Maternal phenylketonuria syndrome

Advocacy intelligence hub — real-time data for patient organizations

View full disease page →Search clinical trials →
Download CSV

At a Glance

Live from database

Regulatory Watchboard

2 events
Jul 2025

Sephience: FDA approved

treatment of hyperphenylalaninemia (HPA) in adult and pediatric patients 1 month of age and older with sepiapterin-responsive phenylketonuria (PKU)

FDAcompleted
Dec 2007

Kuvan: FDA approved

Indicated to reduce blood phenylalanine (Phe) levels in patients with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive Phenylketonuria (PKU). Kuvan is to be used in conjunction with a Phe-restricted diet.

FDAcompleted

Data from FDA regulatory filings and ClinicalTrials.gov. Updated periodically.

Financial Assistance

2 programs

FINANCIAL LANDSCAPE SUMMARY

2

Total programs

2

Open now

Patient Assistance Programs2

Palynziq

BioMarin Pharmaceutical Inc.

OpenContact for detailsApply ↗

Sephience

PTC Therapeutics Inc.

OpenContact for details

View all support programs on disease page →

Approved Treatments

3 FDA-approved

Palynziq

(PEGVALIASE-PQPZ)Orphan drug

BioMarin Pharmaceutical Inc.

Approved Feb 2026FDA label ↗

Sephience

(SEPIAPTERIN)Orphan drug

PTC Therapeutics Inc.

Approved Jul 2025FDA label ↗

Kuvan

(sapropterin)Orphan drug

BioMarin Pharmaceutical, Inc.

12.1 Mechanism of Action KUVAN is a synthetic form of BH4, the cofactor for the enzyme phenylalanine hydroxylase (PAH). PAH hydroxylates Phe through a...

Approved Dec 2007FDA label ↗

View full treatment details on disease page →

Clinical Trial Landscape

No active clinical trials currently recruiting for Maternal phenylketonuria syndrome.
Search all trials →
Search clinical trials for Maternal phenylketonuria syndrome

Recent News & Research

No recent news articles indexed yet for Maternal phenylketonuria syndrome.
Search PubMed for Maternal phenylketonuria syndrome

Browse all Maternal phenylketonuria syndrome news →

Specialist Network

No specialists currently listed for Maternal phenylketonuria syndrome.

View all Maternal phenylketonuria syndrome specialists →

Quick Actions