Sodium Phenylbutyrate
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansion | US (FDA) | OLPRUVA | — | 2025-10-10 | fda.gov ↗ |
| Refused (EMA) | EU (EMA) | Albrioza | — | 2024-01-05 | europa.eu ↗ |
| Approved | EU (EMA) | Ammonaps | — | 1999-12-07 | europa.eu ↗ |
| Approved | US (FDA) | BUPHENYL | — | 1996-04-30 | fda.gov ↗ |
Trials 35
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2024-09-06 | ZevraDenmark | Results Zevra Therapeutics Presented New Data for Arimoclomol and OLPRUVA® (Sodium Phenylbutyrate) at the Society for the Study of Inborn Errors of Metabolism (SSIEM) 2024 Annual Symposium zevra.com ↗
PK modeling studies showed that administration of OLPRUVA while fasting vs fed results in higher drug exposure which may allow for lower effective dosages when taken without food |
| 2022-11-02 | Glenmark Pharmaceuticals Ltd. India | Regulatory Glenmark Pharmaceuticals receives ANDA approval for Sodium Phenylbutyrate Tablets USP, 500 mg glenmarkpharma.com ↗
Glenmark Pharmaceuticals Limited (Glenmark) has received final approval by the United States Food & Drug Administration (U.S. FDA) for Sodium Phenylbutyrate Tablets USP, 500 mg, the generic version of Buphenyl®1 Tablets, 500 mg, of Horizon Therapeutics, LLC. |
All press releases naming this drug 8 releases
Evidence & citations 12 cited values
Every value below carries the sentence it was read from. 46 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | sodium phenylbutyrate | “The purpose of this study is to evaluate the safety, tolerability and clinical impact of 15-grams daily of sodium phenylbutyrate (phenylbutyrate) in Huntington's disease and to...” NCT00212316 ↗30“We, recently, showed that stimulating BCAA oxidation for 2 weeks with sodium-phenylbutyrate (NaPB) treatment -a drug known to accelerate BCAA oxidation- decreased BCAA plasma...” NCT05836350 ↗ “Our study seeks to investigate the potential small molecule inhibition of the kinase that regulates BCKDC by applying a novel activity of sodium phenylbutyrate (NaPBA), in MSUD.” NCT01529060 ↗ “Dose of interventions: 5,000 IU of vitamin D (cholecalciferol tablets) once daily and 500 mg PBA (sodium phenylbutyrate tablets) twice daily for 16 weeks.” NCT01702974 ↗ “Dose of interventions: 5,000 IU of vitamin D (cholecalciferol tablets) once daily and 500 mg PBA (sodium phenylbutyrate tablets) twice daily for 16 weeks.” NCT01698476 ↗ “The purpose of this study is to determine whether sodium phenylbutyrate can reduce Lcn2 urinary expression in proteinuric patients.” NCT02343094 ↗ “Oral sodium phenylbutyrate (Buphenyl®) equivalent to 3 g/m2 of 4-phenylbutyric acid (PBA) per dose” NCT00977600 ↗ “AMX0035 twice daily--a combination of Sodium Phenylbutyrate (3g) and Taurursodiol (1g)” NCT03533257 ↗ “Tauroursodeoxycholic Acid and Sodium Phenylbutyrate orally given twice a day” NCT04516096 ↗ “oral AMX0035 (sodium phenylbutyrate + taurursodiol) versus placebo” NCT07699380 ↗ “Fixed dose combination of Sodium Phenylbutyrate and taurursodiol.” NCT04987671 ↗ |
| Known as | 4-phenylbutyrate | “This is a single patient compassionate use protocol to determine whether Buphenyl (4-phenylbutyrate) will improve the poor bile flow associated with Byler Disease.” NCT01784718 ↗ |
| Known as | 4-phenylbutyric acid, sodium salt | “500 mg sodium phenylbutyrate (4-phenylbutyric acid, sodium salt) in tablet form twice daily and 5000 IU of cholecalciferol once daily will be given orally for 2 months” NCT01580007 ↗ |
| Known as | ACER-001 | “The medication is sodium phenylbutyrate (ACER-001), which is currently FDA approved for the treatment of Urea Cyle Disorders.” NCT06069375 ↗ |
| Known as | Buphenyl | “Buphenyl is currently approved for the treatment of rare inherited disorders of the urea cycle.” NCT00533559 ↗ |
| Known as | Buphenyl-TM | “Sodium phenylbutyrate (Buphenyl-TM) is a drug that has been used to treat other types of urea cycle disorders.” NCT00345605 ↗ |
| Known as | NaPB | “The purpose of the study is to evaluate the safety of sodium phenylbutyrate (NaPB) treatment in subjects with amyotrophic lateral sclerosis (ALS) and the ability to take this...” NCT00107770 ↗2“This study will investigate if the drug sodium phenylbutyrate (NaPB) impacts blood pressure and vascular function in healthy volunteers and in patients with diabetes.” NCT06645769 ↗ “This has led us to try an alternative method, which is to lower BCAA levels using Sodium Phenylbutyrate (NaPB).” NCT05028803 ↗ |
| Known as | NaPBA | “Our study seeks to investigate the potential small molecule inhibition of the kinase that regulates BCKDC by applying a novel activity of sodium phenylbutyrate (NaPBA), in MSUD.” NCT01529060 ↗1“Buphenyl (NaPBA) will be the comparator drug to HPN-100 in this study.” NCT00992459 ↗ |
| Known as | PBA | “Dose of interventions: 5,000 IU of vitamin D (cholecalciferol tablets) once daily and 500 mg PBA (sodium phenylbutyrate tablets) twice daily for 16 weeks.” NCT01702974 ↗1“Immunotherapy using vitamin D (vitD3 ) and phenylbutyrate (PBA) may support standard drug regimens used to treat infectious diseases.” PMID 29696707 ↗ May 2018 |
| Known as | phenylbutyrate | “500 mg sodium phenylbutyrate (4-phenylbutyric acid, sodium salt) in tablet form twice daily and 5000 IU of cholecalciferol once daily will be given orally for 2 months” NCT01580007 ↗16“Combination of 3 g phenylbutyrate and 1 g taurursodiol” NCT05619783 ↗ |
| Modality | Small molecule | “Phenylbutyrate is an aromatic fatty acid” NCT00006450 ↗ |
| Route | Intravenous | “phenylbutyrate administered as a continuous intravenous infusion for 28 days” NCT00001565 ↗ |