tyloxapol
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
Earliest trial started Aug 1, 2014 (NCT02515799)
Timeline
1980s
- Oct 20, 1989
Orphan Drug Designation
1990s
- Aug 2, 1990
GlaxoSmithKline — Earliest FDA Approval
- Aug 2, 1990
GlaxoSmithKline — NDA Secondary Org
- Aug 2, 1990
GlaxoSmithKline — NDA Organization
Indications
Approved for
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
exosurf neonatal
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
- WikipediaTyloxapol ↗
- NCATSY27PUL9H56 ↗
- ChEMBLCHEMBL1201548 ↗
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 ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT02515799 | Phase 4 | Aug 1, 2014 | bene-Arzneimittel GmbH, Medaimun GmbH |
Organizations
Research & Development (2)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| bene-Arzneimittel GmbH | For profit | 1 | 1 | 1 | 2014 |
| Medaimun GmbH | For profit | 1 | 0 | 1 | 2014 |
Marketing (2)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| GlaxoSmithKline | For profit | NDA2 | Aug 2, 1990 |
| GlaxoSmithKline | For profit | NDA | Aug 2, 1990 |