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clemastine

Trade name: TAVIST

Small moleculeapproved

Approved

Feb 25, 1977

Clemastine is an antihistamine with anticholinergic (drying) and sedative side effects. Clemastine is a selective histamine H1 antagonist and binds to the histamine H1 receptor. This blocks the action of endogenous histamine, which subsequently leads to temporary relief of the negative symptoms brought on by histamine. It is used for the relief of symptoms associated with allergic rhinitis such as sneezing, rhinorrhea, pruritus and acrimation. Also for the management of mild, uncomplicated allergic skin manifestations of urticaria and angioedema. Used as self-medication for temporary relief of symptoms associated with the common cold. — NCATS

Clinical trial activity

19 trials · 16 clinical orgs · 12 marketing orgs

Phase 1
5
Phase 2
16
Phase 3
6
Phase 4
0

Earliest trial started Dec 1, 1989 (NCT00913549)

Timeline

1970s

  1. Feb 25, 1977

    Novartis — Earliest FDA Approval

  2. Feb 25, 1977

    Novartis — NDA Secondary Org

  3. Feb 25, 1977

    Novartis — NDA Organization

1980s

  1. Jan 1, 1989

    Sandoz — Earliest Phase 1 Sponsor(trial)

1990s

  1. Jan 31, 1992

    Ani Pharmaceuticals — Marketing Organization

  2. Jan 31, 1992

    Teva — Marketing Organization

  3. Aug 21, 1992

    GlaxoSmithKline — NDA Secondary Org

  4. Oct 31, 1993

    Actavis — Marketing Organization

  5. Oct 31, 1993

    Sandoz — Marketing Organization

  6. Jun 30, 1994

    Genus Oncology, LLC — Marketing Organization

  7. Nov 22, 1995

    Perrigo — Marketing Organization

  8. Dec 17, 1997

    Chartwell Pharmaceuticals — Marketing Organization

  9. Dec 17, 1997

    Lannett Company, Inc. — Marketing Organization

  10. Mar 13, 1998

    Wockhardt — Marketing Organization

2000s

  1. Nov 27, 2000

    Apotex — Marketing Organization

  2. Jan 1, 2007

    Novartis — Earliest Phase 2 Sponsor(trial)

2010s

  1. Jan 1, 2010

    Earliest Phase 3 Sponsor(trial)

Indications

Approved for

Studied for

Mechanism of action

Combination products

Approval history

  • approvedFeb 25, 1977

Chemistry & pharmacology

Loading structure…

SMILES

CN1CCC[C@@H]1CCO[C@](C)(c1ccccc1)c1ccc(Cl)cc1
Mol. weight
343.9 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

  • (+)-(2r)-2-(2-(((r)-p-chloro-α-methyl-α-phenylbenzyl)oxy)ethyl)-1-methylpyrrolidine
  • (+)-(2r)-2-(2-(((r)-p-chloro-α-methyl-α-phenylbenzyl)oxy)ethyl)-1-methylpyrrolidine
  • (+)-(2r)-2-[2-[[(r)-p-chloro-α-methyl-α-phenylbenzyl]oxy]ethyl]-1-methylpyrrolidine
  • (+)-(2r)-2-[2-[[(r)-p-chloro-α-methyl-α-phenylbenzyl]oxy]ethyl]-1-methylpyrrolidine
  • clemastin
  • clemastina
  • clemastina
  • clemastine
  • clemastine
  • clemastine
  • clemastine
  • clemastine
  • clemastine
  • clemastine
  • clemastine
  • clemastine
  • clemastine
  • clemastine fumarate
  • clemastine fumarate
  • clemastine fumarate
  • clemastine fumarate
  • clemastine fumarate
  • clemastinum
  • clemastinum
  • hs-592
  • hs-592
  • meclastin
  • meclastin
  • meclastine
  • tavegil
  • tavegil
  • tavist
  • tavist
  • tavist
  • tavist
  • tavist-1
  • tavist-1

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT07304024Phase 1/Phase 2 (Phase 2)Dec 15, 2025University of Colorado, Denver
NCT06591091Phase 2Oct 31, 2024Cures Within Reach, University of Illinois at Chicago
NCT06315972Phase 2Apr 30, 2024Ludwig Maximilians University
NCT06315699Phase 3Mar 20, 2024Shandong University
NCT06087757Phase 3Jan 31, 2024Tel Aviv University
NCT06065670Phase 1/Phase 2 (Phase 2)Nov 1, 2023University of California, San Francisco
NCT05359653Phase 1/Phase 2 (Phase 2)Feb 1, 2023Department of Defense, University of California, San Francisco
NCT05338450Phase 3Aug 30, 2022Free University of Amsterdam
NCT05131828Phase 2Feb 28, 2022University of Cambridge
NCT03826004N/AMar 1, 2019Chinese Academy of Medical Sciences
NCT02521311Phase 2Aug 1, 2016University of California, San Francisco
NCT02613091Phase 1Apr 1, 2016University of California, San Francisco
NCT02040298Phase 2Jan 1, 2014University of California, San Francisco
NCT01843530Phase 3Nov 1, 2013Technical University of Munich
NCT01239719Phase 3Mar 1, 2011Azidus
NCT01125761Phase 3Nov 1, 2010Azidus
NCT01154361Phase 2Jun 29, 2010Technical University of Munich
NCT00481676Phase 2May 1, 2007Novartis
NCT00913549Phase 1Dec 1, 1989Harris Laboratories, Incorporated, Sandoz
Showing 19 of 19 trials
Page 1 / 1

Organizations

Research & Development (16)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
University of California, San FranciscoAcademic/Hospital5522014
AzidusFor profit2212010
Technical University of MunichAcademic/Hospital2222010
Chinese Academy of Medical SciencesAcademic/Hospital1112019
Cures Within ReachAcademic/Hospital1012024
Department of DefenseGovernment1012023
Free University of AmsterdamAcademic/Hospital1112022
Harris Laboratories, IncorporatedFor profit1011989
Ludwig Maximilians UniversityAcademic/Hospital1112024
NovartisFor profit1112007
SandozFor profit1111989
Shandong UniversityAcademic/Hospital1112024
Tel Aviv UniversityAcademic/Hospital1112024
University of CambridgeAcademic/Hospital1112022
University of Colorado, DenverAcademic/Hospital1112025
University of Illinois at ChicagoAcademic/Hospital1112024
16 organizations
Page 1 / 1

Marketing (16)

OrganizationOrg typeRelationshipDate
ActavisFor profitMKTGOct 31, 1993
Ani PharmaceuticalsFor profitMKTGJan 31, 1992
Ani PharmaceuticalsFor profitSYNJan 31, 1992
ApotexFor profitMKTGNov 27, 2000
Chartwell PharmaceuticalsFor profitMKTGDec 17, 1997
Genus Oncology, LLCFor profitMKTGJun 30, 1994
GlaxoSmithKlineFor profitNDA2Aug 21, 1992
Lannett Company, Inc.For profitMKTGDec 17, 1997
NovartisFor profitNDA2Feb 25, 1977
NovartisFor profitNDAFeb 25, 1977
PerrigoFor profitMKTGNov 22, 1995
PerrigoFor profitSYNOct 31, 1993
SandozFor profitMKTGOct 31, 1993
TevaFor profitMKTGJan 31, 1992
TevaFor profitSYNApr 21, 1992
WockhardtFor profitMKTGMar 13, 1998