Phase II Study of Sodium Phenylbutyrate, Sodium Benzoate, Sodium Phenylacetate, and Dietary Intervention for Urea Cycle Disorders
Completed
Johns Hopkins University
Phase 2
1985-01-01
OBJECTIVES:
I. Assess the safety and efficacy of sodium phenylbutyrate, sodium benzoate, sodium
phenylacetate, and dietary intervention in patients with urea cycle disorders.
Phase II Study of Sodium Phenylbutyrate, Sodium Benzoate, Sodium Phenylacetate, and Dietary Intervention for Urea Cycle Disorders
Completed
National Center for Research Resources (NCRR)
Phase 2
1985-01-01
OBJECTIVES:
I. Assess the safety and efficacy of sodium phenylbutyrate, sodium benzoate, sodium
phenylacetate, and dietary intervention in patients with urea cycle disorders.
Efficacy and Safety Study of Ammonul® in Patients With Grade 3 or 4 Hepatic Encephalopathy
Terminated
Horizon Pharma Ireland, Ltd., Dublin Ireland
Phase 2
2007-12-01
The primary purpose of this study is to evaluate the safety and effectiveness of Ammonul® in
subjects who become hospitalized with Grade 3 or 4 hepatic encephalopathy (HE).
To determine the safety and tolerability of single oral doses of HPN-100 as a formulation
(GT4P-F) and GT4P as the active pharmaceutical ingredient (GT4P-API) administered to healthy
male subjects.
Sponsor Type for SODIUM PHENYLACETATE AND SODIUM BENZOATE
Sponsor
Trials
Industry
3
Other
2
NIH
1
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0
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Last updated: May 28, 2026
Sodium Phenylacetate and Sodium Benzoate Clinical Trials Update, Market Analysis, and Forecast (2026–2036)
No complete and verifiable, source-backed clinical-trials dataset and market sizing inputs were provided for sodium phenylacetate and sodium benzoate. Without those, a complete, accurate update covering trial phases, sponsors, enrollment status, readouts, regulatory milestones, and a quantified market projection cannot be produced.
Which clinical trials involve sodium phenylacetate and sodium benzoate, and what are the latest results?
What diseases are targeted by sodium phenylacetate and sodium benzoate programs?
Which companies are running the key sodium benzoate and sodium phenylacetate trials?
What endpoints are used (ammonia reduction, survival, neurologic outcomes, nitrogen balance)?
What is the current FDA regulatory status for sodium phenylacetate and sodium benzoate?
Is sodium phenylacetate and sodium benzoate listed in the Orange Book?
What are the approved indications and dosing forms (oral, IV) in the US?
Which FDA pathways apply (505(b)(2), 513, orphan drug, breakthrough, fast track)?
When do sodium phenylacetate and sodium benzoate lose exclusivity, and what generic entry risks exist?
What patents protect the active ingredients and fixed combinations?
When do composition-of-matter and method-of-use patents expire (US and key ex-US markets)?
Are there Paragraph IV challenges for sodium phenylacetate and sodium benzoate?
Are there bioequivalence or interchangeability constraints (if applicable)?
How strong is the patent estate for sodium phenylacetate and sodium benzoate (formulations and manufacturing)?
What formulation patents cover salts, particle size, stability, and taste-masking?
What process patents cover GMP manufacturing and impurity limits?
Which jurisdictions have the highest IP enforcement risk for generics?
What market is addressed by sodium phenylacetate and sodium benzoate, and how large is it?
How is demand segmented (indication, setting, pediatrics vs adults)?
How is revenue captured (US sales vs ex-US distributors and tenders)?
What pricing and payer dynamics typically govern access for hyperammonemia therapies?
How should sodium phenylacetate and sodium benzoate revenue grow through 2036 under base, bull, and bear scenarios?
A source-backed clinical trials update with phase-by-phase status and quantified market projections cannot be generated from the information provided.
A complete exclusivity and competitive landscape analysis requires verified Orange Book, patent, and litigation inputs tied to the specific approved product(s) and jurisdiction(s).
A defensible market forecast requires validated commercial base-year sales, adoption assumptions, and payer/access evidence.
FAQs
What is the mechanism of action of sodium phenylacetate and sodium benzoate in hyperammonemia?
Which endpoints matter most in trials for ammonia reduction therapies (and how are they measured)?
Do sodium phenylacetate and sodium benzoate formulations have separate IP for salts, dosing forms, and stability?
How do payer coverage and orphan drug status affect uptake for rare hyperammonemia treatments?
What competitive alternatives can displace ammonia-scavenging products, and how does that impact forecasts?
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