Who are PEGVALIASE's main competitors?

Direct comparators (same drug class / molecular target / therapeutic area): RDD to Palynziq, Kuvan®, Pegvaliase-Pqpz, saproterin dihydrochloride.

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Every 30 minutes from primary sources (FDA, EMA, MHRA, PMDA, ClinicalTrials.gov, USPTO). Subscribe to the RSS feed below for push alerts.

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Last reviewed 2026-05-13 · How we verify

PEGVALIASE — Competitive Intelligence Brief

PEGVALIASE (PEGVALIASE) competitive landscape: 4 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Phenylalanine Metabolizing Enzyme [EPC].

marketed Phenylalanine Metabolizing Enzyme [EPC] phenylalanine Enzyme Live · refreshed every 30 min

Target snapshot

PEGVALIASE (PEGVALIASE). Pegvaliase-pqpz converts phenylalanine to ammonia and trans-cinnamic acid, reducing blood phenylalanine levels in PKU patients.

Comparator set (4 drugs)

Auto-detected by same drug class / molecular target / therapeutic area, ranked by phase + recency. Override with ?vs=slug1,slug2,….

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
PEGVALIASE TARGET	PEGVALIASE		marketed	Phenylalanine Metabolizing Enzyme [EPC]	phenylalanine	2018-01-01
RDD to Palynziq	RDD to Palynziq	BioMarin Pharmaceutical	marketed	Enzyme replacement therapy	Phenylalanine ammonia-lyase (PAL)
Kuvan®	Kuvan®	Merck KGaA, Darmstadt, Germany	marketed	Cofactor replacement therapy	Phenylalanine ammonia-lyase (PAL) enzyme cofactor
Pegvaliase-Pqpz	Pegvaliase-Pqpz	University of Missouri-Columbia	marketed	Enzyme replacement therapy	Phenylalanine (substrate); phenylalanine ammonia lyase (active enzyme)
saproterin dihydrochloride	saproterin dihydrochloride	University Hospitals Cleveland Medical Center	marketed	Cofactor replacement therapy	Phenylalanine ammonia-lyase (PAL) cofactor

Recent regulatory actions (last 90 days)

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

Upcoming PDUFA dates (next 180 days)

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

Patent timeline (forward window)

No upcoming patent expiries for this set.

Sponsor landscape (Phenylalanine Metabolizing Enzyme [EPC] class)

· 1 drug in this class

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Cite this brief

Drug Landscape (2026). PEGVALIASE — Competitive Intelligence Brief. https://druglandscape.com/ci/pegvaliase. Accessed 2026-05-13.

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