trolamine polypeptide oleate condensate
Trade name: cerumenex
Approved
Jun 25, 1958
Trolamine, an organic compound, is the salt formed between triethanolamine and salicylic acid. It is widely used as a topical analgesic. 10% trolamine salicylate medical products sold over-the-counter such as are creams for temporarily relief of minor aches and pains of muscles and joints associated with arthritis, simple backache, lumbago, neuralgia, strains, bruises, and sprains. The FDA approved in 1958 otic solution drops containing triethanolamine polypeptide used in the ear to break down and loosen earwax was discontinued. Trolamine can enhance skin healing by recruiting macrophages and modifying the concentrations of various immunomodulators. Trolamine (Biafine; Genmedix Ltd, France) is commonly prescribed at the beginning of radiotherapy for preventing acute radiation-induced skin toxicity in China. Biafine has been studied in radiodermatitis and Phase 2 clinical trial has been initiated in 2016 by Sun Yat-sen University to establish the efficacy of trolamine (Biafine) for the management of radiation dermatitis in patients with nasopharyngeal carcinoma receiving IMRT. — NCATS
Clinical trial activity
1 trials · 1 clinical orgs · 1 marketing orgs
Earliest trial started Apr 1, 2016 (NCT02729324)
Timeline
1950s
- Jun 25, 1958
Pharmaceutical Research Associates, Inc. (PRA) — Earliest FDA Approval
- Jun 25, 1958
Pharmaceutical Research Associates, Inc. (PRA) — NDA Secondary Org
- Jun 25, 1958
Pharmaceutical Research Associates, Inc. (PRA) — NDA Organization
2010s
- Jan 1, 2016
Earliest Phase 2 Sponsor(trial)
Indications
Approved for
Mechanism of action
- UnclearUnclear
Unclear unclear
Approval history
- approvedJun 25, 1958
Chemistry & pharmacology
SMILES
OCCN(CCO)CCO.CCCCCCCC\C=C/CCCCCCCC(O)=O- Mol. weight
- 431.6496 g/mol
- Lipinski Ro5
- Pass
- Rule of 3
- No
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Topical
- Availability
- Discontinued
Oral
No
Parenteral
No
Topical
Yes
Sources
- NCATSDZ7P3IE35F ↗
- ChEMBLCHEMBL446061 ↗
- ChEMBLCHEMBL1201537 ↗
- NCATS9O3K93S3TK ↗
Also known as
- 2,2',2''-nitrilotriethanol
- 2,2',2''-nitrilotris(ethanol)
- cerumenex
- cerumenex
- cerumenex
- mobisy
- mobisy
- mobisyl [as salicylate]
- nitrilotriethanol
- nitrilotriethanol
- nitrilotriethanol
- nitrilotriethanol
- polypeptide oleate condensate
- potassium coco hydrolyzed animal protein
- sterolamide
- tea-chap
- triethanolamine
- triethanolamine
- triethanolamine
- triethanolamine
- triethanolamine
- triethanolamine
- triethanolamine acetate
- triethanolamine citrate
- triethanolamine citrate (1:1)
- triethanolamine coco hydrolyzed animal protein
- triethanolamine copper salt
- triethanolamine hydrochloride
- triethanolamine iodohydrate
- triethanolamine maleate
- triethanolamine phosphate
- triethanolamine polypeptide oleate condensate
- triethanolamine sulfate
- triethanolamine sulfate (2:1)
- triethanolamine sulfite (1:1)
- triethanolamine tartrate (1:1), (r-(r*,r*))-isomer
- triethanolamine titanium salt
- triethanolammonium chloride
- trolamine
- trolamine
- trolamine
- trolamine
- trolamine
- trolamine
- trolamine
- trolamine
- trolamine polypeptide oleate condensate
- trolamine polypeptide oleate condensate
- trolamine polypeptide oleate-condensate
- xerumenex
- xerumenex
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT02729324 | Phase 2 | Apr 1, 2016 | Sun Yat-Sen University |
Organizations
Research & Development (1)
| Organization | Org type | Trials | As lead sponsor | Phases | Earliest year |
|---|---|---|---|---|---|
| Sun Yat-Sen University | Academic/Hospital | 1 | 1 | 1 | 2016 |
Marketing (2)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| Pharmaceutical Research Associates, Inc. (PRA) | For profit | NDA2 | Jun 25, 1958 |
| Pharmaceutical Research Associates, Inc. (PRA) | For profit | NDA | Jun 25, 1958 |