alcaftadine

Trade name: Lastacaft

Small moleculeapproved

Approved

Jul 28, 2010

Alcaftadine is a broad-spectrum antihistamine displaying a high affinity for histamine H1 and H2 receptors and a lower affinity for H4 receptors. It also exhibits modulatory action on immune cell recruitment and mast cell stabilizing effects. Alcaftadine is an inhibitor of the release of histamine from mast cells. Decreased chemotaxis and inhibition of eosinophil activation has also been demonstrated. LASTACAFT® (alcaftadine ophthalmic solution) indicated for the prevention of itching associated with allergic conjunctivitis. — NCATS

Clinical trial activity

13 trials · 6 clinical orgs · 9 marketing orgs

Phase 1
0
Phase 2
8
Phase 3
7
Phase 4
5

Earliest trial started Sep 1, 2005 (NCT00223951)

Timeline

2000s

  1. Jan 1, 2005

    Vistakon Pharmaceuticals — Earliest Phase 3 Sponsor(trial)

2010s

  1. Jul 28, 2010

    Vistakon Pharmaceuticals — Earliest FDA Approval

  2. Jul 28, 2010

    Allergan — NDA Secondary Org

  3. Jul 28, 2010

    Vistakon Pharmaceuticals — NDA Organization

  4. Jul 28, 2010

    AbbVie — Marketing Organization

  5. Jul 28, 2010

    AbbVie — NDA Secondary Org

  6. Aug 5, 2010

    Braintree Laboratories — NDA Secondary Org

  7. Sep 24, 2010

    Bayer — NDA Secondary Org

  8. Oct 28, 2010

    Sumitomo Dainippon — NDA Secondary Org

  9. Jan 1, 2012

    Allergan — Earliest Phase 2 Sponsor(trial)

2020s

  1. Jun 23, 2023

    Eugia Pharma — Marketing Organization

  2. Mar 1, 2024

    Gland Pharma Ltd — Marketing Organization

  3. Oct 2, 2024

    Alembic — Marketing Organization

Indications

Mechanism of action

Approval history

  • approvedJul 28, 2010

Chemistry & pharmacology

Loading structure…

SMILES

CN1CCC(CC1)=C2C3=NC=C(C=O)N3CCC4=C2C=CC=C4
Mol. weight
307.3895 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Topical
Availability
Over the Counter

Oral

No

Parenteral

No

Topical

Yes

Sources

Also known as

  • 6,11-dihydro-11-(1-methyl-4-piperidinylidene)-5h-imidazo[2,1-b][3]benzazepine-3-carboxaldehyde
  • agn-229666
  • alacaftadine
  • alcaftadina
  • alcaftadina
  • alcaftadine
  • alcaftadine
  • alcaftadine
  • alcaftadine
  • alcaftadine
  • alcaftadine
  • alcaftadine
  • alcaftadine
  • alcaftadine
  • alcaftadinum
  • alcaftadinum
  • lastacaft
  • lastacaft
  • lastacaft
  • lastacaft
  • lastacaft
  • r89674
  • r89674
  • r 89674
  • r 89674
  • r 89674
  • r 89674
  • r 89674
  • r-89674
  • r-89674
  • vilasta
  • vilasta

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT02308501Phase 4Dec 1, 2014ORA, Inc.
NCT02161146Phase 3Jun 1, 2014Allergan
NCT02082262Phase 3Mar 1, 2014Allergan
NCT01808768Phase 4Apr 1, 2013Starx Research Center, LLC
NCT01732757Phase 4Nov 1, 2012Allergan
NCT01754766Phase 2Oct 1, 2012Allergan
NCT01470118Phase 4Oct 1, 2011Allergan
NCT01390961Phase 4Aug 1, 2011Allergan, Hom, Milton M., OD, FAAO
NCT00889330Phase 3Apr 1, 2009Vistakon Pharmaceuticals
NCT00364091Phase 3Aug 1, 2006Vistakon Pharmaceuticals
NCT00244543Phase 3Oct 1, 2005Johnson and Johnson, Vistakon Pharmaceuticals
NCT00241319Phase 3Oct 1, 2005Johnson and Johnson, Vistakon Pharmaceuticals
NCT00223951Phase 3Sep 1, 2005ORA, Inc., Vistakon Pharmaceuticals
Showing 13 of 13 trials
Page 1 / 1

Organizations

Research & Development (6)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
AllerganFor profit6532011
Vistakon PharmaceuticalsFor profit5512005
Johnson and JohnsonFor profit2012005
ORA, Inc.For profit2122005
Hom, Milton M., OD, FAAOAcademic/Hospital1112011
Starx Research Center, LLCFor profit1112013
6 organizations
Page 1 / 1

Marketing (11)

OrganizationOrg typeRelationshipDate
AbbVieFor profitMKTGJul 28, 2010
AbbVieFor profitNDA2Jul 28, 2010
AlembicFor profitMKTGOct 2, 2024
AllerganFor profitNDA2Jul 28, 2010
BayerFor profitNDA2Sep 24, 2010
Braintree LaboratoriesFor profitNDA2Aug 5, 2010
Eugia PharmaFor profitMKTGJun 23, 2023
Gland Pharma LtdFor profitMKTGMar 1, 2024
Gland Pharma LtdFor profitSYNMar 1, 2024
Sumitomo DainipponFor profitNDA2Oct 28, 2010
Vistakon PharmaceuticalsFor profitNDAJul 28, 2010