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Last reviewed 2026-06-10 · How we verify

Hyperammonemia associated with N-acetylglutamate synthase deficiency — Treatment Landscape & Competitive Intelligence

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Hyperammonemia associated with N-acetylglutamate synthase deficiency (disease) competitive landscape: 2 marketed treatments tracked, 0 Phase 3 candidates, 0 Phase 2 candidates. Recent regulatory actions and upcoming PDUFA dates across the entire treatment set.

2 marketed 0 Phase 3 0 Phase 2 Live · 30-min refresh

Marketed treatment landscape

Approved drugs treating Hyperammonemia associated with N-acetylglutamate synthase deficiency, deduplicated by molecule. See the full disease page for line-of-therapy detail.

Drug	Generic	Sponsor	Class	Target	Line of therapy	First approval
Carbaglu	CARGLUMIC ACID	Recordati	Carbamoyl Phosphate Synthetase 1 Activator [EPC]	Carbamoyl-phosphate synthase [ammonia], mitochondrial		2010-01-01
Carbaglu	Carbaglu	Mendel Tuchman		Carbamoyl-phosphate synthase [ammonia], mitochondrial

Phase 3 pipeline

No Phase 3 pipeline candidates tracked.

Phase 2 pipeline

No Phase 2 pipeline candidates tracked.

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this treatment set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this treatment set.

Sponsor landscape

Mendel Tuchman · 1 drug in Hyperammonemia associated with N-acetylglutamate synthase deficiency
Recordati · 1 drug in Hyperammonemia associated with N-acetylglutamate synthase deficiency

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Cite this brief

Drug Landscape (2026). Hyperammonemia associated with N-acetylglutamate synthase deficiency — Treatment Landscape & Competitive Intelligence Brief. https://druglandscape.com/ci/disease/hyperammonemia-associated-with-n-acetylglutamate-synthase-deficiency. Accessed 2026-06-10.

Hyperammonemia associated with N-acetylglutamate synthase deficiency full disease profile — treatment pathway, diagnostics, guidelines
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing