatment of Chronic Hepatitis D Virus Infection |
| NCT00528060 ANRS134COPHAR3 | ANRS 134 Cophar 3 2007-003203-12 | Ph 2 | completed | Measure of Pharmacokinetic Parameters and Adherence With MEMS in Naive HIV Infected Patients Treated With Reyataz Once Daily Combined With Norvir and Truvada |
| NCT05965726 RECOVER-VITAL results posted | Pro00111697_A OTA-21-015G | Ph 2 | completed | RECOVER-VITAL: Platform Protocol, Appendix to Measure the Effects of Paxlovid on Long COVID Symptoms |
| NCT05150691 | DB-1303-O-1001 | Ph 1, Ph 2 | recruiting | A Phase 1/2a Study of DB-1303/BNT323 in Advanced/Metastatic Solid Tumors |
| NCT05576662 STOP-PASC results posted | 66994 | Ph 2 | completed | Paxlovid for Treatment of Long Covid |
| NCT02470650 | Cost-Effect-Clinic 2014-004820-24 | Ph 4 | withdrawn | Cost-effectiveness of Different Antiretroviral Treatment in Patients HIV Naive |
| NCT05386472 | C4671035 NCT05386472 | Ph 1 | terminated | A Study to Learn About the Study Medicine (Nirmatrelvir Plus Ritonavir) in Pregnant Women With COVID-19 |
| NCT05261139 | C4671026 2023-509773-23-00 | Ph 3 | recruiting | EPIC-Peds: A Study to Learn About the Study Medicine Called PF-07321332 (Nirmatrelvir)/Ritonavir in Patients Under 18 Years of Age With COVID-19 That Are Not Hospitalized But Are at Risk for Severe Disease |
| NCT04960202 results posted | C4671005 2021-002895-38, EPIC-HR | Ph 2, Ph 3 | completed | EPIC-HR: Study of Oral PF-07321332/Ritonavir Compared With Placebo in Nonhospitalized High Risk Adults With COVID-19 |
| NCT06428045 STARLITE | 20231163 | Ph 1 | recruiting | STARLITE for Unresectable High-Grade Gliomas |
| NCT03593954 | CR108479 61393215EDI1003 | Ph 1 | completed | A Study to Assess the Effect of Ritonavir on the Single-Dose Pharmacokinetics of JNJ-61393215 in Healthy Participants |
| NCT06710990 | SHR-A1811-105 | Ph 1 | recruiting | Investigation of Drug-drug Interaction of Ritonavir and Itraconazole on the Pharmacokinetics of SHR-A1811 in Subjects With HER2-expressing Advanced Breast Cancer |
| NCT04208061 | CR108697 2019-003328-19, TMC114FD1HTX1002 | Ph 1 | completed | A Study of Darunavir in Combination With Cobicistat or Ritonavir, and Dabigatran Etexilate in Healthy Participants |
| NCT05668091 | 2000034086 CIICORE-01 | Ph 2 | completed | A Decentralized, Randomized Phase 2 Efficacy and Safety Study of Nirmatrelvir/Ritonavir in Adults with Long COVID. |
| NCT01400412 results posted | ACTG A5303 1U01AI068636 | Ph 2 | completed | Bone, Immunologic, and Virologic Effects of a Antiretroviral Regimen |
| NCT05567952 results posted | C4671042 2022-002827-36 | Ph 2 | completed | A Study to Learn About a Repeat 5-Day Treatment With the Study Medicines (Called Nirmatrelvir/Ritonavir) in People 12 Years Old or Older With Return of COVID-19 Symptoms and SARS-CoV-2 Positivity After Finishing Treatment With Nirmatrelvir/Ritonavir |
| NCT02275780 DRIVE-FORWARD results posted | 1439-018 MK-1439-018, 2014-001127-69 | Ph 3 | completed | Safety and Efficacy of Doravirine (MK-1439) in Participants With Human Immunodeficiency Virus 1 (HIV-1) (MK-1439-018) |
| NCT05438602 results posted | C4671034 2022-001362-35 | Ph 2 | completed | A Study to Learn About the Study Medicines (Nirmatrelvir Plus Ritonavir) in People Aged 12 Years or Older With COVID-19 and a Compromised Immune System |
| NCT05679388 | IRB22-1150 | Ph 1 | terminated | A Study of Extending Relugolix Dosing Intervals Through Addition of Itraconazole or Ritonavir in Prostate Cancer Patients |
| NCT02460133 | SAIL-001 | Ph 4 | active not recruiting | Understanding HCV Reinfection Rates in an Incarcerated Population After Cure With Interferon Free HCV Treatment |
| NCT01910402 results posted | 117172 2012-005823-34 | Ph 3 | completed | 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) |
| NCT01620944 results posted | AI424-494 2011-006187-47 | Ph 3 | terminated | 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 |
| NCT02437110 results posted | 150126 15-N-0126 | Ph 1 | completed | HERV-K Suppression Using Antiretroviral Therapy in Volunteers With Amyotrophic Lateral Sclerosis (ALS) |
| NCT01605084 SUPPRESS | AI424-493 2011-006186-18 | Ph 3 | withdrawn | Second-line Treatment of HIV-1 With Ritonavir Boosted Atazanavir or Darunavir With an Optimized NRTI Backbone |
| NCT03383692 results posted | DS8201-A-A104 173790 | Ph 1 | completed | Study of DS-8201a for Participants With Advanced Solid Malignant Tumors |
| NCT05129475 results posted | C4671019 | Ph 1 | completed | Food Effect Study to Evaluate the Effect of High-Fat Meal on the Relative Bioavailability of PF-07321332 Boosted With Ritonavir in Healthy Adult Participants |
| NCT05005312 results posted | C4671010 | Ph 1 | completed | Study to Estimate the Effects of Hepatic Impairment on the Pharmacokinetics (PK) of PF-07321332 |
| NCT05011513 results posted | C4671002 2021-002857-28, EPIC-SR | Ph 2, Ph 3 | terminated | Evaluation of Protease Inhibition for COVID-19 in Standard-Risk Patients (EPIC-SR). |
| NCT02527707 LOWR-4 results posted | EIG-LNF-002 | Ph 2 | completed | Titrating-Dose of Lonafarnib in Combination With Ritonavir |
| NCT05047601 results posted | C4671006 2021-002894-24, EPIC-PEP | Ph 2, Ph 3 | completed | A Study of a Potential Oral Treatment to Prevent COVID-19 in Adults Who Are Exposed to Household Member(s) With a Confirmed Symptomatic COVID-19 Infection |
| NCT03719313 D-LIVR | EIG-LNF-011 | Ph 3 | completed | Study of the Efficacy and Safety of Lonafarnib / Ritonavir With and Without Pegylated Interferon -Alfa-2a |
| NCT02430194 LOWR-2 results posted | EIG-300-Amendment 3 | Ph 2 | completed | Lonafarnib Boosted With Ritonavir With and Without Peginterferon Alfa-2a (PEG IFN-a) in HDV (LOWR-2) |
| NCT05545319 EPIC-HOS | C4671031 2022-002447-22 | Ph 2 | withdrawn | A Study to Learn About the Medicine Called Nirmatrelvir Used in Combination With Ritonavir in People With Weakened Immune Systems or at Increased Risk for Poor Outcomes Who Are Hospitalized Due to Severe COVID-19 |
| NCT02430181 LOWR-1 results posted | EIG-300 Application #1128309 | Ph 2 | completed | Lonafarnib With and Without Ritonavir in HDV (LOWR-1) |
| NCT01281813 results posted | CR017230 TMC114IFD3001, 2017-000285-30 | Ph 3 | completed | TMC114IFD3001 - Study Providing Continued Access to Treatment With Darunavir (DRV)/Ritonavir(Rtv) in HIV1 Infected Adults, Adolescents and Children Aged 3 Years or Above and Coming From Previous Company Sponsored Studies With DRV |
| NCT04246723 | CJ05013053 | Ph 2 | completed | Efficacy and Safety of All-Oral Combination of Narlaprevir/Ritonavir and Sofosbuvir in Treatment-naïve Patients With Chronic Hepatitis C Genotype 1 |
| NCT05011812 | PBI-0451-0001 | Ph 1 | completed | Study of PBI-0451 in Healthy Subjects. |
| NCT03600714 results posted | 180123 18-DK-0123 | Ph 2 | completed | Treatment of Chronic Delta Hepatitis With Lonafarnib, Ritonavir and Lambda Interferon |
| NCT02770378 | CUSP9v3 | Ph 1, Ph 2 | completed | A Proof-of-concept Clinical Trial Assessing the Safety of the Coordinated Undermining of Survival Paths by 9 Repurposed Drugs Combined With Metronomic Temozolomide (CUSP9v3 Treatment Protocol) for Recurrent Glioblastoma |
| NCT04459702 | PRG-043 | Ph 2 | withdrawn | A Study of Combination Therapies to Treat COVID-19 Infection |
| NCT03020082 results posted | ASC08201503 | Ph 3 | completed | Efficacy and Safety of Danoprevir/r + PR 12week Triple Therapy in Treatment Naive Non-Cirrhotic G1 CHC China III |
| NCT01825980 CBZF961X2201 | CBZF961X2201 2012-003103-35 | Ph 1, Ph 2 | completed | Proof of Concept Study to Determine the Safety and Antiviral Effect of BZF961 With or Without Ritonavir Boosting in Hepatitis C Virus Infected Patients |
| NCT02948283 | 16331 NCI-2016-01586, 16331 | Ph 1 | completed | Metformin Hydrochloride and Ritonavir in Treating Patients With Relapsed or Refractory Multiple Myeloma or Chronic Lymphocytic Leukemia |
| NCT02565888 DATE-4 | UMCN-AKF 14.12 | Ph 1 | completed | A Drug-drug Interaction Study Between Daclatasvir and Atazanavir/Ritonavir or Atazanavir/Cobicistat |
| NCT00817765 EPOS | UMCN-AKF 08.03 | Ph 1 | completed | Pharmacokinetic Study of Posaconazole Boosted Fosamprenavir |
| NCT04183738 i2-D²EFT | 2019-10-i2-DEFT 18Q065 | Ph 4 | withdrawn | Inflammation and Co-Infections in D²EFT |
| NCT03020095 results posted | ASC162001 | Ph 2 | completed | Efficacy and Safety of Ravidasvir + Danoprevir/r 12-week Oral Therapy in Treatment-Naive Non Cirrhotic G1 CHC Taiwan |
| NCT01695954 results posted | 11-01787 | Ph 1 | completed | Pharmacokinetic Study of Pitavastatin and Ritonavir-Boosted Darunavir or Efavirenz |
| NCT03362814 | ASC-ASC16-II/III-CTP-1-01 | Ph 2, Ph 3 | completed | Efficacy and Safety of Ravidasvir in Combination With Danoprevir/r and Ribavirin(RBV) in Treatment-naive, Non-cirrhotic, Chronic Hepatitis C Virus Genotype1 Infected Subjects. |
Showing 50 of 155 trials
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
RITONAVIR FDA Label Details
Indications & Usage
FDA Label (PDF)RITONAVIR is indicated for the treatment of HIV-1 Infection.
WARNING: DRUG-DRUG INTERACTIONS LEADING TO POTENTIALLY SERIOUS AND/OR LIFE THREATENING REACTIONS Co-administration of ritonavir with several classes of drugs including sedative hypnotics, antiarrhythmics, or ergot alkaloid preparations may result in potentially serious and/or life-threatening advers...
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Full clinical data, patents, trials, and competitive landscape for ritonavir.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.