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hydroxychloroquine

Trade name: plaquenil

Small moleculeapproved

Approved

Apr 18, 1955

Hydroxychloroquine possesses antimalarial properties and also exerts a beneficial effect in lupus erythematosus (chronic discoid or systemic) and acute or chronic rheumatoid arthritis. Although the exact mechanism of action is unknown, it may be based on ability of hydroxychloroquine to bind to and alter DNA. Hydroxychloroquine has also has been found to be taken up into the acidic food vacuoles of the parasite in the erythrocyte. This increases the pH of the acid vesicles, interfering with vesicle functions and possibly inhibiting phospholipid metabolism. In suppressive treatment, hydroxychloroquine inhibits the erythrocytic stage of development of plasmodia. In acute attacks of malaria, it interrupts erythrocytic schizogony of the parasite. Its ability to concentrate in parasitized erythrocytes may account for their selective toxicity against the erythrocytic stages of plasmodial infection. As an antirheumatic, hydroxychloroquine is thought to act as a mild immunosuppressant, inhibiting the production of rheumatoid factor and acute phase reactants. It also accumulates in white blood cells, stabilizing lysosomal membranes and inhibiting the activity of many enzymes, including collagenase and the proteases that cause cartilage breakdown. Hydroxychloroquine is used for the suppressive treatment and treatment of acute attacks of malaria due to Plasmodium vivax, P. malariae, P. ovale, and susceptible strains of P. falciparum. It is also indicated for the treatment of discoid and systemic lupus erythematosus, and rheumatoid arthritis. — NCATS

Clinical trial activity

477 trials · 536 clinical orgs · 28 marketing orgs

Phase 1
97
Phase 2
286
Phase 3
144
Phase 4
68

Earliest trial started Jul 1, 1993 (NCT00946790)

Timeline

1950s

  1. Apr 18, 1955

    Advanz Pharma — Earliest FDA Approval

  2. Apr 18, 1955

    Advanz Pharma — Marketing Organization

  3. Apr 18, 1955

    Advanz Pharma — NDA Organization

  4. Apr 18, 1955

    Advanz Pharma — NDA Secondary Org

1990s

  1. Jan 1, 1993

    Sandoz — Earliest Phase 1 Sponsor(trial)

  2. Sep 30, 1994

    Teva — Marketing Organization

  3. Nov 30, 1995

    Watson Pharmaceuticals — Marketing Organization

  4. Nov 30, 1995

    Sandoz — Marketing Organization

  5. Jan 27, 1996

    Invatech — Marketing Organization

  6. Jan 27, 1996

    CREEKWOOD PHARMS — Marketing Organization

  7. Jan 27, 1996

    Allied Pharmaceutical Services — Marketing Organization

  8. May 29, 1998

    Aurobindo Pharma — Marketing Organization

  9. May 29, 1998

    Mylan — Marketing Organization

  10. Jan 1, 1999

    Earliest Phase 3 Sponsor(trial)

2000s

  1. Jan 1, 2003

    Earliest Phase 2 Sponsor(trial)

  2. Jun 14, 2007

    IPCA Laboratories Ltd. — Marketing Organization

  3. Aug 15, 2007

    Hikma — Marketing Organization

  4. Sep 21, 2007

    Zydus Discovery DMCC — Marketing Organization

2010s

  1. May 1, 2018

    Appco Pharma — Marketing Organization

  2. May 1, 2018

    TWi Biotechnology, Inc. — Marketing Organization

  3. May 1, 2018

    Dr. Reddy's Laboratories — Marketing Organization

  4. May 8, 2018

    Alkaloida Zrt — Marketing Organization

  5. May 15, 2018

    Amneal Pharmaceuticals — Marketing Organization

  6. Jul 6, 2018

    Lupin — Marketing Organization

  7. Jul 6, 2018

    Chartwell Pharmaceuticals — Marketing Organization

  8. Jan 15, 2019

    Laurus Labs Ltd — Marketing Organization

  9. Jan 15, 2019

    Rising Pharmaceuticals — Marketing Organization

2020s

  1. Apr 7, 2020

    Accord Research — Marketing Organization

  2. May 14, 2020

    Aavis Pharma — Marketing Organization

  3. May 14, 2020

    Senores Pharms — Marketing Organization

  4. May 14, 2020

    RISE PHARMA — Marketing Organization

  5. May 14, 2020

    ANDA Repository — Marketing Organization

  6. Jan 14, 2022

    Novitium Pharma — Marketing Organization

  7. Jan 14, 2022

    Ani Pharmaceuticals — NDA Secondary Org

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedApr 18, 1955

Chemistry & pharmacology

Loading structure…

SMILES

CCN(CCO)CCCC(C)Nc1ccnc2cc(Cl)ccc12
Mol. weight
335.88 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Racemic Mixture
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Sources

Also known as

  • 2-((4-((7-chloro-4-quinolyl)amino)pentyl)ethylamino)ethanol
  • 2-((4-((7-chloro-4-quinolyl)amino)pentyl)ethylamino)ethanol
  • 2-(n-(4-(7-chlor-4-chinolylamino)-4-methylbutyl)ethylamino)ethanol
  • 2-(n-(4-(7-chlor-4-chinolylamino)-4-methylbutyl)ethylamino)ethanol
  • 4,5-dihydro-2-(2,4-dihydroxyphenyl)-4-methylthiazole-4-carboxylic acid
  • 4,5-dihydro-2-(2-hydroxy-4-hydroxyphenyl)-4-methylthiazole-4-carboxylic acid
  • 4'-hydroxydesazadesferrithiocin
  • 7-chloro-4-(4-(ethyl(2-hydroxyethyl)amino)-1-methylbutylamino)quinoline
  • 7-chloro-4-(4-(ethyl(2-hydroxyethyl)amino)-1-methylbutylamino)quinoline
  • 7-chloro-4-(4-(n-ethyl-n-beta-hydroxyethylamino)-1-methylbutylamino)quinoline
  • 7-chloro-4-(4-(n-ethyl-n-beta-hydroxyethylamino)-1-methylbutylamino)quinoline
  • 7-chloro-4-[4-(n-ethyl-n-beta-hydroxyethylamino)-1-methylbutylamino]quinoline
  • 7-chloro-4-[4-(n-ethyl-n-beta-hydroxyethylamino)-1-methylbutylamino]quinoline
  • 7-chloro-4-[5-(n-ethyl-n-2-hydroxyethylamino)-2-pentyl]aminoquinoline
  • 7-chloro-4-[5-(n-ethyl-n-2-hydroxyethylamino)-2-pentyl]aminoquinoline
  • deferitrin
  • deferitrin
  • deferitrin
  • deferitrin
  • ercoquin
  • ercoquin
  • gt56-252
  • gt56-252
  • hidroxicloroquina
  • hidroxicloroquina
  • hydrochloroquine
  • hydrocholoquine
  • hydroxychloroquine
  • hydroxychloroquine
  • hydroxychloroquine
  • hydroxychloroquine
  • hydroxychloroquine
  • hydroxychloroquine
  • hydroxychloroquine
  • hydroxychloroquine
  • hydroxychloroquine
  • hydroxychloroquine
  • (+-)-hydroxychloroquine
  • (+-)-hydroxychloroquine
  • (±)-hydroxychloroquine
  • (±)-hydroxychloroquine
  • hydroxychloroquine sulfate
  • hydroxychloroquine sulfate
  • hydroxychloroquine sulfate
  • hydroxychloroquine sulfate
  • hydroxychloroquinum
  • hydroxychloroquinum
  • nsc4375
  • nsc4375
  • oxichlorochine
  • oxichlorochine
  • oxichlorochine
  • oxichlorochine sulfate
  • oxichlorochine sulfate
  • oxichloroquine
  • oxichloroquine
  • oxichloroquine
  • oxiklorin
  • oxychlorochin
  • oxychloroquine
  • plaquenil
  • plaquenil
  • plaquenil
  • plaquenil
  • polirreumin
  • polirreumin
  • quensyl
  • quensyl
  • quinoric
  • tcmdc-123987
  • tcmdc-123987

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07230028Phase 4Mar 1, 2026Radboud University
NCT06971744Phase 2Jan 1, 2026Medical University of South Carolina
NCT07138898Phase 2Sep 30, 2025New York University
NCT07265297Phase 3Aug 12, 2025National Taiwan University
NCT07061717Phase 3Jul 1, 2025Sun Yat-Sen University
NCT06816810Phase 2Mar 31, 2025University of Ottawa
NCT06862284Phase 2Mar 10, 2025Peking University
NCT06768294Phase 2Jan 31, 2025I.R.C.C.S Ospedale Galeazzi-Sant'Ambrogio
NCT06939582Phase 1/Phase 2 (Phase 2)Dec 22, 2024Sichuan University
NCT06652113N/ADec 1, 2024Sun Yat-Sen University
NCT06676384Phase 4Nov 30, 2024Christian Medical College, Vellore, India, India Alliance, Medical Research Council, University of Leicester, University of Queensland
NCT06350630Phase 2Oct 31, 2024Government of France, University of Lyon
NCT06408298Early Phase 1 (Phase 1)Sep 30, 2024Dartmouth University
NCT06479291N/AJul 31, 2024Dr. Stanley Ho Medical Foundation, Macau, Fudan University, Government of China, Macau University of Science and Technology Hospital
NCT06519617Phase 2Jul 13, 2024Peking University
NCT06467526Phase 2Jul 1, 2024Chang Gung University
NCT06389201N/AMay 1, 2024Nantong University
NCT06479317N/AApr 24, 2024Dr. Stanley Ho Medical Foundation, Macau, Fudan University, Government of China, Macau University of Science and Technology Hospital
NCT06479304N/AApr 24, 2024Dr. Stanley Ho Medical Foundation, Macau, Fudan University, Government of China, Macau University of Science and Technology Hospital
NCT06174766Phase 3Apr 1, 2024Hanmi Pharmaceutical
Showing 20 of 477 trials
Page 1 / 24

Organizations

Research & Development (536)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
National Cancer Institute (NCI)Government29432002
University of PennsylvaniaAcademic/Hospital211922007
Rutgers UniversityAcademic/Hospital14922008
Harvard UniversityAcademic/Hospital13942007
University of PittsburghAcademic/Hospital10932010
Fudan UniversityAcademic/Hospital8642017
PfizerFor profit8242004
SanofiFor profit8532008
Assistance Publique - Hôpitaux de ParisAcademic/Hospital6622020
Jiao Tong UniversityAcademic/Hospital6632016
University of LyonAcademic/Hospital6542019
University of UtahAcademic/Hospital6432016
Medical Research CouncilGovernment5132008
New York UniversityAcademic/Hospital5522011
Peking UniversityAcademic/Hospital5532014
Shahid Beheshti University of Medical SciencesAcademic/Hospital5512020
University of BarcelonaAcademic/Hospital5532018
University of LondonAcademic/Hospital5432013
University of Texas at HoustonAcademic/Hospital5422011
Assiut UniversityAcademic/Hospital4422017
536 organizations
Page 1 / 27

Marketing (33)

OrganizationOrg typeRelationshipDate
ANDA RepositoryFor profitMKTGMay 14, 2020
Aavis PharmaFor profitMKTGMay 14, 2020
Accord ResearchFor profitMKTGApr 7, 2020
Advanz PharmaFor profitMKTGApr 18, 1955
Advanz PharmaFor profitNDAApr 18, 1955
Advanz PharmaFor profitNDA2Apr 18, 1955
Advanz PharmaFor profitSYNApr 18, 1955
Alkaloida ZrtFor profitMKTGMay 8, 2018
Allied Pharmaceutical ServicesFor profitMKTGJan 27, 1996
Amneal PharmaceuticalsFor profitMKTGMay 15, 2018
Ani PharmaceuticalsFor profitNDA2Jan 14, 2022
Appco PharmaFor profitMKTGMay 1, 2018
Aurobindo PharmaFor profitMKTGMay 29, 1998
CREEKWOOD PHARMSFor profitMKTGJan 27, 1996
Chartwell PharmaceuticalsFor profitMKTGJul 6, 2018
Dr. Reddy's LaboratoriesFor profitMKTGMay 1, 2018
HikmaFor profitSYNAug 15, 2007
HikmaFor profitMKTGAug 15, 2007
IPCA Laboratories Ltd.For profitMKTGJun 14, 2007
InvatechFor profitMKTGJan 27, 1996
Laurus Labs LtdFor profitMKTGJan 15, 2019
Laurus Labs LtdFor profitMKTGJan 15, 2019
LupinFor profitMKTGJul 6, 2018
MylanFor profitMKTGMay 29, 1998
Novitium PharmaFor profitMKTGJan 14, 2022
RISE PHARMAFor profitMKTGMay 14, 2020
Rising PharmaceuticalsFor profitMKTGJan 15, 2019
SandozFor profitMKTGNov 30, 1995
Senores PharmsFor profitMKTGMay 14, 2020
TWi Biotechnology, Inc.For profitMKTGMay 1, 2018
TevaFor profitMKTGSep 30, 1994
Watson PharmaceuticalsFor profitMKTGNov 30, 1995
Zydus Discovery DMCCFor profitMKTGSep 21, 2007