CDEK by Data4ThePeople
Sign in Sign up
← All drugs Report issue

lopinavir

Trade name: Kaletra

Small moleculeapprovedCOVID-19Fast Track FDA

Approved

Sep 15, 2000

Lopinavir (ABT-378) is an antiretroviral of the protease inhibitor class. It is used against HIV infections as a fixed-dose combination with another protease inhibitor, ritonavir, under the trade names Kaletra. — NCATS

Clinical trial activity

321 trials · 353 clinical orgs · 12 marketing orgs

Phase 1
38
Phase 2
139
Phase 3
98
Phase 4
91

Earliest trial started Nov 1, 1997 (NCT00004578)

Timeline

1990s

  1. Jan 1, 1997

    Abbott — Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 1999

    Earliest Phase 2 Sponsor(trial)

  3. Jan 1, 1999

    Earliest Phase 3 Sponsor(trial)

2000s

  1. Sep 15, 2000

    Earliest FDA Approval

  2. Sep 15, 2000

    AbbVie — NDA Secondary Org

  3. Mar 10, 2009

    Matrix Laboratories Limited — Marketing Organization

  4. Mar 10, 2009

    Aurobindo Pharma — Marketing Organization

  5. Nov 20, 2009

    Cipla — Marketing Organization

2010s

  1. Jun 8, 2011

    Mylan — Marketing Organization

  2. May 23, 2012

    Hetero Labs Ltd — Marketing Organization

  3. May 21, 2015

    Cipla — NDA Secondary Org

  4. Mar 7, 2016

    Macleods Pharmaceuticals, Ltd — Marketing Organization

  5. Mar 7, 2016

    Neogen — Marketing Organization

  6. Dec 27, 2016

    Lannett Company, Inc. — Marketing Organization

2020s

  1. Mar 21, 2022

    Laurus Labs Ltd — Marketing Organization

  2. Dec 11, 2025

    Micro Labs Ltd India — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Combination products

  • kaletra

    with ritonavir

    Also known as lopinavir: ritonavir, lopinavir/ritonavir

Approval history

  • approvedPriority reviewAcceleratedFast trackSep 15, 2000

Chemistry & pharmacology

Loading structure…

SMILES

CC(C)[C@H](N1CCCNC1=O)C(=O)N[C@H](C[C@H](O)[C@H](CC2=CC=CC=C2)NC(=O)COC3=C(C)C=CC=C3C)CC4=CC=CC=C4
Mol. weight
628.8008 g/mol
Lipinski Ro5
1 violation(s)
Rule of 3
No
Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Sources

Also known as

  • a-157378-0
  • a-157378-0
  • a-157378.0
  • a-157378.0
  • abt-378
  • abt-378
  • aluvia
  • aluviran
  • kaletra
  • kaletra
  • kaletra
  • kaletra
  • kaletra
  • koletra
  • lopimune
  • lopinavir
  • lopinavir
  • lopinavir
  • lopinavir
  • lopinavir
  • lopinavir
  • lopinavir
  • lopinavir
  • lopinavir
  • lopinavir
  • lopinavir mixture with ritonavir
  • lopinavir / ritonavir
  • lopinavir/ritonavir
  • lopinavir/ritonavir
  • lopinavir-ritonavir drug combination
  • lpv
  • lpv

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07181148Phase 3Oct 31, 2025Mather's Pharm. Co., Ltd.
NCT06780033Phase 1Mar 17, 2025Arnatar Therapeutics, Inc.
NCT06337032Phase 4Aug 27, 2024Gilead Sciences
NCT05850728Phase 1Apr 1, 2023National Institute of Allergy and Infectious Diseases (NIAID), University of Washington
NCT05334004Phase 1Jan 31, 2023University of Wisconsin, Wisconsin Partnership Program
NCT04466241Phase 2/Phase 3 (Phase 3)Nov 27, 2020Government of France, Programme PACCI Abidjan, University of Bordeaux
NCT04738045Phase 4Nov 1, 2020Beni Suef University, October 6 University
NCT04455958Phase 2Nov 1, 2020OHSU Knight Cancer Institute, Oregon Health and Science University
NCT04518228Phase 4Oct 15, 2020Boston University, Gilead Sciences, Merck, National Institute of Allergy and Infectious Diseases (NIAID), National Institute of Child Health and Human Development (NICHD), National Institute of Mental Health (NIMH), National Institutes of Health (NIH), ViiV Healthcare
NCT04779047Phase 4Oct 1, 2020Beni Suef University, October 6 University
NCT04499677Phase 2Sep 24, 2020LifeArc, University of London
NCT04521400Phase 2Aug 20, 2020Shahid Beheshti University of Medical Sciences
NCT04459702Phase 2Jul 31, 2020Big Corona Ltd., ProgenaBiome
NCT04483960Phase 3Jul 28, 2020Australasian Society for Infectious Diseases, Melbourne Health, The Peter Doherty Institute, University of Melbourne
NCT04390152Phase 1/Phase 2 (Phase 2)Jun 30, 2020BioXcellerator, Clinica Somer
NCT04311957Phase 4Jun 1, 2020Analysis Group, Inc., Cornell University, Haitian Group for the Study of Kaposi's Sarcoma and Opportunistic, Harvard University
NCT04409483Phase 3Jun 1, 2020Centre de Recherche Médicale et Sanitaire, Epicentre, Hôpital Général de Référence de Niamey, Ministry of Public Health, Republic of Niger, Université Abdou Moumouni
NCT04372628Phase 2May 31, 2020AbbVie, Vanderbilt University
NCT04403100Phase 3May 28, 2020Cardresearch - Cardiologia Assistencial e de Pesquisa LTDA, Cytel Inc.
NCT04386070Phase 3May 15, 2020Christian Medical College, Vellore, India, Hospital Espanol de Veracruz, Istituto Clinico Humanitas - Rozzano (MI), Italy, Kigali Central University Hospital, Rwanda, Tamale Teaching Hospital, Tamale, Université d'Abomey-Calavi, University of Birmingham, University of Cape Town, University of Edinburgh, University of Lagos, University of the Witwatersrand
Showing 20 of 321 trials
Page 1 / 17

Organizations

Research & Development (353)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
AbbottFor profit561751997
National Institute of Allergy and Infectious Diseases (NIAID)Government533552000
National Institutes of Health (NIH)Government26452002
Gilead SciencesFor profit21942005
French National Agency for Research on AIDS and Viral HepatitisGovernment171732000
University of BarcelonaAcademic/Hospital141042003
MerckFor profit13342007
The HIV Netherlands Australia Thailand Research CollaborationAcademic/Hospital131342003
GlaxoSmithKlineFor profit12632001
AIDS Clinical Trials GroupAcademic/Hospital9732005
Bristol-Myers SquibbFor profit9832001
Chulalongkorn UniversityAcademic/Hospital9042006
RocheFor profit9242002
Harvard UniversityAcademic/Hospital8342006
University of the WitwatersrandAcademic/Hospital8042005
University of WashingtonAcademic/Hospital8342001
University of California, San DiegoAcademic/Hospital7032001
University of California, San FranciscoAcademic/Hospital7742005
Badalona Hospital Germans Trias i PujolAcademic/Hospital6522003
Johns Hopkins UniversityAcademic/Hospital6032002
353 organizations
Page 1 / 18

Marketing (14)

OrganizationOrg typeRelationshipDate
AbbVieFor profitNDA2Sep 15, 2000
AbbottFor profitNDA—
Aurobindo PharmaFor profitMKTGMar 10, 2009
CiplaFor profitMKTGNov 20, 2009
CiplaFor profitNDA2May 21, 2015
Hetero Labs LtdFor profitMKTGMay 23, 2012
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 profitMKTGJun 8, 2011
MylanFor profitSYNFeb 7, 2024
NeogenFor profitMKTGMar 7, 2016