benzyl alcohol
Trade name: ulesfia
Approved
Apr 9, 2009
Benzyl Alcohol is an aromatic alcohol used in a wide variety of cosmetic formulations as a fragrance component, preservative, solvent, and viscosity-decreasing agent. FDA agency approved benzyl alcohol for the treatment of head lice. The drug acts on head lice by inhibiting them from closing their respiratory spiracles, allowing the vehicle to obstruct the spiracles and causing the lice to asphyxiate. — NCATS
Clinical trial activity
6 trials · 13 clinical orgs · 2 marketing orgs
Earliest trial started Sep 1, 2005 (NCT00143819)
Timeline
2000s
- Jan 1, 2005
Earliest Phase 2 Sponsor(trial)
- Jan 1, 2006
Summers Laboratories — Earliest Phase 3 Sponsor(trial)
- Apr 9, 2009
Summers Laboratories — Earliest FDA Approval
- Apr 9, 2009
Summers Laboratories — NDA Organization
- Apr 9, 2009
Shionogi — Marketing Organization
- Apr 9, 2009
Shionogi — NDA Secondary Org
Indications
Approved for
Mechanism of action
- Unspecified targetOTHER
Unknown
Approval history
- approvedApr 9, 2009
Chemistry & pharmacology
SMILES
OCC1=CC=CC=C1- Mol. weight
- 108.1378 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- Yes
- Chirality
- Achiral Molecule
- Inorganic
- No
- Polymer
- No
- Delivery
- Topical
- Availability
- Discontinued
Oral
No
Parenteral
No
Topical
Yes
Sources
- WikipediaBenzyl alcohol ↗
- NCATSLKG8494WBH ↗
- ChEMBLCHEMBL720 ↗
Also known as
- alcoholum benzylicum
- alcoholum benzylicum
- alcoolbenzylique
- alcoolbenzylique
- alcool benzylique
- alcool benzylique
- alpha-hydroxytoluene
- alpha-hydroxytoluene
- alpha-toluenol
- alpha-toluenol
- aromatic alcohol
- aromatic alcohol
- bentalol
- bentalol
- benzalalcohol
- benzalalcohol
- benzalcohol
- benzalcohol
- benzenecarbinol
- benzenecarbinol
- benzenemethanol
- benzenemethanol
- benzenemethanol
- benzoyl alcohol
- benzoyl alcohol
- benzyl alcohol
- benzyl alcohol
- benzyl alcohol
- benzyl alcohol
- benzyl alcohol
- benzyl alcohol
- benzyl alcohol
- benzyl alcohol
- benzyl alcohol
- benzyl alcohol
- benzyl alcohol
- benzyl alcohol
- benzylalkohol
- benzylalkohol
- benzylic alcohol
- benzylic alcohol
- e1519
- e1519
- hydroxymethylbenzene
- hydroxymethylbenzene
- (hydroxymethyl)benzene
- (hydroxymethyl)benzene
- hydroxytoluene
- phenylcarbinol
- phenylcarbinol
- phenylcarbinol
- phenylcarbinol
- phenylmethanol
- phenylmethanol
- phenylmethanol
- phenylmethyl alcohol
- phenylmethyl alcohol
- ulesfia
- ulesfia
- ulesfia
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT02624843 | Phase 3 | Aug 1, 2015 | Akorn, Inc., AXIS Clinicals Limited, Insect Research and Development LTD, South Florida Family Health and Research Centers |
| NCT01937494 | N/A | May 1, 2013 | Free University of Brussels |
| NCT00301340 | Phase 3 | Mar 1, 2006 | Advanced Clinical Research Inc., Alegent Health, Diagnostic Clinic of Longview, Tx, Global Health Associates of Miami, Summers Laboratories |
| NCT00301327 | Phase 3 | Jan 1, 2006 | Advanced Clinical Research Inc., Alegent Health, Diagnostic Clinic of Longview, Tx, Global Health Associates of Miami, Summers Laboratories |
| NCT00479310 | Phase 3 | Jan 1, 2006 | Summers Laboratories |
| NCT00143819 | Phase 2 | Sep 1, 2005 | AVVAA World Healthcare Products, Inc., Rutgers University, University of Medicine and Dentistry of New Jersey |
Organizations
Research & Development (13)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Summers Laboratories | For profit | 3 | 3 | 1 | 2006 |
| Advanced Clinical Research Inc. | For profit | 2 | 0 | 1 | 2006 |
| Alegent Health | Academic/Hospital | 2 | 0 | 1 | 2006 |
| Diagnostic Clinic of Longview, Tx | Academic/Hospital | 2 | 0 | 1 | 2006 |
| Global Health Associates of Miami | Academic/Hospital | 2 | 0 | 1 | 2006 |
| Akorn, Inc. | For profit | 1 | 1 | 1 | 2015 |
| AVVAA World Healthcare Products, Inc. | For profit | 1 | 0 | 1 | 2005 |
| AXIS Clinicals Limited | For profit | 1 | 0 | 1 | 2015 |
| Free University of Brussels | Academic/Hospital | 1 | 1 | 1 | 2013 |
| Insect Research and Development LTD | For profit | 1 | 0 | 1 | 2015 |
| Rutgers University | Academic/Hospital | 1 | 0 | 1 | 2005 |
| South Florida Family Health and Research Centers | Academic/Hospital | 1 | 0 | 1 | 2015 |
| University of Medicine and Dentistry of New Jersey | Academic/Hospital | 1 | 1 | 1 | 2005 |
Marketing (4)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Shionogi | For profit | MKTG | Apr 9, 2009 |
| Shionogi | For profit | NDA2 | Apr 9, 2009 |
| Shionogi | For profit | SYN | Apr 9, 2009 |
| Summers Laboratories | For profit | NDA | Apr 9, 2009 |