Ritonavir clinical trials
Ritonavir is named as an intervention in 3 current clinical trials in our USA, UK, Mexico, Japan, China, South Korea, Taiwan, Australia, Israel and Brazil registers. 2 are recruiting patients now. The most common phase is Phase 3. The sponsor with the most trials is Pfizer (1). The most-studied condition is COVID-19. The EU clinical trials register (CTIS) separately lists 2 authorised or ongoing trials.
Where Ritonavir is approved
All regulators →Of the three regulators tracked here, the first to approve Ritonavir was the US, on 1 Mar 1996. It is approved in 3 of the 3 regulators tracked here.
- 2 EU safety letters (DHPC), latest: adverse event for Paxlovid, 21 Mar 2024
From the regulators' own registers: FDA Drugs@FDA, the EMA medicines list and Health Canada's Notice of Compliance database. Dates are the first listed approval of a product containing only this substance; combination products and nationally authorised EU medicines are not counted.
What health systems spend on Ritonavir
All medicines →From NHSBSA Prescription Cost Analysis (Open Government Licence v3.0) and CMS State Drug Utilization Data. Both are gross amounts: neither system publishes its discounts or rebates per drug. Products combining several substances are not counted here.
How Ritonavir works
All drug targets →- Human immunodeficiency virus type 1 protease inhibitor InhibitorChEMBL only
- Cytochrome P450 3A inhibitor InhibitorTarget: Cytochrome P450 3A✓ In ChEMBL and the Guide to Pharmacology
- COVID-19Phase 3
- COVID-19–associated multisystem inflammatory syndrome in childrenPhase 3
- Orthomyxoviridae infectious diseasePhase 3
- Cirrhosis of liverPhase 3
- Hepatitis B virus infectionPhase 3
- Hepatitis D virus infectionPhase 3
- Hepatocellular carcinomaPhase 3
- HyperlipidemiaPhase 3
- MalariaPhase 3
- TuberculosisPhase 3
Mechanisms and diseases from ChEMBL via the Open Targets Platform (release 26.09), ChEMBL record CHEMBL163, CC BY-SA 3.0. Targets checked against the IUPHAR/BPS Guide to PHARMACOLOGY (2026.3.1), ligand 8804, CC BY-SA 4.0. Trial phases are not approvals: approved uses are shown from the regulators' own records where we hold them.
NICE appraisals of Ritonavir
All NICE appraisals →NICE, which decides whether the NHS in England should fund new medicines, has published 1 technology appraisal of Ritonavir. 1 is current, and 1 of it recommends it for at least some patients.
| Appraisal | NICE recommendation | Published | Status |
|---|---|---|---|
| Ombitasvir–paritaprevir–ritonavir with or without dasabuvir for treating chronic hepatitis C NICE TA365 | Recommended | 25 Nov 2015 | Current |
NICE decisions apply to the NHS in England. In Ireland the HSE decides on reimbursement, advised by the National Centre for Pharmacoeconomics. Titles, categories and dates link to the guidance on nice.org.uk. © NICE 2026 technology appraisal guidance. Available from www.nice.org.uk/guidance. All rights reserved. Subject to Notice of rights. NICE guidance is prepared for the National Health Service in England. All NICE guidance is subject to regular review and may be updated or withdrawn. NICE accepts no responsibility for the use of its content in this product/publication.
Patient leaflets for Ritonavir
The package leaflet is the official guide for patients that comes with every medicine. These links go to the regulators that publish it.
- IEIreland: 3 products on the HPRA listEach product record links to the HPRA, which publishes the leaflet and SmPC.
- EUEuropean Union: Norvir, Ritonavir Viatris (previously Ritonavir Mylan) (generic)EMA product information: package leaflet and summary of product characteristics in every EU language.
- UKUnited Kingdom: Search MHRA ProductsPatient information leaflets and SmPCs for UK-licensed products.
- USUnited States: Search DailyMedFDA-approved labels, including patient and medication guides.
Leaflets differ between brands and countries; always read the one that comes with your own medicine. This is regulatory information, not medical advice.
Reference identifiers for Ritonavir
- ATC code
- J05AE03
- ChEMBL
- CHEMBL163
- DrugBank
- DB00503
- PubChem CID
- 392622
- CAS number
- 155213-67-5
- FDA UNII
- O3J8G9O825
- Wikidata
- Q422618
- Wikipedia
- Ritonavir
Codes that identify this medicine in other databases, from Wikidata (CC0), matched by its ChEMBL ID. The ATC code is the WHO classification of what the medicine is used for.
Trials by status
Trials by phase
Clinical trials of Ritonavir
3 trials| Study | Phase | Status | Lead sponsor | Registers |
|---|---|---|---|---|
|
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
NCT05261139 · COVID-19
|
Phase 3 | Recruiting | Pfizer | UK, USA, Mexico, Japan |
|
A Phase 1/2a Study of DB-1303/BNT323 in Advanced/Metastatic Solid Tumors
NCT05150691 · HER2-positive Advanced Solid Tumor
|
Phase 1/2 | Recruiting | DualityBio Inc | USA, China, South Korea, Taiwan, Australia, Israel |
|
Clinical Trial of Gammora® Plus Antiretroviral Treatment for HIV
NCT06799650 · HIV Seropositivity
|
Phase 2 | Active, closed | Federal University of São Paulo | Brazil |
Registers list studies that are recruiting, about to open, active but closed to enrolment, or enrolling by invitation. The UK and USA registers cover industry-sponsored studies only. Trial titles and statuses are copied from the registry as published.
Ritonavir in the EU trials register (CTIS)
2 trialsAuthorised or ongoing trials in the EU Clinical Trials Information System that list a product containing Ritonavir. Many trials are registered in both CTIS and ClinicalTrials.gov, so these are shown separately rather than added to the count above. Trials with a site in Ireland are listed first.
| Study | Phase | Status | Sponsor | Countries |
|---|---|---|---|---|
|
HOVON 185: Pharmacokinetic boosting of ibrutinib with ritonavir in patients with chronic lymphocytic leukemia, lymphoplasmacytic- and mantle cell lymphoma
2026-526101-15-00 · CTIS ↗ · Hemic and Lymphatic Diseases
|
Phase 2 | Authorised | Hemato-Oncologie voor Volwassenen Nederland (Hovon) Stichting | Netherlands |
|
A Phase 3, Randomized, Open-label Study to Evaluate the Efficacy and Safety of Switching to a Regimen of Broadly Neutralizing
Antibodies Teropavimab and Zinlirvimab in Combination with Capsid Inhibitor Lenacapavir Twice Yearly in Virologically Suppressed Adults with HIV-1 Infection on Stable Oral Treatment Regimens
2025-524336-19-00 · Virus Diseases
|
Phase 3 | Ongoing | Gilead Sciences Inc | Poland, Italy, France + 3 more |
Ritonavir across our data
Ireland · EU · USThe same active substance in our other registers, matched by its exact name. Each entry links to the register record it comes from.
Licensed in Ireland (HPRA)
3 single-substance products containing Ritonavir on the HPRA medicines list.
- Norvir 100 mg film-coated tabletsAbbVie Deutschland GmbH & Co. KG · EU/1/96/016/005-006
- Norvir 100 mg powder for oral suspensionAbbVie Deutschland GmbH & Co. KG · EU/1/96/016/009
- Ritonavir Viatris 100 mg Film-coated tabletViatris Limited · EU/1/17/1242/001-003
Supply shortages
- Lopinavir and Ritonavir TabletUS (FDA) · Resolved · updated 24 Jul 2026
- Ritonavir Oral PowderUS (FDA) · Resolved · updated 24 Jul 2026
- Ritonavir TabletUS (FDA) · Resolved · updated 24 Jul 2026
- Lopinavir and Ritonavir Oral SolutionUS (FDA) · Resolved · updated 24 Jul 2026
- Ritonavir Viatris 100 mg Filmtabletten - OP30Germany (BfArM) · Other reason · 12 Feb 2026 to 30 Sep 2027
- Ritonavir Viatris 100 mg Filmtabletten - OP30Germany (BfArM) · Other reason · 12 Feb 2026 to 30 Sep 2027
Conditions studied with Ritonavir
3 conditionsSponsors
lead sponsor per trial| Lead sponsor | Trials |
|---|---|
| Pfizer | 1 |
| DualityBio Inc | 1 |
| Federal University of São Paulo | 1 |
By country register
A trial with sites in more than one country appears in each of those registers. CTIS does not publish a recruiting flag; its trials may also appear in the registers above.
Related compounds
Questions about Ritonavir trials
How many clinical trials are testing Ritonavir?
3 current trials in our USA, UK, Mexico, Japan, China, South Korea, Taiwan, Australia, Israel and Brazil registers name Ritonavir as a drug or biological intervention, as of the registry sync on 10 November 2026. Completed and withdrawn studies are not counted.
Are Ritonavir trials recruiting patients?
Yes. 2 of the 3 trials are recruiting: 2 with sites in USA, 1 with sites in UK, 1 with sites in Mexico, 1 with sites in Japan, 1 with sites in China, 1 with sites in South Korea, 1 with sites in Taiwan, 1 with sites in Australia and 1 with sites in Israel. Eligibility and site contacts are on each trial's record. Only the study team can confirm whether a patient is eligible.
Who sponsors Ritonavir clinical trials?
Pfizer (1), DualityBio Inc (1) and Federal University of São Paulo (1). The number in brackets is how many trials each organisation leads.
Is Ritonavir licensed in Ireland?
Yes. The HPRA medicines list includes 3 single-substance products containing Ritonavir, for example Norvir 100 mg film-coated tablets (AbbVie Deutschland GmbH & Co. KG). A licence does not mean a product is currently marketed or reimbursed; see each product's record.
Is there a Ritonavir shortage?
The registers we track list 6 entries for Ritonavir: US FDA: resolved; US FDA: resolved; US FDA: resolved; US FDA: resolved; 2 German notices. Shortages are product- and country-specific; check with a pharmacist.
Where does this information come from?
Every trial, status, phase and sponsor on this page is copied from public ClinicalTrials.gov records by a daily sync. Nothing here describes how Ritonavir works or whether it is effective, and it is not medical advice.
How this page is built
Everything on this page is copied from public ClinicalTrials.gov registry records — it is not written from memory, and nothing here describes how Ritonavir works or whether it is effective. Each trial links to its own record so you can check it yourself.
- ClinicalTrials.gov (U.S. National Library of Medicine) ↗ Trial IDs, titles, intervention names and synonyms, phase, overall status, lead sponsor and conditions for every trial on this page
This page is built automatically: a daily sync job reads the registry records behind our country trial registers, collects every trial that lists Ritonavir (or a registered synonym) as a drug or biological intervention, and tabulates the registry fields directly. Placebos and generic comparators are excluded. There is no AI drafting and no per-compound editorial pass, and the page has not been clinically reviewed. The “last verified” date above is the timestamp of that sync, not a review date. Our general editorial approach is described in our editorial standards and corrections policy. The ClinicalTrials.gov data on this page was last retrieved on 10 Nov 2026. How every register is built: methodology · fixes we have made: corrections log.