Urea Cycle Disorders
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Sign up freeTop drugs studied for this disease
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FDA approval · 2017-04-28FDA Approved: GLYCEROL PHENYLBUTYRATE — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA approved Lupin Pharmaceuticals, Inc.'s supplemental application for glycerol phenylbutyrate.
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CLINICAL_TRIALS trial_result · 2017-03-09Clinical Trial Update: Protein Sorbent Properties of Montmorillonite in Vitro and in Vivo Models [NA]
A completed study evaluating montmorillonite's protein-sorbent properties in vitro and in vivo models relevant to urea cycle disorders and o…
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FDA approval · 2016-09-08FDA Approved: GLYCEROL PHENYLBUTYRATE — Supplemental Application (Lupin Pharmaceuticals, Inc.)
The FDA approved a supplemental application for glycerol phenylbutyrate from Lupin Pharmaceuticals, updating or expanding its regulatory sta…
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FDA approval · 2016-08-04FDA Approved: SODIUM PHENYLACETATE AND SODIUM BENZOATE — Original Application (Zydus Pharmaceuticals USA Inc.)
FDA approved an original Abbreviated New Drug Application for a generic combination of sodium phenylacetate and sodium benzoate manufactured…
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FDA approval · 2016-06-15FDA Approved: SODIUM PHENYLBUTYRATE — Original Application (ENDO USA, Inc.)
FDA approved an original application for a generic sodium phenylbutyrate from ENDO USA, Inc. for the treatment of urea cycle disorders.
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FDA approval · 2016-04-15FDA Approved: SODIUM PHENYLBUTYRATE — Original Application (ENDO USA, Inc.)
FDA approved the original application for sodium phenylbutyrate tablets, 500 mg, by Endo USA, Inc., establishing a generic version of the dr…
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CLINICAL_TRIALS trial_result · 2016-02-08Clinical Trial Update: Human Heterologous Liver Cells for Infusion in Children With Urea Cycle Disorders [Phase 2]
Phase 2 trial evaluating infusion of human heterologous liver cells in children with urea cycle disorders has been completed.
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CLINICAL_TRIALS trial_result · 2016-02-08Clinical Trial Update: Human Heterologous Liver Cells for Infusion in Children With Urea Cycle Disorders [Phase 2]
Phase 2 clinical trial evaluating allogeneic hepatocyte infusions for children with urea cycle disorders was terminated.
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FDA approval · 2015-10-06FDA Approved: BUPHENYL — Supplemental Application (Horizon Therapeutics USA, Inc.)
The FDA approved a supplemental application for BUPHENYL (sodium phenylbutyrate) submitted by Horizon Therapeutics USA, Inc.
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CLINICAL_TRIALS trial_result · 2015-10-02Clinical Trial Update: Oxidative Stress, Inflammation and Acute Decompensation in Urea Cycle Disorders
The clinical trial investigating oxidative stress, inflammation, and acute decompensation in urea cycle disorders has been terminated. No re…
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FDA approval · 2015-07-27FDA Approved: GLYCEROL PHENYLBUTYRATE — Supplemental Application (Lupin Pharmaceuticals, Inc.)
The FDA approved Lupin Pharmaceuticals' supplemental application for glycerol phenylbutyrate. The drug is used as a nitrogen scavenger for t…
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CLINICAL_TRIALS trial_result · 2015-06-01Clinical Trial Update: Pilot Study For Hypothermia Treatment In Hyperammonemic Encephalopathy In Neonates And Very Young Infants [Phase 2]
This update reports the completion of a Phase 2 pilot trial evaluating hypothermia treatment for hyperammonemic encephalopathy in neonates a…
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CLINICAL_TRIALS trial_result · 2015-05-28Clinical Trial Update: Study of the Safety, Pharmacokinetics and Efficacy of HPN-100, in Pediatric Subjects With Urea Cycle Disorders (UCDs) [Phase 3]
Phase 3 study of HPN-100 in pediatric patients with urea cycle disorders has completed and results were posted in 2015.
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CLINICAL_TRIALS trial_result · 2015-05-12Clinical Trial Update: Dose-Escalation Safety Study of HPN-100 to Treat Urea Cycle Disorders [Phase 2]
This clinical trial update reports a Phase 2 dose-escalation safety study of HPN-100 for urea cycle disorders, completed with results posted…
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FDA approval · 2015-01-05FDA Approved: GLYCEROL PHENYLBUTYRATE — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA approved a supplemental application for glycerol phenylbutyrate by Lupin Pharmaceuticals, extending its regulatory approval.
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FDA approval · 2014-06-24FDA Approved: GLYCEROL PHENYLBUTYRATE — Supplemental Application (Lupin Pharmaceuticals, Inc.)
FDA approved Lupin Pharmaceuticals' supplemental application for glycerol phenylbutyrate, a drug used to treat urea cycle disorders.
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CLINICAL_TRIALS withdrawal · 2014-05-29Clinical Trial Update: Increasing Ureagenesis in Inborn Errors of Metabolism With N-Carbamylglutamate [Phase 2]
Phase 2 trial of N-Carbamylglutamate to increase ureagenesis in urea cycle disorders and other inborn errors of metabolism has been withdraw…
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CLINICAL_TRIALS trial_result · 2013-12-25Clinical Trial Update: Study of the Safety and Tolerability of HPN-100 Compared to Sodium Phenylbutyrate in Children With Urea Cycle Disorders [Phase 2]
Phase 2 trial comparing HPN-100 to sodium phenylbutyrate in children with urea cycle disorders to assess safety and tolerability. The study …
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CLINICAL_TRIALS trial_result · 2013-08-15Clinical Trial Update: Study of the Safety of HPN (Hyperion)-100 for the Long-Term Treatment of Urea Cycle Disorders (Treat UCD) [Phase 3]
Phase 3 trial assessing the safety of HPN (Hyperion)-100 for long-term treatment of urea cycle disorders has completed, with results posted …
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CLINICAL_TRIALS trial_result · 2013-08-12Clinical Trial Update: Efficacy and Safety of HPN-100 for the Treatment of Adults With Urea Cycle Disorders [Phase 3]
Amgen completed a Phase 3 trial evaluating the efficacy and safety of HPN-100 in adults with urea cycle disorders, with results published in…
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FDA approval · 2013-08-02FDA Approved: BUPHENYL — Supplemental Application (Horizon Therapeutics USA, Inc.)
The FDA approved a supplemental application for BUPHENYL (sodium phenylbutyrate) from Horizon Therapeutics USA, Inc.
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CLINICAL_TRIALS trial_result · 2013-06-26Clinical Trial Update: Study in Healthy Subjects, Patients With Urea Cycle Disorders (UCD) and Carriers of UCD Mutations to Evaluate Urea Cycle Function [NA]
A completed clinical trial by Cytonet assessing urea cycle function in healthy subjects, patients with urea cycle disorders, and carriers of…
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FDA approval · 2013-03-22FDA Approved: SODIUM PHENYLBUTYRATE — Original Application (Sigmapharm Laboratories, LLC)
FDA approves an original application for a generic sodium phenylbutyrate (Sigmapharm Laboratories, LLC) to be used as an ammonia scavenger i…
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FDA approval · 2013-02-01FDA Approved: GLYCEROL PHENYLBUTYRATE — Original Application (Lupin Pharmaceuticals, Inc.)
FDA approved glycerol phenylbutyrate under Original Application (NDA 203284) from Lupin Pharmaceuticals for the treatment of urea cycle diso…
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CLINICAL_TRIALS trial_result · 2010-01-15Clinical Trial Update: Study to Evaluate 13 C Isotope Ratio Measurement for Urea Cycle Capacity Assessment [NA]
This update notes the completion of a study evaluating 13C isotope ratio measurement for urea cycle capacity assessment, sponsored by Cytone…