Data updated: May 26, 2026
NORVIR (ritonavir)
Trial Activity: Declining 5 active trials
Infectious Disease
Approved 1996-03-01
Development Insights
Hoffmann-La Roche conducting 29 trials (17%)
107 indications explored (Broad Platform)
→ healthy volunteer (22 trials)
→ hiv (17 trials)
→ hiv infections (16 trials)
7
Indications
--
Phase 3 Trials
5
Priority Reviews
30
Years on Market
Details
- Status
- Discontinued
- First Approved
- 1996-03-01
- Routes
- ORAL
- Dosage Forms
- CAPSULE, POWDER, SOLUTION, TABLET
NORVIR Approval History
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
140 FDA actions from 1996 to 2022 · 3 indication expansions
Dec 2002 SUPPL
Mfg
Sep 2002 SUPPL
Mfg
Sep 2002 SUPPL
Mfg
Feb 2001 SUPPL
Mfg
Sep 2000 SUPPL Priority
Mfg
May 2000 SUPPL
Label
Dec 1999 SUPPL
Mfg
Oct 1999 SUPPL Priority
Mfg
Oct 1999 SUPPL
Label
Oct 1999 SUPPL
Label
May 1999 SUPPL Priority
Efficacy
Apr 1999 SUPPL Priority
Label
Apr 1999 SUPPL Priority
Label
Apr 1999 SUPPL Priority
Label
Feb 1999 SUPPL Priority
Mfg
Oct 1998 SUPPL
Label
Sep 1998 SUPPL Priority
Mfg
Jul 1998 SUPPL Priority
Mfg
May 1998 SUPPL Priority
Mfg
May 1998 SUPPL Priority
Mfg
Feb 1998 SUPPL Priority
Label
Jan 1998 SUPPL Priority
Mfg
Oct 1997 SUPPL Priority
Label
Sep 1997 SUPPL Priority
Mfg
Sep 1997 SUPPL Priority
Mfg
Jul 1997 SUPPL Priority
Mfg
May 1997 SUPPL Priority
Mfg
Mar 1997 SUPPL Priority
Efficacy
Jan 1997 SUPPL Priority
Label
Oct 1996 SUPPL Priority
Mfg
Sep 1996 SUPPL Priority
Label
Mar 1996 ORIGINAL Priority
New Form
What NORVIR Treats
7 FDA approvalsOriginally approved for its first indication in 1996 . Covers 7 distinct patient populations.
- Other (7)
Other
(7 approvals)- • Approved indication (Mar 1996) Priority
- • Approved indication (Mar 1997) Priority
- • Approved indication (May 1999) Priority
- • Approved indication (Jun 1999)Label Letter
- • Approved indication (Oct 2005) PriorityLabel Letter
- • Approved indication (Feb 2010)Label Letter
- • Approved indication (Jun 2017) PriorityLabel Letter
📋
Clinical Trial Registry
156 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 |
| NCT02486133 Dualis | DUA-1463-SPI-0320-I | Ph 3 | completed | Dual Therapy With Boosted Darunavir + Dolutegravir |
| 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 |
Showing 50 of 156 trials
🔬
Pro Active Pipeline
Ongoing clinical trials by development phase
Loading...
⭐
Pro Key Completed Trials
Completed studies with published results, ranked by significance
Loading...
📊
Trial Timeline
Full development history with FDA approval milestones
|
Loading...
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.
NORVIR FDA Label Details
Track NORVIR with TheraRadar Pro
Watchlist alerts, full database access, CSV exports across 14,000+ drugs.
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment