Overview
Glycerol phenylbutyrate is a nitrogen-binding agent. Chemically, it is a triglyceride in which three molecules of phenylbutyrate are linked to a glycerol backbone. FDA approved on February 1, 2013.
Background
Glycerol phenylbutyrate is a nitrogen-binding agent. Chemically, it is a triglyceride in which three molecules of phenylbutyrate are linked to a glycerol backbone. FDA approved on February 1, 2013.
Indication
Glycerol phenylbutyrate is a nitrogen-binding agent for the chronic management of adult and pediatric patients ≥2 years of age with urea cycle disorders (UCDs) who cannot be managed by dietary protein restriction and/or amino acid supplementation alone.
Associated Conditions
- Disorders of urea cycle metabolism
Clinical Trials
Title | Posted | Study ID | Phase | Status | Sponsor |
|---|---|---|---|---|---|
2025/04/01 | N/A | Not yet recruiting | |||
2023/08/09 | Phase 2 | Recruiting | Technical University of Munich | ||
2017/11/07 | Phase 4 | Completed | |||
2014/12/23 | Phase 1 | Terminated | |||
2014/09/22 | Phase 4 | Completed | |||
2014/03/21 | N/A | NO_LONGER_AVAILABLE | Robert Squires, Jr. | ||
2014/01/27 | Phase 1 | Completed | |||
2013/09/24 | N/A | NO_LONGER_AVAILABLE | |||
2013/06/20 | Phase 1 | Completed | |||
2011/05/04 | Phase 3 | Completed |
FDA Drug Approvals
Approved Product | Manufacturer | NDC Code | Route | Strength | Effective Date |
|---|---|---|---|---|---|
| Horizon Therapeutics USA, Inc. | 75987-050 | ORAL | 1.1 g in 1 mL | 9/13/2021 |
EMA Drug Approvals
Approved Product | Authorization Holder | Status | Issued Date |
|---|---|---|---|
Authorised | 11/26/2015 | ||
Authorised | 11/26/2015 |
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 |
|---|---|---|---|---|---|
| Glycerol Phenylbutyrate Oral Liquid | 国药准字HJ20230071 | 化学药品 | 口服溶液剂 | 7/10/2023 |
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. | |||||