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cyproheptadine

Trade name: periactin

Small moleculeapproved

Approved

Oct 17, 1961

Glutodine (Cyproheptadine), sold under the brand name Periactin or Peritol, is a first-generation antihistamine with additional antiserotonergic, anticholinergic and local anesthetic properties. Glutodine is a white to slightly yellowish crystalline solid, which is soluble in water, freely soluble in methanol, sparingly soluble in ethanol, soluble in chloroform, and practically insoluble in ether. Cyproheptadine is used to treat allergic reactions (specifically hay fever), Vasomotor rhinitis, Allergic conjunctivitis due to inhalant allergens and foods, uncomplicated allergic skin manifestations of urticaria and angioedema amelioration of allergic reactions to blood or plasma, Cold urticaria, and Dermatographism. Cyproheptadine is used off-label to treat Spasticity Associated With Spinal Cord, Migraine Headache Prophylaxis, Decreased Appetite Secondary to Chronic Disease, Drug-Induced Sexual Dysfunction, Serotonin Syndrome. — NCATS

Clinical trial activity

20 trials · 33 clinical orgs · 42 marketing orgs

Phase 1
2
Phase 2
9
Phase 3
4
Phase 4
5

Earliest trial started Jun 1, 2003 (NCT00066248)

Timeline

1960s

  1. Oct 17, 1961

    Merck — Earliest FDA Approval

  2. Oct 17, 1961

    Merck — NDA Organization

1970s

  1. Apr 23, 1979

    Mylan — Marketing Organization

1980s

  1. Jan 10, 1980

    Heritage Pharma — Marketing Organization

  2. Apr 16, 1980

    Actavis — Marketing Organization

  3. Oct 14, 1980

    Lumara Health — Marketing Organization

  4. Feb 24, 1981

    Fosun — Marketing Organization

  5. May 18, 1981

    Superpharm — Marketing Organization

  6. Jul 9, 1981

    Par Pharmaceuticals — Marketing Organization

  7. Sep 14, 1981

    Watson Pharmaceuticals — Marketing Organization

  8. Nov 22, 1982

    Vitarine — Marketing Organization

  9. May 26, 1983

    Chartwell Pharmaceuticals — Marketing Organization

  10. Jul 26, 1983

    Pliva — Marketing Organization

  11. Oct 25, 1983

    Duramed Research — Marketing Organization

  12. Jul 3, 1986

    Halsey — Marketing Organization

  13. Dec 21, 1987

    Naska Pharmacal — Marketing Organization

2000s

  1. Jan 1, 2003

    Earliest Phase 2 Sponsor(trial)

  2. Sep 30, 2003

    Rocky Mountain Labs — Marketing Organization

  3. May 30, 2006

    Boscogen — Marketing Organization

  4. May 30, 2006

    Kenton — Marketing Organization

  5. Jun 28, 2006

    Lyne Laboratories — Marketing Organization

2010s

  1. Jan 1, 2010

    Earliest Phase 3 Sponsor(trial)

  2. Jan 1, 2011

    Earliest Phase 1 Sponsor(trial)

  3. Mar 28, 2013

    Pharmaceutical Associates — Marketing Organization

  4. Sep 23, 2015

    Novast Labs — Marketing Organization

  5. Nov 29, 2016

    TWi Biotechnology, Inc. — Marketing Organization

  6. Nov 29, 2016

    Appco Pharma — Marketing Organization

  7. Dec 27, 2016

    Torrent Pharmaceuticals Limited — Marketing Organization

  8. Dec 27, 2016

    ANDA Repository — Marketing Organization

  9. Dec 27, 2016

    Patrin Pharma Inc — Marketing Organization

  10. Dec 29, 2016

    Apex Bioscience — Marketing Organization

  11. Dec 29, 2016

    Rising Pharmaceuticals — Marketing Organization

  12. Jan 31, 2017

    Apnar Pharma — Marketing Organization

  13. Jan 31, 2017

    Elysium Health — Marketing Organization

  14. May 19, 2017

    Zydus Discovery DMCC — Marketing Organization

  15. Jul 13, 2017

    Lannett Company, Inc. — Marketing Organization

  16. Apr 11, 2018

    Strides Pharma Science — Marketing Organization

  17. Oct 16, 2018

    Invatech — Marketing Organization

  18. Apr 12, 2019

    Beximco — Marketing Organization

  19. May 22, 2019

    Quagen Pharma — Marketing Organization

2020s

  1. Dec 21, 2021

    Tris Pharma, Inc. — Marketing Organization

Indications

Approved for

Studied for

Mechanism of action

Approval history

  • approvedOct 17, 1961

Chemistry & pharmacology

Loading structure…

SMILES

CN1CCC(=C2c3ccccc3C=Cc3ccccc32)CC1
Mol. weight
287.41 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Oral
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

No

Sources

Also known as

  • 1-methyl-4-(5-dibenzo(a,e)cycloheptatrienylidene)piperidine
  • 1-methyl-4-(5-dibenzo(a,e)cycloheptatrienylidene)piperidine
  • 1-methyl-4-(5h-dibenzo(a,d)cycloheptenylidene)piperidine
  • 1-methyl-4-(5h-dibenzo(a,d)cycloheptenylidene)piperidine
  • 4-(5-dibenzo(a,d)cyclohepten-5-ylidine)-1-methylpiperidine
  • 4-(5-dibenzo(a,d)cyclohepten-5-ylidine)-1-methylpiperidine
  • 4-(5h-dibenzo(a,d)cyclohepten-5-ylidene)-1-methylpiperidine
  • 4-(5h-dibenzo(a,d)cyclohepten-5-ylidene)-1-methylpiperidine
  • 4-dibenzo[a,d]cyclohepten-5-ylidene-1-methyl-piperidine
  • 4-dibenzo[a,d]cyclohepten-5-ylidene-1-methyl-piperidine
  • 5-(1-methylpiperidylidene-4)-5h-dibenzo(a,d)cyclopheptene
  • 5-(1-methylpiperidylidene-4)-5h-dibenzo(a,d)cyclopheptene
  • axoprol
  • axoprol
  • ciproheptadina
  • ciproheptadina
  • cycloheptadine
  • cyproheptadin
  • cyproheptadin
  • cyproheptadine
  • cyproheptadine
  • cyproheptadine
  • cyproheptadine
  • cyproheptadine
  • cyproheptadine
  • cyproheptadine
  • cyproheptadine
  • cyproheptadine hcl
  • cyproheptadine hcl
  • cyproheptadine hcl
  • cyproheptadine hydrochloride
  • cyproheptadine hydrochloride
  • cyproheptadine hydrochloride
  • cyproheptadine hydrochloride
  • cyproheptadine hydrochloride
  • cyproheptadine hydrocloride
  • cyproheptadine hydrocloride
  • cyproheptadinum
  • cyproheptadinum
  • dihexazin
  • dihexazin
  • glutodina
  • glutodina
  • periactin
  • periactin
  • periactin
  • periactin
  • periactin
  • periactin
  • periactin
  • periactinol

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT06751290Phase 4Jan 31, 2025University of Miami
NCT06147622Phase 1Feb 29, 2024Kinnov Therapeutics
NCT06175273Phase 2/Phase 3 (Phase 3)Jan 31, 2024National Center for Advancing Translational Science (NCATS), University of Kentucky
NCT05469165Phase 2Sep 30, 2022Canadian Institutes of Health Research (CIHR), Laval University
NCT05087381Phase 4Oct 1, 2021Chulalongkorn University, Government of Thailand, Mae Fah Luang University Hospital, Mahidol University, Rajavithi Hospital, Bangkok, University of Queensland, University of Western Australia, Washington University in St. Louis, Yamagata Prefectural Central Hospital
NCT04979221Phase 3Jul 26, 2021Federal University of Health Science of Porto Alegre
NCT04876573Phase 2Jun 1, 2021Ciusss de L'Est de l'Île de Montréal
NCT04820751Phase 3Apr 10, 2021Ciusss de L'Est de l'Île de Montréal, Covid-19 Early Treatment Fund
NCT04108104Phase 2Oct 31, 2019ECSOR, Kinnov Therapeutics
NCT03593811N/AAug 3, 2018Vanderbilt University
NCT02568007Phase 4Dec 1, 2015Medical College of Wisconsin
NCT02418949N/ANov 30, 2015National Institutes of Health (NIH), North Carolina State University, Shirley Ryan AbilityLab
NCT01940978Phase 4Mar 1, 2014Douglas Sears, Sears, Douglas, M.D.
NCT01675050Phase 2Aug 1, 2012University of Michigan
NCT01538693N/ADec 1, 2011Northwestern University, University of Medicine and Dentistry of New Jersey
NCT01688570Early Phase 1 (Phase 1)Aug 1, 2011Medical College of Wisconsin
NCT01314989Phase 4Dec 1, 2010University of Montreal
NCT01132547Phase 3Jun 1, 2010National Cancer Institute (NCI), University of South Florida
NCT01076283Phase 2Dec 1, 2009Brown University
NCT00066248Phase 2Jun 1, 2003National Cancer Institute (NCI), University of South Florida
Showing 20 of 20 trials
Page 1 / 1

Organizations

Research & Development (33)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Ciusss de L'Est de l'Île de MontréalAcademic/Hospital2222021
Kinnov TherapeuticsFor profit2222019
Medical College of WisconsinAcademic/Hospital2222011
National Cancer Institute (NCI)Government2022003
University of South FloridaAcademic/Hospital2222003
Brown UniversityAcademic/Hospital1112009
Canadian Institutes of Health Research (CIHR)Academic/Hospital1012022
Chulalongkorn UniversityAcademic/Hospital1112021
Covid-19 Early Treatment FundAcademic/Hospital1012021
Douglas SearsAcademic/Hospital1112014
ECSORFor profit1012019
Federal University of Health Science of Porto AlegreAcademic/Hospital1112021
Government of ThailandGovernment1012021
Laval UniversityAcademic/Hospital1112022
Mae Fah Luang University HospitalAcademic/Hospital1012021
Mahidol UniversityAcademic/Hospital1012021
National Center for Advancing Translational Science (NCATS)Government1012024
National Institutes of Health (NIH)Government1012015
North Carolina State UniversityAcademic/Hospital1012015
Northwestern UniversityAcademic/Hospital1012011
33 organizations
Page 1 / 2

Marketing (44)

OrganizationOrg typeRelationshipDate
ANDA RepositoryFor profitMKTGDec 27, 2016
ActavisFor profitMKTGApr 16, 1980
Am TherapFor profitMKTG—
Apex BioscienceFor profitMKTGDec 29, 2016
Apnar PharmaFor profitMKTGJan 31, 2017
Appco PharmaFor profitMKTGNov 29, 2016
Ascot PharmaceuticalsFor profitMKTG—
BeximcoFor profitMKTGApr 12, 2019
BoscogenFor profitMKTGMay 30, 2006
Chartwell PharmaceuticalsFor profitSYNJul 13, 2017
Chartwell PharmaceuticalsFor profitMKTGMay 26, 1983
Dow ChemicalFor profitMKTG—
Duramed ResearchFor profitMKTGOct 25, 1983
Elysium HealthFor profitMKTGJan 31, 2017
FosunFor profitMKTGFeb 24, 1981
HalseyFor profitMKTGJul 3, 1986
Heritage PharmaFor profitMKTGJan 10, 1980
InvatechFor profitMKTGOct 16, 2018
KentonFor profitMKTGMay 30, 2006
Lannett Company, Inc.For profitMKTGJul 13, 2017
Lumara HealthFor profitMKTGOct 14, 1980
Lyne LaboratoriesFor profitMKTGJun 28, 2006
MD PharmaFor profitMKTG—
MerckFor profitNDAOct 17, 1961
Morton Grove PharmaceuticalsFor profitMKTG—
MylanFor profitMKTGApr 23, 1979
Naska PharmacalFor profitMKTGDec 21, 1987
Novast LabsFor profitMKTGSep 23, 2015
Par PharmaceuticalsFor profitMKTGJul 9, 1981
Patrin Pharma IncFor profitMKTGDec 27, 2016
Patrin Pharma IncFor profitSYNDec 27, 2016
Pharmaceutical AssociatesFor profitMKTGMar 28, 2013
PlivaFor profitMKTGJul 26, 1983
Quagen PharmaFor profitMKTGMay 22, 2019
Rising PharmaceuticalsFor profitMKTGDec 29, 2016
Rocky Mountain LabsAcademic/HospitalMKTGSep 30, 2003
Strides Pharma ScienceFor profitMKTGApr 11, 2018
SuperpharmFor profitMKTGMay 18, 1981
TWi Biotechnology, Inc.For profitMKTGNov 29, 2016
Torrent Pharmaceuticals LimitedFor profitMKTGDec 27, 2016
Tris Pharma, Inc.For profitMKTGDec 21, 2021
VitarineFor profitMKTGNov 22, 1982
Watson PharmaceuticalsFor profitMKTGSep 14, 1981
Zydus Discovery DMCCFor profitMKTGMay 19, 2017