Carglumic acid
Also known as: Carbaglu · Ucedane
General information only. Anpheros does not diagnose and does not recommend treatment. Talk to a doctor or pharmacist about your situation. In an emergency, call 112 (or your local emergency number).
In short
In the European Union, carglumic acid is indicated for the treatment of hyperammonaemia due to N-acetylglutamate-synthase primary deficiency, isovaleric acidaemia, methylmalonic acidaemia, and propionic acidaemia. In the United States, carglumic acid tablets for oral suspension are a carbamoyl phosphate synthetase 1 activator indicated in pediatric and adult patients as an adjunctive therapy to standard of care for the treatment of acute hyperammonemia due to N-acetylglutamate synthase deficiency. In the United States, it is also indicated as maintenance therapy for the treatment of chronic hyperammonemia due to N-acetylglutamate synthase deficiency.
From: Source: European Medicines Agency (EMA), Carbaglu — EPAR, 09/12/2025. © European Medicines Agency. · Data provided by the U.S. Food and Drug Administration.
AI-generated summary of the sources cited on this page, checked automatically against them. Not reviewed by a clinician; not medical advice.
Codes
- RxNorm
- 401713 carglumic acid
- EMA
- EMEA/H/C/000461, EMEA/H/C/004019
Official indications
Quoted unchanged from official product information, in English. Listed alphabetically by product, not ranked.
EMA (EU) Carbaglu
Carbaglu is indicated in treatment of: hyperammonaemia due to N-acetylglutamate-synthase primary deficiency; hyperammonaemia due to isovaleric acidaemia; hyperammonaemia due to methymalonic acidaemia; hyperammonaemia due to propionic acidaemia.
Source: European Medicines Agency (EMA), Carbaglu — EPAR, 09/12/2025. © European Medicines Agency.
Document date: 09/12/2025 · Official document →
FDA (USA) Carglumic Acid
1 INDICATIONS & USAGE Carglumic acid tablets for oral suspension is a carbamoyl phosphate synthetase 1 (CPS 1) activator indicated in pediatric and adult patients as: Adjunctive therapy to standard of care for the treatment of acute hyperammonemia due to N-acetylglutamate synthase (NAGS) deficiency. (1.1) Maintenance therapy for the treatment of chronic hyperammonemia due to NAGS deficiency. (1.1) 1.1 Acute and Chronic Hyperammonemia due to N-acetylglutamate Synthase (NAGS) Deficiency Carglumic acid tablets for oral suspension are indicated in adult and pediatric patients as: Adjunctive therapy to standard of care for the treatment of acute hyperammonemia due to NAGS deficiency. Maintenance therapy for the treatment of chronic hyperammonemia due to NAGS deficiency.
Data provided by the U.S. Food and Drug Administration.
Document date: 20260303 · Official document →
Other treatments A–Z
What people report
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External resources
Questions
What is Carglumic acid approved for in the European Union?
Carbaglu is indicated in treatment of: hyperammonaemia due to N-acetylglutamate-synthase primary deficiency; hyperammonaemia due to isovaleric acidaemia; hyperammonaemia due to methymalonic acidaemia; hyperammonaemia due to propionic acidaemia. (Source: European Medicines Agency (EMA), Carbaglu — EPAR, 09/12/2025. © European Medicines Agency.)
Sources and attribution
- Source: European Medicines Agency (EMA) — EPAR. © European Medicines Agency.
- Names other than the official source titles: Anpheros translations and plain-language names, made with AI assistance and checked automatically; the source names are in English.
- Data provided by the U.S. Food and Drug Administration.
- This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product.
- Source: European Medicines Agency (EMA), Carbaglu — EPAR, 09/12/2025. © European Medicines Agency.
Anpheros Search catalog 2026.10.5, published 17 October 2026. About the data →
About this page. This page brings together public information from official sources, each cited where it is used. It is not medical advice, it is not a diagnosis, and it does not tell you which treatment to take.
Treatments. Indications are quoted unchanged from official product information (European Medicines Agency, U.S. Food and Drug Administration). They describe what a medicine is approved for, not whether it is right for you. Approved uses can differ between countries. Always read the package leaflet and follow your doctor's or pharmacist's advice.
What people report. Figures marked "reported by Anpheros users" are anonymous counts from at least 20 people who agreed to share them. They show what people report, not what works, and they are not clinical evidence.
Links between terms. "May be associated with" means the link appears in a cited source. It does not mean you have that condition.
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