Overview
Poloxamer 188 (P188) is a nonionic block linear copolymer that exhibits rheologic, anti-thrombotic, anti-inflammatory, and cytoprotective activities in various tissue injury models . Composed of two hydrophilic side-chains attached to a hydrophobic center core , its average molecular weight is 8400 Daltons. P188 was originally approved by the FDA in the 1960s as a therapeutic agent to reduce viscosity in the blood before transfusions, however it is no longer available in any approved products . Due to its sufactant properties, P188 may also be found in over-the-counter (OTC) products such as toothpaste, laxatives and mouthwash, and used in various cosmetic, industrial and pharmaceutical applications. There is an evidence of P188 increasing the structural stability and resealing of the plasma membrane via direct incorporation into the phospholipid bilayer . The ability of P188 in attenuating membrane damage and cell injury has been demonstrated in a variety of in vivo and in vitro models . The use of P188 as a potential treatment in different pathological conditions, such as chronic microvascular diseases and skeletal muscle deficiencies, is under investigation .
Background
Poloxamer 188 (P188) is a nonionic block linear copolymer that exhibits rheologic, anti-thrombotic, anti-inflammatory, and cytoprotective activities in various tissue injury models . Composed of two hydrophilic side-chains attached to a hydrophobic center core , its average molecular weight is 8400 Daltons. P188 was originally approved by the FDA in the 1960s as a therapeutic agent to reduce viscosity in the blood before transfusions, however it is no longer available in any approved products . Due to its sufactant properties, P188 may also be found in over-the-counter (OTC) products such as toothpaste, laxatives and mouthwash, and used in various cosmetic, industrial and pharmaceutical applications. There is an evidence of P188 increasing the structural stability and resealing of the plasma membrane via direct incorporation into the phospholipid bilayer . The ability of P188 in attenuating membrane damage and cell injury has been demonstrated in a variety of in vivo and in vitro models . The use of P188 as a potential treatment in different pathological conditions, such as chronic microvascular diseases and skeletal muscle deficiencies, is under investigation .
Indication
Indicated to reduce viscosity in the blood before transfusions.
Associated Conditions
No associated conditions information available.
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2018/06/15 | Phase 2 | Terminated | |||
2016/01/05 | Phase 1 | Completed | |||
2015/11/04 | Phase 2 | Terminated | |||
2015/05/20 | Phase 3 | Completed | |||
2014/03/21 | Phase 2 | Terminated | |||
2012/11/30 | Phase 3 | Completed | |||
1999/10/19 | Phase 3 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| No FDA approvals found for this drug. | |||||
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
| No EMA approvals found for this drug. | |||
HSA Drug Approvals
Approved Product | Manufacturer | Approval Number | Dosage Form | Strength | Approval Date |
|---|---|---|---|---|---|
| No HSA approvals found for this drug. | |||||
NMPA Drug Approvals
Approved Product | Company | Approval Number | Drug Type | Dosage Form | Approval Date |
|---|---|---|---|---|---|
| No NMPA approvals found for this drug. | |||||
PPB Drug Approvals
Approved Product | Registration No. | Company | Licence No. | Strength | Registration Date |
|---|---|---|---|---|---|
| No PPB approvals found for this drug. | |||||
TGA Drug Approvals
Approved Product | ARTG ID | Sponsor | Registration Type | Status | Registration Date |
|---|---|---|---|---|---|
| No TGA approvals found for this drug. | |||||