emedastine

Trade name: emadine

Small moleculeapproved

Approved

Dec 29, 1997

Emedastine is an antihistaminic agent, which was approved by FDA for the treatment of allergic conjunctivitis (Emadine brand name). The drug acts selectively on H1 receptors with lower affinity to H2 and H3 subtypes. Emedastine has a relatively unfavorable CNS effect profile. A small percentage of patients reported somnolence as an adverse effect after administration. — NCATS

Clinical trial activity

1 trials · 2 clinical orgs · 1 marketing orgs

Phase 1
0
Phase 2
0
Phase 3
0
Phase 4
1

Earliest trial started Mar 31, 2022 (NCT05318157)

Timeline

1990s

  1. Dec 29, 1997

    Novartis — Earliest FDA Approval

  2. Dec 29, 1997

    Novartis — NDA Organization

  3. Dec 29, 1997

    Novartis — NDA Secondary Org

  4. Dec 29, 1997

    Novartis — Marketing Organization

Indications

Mechanism of action

Approval history

  • approvedDec 29, 1997

Chemistry & pharmacology

Loading structure…

SMILES

CCOCCn1c(N2CCCN(C)CC2)nc2ccccc21
Mol. weight
302.42 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Topical
Availability
Discontinued

Oral

No

Parenteral

No

Topical

Yes

Sources

Also known as

  • 1-(2-ethoxy-ethyl)-2-(4-methyl-[1,4]diazepan-1-yl)-1h-benzoimidazole
  • 1-(2-ethoxy-ethyl)-2-(4-methyl-[1,4]diazepan-1-yl)-1h-benzoimidazole
  • 1-[2-(ethoxy)ethyl]-2-(4-methyl-1-homopiperazinyl)benzimidazole
  • 1-[2-(ethoxy)ethyl]-2-(4-methyl-1-homopiperazinyl)benzimidazole
  • 1-(2-ethoxyethyl)-2-(4-methyl-1-homopiperazinyl)benzimidazole difumarate
  • 1-(2-ethoxyethyl)-2-(hexahydro-4-methyl-1h-1,4-diazepin-1-yl)benzimidazole
  • 1-(2-ethoxyethyl)-2-(hexahydro-4-methyl-1h-1,4-diazepin-1-yl)benzimidazole
  • al-3432a
  • al-3432a
  • daren
  • emadine
  • emadine
  • emadine
  • emadine
  • emadine
  • emedastina
  • emedastina
  • emedastine
  • emedastine
  • emedastine
  • emedastine
  • emedastine
  • emedastine
  • emedastine
  • emedastine
  • emedastine
  • emedastine difumarate
  • emedastine difumarate
  • emedastine difumarate
  • emedastine difumarate
  • emedastine difumarate
  • emedastine difumarate ophthalmic solution
  • emedastine difumarate ophthalmic solution
  • emedastine difumarate ophthalmic solution
  • emedastine difumarate ophthalmic solution
  • emedastine difumarate ophthalmic solution
  • emedastine fumarate
  • emedastinum
  • emedastinum
  • kb 2413
  • kb-2413
  • kg 2413
  • kg-2413

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT05318157Phase 4Mar 31, 2022Capital Medical University, Peking University
Showing 1 of 1 trials
Page 1 / 1

Organizations

Research & Development (2)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Capital Medical UniversityAcademic/Hospital1112022
Peking UniversityAcademic/Hospital1012022
2 organizations
Page 1 / 1

Marketing (3)

OrganizationOrg typeRelationshipDate
NovartisFor profitNDADec 29, 1997
NovartisFor profitNDA2Dec 29, 1997
NovartisFor profitMKTGDec 29, 1997