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ritonavir

Trade name: Norvir

Small moleculeapprovedCOVID-19

Approved

Mar 1, 1996

Ritonavir is a protease inhibitor with activity against Human Immunodeficiency Virus Type 1 (HIV-1). Ritonavir binds to the protease active site and inhibits the activity of the enzyme. It is FDA approved for the treatment of HIV-1 infection. In patients receiving medications metabolized by CYP3A or initiation of medications metabolized by CYP3A in patients already receiving Ritonavir, may increase plasma concentrations of medications metabolized by CYP3A. The most frequently reported adverse drug reactions among patients receiving Ritonavir alone or in combination with other antiretroviral drugs were gastrointestinal (including diarrhea, nausea, vomiting, abdominal pain (upper and lower)), neurological disturbances (including paresthesia and oral paresthesia), rash, and fatigue/asthenia. — NCATS

Clinical trial activity

867 trials · 490 clinical orgs · 18 marketing orgs

Phase 1
255
Phase 2
371
Phase 3
203
Phase 4
175

Earliest trial started Jun 1, 1997 (NCT00003008)

Timeline

1990s

  1. Mar 1, 1996

    Abbott — Earliest FDA Approval

  2. Mar 1, 1996

    AbbVie — NDA Secondary Org

  3. Mar 1, 1996

    Abbott — NDA Organization

  4. Jan 1, 1997

    Abbott — Earliest Phase 1 Sponsor(trial)

  5. Jan 1, 1997

    Earliest Phase 2 Sponsor(trial)

  6. Jan 1, 1999

    Earliest Phase 3 Sponsor(trial)

2000s

  1. Mar 10, 2009

    Aurobindo Pharma — Marketing Organization

  2. Mar 10, 2009

    Matrix Laboratories Limited — Marketing Organization

  3. Nov 20, 2009

    Cipla — NDA Secondary Org

2010s

  1. Nov 18, 2011

    Mylan — NDA Secondary Org

  2. May 23, 2012

    Hetero Labs Ltd — Marketing Organization

  3. Mar 17, 2014

    Emcure — Marketing Organization

  4. Mar 17, 2014

    Emcure — NDA Secondary Org

  5. Jan 15, 2015

    West-Ward Pharmaceutical — Marketing Organization

  6. Jan 15, 2015

    Hikma — Marketing Organization

  7. Mar 27, 2015

    Cipla — Marketing Organization

  8. Mar 2, 2016

    Mylan — Marketing Organization

  9. Mar 7, 2016

    Macleods Pharmaceuticals, Ltd — Marketing Organization

  10. Mar 7, 2016

    Neogen — Marketing Organization

  11. Dec 27, 2016

    Lannett Company, Inc. — Marketing Organization

  12. Sep 17, 2018

    Amneal Pharmaceuticals — Marketing Organization

2020s

  1. Mar 21, 2022

    Laurus Labs Ltd — Marketing Organization

  2. May 25, 2023

    Pfizer — NDA Secondary Org

  3. Feb 16, 2024

    Quagen Pharma — Marketing Organization

  4. Dec 11, 2025

    Micro Labs Ltd India — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Combination products

  • kaletra

    with lopinavir

    Also known as lopinavir: ritonavir, lopinavir/ritonavir

  • paxlovid (copackaged)

    with nirmatrelvir

    Also known as nirmatrelvir and ritonavir, nirmatrelvir, ritonavir

  • technivie

    with ombitasvir, paritaprevir

    Also known as ombitasvir, paritaprevir, ritonavir

  • viekira pak (copackaged)

    with ombitasvir, paritaprevir, dasabuvir

    Also known as dasabuvir, ombitasvir, paritaprevir, and ritonavir, ombitasvir and paritaprevir and ritonavir and dasabuvir, viekira xr

Approval history

  • approvedPriority reviewAcceleratedMar 1, 1996

Chemistry & pharmacology

Loading structure…

SMILES

CC(C)[C@H](NC(=O)N(C)CC1=CSC(=N1)C(C)C)C(=O)N[C@H](C[C@H](O)[C@H](CC2=CC=CC=C2)NC(=O)OCC3=CN=CS3)CC4=CC=CC=C4
Mol. weight
720.944 g/mol
Lipinski Ro5
2 violation(s)
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Black box warning

Sources

Also known as

  • a 84538
  • a-84538
  • a-84538
  • a-84538
  • abbott-84538
  • abbott-84538
  • abt538
  • abt538
  • abt538
  • abt538
  • abt538
  • abt538
  • abt-538
  • lopinavir mixture with ritonavir
  • lopinavir / ritonavir
  • lopinavir/ritonavir
  • lopinavir/ritonavir
  • norvir
  • norvir
  • norvir
  • norvir
  • norvir
  • ombitasvir / paritaprevir / ritonavir
  • ritonavir
  • ritonavir
  • ritonavir
  • ritonavir
  • ritonavir
  • ritonavir
  • ritonavir
  • ritonavir
  • ritonavir
  • ritonavir
  • ritonavirum
  • ritonavirum

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07181148Phase 3Oct 31, 2025Mather's Pharm. Co., Ltd.
NCT06747507Phase 3Jun 30, 2025Government of Mozambique, Muhimbili University, SolidarMed, University of London, University of Nairobi
NCT06780033Phase 1Mar 17, 2025Arnatar Therapeutics, Inc.
NCT06397144Phase 1Feb 14, 2025Pfizer
NCT06792214Phase 4Jan 3, 2025Kingston Health Sciences Centre, Niagara Health System, Unity Health Toronto, University of Toronto
NCT06710990Phase 1Dec 31, 2024Hengrui Therapeutics, Inc.
NCT06338826Phase 2Oct 1, 2024Assistance Publique - Hôpitaux de Paris, Government of France
NCT06337032Phase 4Aug 27, 2024Gilead Sciences
NCT06139796Phase 1/Phase 2 (Phase 2)Jun 30, 2024AMS-PHPT Research Collaboration, Baylor University, Institut National de la Santé Et de la Recherche Médicale, France, PENTA Foundation, University of Zimbabwe
NCT06441955Phase 4Mar 1, 2024Well- Konnect Healthcare Services and Research Firm
NCT05938140Phase 4Jun 22, 2023People's Liberation Army of China
NCT05898672Phase 1Jun 9, 2023Pfizer
NCT06087055Phase 1May 12, 2023Government of China
NCT05852873Phase 3May 12, 2023Norwegian University of Science and Technology, University of Bergen, University of Oslo
NCT06084507Phase 1May 4, 2023Government of China
NCT05823896Phase 2May 1, 2023Karolinska Institute, Pfizer
NCT05927779Phase 1/Phase 2 (Phase 2)Apr 17, 2023Fudan University, Shaanxi Buchang Pharmaceutical Co., Ltd
NCT05826249Phase 1Apr 7, 2023Shandong Province Qianfoshan Hospital, Simcere Pharmaceutical Co., Ltd
NCT05850728Phase 1Apr 1, 2023National Institute of Allergy and Infectious Diseases (NIAID), University of Washington
NCT05731804Phase 1Mar 1, 2023Shandong first medical University, Simcere Pharmaceutical Co., Ltd
Showing 20 of 867 trials
Page 1 / 44

Organizations

Research & Development (490)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
National Institute of Allergy and Infectious Diseases (NIAID)Government1057751998
Boehringer IngelheimFor profit645951999
AbbVieFor profit605042002
AbbottFor profit552451997
Bristol-Myers SquibbFor profit503651999
RocheFor profit463651999
GlaxoSmithKlineFor profit431552001
National Institutes of Health (NIH)Government40751999
PfizerFor profit372452007
Gilead SciencesFor profit362142002
MerckFor profit341351999
TibotecFor profit302142003
ViiV HealthcareFor profit272342001
French National Agency for Research on AIDS and Viral HepatitisGovernment252542000
University of BarcelonaAcademic/Hospital221742003
Johnson and JohnsonFor profit191442007
AIDS Clinical Trials GroupAcademic/Hospital181352003
The HIV Netherlands Australia Thailand Research CollaborationAcademic/Hospital181852003
Janssen Pharmaceutica NVFor profit17152008
University of New South WalesAcademic/Hospital151352003
490 organizations
Page 1 / 25

Marketing (28)

OrganizationOrg typeRelationshipDate
AbbVieFor profitNDA2Mar 1, 1996
AbbVieFor profitSYNDec 19, 2014
AbbottFor profitNDAMar 1, 1996
Amneal PharmaceuticalsFor profitMKTGSep 17, 2018
Amneal PharmaceuticalsFor profitSYNSep 17, 2018
Aurobindo PharmaFor profitMKTGMar 10, 2009
CiplaFor profitSYNJan 15, 2015
CiplaFor profitNDA2Nov 20, 2009
CiplaFor profitMKTGMar 27, 2015
EmcureFor profitMKTGMar 17, 2014
EmcureFor profitNDA2Mar 17, 2014
Hetero Labs LtdFor profitMKTGMay 23, 2012
HikmaFor profitMKTGJan 15, 2015
HikmaFor profitSYNJan 15, 2015
Lannett Company, Inc.For profitMKTGDec 27, 2016
Laurus Labs LtdFor profitMKTGMar 21, 2022
Macleods Pharmaceuticals, LtdFor profitMKTGMar 7, 2016
Matrix Laboratories LimitedFor profitMKTGMar 10, 2009
Micro Labs Ltd IndiaFor profitMKTGDec 11, 2025
MylanFor profitSYNSep 4, 2014
MylanFor profitSYNJun 8, 2011
MylanFor profitMKTGMar 2, 2016
MylanFor profitNDA2Nov 18, 2011
MylanFor profitSYNFeb 16, 2024
NeogenFor profitMKTGMar 7, 2016
PfizerFor profitNDA2May 25, 2023
Quagen PharmaFor profitMKTGFeb 16, 2024
West-Ward PharmaceuticalFor profitMKTGJan 15, 2015