naphazoline

Trade name: visine

Small moleculeapproved

Approved

Jun 7, 1971

Naphazoline is a direct acting sympathomimetic adrenergic alpha-agonist used to induce systemic vasoconstriction, thereby decreasing nasal congestion and inducing constriction around the conjunctiva. The sympathomimetic action of Naphazoline constricts the smaller arterioles of the nasal passages, producing a decongesting effect. Naphazoline ophthalmic causes constriction of blood vessels in the eyes. It also decreases itching and irritation of the eyes. aphazoline constricts the vascular system of the conjunctiva. It is presumed that this effect is due to direct stimulation action of the drug upon the alpha adrenergic receptors in the arterioles of the conjunctiva resulting in decreased conjunctival congestion. Naphazoline belongs to the imidazoline class of sympathomimetics. Naphazoline is a direct acting sympathomimetic drug, which acts on alpha-adrenergic receptors in the arterioles of the nasal mucosa. This activates the adrenal system to yield systemic vasoconstrction. In producing vasoconstriction, the result is a decrease in blood flow in the nasal passages and consequently decreased nasal congestion. The vasoconstriction means that there is less pressure in the capillaries and less water can filter out, thus less discharge is made. Naphazoline is primarily indicated in conditions like Corneal vascularity, Hyperaemia, Itching, Nasal congestion, and can also be given in adjunctive therapy as an alternative drug of choice in Sinusitis. — NCATS

Clinical trial activity

9 trials · 9 clinical orgs · 11 marketing orgs

Phase 1
2
Phase 2
6
Phase 3
5
Phase 4
1

Earliest trial started May 1, 2008 (NCT00697541)

Timeline

1970s

  1. Jun 7, 1971

    Earliest FDA Approval

  2. Jun 7, 1971

    Novartis — Marketing Organization

  3. Mar 24, 1972

    Allergan — Marketing Organization

  4. Mar 6, 1974

    Alcon — Marketing Organization

  5. Aug 22, 1974

    Akorn, Inc. — Marketing Organization

  6. Aug 22, 1974

    Rising Pharmaceuticals — Marketing Organization

1980s

  1. Dec 1, 1981

    Bausch & Lomb — Marketing Organization

1990s

  1. Apr 30, 1990

    Novartis — NDA Secondary Org

  2. Jun 8, 1994

    Bausch & Lomb — NDA Secondary Org

  3. Jun 8, 1994

    Nestle — NDA Secondary Org

  4. Jan 31, 1996

    Pfizer — First NDA Organization

  5. Jan 31, 1996

    Johnson and Johnson — Marketing Organization

  6. Jan 31, 1996

    Pfizer — NDA Organization

  7. Jan 31, 1996

    Johnson and Johnson — NDA Secondary Org

2000s

  1. Jan 1, 2008

    Earliest Phase 2 Sponsor(trial)

  2. Jan 1, 2008

    Bausch & Lomb — Earliest Phase 3 Sponsor(trial)

2010s

  1. Sep 27, 2010

    Altair Therapeutics — Marketing Organization

  2. Jan 1, 2017

    Earliest Phase 1 Sponsor(trial)

Indications

Mechanism of action

Combination products

Approval history

  • approvedJun 7, 1971

Chemistry & pharmacology

Loading structure…

SMILES

c1ccc2c(CC3=NCCN3)cccc2c1
Mol. weight
210.28 g/mol
Lipinski Ro5
Pass
Rule of 3
Yes
Chirality
Achiral Molecule
Inorganic
No
Polymer
No
Delivery
Topical
Availability
Over the Counter

Oral

No

Parenteral

No

Topical

Yes

Sources

Also known as

  • albalon
  • albalon
  • antistin-privine
  • gppe nsl soln
  • nafazair
  • nafazair
  • nafazolin
  • nafazolin
  • naphaz hcl
  • naphazoline
  • naphazoline
  • naphazoline
  • naphazoline
  • naphazoline
  • naphazoline
  • naphazoline
  • naphazoline
  • naphazoline
  • naphazoline hcl
  • naphazoline hcl
  • naphazoline hcl
  • naphazoline hydrochloride
  • naphazoline hydrochloride
  • naphazoline hydrochloride
  • naphazoline hydrochloride
  • naphazoline hydrocloride
  • naphazoline nitrate
  • naphazoline nitrate
  • naphazoline nitrate
  • naphazoline nitrate
  • naphazoline nitrate
  • naphazoline nitrate
  • naphcon
  • naphcon
  • naphcon forte
  • naphcon forte
  • naphthazoline
  • naphthizine
  • nephazoline
  • opcon
  • opcon
  • rhinazine
  • vasocon
  • vasocon
  • vasocon

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT05470868Phase 1Aug 1, 2022Laboratorios Sophia S.A de C.V.
NCT03324113Phase 1Oct 17, 2017Sanofi
NCT02601235Phase 3Mar 1, 2016EMS S/A, Faculdade de Medicina do ABC
NCT01533220Phase 3Jun 1, 2013EMS S/A
NCT01390961Phase 4Aug 1, 2011Allergan, Hom, Milton M., OD, FAAO
NCT01159015Phase 3Jul 1, 2010Bausch & Lomb
NCT00770133Phase 3Feb 1, 2010Bausch & Lomb
NCT00769886Phase 3Oct 1, 2008Bausch & Lomb
NCT00697541Phase 2May 1, 2008Galderma, KGL, Inc.
Showing 9 of 9 trials
Page 1 / 1

Organizations

Research & Development (9)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
Bausch & LombFor profit3312008
EMS S/AFor profit2212013
AllerganFor profit1012011
Faculdade de Medicina do ABCAcademic/Hospital1012016
GaldermaFor profit1112008
Hom, Milton M., OD, FAAOAcademic/Hospital1112011
KGL, Inc.For profit1012008
Laboratorios Sophia S.A de C.V.For profit1112022
SanofiFor profit1112017
9 organizations
Page 1 / 1

Marketing (15)

OrganizationOrg typeRelationshipDate
Akorn, Inc.For profitMKTGAug 22, 1974
Akorn, Inc.For profitSYNAug 22, 1974
AlconFor profitMKTGMar 6, 1974
AllerganFor profitMKTGMar 24, 1972
Altair TherapeuticsFor profitMKTGSep 27, 2010
Bausch & LombFor profitMKTGDec 1, 1981
Bausch & LombFor profitNDA2Jun 8, 1994
Johnson and JohnsonFor profitMKTGJan 31, 1996
Johnson and JohnsonFor profitNDA2Jan 31, 1996
NestleFor profitNDA2Jun 8, 1994
NovartisFor profitMKTGJun 7, 1971
NovartisFor profitNDA2Apr 30, 1990
PfizerFor profitNDAJan 31, 1996
PharmafairFor profitMKTG
Rising PharmaceuticalsFor profitMKTGAug 22, 1974