betaxolol

Trade name: kerlone

Small moleculeapproved

Approved

Aug 30, 1985

Betaxolol or SL 75212, (± )-1-(isopropylamino)-3-(p-(cyclopropylmethoxyethyl-phenoxy)2-propranol, is a potent cardioselective beta1-adrenoceptor antagonist devoid of intrinsic sympathomimetic activity with very weak local anaesthetic properties. Oral betaxolol has been used for the treatment of essential hypertension. Betaxolol is used topically in glaucoma and ocular hypertension. — NCATS

Clinical trial activity

4 trials · 9 clinical orgs · 15 marketing orgs

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

Earliest trial started Oct 1, 1992 (NCT00000132)

Timeline

1980s

  1. Aug 30, 1985

    Earliest FDA Approval

  2. Aug 30, 1985

    Sandoz — NDA Secondary Org

  3. Aug 30, 1985

    Sandoz — Marketing Organization

  4. Oct 27, 1989

    Sanofi-Aventis — NDA Secondary Org

  5. Dec 29, 1989

    Novartis — NDA Secondary Org

  6. Dec 29, 1989

    Novartis — Marketing Organization

1990s

  1. Jan 1, 1992

    Earliest Phase 3 Sponsor(trial)

  2. Apr 17, 1997

    Alcon — Marketing Organization

  3. Apr 17, 1997

    Nestle — NDA Secondary Org

  4. Oct 22, 1999

    Epic Pharma Llc — Marketing Organization

2000s

  1. Jun 30, 2000

    Akorn, Inc. — Marketing Organization

  2. Jun 30, 2000

    Sciegen Pharmaceticals — Marketing Organization

  3. Jun 30, 2000

    PHARMOBEDIENT — Marketing Organization

  4. Sep 28, 2000

    Apotex — Marketing Organization

  5. Apr 12, 2001

    Medimetriks — Marketing Organization

  6. Jun 27, 2008

    Kvk Tech Inc — Marketing Organization

  7. Nov 16, 2009

    Wockhardt — Marketing Organization

  8. Nov 16, 2009

    Acella Pharmaceuticals — Marketing Organization

  9. Nov 16, 2009

    Chartwell Pharmaceuticals — Marketing Organization

2010s

  1. Jan 1, 2011

    Earliest Phase 1 Sponsor(trial)

Indications

Mechanism of action

Combination products

Approval history

  • approvedPriority reviewAug 30, 1985

Chemistry & pharmacology

Loading structure…

SMILES

CC(C)NCC(O)COc1ccc(CCOCC2CC2)cc1
Mol. weight
307.43 g/mol
Lipinski Ro5
Pass
Rule of 3
No
Chirality
Racemic Mixture
Inorganic
No
Polymer
No
Delivery
Oral, Topical
Availability
Prescription Only

Oral

Yes

Parenteral

No

Topical

Yes

Sources

Also known as

  • 1-(4-(2-(cyclopropylmethoxy)ethyl)phenoxy)-3-((1-methylethyl)amino)-2-propanol
  • 1-(4-(2-(cyclopropylmethoxy)ethyl)phenoxy)-3-((1-methylethyl)amino)-2-propanol
  • 1-(isopropylamino)-3-[p-(cyclopropylmethoxyethyl)phenoxy]-2-propanol
  • 1-(isopropylamino)-3-[p-(cyclopropylmethoxyethyl)phenoxy]-2-propanol
  • alo-1401-02
  • alo-1401-02
  • betaxolol
  • betaxolol
  • betaxolol
  • betaxolol
  • betaxolol
  • betaxolol
  • betaxolol
  • betaxolol
  • betaxolol
  • betaxolol
  • (+/-)-betaxolol
  • betaxolol hcl
  • betaxolol hcl
  • betaxolol hcl
  • betaxolol hydrochloride
  • betaxolol hydrochloride
  • betaxolol hydrochloride
  • betaxolol hydrochloride
  • betaxololum
  • betaxololum
  • betoptic
  • betoptic
  • betoptic
  • betoptic s
  • betoptic s
  • betoptic susp
  • kerledex
  • kerledex
  • kerlone
  • kerlone
  • sl 75.212-10
  • sl 75.212-10
  • sl-75212-10
  • sl-75212-10

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT02617459Phase 3Nov 1, 2015Lee's Pharmaceutical, Xiamen University
NCT01660620Phase 1Apr 1, 2011Ohio State University, Smith-Kettlewell Eye Research Institute, University of Minnesota, University of Oklahoma, University of Texas at Houston
NCT00061542Phase 3Jan 1, 2003Alcon
NCT00000132Phase 3Oct 1, 1992National Eye Institute (NEI)
Showing 4 of 4 trials
Page 1 / 1

Organizations

Research & Development (9)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
AlconFor profit1112003
Lee's PharmaceuticalFor profit1112015
National Eye Institute (NEI)Government1111992
Ohio State UniversityAcademic/Hospital1012011
Smith-Kettlewell Eye Research InstituteAcademic/Hospital1112011
University of MinnesotaAcademic/Hospital1012011
University of OklahomaAcademic/Hospital1012011
University of Texas at HoustonAcademic/Hospital1012011
Xiamen UniversityAcademic/Hospital1012015
9 organizations
Page 1 / 1

Marketing (18)

OrganizationOrg typeRelationshipDate
Acella PharmaceuticalsFor profitMKTGNov 16, 2009
Akorn, Inc.For profitMKTGJun 30, 2000
AlconFor profitNDA
AlconFor profitMKTGApr 17, 1997
ApotexFor profitMKTGSep 28, 2000
Chartwell PharmaceuticalsFor profitMKTGNov 16, 2009
Epic Pharma LlcFor profitMKTGOct 22, 1999
Kvk Tech IncFor profitMKTGJun 27, 2008
MedimetriksFor profitMKTGApr 12, 2001
NestleFor profitNDA2Apr 17, 1997
NovartisFor profitNDA2Dec 29, 1989
NovartisFor profitMKTGDec 29, 1989
PHARMOBEDIENTFor profitMKTGJun 30, 2000
SandozFor profitNDA2Aug 30, 1985
SandozFor profitMKTGAug 30, 1985
Sanofi-AventisFor profitNDA2Oct 27, 1989
Sciegen PharmaceticalsFor profitMKTGJun 30, 2000
WockhardtFor profitMKTGNov 16, 2009