tyloxapol

Small moleculeapprovedOrphan Drug FDA

Approved

Aug 2, 1990

Tyloxapol is a nonionic liquid polymer of the alkyl aryl polyether alcohol type that is used as a surfactant to aid liquefaction and removal of mucopurulent (containing mucus and pus) bronchopulmonary secretions. Tyloxapol is also used as a detergent, dispersing agent, encapsulating agent and a hydroxy radical scavenger. Tyloxapol has been used as a mucolytic agent for over 50 years and has proven to be well tolerated during this time. Tyloxapol influences the respiratory system by the following four different action mechanisms: secretolytic action, reduction of surface tension, dissolution of coatings and down-regulation of inflammation. Several studies have shown that small quantities of Tyloxapol applied as an aerosol liquefy sputum. The viscosity of sputum is reduced by 10% to 20% according to rotational viscosimetry measurements. Tyloxapol also penetrates the mucous wall and dissolves viscous and dried secretions, thus enabling increased ciliary activity in the respiratory tract. Although the mechanism of Tyloxapol has been well described, and there is a long-standing basis for its clinical usefulness, there are almost no randomized, double-blind, placebo-controlled trials available that demonstrate the superiority of Tyloxapol vs. saline. Side-effects in the form of hypersensitivity reactions have only occurred very rarely. — 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 Aug 1, 2014 (NCT02515799)

Timeline

1980s

  1. Oct 20, 1989

    Orphan Drug Designation

1990s

  1. Aug 2, 1990

    GlaxoSmithKline — Earliest FDA Approval

  2. Aug 2, 1990

    GlaxoSmithKline — NDA Secondary Org

  3. Aug 2, 1990

    GlaxoSmithKline — NDA Organization

Indications

Mechanism of action

  • Unspecified targetOTHER

    Surfactant agent

    Replaces endogenous surfactant in case of deficiency; endogenous pulmonary surfactant lower surface tension at the air-liquid of the alveolar surfaces

  • Unspecified targetSurfactant

    Surfactant

    Replaces endogenous surfactant in case of deficiency; endogenous pulmonary surfactant lower surface tension at the air-liquid of the alveolar surfaces

Combination products

Approval history

  • approvedPriority reviewAug 2, 1990

Chemistry & pharmacology

Chirality
Single Stereoisomer
Inorganic
No
Polymer
No
Delivery
Parenteral
Availability
Discontinued

Oral

No

Parenteral

Yes

Topical

No

Sources

Also known as

  • 4-(1,1,3,3-tetramethylbutyl)phenol, polymer with formaldehyde & oxirane
  • alevaire
  • alevaire
  • alevaire
  • alevaire
  • enuclene
  • formaldehyde, polymer with oxirane and 4-(1,1,3,3-tetramethylbutyl)phenol
  • oxyethylated tertiary octylphenol formaldehyde polymer
  • p-isooctylpolyoxyethylenephenol formaldehyde polymer
  • polyhydroxyethyl-tert-octylphenolformaldehyde
  • superinone
  • superinone
  • superinone
  • supervent
  • tacholiquine
  • translight
  • triton a 20
  • triton wr 1339
  • triton wr-1339
  • tyloxapol
  • tyloxapol
  • tyloxapol
  • tyloxapol
  • tyloxapol
  • tyloxapol
  • tyloxapol
  • tyloxapol
  • tyroxapol
  • wr-1339

Clinical trials

NCT IDPhaseStart dateSponsor(s)
NCT02515799Phase 4Aug 1, 2014bene-Arzneimittel GmbH, Medaimun GmbH
Showing 1 of 1 trials
Page 1 / 1

Organizations

Research & Development (2)

OrganizationOrg typeTrialsAs lead sponsorPhasesEarliest year
bene-Arzneimittel GmbHFor profit1112014
Medaimun GmbHFor profit1012014
2 organizations
Page 1 / 1

Marketing (2)

OrganizationOrg typeRelationshipDate
GlaxoSmithKlineFor profitNDA2Aug 2, 1990
GlaxoSmithKlineFor profitNDAAug 2, 1990