Hyperammonemia
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Sign up freeTop drugs studied for this disease
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FDA approval · 2026-02-17FDA Approved: SODIUM PHENYLBUTYRATE — Original Application (Zydus Pharmaceuticals USA Inc.)
FDA approves an original ANDA for sodium phenylbutyrate by Zydus Pharmaceuticals USA Inc., enabling a generic version of the drug.
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CLINICAL_TRIALS trial_result · 2025-10-06Clinical Trial Update: At Home Ammonia Monitoring of Inborn Errors of Ammonia Metabolism [NA]
Clinical trial update on at-home ammonia monitoring for individuals with inborn errors of ammonia metabolism; enrollment is by invitation.
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CLINICAL_TRIALS research · 2025-06-24Clinical Trial Update: Continuous Renal Replacement Therapy Intensity in Hyperammonemia [NA]
A clinical trial is evaluating the effect of different intensities of continuous renal replacement therapy on hyperammonemia in patients wit…
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CLINICAL_TRIALS trial_result · 2025-04-25Clinical Trial Update: A Phase 1 Study to Evaluate PK Profile and Food Effects on PK Parameters of TNP-2092 Capsules [Phase 1]
A Phase 1 trial evaluating the pharmacokinetic profile of TNP-2092 capsules and the effect of food on PK in hyperammonemia; the study has co…
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CLINICAL_TRIALS research · 2025-04-15Clinical Trial Update: An Observational Study of Carbaglu® for the Treatment of MMA and PA in Adults and Pediatrics
An observational study update evaluating Carbaglu (carglumic acid) for the treatment of hyperammonemia in adults and children with methylmal…
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EMA approval · 2024-09-25EMA Authorised: Ucedane (carglumic acid) — Eurocept International BV
The European Medicines Agency has authorised Ucedane (carglumic acid) by Eurocept International BV for the treatment of hyperammonemia due t…
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CLINICAL_TRIALS research · 2024-09-20Clinical Trial Update: A Study of Cases with Abnormal Serum Ammonia in Neonate and Children Attending Assiut University Children Hospital
A clinical trial assessing cases with abnormal serum ammonia in neonates and children at Assiut University Children Hospital, currently not …
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FDA approval · 2024-05-30FDA Approved: CARGLUMIC ACID — Supplemental Application (Eton Pharmaceuticals, Inc.)
The FDA approved a supplemental application for carglumic acid submitted by Eton Pharmaceuticals, Inc.
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CLINICAL_TRIALS trial_result · 2024-05-10Clinical Trial Update: PK Profile and Preliminary Efficacy of TNP-2092 Capsules in Liver Cirrhosis Patients With Hyperammonemia [Phase 1, Phase 2]
The update reports the pharmacokinetic profile and preliminary efficacy signals of the investigational drug TNP-2092 in patients with liver …
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FDA approval · 2024-01-19FDA Approved: CARBAGLU — Supplemental Application (Recordati Rare Diseases)
FDA approved a supplemental application for CARBAGLU (carbaglumic acid) submitted by Recordati Rare Diseases.
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FDA approval · 2023-07-14FDA Approved: SODIUM PHENYLACETATE AND SODIUM BENZOATE — Original Application (Zydus Pharmaceuticals USA Inc.)
FDA approved an original application for sodium phenylacetate and sodium benzoate to treat hyperammonemia due to urea cycle disorders.
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FDA approval · 2023-05-04FDA Approved: SODIUM PHENYLACETATE AND SODIUM BENZOATE — Supplemental Application (MAIA PHARMACEUTICALS, INC)
FDA approved a supplemental application for sodium phenylacetate and sodium benzoate from Maia Pharmaceuticals, indicating approval of an ex…
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FDA approval · 2022-11-01FDA Approved: SODIUM PHENYLBUTYRATE — Original Application (GLENMARK PHARMACEUTICALS INC., USA)
FDA approved Glenmark's generic sodium phenylbutyrate (Original Application) for use in treating patients with urea cycle disorders, expandi…
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FDA approval · 2021-08-05FDA Approved: CARBAGLU — Supplemental Application (Recordati Rare Diseases)
The FDA approved a supplemental application for CARBAGLU (carbaglumic acid) from Recordati Rare Diseases, extending its approved use for pat…
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FDA approval · 2021-06-10FDA Approved: SODIUM PHENYLACETATE AND SODIUM BENZOATE — Original Application (MAIA PHARMACEUTICALS)
The FDA approved Maia Pharmaceuticals' original application for sodium phenylacetate and sodium benzoate, a therapy for managing hyperammone…
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FDA approval · 2021-01-22FDA Approved: CARBAGLU — Supplemental Application (Recordati Rare Diseases)
The FDA approved a supplemental application for CARBAGLU (carglumic acid) from Recordati Rare Diseases. The action pertains to a supplement …
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FDA approval · 2020-08-26FDA Approved: CARBAGLU — Supplemental Application (Recordati Rare Diseases)
The FDA approved a supplemental application for CARBAGLU (carglumic acid) submitted by Recordati Rare Diseases.
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CLINICAL_TRIALS trial_result · 2020-02-17Clinical Trial Update: N-Carbamylglutamate (Carbaglu) In The Treatment Of Hyperammonemia [Phase 2, Phase 3]
Phase 2/3 trial update for N-Carbamylglutamate (Carbaglu) in the treatment of hyperammonemia due to inborn errors of metabolism.
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FDA approval · 2017-05-08FDA Approved: SODIUM PHENYLACETATE AND SODIUM BENZOATE — Original Application (MAIA PHARMACEUTICALS, INC)
FDA approved an original application for the generic combination product sodium phenylacetate and sodium benzoate for the treatment of hyper…
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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 · 2016-02-24FDA Approved: SODIUM PHENYLACETATE AND SODIUM BENZOATE — Original Application (Omnivium Pharmaceuticals LLC)
FDA approved Omnivium's generic sodium phenylacetate and sodium benzoate (original application) for treatment of hyperammonemia due to urea …
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FDA approval · 2013-08-05FDA Approved: CARBAGLU — Supplemental Application (Recordati Rare Diseases)
The FDA approved a supplemental application for CARBAGLU (carglumic acid) submitted by Recordati Rare Diseases.
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FDA approval · 2013-07-22FDA Approved: CARBAGLU — Supplemental Application (Recordati Rare Diseases)
The FDA approved a supplemental application for CARBAGLU (carbaglumic acid) submitted by Recordati Rare Diseases. This action authorizes cha…
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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 · 2009-03-31FDA Approved: BUPHENYL — Supplemental Application (Horizon Therapeutics USA, Inc.)
FDA approved a supplemental application for BUPHENYL (sodium phenylbutyrate) submitted by Horizon Therapeutics USA, Inc.