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quinine

Trade name: qualaquin

Small moleculeapprovedOrphan Drug FDA

Approved

Aug 12, 2005

QUININE HYPOPHOSPHITE, a salt of quinine, was formerly used, along with the hypophosphites of sodium, potassium, calcium, and iron, in the treatment of phthisis and neurasthenic conditions. — NCATS

Clinical trial activity

45 trials · 58 clinical orgs · 10 marketing orgs

Phase 1
13
Phase 2
15
Phase 3
6
Phase 4
7

Earliest trial started Nov 2, 1999 (NCT00000706)

Timeline

1820s

  1. Dec 1, 1822

    Rosengarten & Sons, Inc. — Marketing Organization

1840s

  1. Jun 1, 1847

    Farr and Kunzi — First NDA Organization

  2. Jun 1, 1847

    Farr and Kunzi — NDA Organization

2000s

  1. Jan 1, 2000

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2003

    Earliest Phase 1 Sponsor(trial)

  3. Jan 1, 2003

    Earliest Phase 3 Sponsor(trial)

  4. Jun 3, 2004

    Orphan Drug Designation

  5. Aug 12, 2005

    Earliest FDA Approval

  6. Aug 12, 2005

    Sun Pharmaceuticals — NDA Secondary Org

2010s

  1. Sep 28, 2012

    Teva — Marketing Organization

  2. Dec 14, 2012

    Mylan — Marketing Organization

  3. Dec 14, 2012

    Aurobindo Pharma — Marketing Organization

  4. Apr 24, 2015

    Lupin — Marketing Organization

  5. Jul 15, 2015

    Amneal Pharmaceuticals — Marketing Organization

  6. Jul 22, 2015

    Novast Labs — Marketing Organization

  7. Jul 22, 2015

    Ingenus Pharmaceuticals — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedAug 12, 2005

Chemistry & pharmacology

Loading structure…

SMILES

OP=O.COC1=CC2=C(C=CN=C2C=C1)[C@@H](O)[C@@H]3C[C@@H]4CC[N@]3C[C@@H]4C=C
Mol. weight
390.4131 g/mol
Lipinski Ro5
Pass
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

  • 6'-methoxycinchonidine
  • 6'-methoxycinchonidine
  • (8r,9s)-quinidine
  • (8r,9s)-quinidine
  • (8s,9r)-quinine
  • (8s,9r)-quinine
  • ar-102
  • ar-102
  • chinin
  • chinin
  • chinine
  • chinine
  • chinine
  • chininum
  • chininum
  • qualaquin
  • qualaquin
  • qualaquin
  • quinate
  • quinate
  • quinin
  • quinin
  • quinina
  • quinina
  • quinine
  • quinine
  • quinine
  • quinine
  • quinine
  • quinine
  • quinine
  • quinine
  • quinine
  • (-)-quinine
  • (-)-quinine
  • quinine bisulfate
  • quinine bisulfate
  • quinine bisulfate heptahydrate
  • quinine bisulfate heptahydrate
  • quinine bisulfate heptahydrate
  • quinine bisulfate heptahydrate
  • quinine bisulfate heptahydrate
  • quinine bisulfate heptahydrate
  • quinine dihydrochloride
  • quinine dihydrochloride
  • quinine hcl
  • quinine hcl
  • quinine hemisulfate
  • quinine hydrochloride
  • quinine hydrochloride
  • quinine sulfate
  • quinine sulfate
  • quinine sulfate
  • quinine sulfate
  • quinine sulfate dihydrate
  • quinine sulphate
  • quinine sulphate
  • (r)-(-)-quinine
  • (r)-(-)-quinine

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT05682339N/AJun 19, 2023University of Adelaide
NCT06472258N/AMar 1, 2023RESnTEC, Institute of Research
NCT05720390N/AFeb 2, 2023University of Adelaide
NCT05808231N/AApr 26, 2021Government of Indonesia, Padjadjaran University, Prodia Diacro Laboratories P.T.
NCT04873011Phase 1Oct 29, 2020Katholieke Universiteit Leuven
NCT04553705Phase 2/Phase 3 (Phase 3)Sep 20, 2020Beni Suef University, Maternity and Children Hospital, Makkah, Maternity and Children hospital,Mecca, Saudi Arabia, University of Arizona
NCT04408183Phase 2May 31, 2020GeneOne Life Science
NCT04060316Phase 2Sep 30, 2019GeneOne Life Science
NCT03565133N/AAug 17, 2018Maastricht University
NCT03985865Phase 4Mar 2, 2017Katholieke Universiteit Leuven
NCT02630472Phase 1/Phase 2 (Phase 2)Oct 1, 2016University of Pennsylvania
NCT02946970N/ASep 30, 2015Katholieke Universiteit Leuven
NCT02492178Phase 2Jul 1, 2015University of Kinshasa, University of Oxford
NCT02276989Phase 2Dec 1, 2014Georgetown University
NCT02092766Phase 4Jun 1, 2014University of Kinshasa, University of Oxford
NCT02563704Phase 3Sep 1, 2013University of Yaounde
NCT01805232Phase 4Mar 1, 2013University of Kassala, University of Khartoum
NCT02255812N/AMar 1, 2013University of Bern
NCT02974348Phase 3Jan 1, 2013Chinese Academy of Medical Sciences, Government of China, University of Bamenda
NCT01851473Phase 1Oct 24, 2012National Institute on Drug Abuse (NIDA)
Showing 20 of 45 trials
Page 1 / 3

Organizations

Research & Development (58)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Mutual PharmaceuticalFor profit9912004
Katholieke Universiteit LeuvenAcademic/Hospital4432011
PRACSFor profit4012004
Makerere UniversityAcademic/Hospital3222003
University of KinshasaAcademic/Hospital3032012
GeneOne Life ScienceFor profit2212019
Government of UgandaGovernment2022003
MDS PharmaFor profit2012007
National Institute of Allergy and Infectious Diseases (NIAID)Government2221999
Proto Pharma LtdFor profit2222009
University of AdelaideAcademic/Hospital2212023
University of OxfordAcademic/Hospital2222014
Xidea Solutions LtdFor profit2022009
Aerie PharmaceuticalsFor profit1112007
Albert Schweitzer HospitalAcademic/Hospital1112003
Beni Suef UniversityAcademic/Hospital1112020
Centre MurazAcademic/Hospital1012012
Chinese Academy of Medical SciencesAcademic/Hospital1012013
EpicentreFor profit1112006
European and Developing Countries Clinical Trials Partnership (EDCTP)Academic/Hospital1012012
58 organizations
Page 1 / 3

Marketing (11)

OrganizationOrg typeRelationshipDate
Amneal PharmaceuticalsFor profitMKTGJul 15, 2015
Aurobindo PharmaFor profitMKTGDec 14, 2012
Farr and KunziFor profitNDAJun 1, 1847
Ingenus PharmaceuticalsFor profitMKTGJul 22, 2015
LupinFor profitMKTGApr 24, 2015
LupinFor profitSYNApr 24, 2015
MylanFor profitMKTGDec 14, 2012
Novast LabsFor profitMKTGJul 22, 2015
Rosengarten & Sons, Inc.For profitMKTGDec 1, 1822
Sun PharmaceuticalsFor profitNDA2Aug 12, 2005
TevaFor profitMKTGSep 28, 2012