What's the most recent regulatory action in Disorder of the urea cycle metabolism?

Most recent: Ravicti — FDA approved.

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Subscribe to /feed/disease/disorder-of-the-urea-cycle-metabolism.xml in Feedly / Inoreader. Every regulatory action, PDUFA date, or trial completion in this treatment area lands in your feed automatically.

Last reviewed 2026-06-10 · How we verify

Disorder of the urea cycle metabolism — Treatment Landscape & Competitive Intelligence

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

Disorder of the urea cycle metabolism (disease) competitive landscape: 3 marketed treatments tracked, 0 Phase 3 candidates, 0 Phase 2 candidates. Recent regulatory actions and upcoming PDUFA dates across the entire treatment set.

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

Marketed treatment landscape

Approved drugs treating Disorder of the urea cycle metabolism, deduplicated by molecule. See the full disease page for line-of-therapy detail.

Drug	Generic	Sponsor	Class	Target	First approval
Ravicti	GLYCEROL PHENYLBUTYRATE	Horizon Therap Us	glycerol phenylbutyrate		2013-01-01
Buphenyl	Buphenyl	Amgen		Aldose reductase, Histone deacetylase 1, Histone deacetylase 2
Ravicti	Ravicti	University of Pittsburgh

Phase 3 pipeline

No Phase 3 pipeline candidates tracked.

Phase 2 pipeline

No Phase 2 pipeline candidates tracked.

Recent regulatory actions (last 90 days)

2026-04-15 — Ravicti · FDA · approved · US
2026-04-15 — Ravicti · FDA · approved · US
2026-04-15 — Ravicti · FDA · approved · US

Upcoming PDUFA dates (next 180 days)

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

Sponsor landscape

Amgen · 1 drug in Disorder of the urea cycle metabolism
Horizon Therap Us · 1 drug in Disorder of the urea cycle metabolism
University of Pittsburgh · 1 drug in Disorder of the urea cycle metabolism

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Every new regulatory action, PDUFA date, or trial completion in Disorder of the urea cycle metabolism:

Cite this brief

Drug Landscape (2026). Disorder of the urea cycle metabolism — Treatment Landscape & Competitive Intelligence Brief. https://druglandscape.com/ci/disease/disorder-of-the-urea-cycle-metabolism. Accessed 2026-06-10.

Disorder of the urea cycle metabolism full disease profile — treatment pathway, diagnostics, guidelines
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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing