colfosceril palmitate
Approved
Aug 2, 1990
Colfosceril palmitate (dipalmitoylphosphatidylcholine) is a synthetic pulmonary surfactant, which is used in infants with respiratory distress syndrome it was approved in 1990, but nowadays it is under the state of canceled post-marketing. Colfosceril palmitate is reducing the tension and stabilizing the alveoli from collapsing. — NCATS
Clinical trial activity
10 trials · 22 clinical orgs · 1 marketing orgs
Earliest trial started Jan 1, 1991 (NCT01203358)
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
- Jan 1, 1991
Earliest Phase 2 Sponsor(trial)
2000s
- Jan 1, 2000
Earliest Phase 3 Sponsor(trial)
Indications
Studied for
- Bronchopulmonary Dysplasia · Phase 2/Phase 3
- Cystic Fibrosis · Phase 2
- Infant, Low Birth Weight · Phase 2/Phase 3
- Infant, Newborn · Phase 2/Phase 3
- Infant, Premature · Phase 2/Phase 3
- Infant, Small for Gestational Age · Phase 2/Phase 3
- Meconium Aspiration Syndrome · Phase 3
- Obesity · Phase 2
- Premature Birth · Phase 2
- Respiratory Distress Syndrome · Phase 2
- Respiratory Distress Syndrome, Newborn · Phase 2
- Respiratory Insufficiency · Phase 2
- Sleep Apnea, Obstructive · Phase 2
- Sleep Apnea Syndromes · Phase 2
Mechanism of action
- Unspecified targetOTHER
Lung surfactant
Replaces deficient surfactant
- Unspecified targetSurfactant
surfactant
Combination products
exosurf neonatal
with tyloxapol, cetyl alcohol
Approval history
- approvedPriority reviewAug 2, 1990
Chemistry & pharmacology
SMILES
CCCCCCCCCCCCCCCC(=O)OC[C@H](COP([O-])(=O)OCC[N+](C)(C)C)OC(=O)CCCCCCCCCCCCCCC- Mol. weight
- 734.0389 g/mol
- Lipinski Ro5
- 2 violation(s)
- Rule of 3
- No
- Chirality
- Single Stereoisomer
- Inorganic
- No
- Polymer
- No
- Delivery
- Parenteral
- Availability
- Discontinued
Oral
No
Parenteral
Yes
Topical
No
Sources
- WikipediaColfosceril palmitate ↗
- NCATS319X2NFW0A ↗
- ChEMBLCHEMBL1200737 ↗
Also known as
- 129y83
- 129y83
- 1,2-dipalmitoyl-sn-glycero-3-phosphocholine
- colfosceril palmitate
- colfosceril palmitate
- colfosceril palmitate
- colfosceril palmitate
- colfosceril palmitate
- colfosceril palmitate
- colfosceril palmitate
- colfosceril palmitate
- colfosceril palmitate
- colfosceril palmitate
- colfosceril palmitate
- l-dipalmitoyl lecithin
Clinical trials
| NCT ID | Phase | Start date | Sponsor(s) |
|---|---|---|---|
| NCT02636868 | Phase 2 | Dec 1, 2015 | Windtree Therapeutics |
| NCT02528318 | Phase 2 | Aug 1, 2015 | National Heart, Lung, and Blood Institute (NHLBI), Windtree Therapeutics |
| NCT01765608 | Phase 2 | Mar 1, 2010 | Eisai, University of Gothenburg |
| NCT00934362 | Phase 2 | Oct 1, 2008 | Cystic Fibrosis Foundation Therapeutics, University of North Carolina at Chapel Hill, Windtree Therapeutics |
| NCT00578734 | Phase 2 | Jun 1, 2007 | Harvard University, Pennsylvania State University, Windtree Therapeutics |
| NCT00215540 | Phase 2 | Feb 1, 2005 | University of North Carolina at Chapel Hill, Windtree Therapeutics |
| NCT00807235 | Phase 2 | Jan 1, 2005 | University of California, San Diego, Windtree Therapeutics |
| NCT00215553 | Phase 2 | May 1, 2001 | Windtree Therapeutics |
| NCT00004500 | Phase 3 | Mar 1, 2000 | Windtree Therapeutics |
| NCT01203358 | Phase 2/Phase 3 (Phase 3) | Jan 1, 1991 | Case Western Reserve University, Emory University, George Washington University, Indiana University, National Institute of Child Health and Human Development (NICHD), Stanford University, The University of Texas, Dallas, University of Cincinnati, University of Miami, University of New Mexico, University of Tennessee, University of Vermont, Wayne State University |
Organizations
Research & Development (22)
Marketing (2)
| Organization | Org type | Relationship | Date |
|---|---|---|---|
| GlaxoSmithKline | For profit | NDA2 | Aug 2, 1990 |
| GlaxoSmithKline | For profit | NDA | Aug 2, 1990 |