cytisine

Small moleculeexperimental

Cytisine, also known as baptitoxine, cytisinicline, or sophorine, is an alkaloid that occurs naturally in several plant genera, such as Laburnum and Cytisus of the family Fabaceae. It has been used medically to help with smoking cessation. It has been found effective in several randomized clinical trials, including in the United States and New Zealand, and is being investigated in additional trials in the United States and a non-inferiority trial in Australia in which it is being compared head-to-head with the smoking cessation aid varenicline. It has also been used entheogenically via mescalbeans by some Native American groups, historically in the Rio Grande Valley predating even peyote. — Wikipedia

Clinical trial activity

15 trials · 17 clinical orgs · 0 marketing orgs

Phase 1
4
Phase 2
6
Phase 3
4
Phase 4
2

Earliest trial started Aug 8, 2017 (NCT03268343)

Timeline

2010s

  1. Jan 1, 2017

    Earliest Phase 1 Sponsor(trial)

  2. Jan 1, 2018

    Earliest Phase 2 Sponsor(trial)

  3. Jan 1, 2019

    Earliest Phase 3 Sponsor(trial)

Indications

Approved for

Mechanism of action

  • Unspecified targetUnclear

    unclear

Chemistry & pharmacology

Oral

No

Parenteral

No

Topical

No

Sources

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07274475N/ADec 1, 2025University of Toronto
NCT06832085Phase 4Apr 30, 2025University of Ottawa
NCT06945770N/AMay 1, 2024Ege University
NCT05729243Phase 4Feb 8, 2023University of Toronto
NCT05311085Phase 3May 6, 2022University of Auckland
NCT05102123Phase 2/Phase 3 (Phase 3)Apr 1, 2022McMaster University
NCT04286295N/AMar 1, 2020University of Ottawa
NCT04126135Phase 3Oct 31, 2019Loma Linda University, Mongolian National University of Medical Sciences, Pfizer
NCT04015414Phase 3Sep 1, 2019Harvard University, University of Ljubljana, University of Zagreb
NCT03848208Phase 1Feb 28, 2019Achieve Life Sciences, Hospital da Prelada
NCT03709823Phase 2Nov 13, 2018Achieve Life Sciences, Los Angeles Clinical Trials
NCT03654105Phase 2Oct 31, 2018Mario Negri Institute, University of Milan
NCT03509948Phase 1Apr 27, 2018Achieve Life Sciences, Simbec-Orion
NCT03303911Phase 1/Phase 2 (Phase 2)Oct 6, 2017Achieve Life Sciences, Simbec-Orion
NCT03268343Phase 1Aug 8, 2017Achieve Life Sciences, Simbec-Orion
Showing 15 of 15 trials
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Organizations

Research & Development (17)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Achieve Life SciencesFor profit5522017
Simbec-OrionFor profit3022017
University of OttawaAcademic/Hospital2222020
University of TorontoAcademic/Hospital2222023
Ege UniversityAcademic/Hospital1112024
Harvard UniversityAcademic/Hospital1012019
Hospital da PreladaAcademic/Hospital1012019
Loma Linda UniversityAcademic/Hospital1112019
Los Angeles Clinical TrialsFor profit1012018
Mario Negri InstituteAcademic/Hospital1012018
McMaster UniversityAcademic/Hospital1112022
Mongolian National University of Medical SciencesAcademic/Hospital1012019
PfizerFor profit1012019
University of AucklandAcademic/Hospital1112022
University of LjubljanaAcademic/Hospital1012019
University of MilanAcademic/Hospital1112018
University of ZagrebAcademic/Hospital1112019
17 organizations
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