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Drug

Ritonavir

Approved · FDA / EMA
Emerging researchLate-stage developmentSteady momentum
Also known as Kaletra, Lopinavir-Ritonavir, Norvir, Technivie+1 more

Kaletra, Lopinavir-Ritonavir, Norvir, Technivie, Ritonavirum.

RxNorm85762ChEMBLCHEMBL163UNIIO3J8G9O825
5
Research papers
4
Active clinical trials
113
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A PHASE 2/3, INTERVENTIONAL SAFETY, PHARMACOKINETICS, AND EFFICACY, OPEN-LABEL, MULTI-CENTER, SINGLE-ARM STUDY TO INVESTIGATE ORALLY ADMINISTERED PF-07321332 (NIRMATRELVIR)/RITONAVIR IN NONHOSPITALIZED SYMPTOMATIC PEDIATRIC PARTICIPANTS WITH COVID-19 WHO ARE AT RISK OF PROGRESSION TO SEVERE DISEASE

Clinical trial2026-07-30Primary completion · ClinicalTrials.gov

Label change: LOPINAVIR AND RITONAVIR (NDA021251)

Regulatory2026-07-23FDA

Label change: LOPINAVIR AND RITONAVIR (NDA021906)

Regulatory2026-07-23FDA

Label change: RITONAVIR (NDA022417)

Regulatory2026-07-23FDA

Label change: RITONAVIR (NDA209512)

Regulatory2026-07-23FDA

Synergistic Treatment With Antiretrovirals and Laser Interstitial Thermal thErapy (STARLITE) for Unresectable High-Grade Gliomas: A Phase 1 Study

Clinical trial2026-06-25Results expected Q2 2029 · ClinicalTrials.gov

A PHASE I, MULTIPLE DOSE, OPEN-LABEL PHARMACOKINETIC STUDY OF NIRMATRELVIR/RITONAVIR IN HEALTHY LACTATING WOMEN

Clinical trial2026-05-01Results posted · ClinicalTrials.gov

Randomised Evaluation of COVID-19 Therapy

Clinical trial2026-04-21Results expected Q3 2028 · ClinicalTrials.gov

Digital Biometric Measures in Long COVID: A Secondary Analysis of the STOP-PASC Randomized Clinical Trial.

Research2025-08-01JAMA network open

Nirmatrelvir-Ritonavir and Symptoms in Adults With Postacute Sequelae of SARS-CoV-2 Infection: The STOP-PASC Randomized Clinical Trial.

Research2024-09-01JAMA internal medicine

Pharmacokinetics and 48-week safety and antiviral activity of fosamprenavir-containing regimens in HIV-infected 2- to 18-year-old children.

Research2014-01-01Fortuny C · The Pediatric infectious disease journal

A randomized, double-blind comparison of coformulated elvitegravir/cobicistat/emtricitabine/tenofovir DF vs ritonavir-boosted atazanavir plus coformulated emtricitabine and tenofovir DF for initial treatment of HIV-1 infection: analysis of week 96 results.

Research2013-04-01Rockstroh JK · Journal of acquired immune deficiency syndromes (1999)

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Ritonavir
Aliases & brands
KaletraLopinavir-RitonavirNorvirTechnivieRitonavirum
RxNorm CUI
85762
ChEMBL ID
CHEMBL163
UNII
O3J8G9O825
Regulatory jurisdictions
emafda

Regulatory timeline

113 events

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Approval / market entry confirmed across FDA and EMA (2017-06-07 → 2017-11-09)
Earliest approval
1996-08-25
Latest approval
2017-11-09
Authorities
FDA · EMA
Total events
113
fdaU.S. Food and Drug Administration· 111 events
2026-07-23Label change
Label change: RITONAVIR (NDA022417)
Evidence ↗
2026-07-23Label change
Label change: RITONAVIR (NDA209512)
Evidence ↗
2026-07-23Label change
Label change: LOPINAVIR AND RITONAVIR (NDA021906)
Evidence ↗
emaEuropean Medicines Agency· 2 events
2017-11-09ApprovalMulti-authority
Approval: Ritonavir Viatris (previously Ritonavir Mylan) (EMA)

Indication: Ritonavir is indicated in combination with other antiretroviral agents for the treatment of HIV 1 infected patients (adults and children of 2 years of age and older).

Evidence ↗
1996-08-25Approval
Approval: Norvir (EMA)

Indication: Ritonavir is indicated in combination with other antiretroviral agents for the treatment of HIV-1-infected patients (adults and children of two years of age and older).

Evidence ↗

Data from the U.S. Food and Drug Administration (U.S. Food and Drug Administration), public domain (CC0).

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

185 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
185
registered trials across all phases
LATEST COMPLETION 2025
4
Active studies
3
Recruiting
54
Late-stage (III+)
151
Completed
30
Discontinued
PHASE DISTRIBUTIONn = 185
Early Phase 11Phase 175Phase 1 / 24Phase 251Phase 2 / 32Phase 324Phase 414Phase N / A14

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

Understanding HCV Reinfection Rates in an Incarcerated Population After Cure With Interferon Free HCV Treatment: A Pilot Project

Active, not recruitingPH IVNova Scotia Health Authorityn=442025

Body Composition Sub-study of the D2EFT Trial

CompletedPH IVKirby Instituten=1552024

The Impact of Co-infections on Inflammation in Patients Commencing Second-line Antiretroviral Therapy. A Sub-study of D²EFT (Dolutegravir and Darunavir Evaluation in Adults Failing Therapy)

WithdrawnPH IVKirby Institute2022

Cost-effectiveness of Different Antiretroviral Treatment in Patients HIV Naive. Randomized Clinical, Not Masked, Trial Comparing DRVr3TC, ABC3TC (Kivexa) RPV, or EVG COBI FTC TDF (Stribild) for 48 Weeks

WithdrawnPH IVJuan A. Arnaiz2017

An Open-Label, Randomized Study Evaluating a Switch From a Regimen of Two Nucleoside Reverse Transcriptase Inhibitors Regimen Plus Any Third Agent to Either a Regimen of Atazanavir/Ritonavir Once Daily and Raltegravir Twice Daily or to a Regimen of Atazanavir/Ritonavir Once Daily and Tenofovir/Emtricitabine Once Daily in Virologically Suppressed HIV-1 Infected Subjects With Safety and/or Tolerability Issues on Their Present Treatment Regimen.

CompletedPH IVBristol-Myers Squibbn=1322014

Recent completions

Trials that read out recently, adding to the completed evidence base.

RECOVER-VITAL: A Platform Protocol for Evaluation of Interventions for Viral Persistence, Viral Reactivation, and Immune Dysregulation in Post-Acute Sequelae of SARS-CoV-2 Infection (PASC)

CompletedPH IIKanecia Obie Zimmermann=9642025

An Interventional Decentralized Phase 2, Randomized, Double-Blind, 2-Arm Study to Investigate the Efficacy and Safety of Orally Administered Nirmatrelvir/Ritonavir Compared with Placebo/Ritonavir in Participants with Long COVID

CompletedPH IIHarlan M Krumholzn=1002024

AN INTERVENTIONAL, EFFICACY AND SAFETY, PHASE 2, RANDOMIZED, DOUBLE-BLIND, 2-ARM STUDY TO INVESTIGATE A REPEAT 5-DAY COURSE OF NIRMATRELVIR/RITONAVIR COMPARED TO PLACEBO/RITONAVIR IN PARTICIPANTS AT LEAST 12 YEARS OF AGE WITH REBOUND OF COVID-19 SYMPTOMS AND RAPID ANTIGEN TEST POSITIVITY

CompletedPH IIPfizern=4362024

Body Composition Sub-study of the D2EFT Trial

CompletedPH IVKirby Instituten=1552024

A PHASE I, MULTIPLE DOSE, OPEN-LABEL PHARMACOKINETIC STUDY OF NIRMATRELVIR/RITONAVIR IN HEALTHY LACTATING WOMEN

CompletedPH IPfizern=82023

AN INTERVENTIONAL EFFICACY AND SAFETY, PHASE 2, RANDOMIZED, DOUBLE-BLIND, 3-ARM STUDY TO INVESTIGATE NIRMATRELVIR/RITONAVIR IN NONHOSPITALIZED PARTICIPANTS AT LEAST 12 YEARS OF AGE WITH SYMPTOMATIC COVID-19 WHO ARE IMMUNOCOMPROMISED

CompletedPH IIPfizern=1582023

Research activity

5 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20122025
Most influential

Co-formulated elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate versus ritonavir-boosted atazanavir plus co-formulated emtricitabine and tenofovir disoproxil fumarate for initial treatment of HIV-1 infection: a randomised, double-blind, phase 3, non-inferiority trial.

Lancet (London, England) · 2012 · 264 cites

A randomized, double-blind comparison of coformulated elvitegravir/cobicistat/emtricitabine/tenofovir DF vs ritonavir-boosted atazanavir plus coformulated emtricitabine and tenofovir DF for initial treatment of HIV-1 infection: analysis of week 96 results.

Journal of acquired immune deficiency syndromes (1999) · 2013 · 89 cites

Nirmatrelvir-Ritonavir and Symptoms in Adults With Postacute Sequelae of SARS-CoV-2 Infection: The STOP-PASC Randomized Clinical Trial.

JAMA internal medicine · 2024 · 78 cites

Pharmacokinetics and 48-week safety and antiviral activity of fosamprenavir-containing regimens in HIV-infected 2- to 18-year-old children.

The Pediatric infectious disease journal · 2014 · 8 cites
Recent papers

Digital Biometric Measures in Long COVID: A Secondary Analysis of the STOP-PASC Randomized Clinical Trial.

JAMA network open · 2025

Nirmatrelvir-Ritonavir and Symptoms in Adults With Postacute Sequelae of SARS-CoV-2 Infection: The STOP-PASC Randomized Clinical Trial.

JAMA internal medicine · 2024 · 78 cites

Pharmacokinetics and 48-week safety and antiviral activity of fosamprenavir-containing regimens in HIV-infected 2- to 18-year-old children.

The Pediatric infectious disease journal · 2014 · 8 cites

A randomized, double-blind comparison of coformulated elvitegravir/cobicistat/emtricitabine/tenofovir DF vs ritonavir-boosted atazanavir plus coformulated emtricitabine and tenofovir DF for initial treatment of HIV-1 infection: analysis of week 96 results.

Journal of acquired immune deficiency syndromes (1999) · 2013 · 89 cites

Co-formulated elvitegravir, cobicistat, emtricitabine, and tenofovir disoproxil fumarate versus ritonavir-boosted atazanavir plus co-formulated emtricitabine and tenofovir disoproxil fumarate for initial treatment of HIV-1 infection: a randomised, double-blind, phase 3, non-inferiority trial.

Lancet (London, England) · 2012 · 264 cites
Major research themes8
COVID-192COVID-19 Drug Treatment2Ritonavir2Biometry1HIV-11Post-Acute COVID-19 Syndrome1SARS-CoV-21Wearable Electronic Devices1
Journals, researchers & institutions
Top journals
  • JAMA internal medicine1
  • JAMA network open1
  • Journal of acquired immune deficiency syndromes (1999)1
  • Lancet (London, England)1
  • The Pediatric infectious disease journal1
Leading researchers
  • Bonilla H2
  • Botzheim B2
  • Cheng AK2
  • DeJesus E2
  • Deng Y2
  • Gathe J2
  • Geng LN2
  • Hedlin H2
Leading institutions
free-text, unnormalised
  • Stanford University2
  • Stanford University School of Medicine2
  • University of Bonn2
  • AP-HP and University of Paris Diderot1
  • Clinical Research Collaborations COE1
  • From the *Sant Joan de Déu Hospital1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.