SEPIAPTERIN

Information current as at: 1 July 2026

PBAC meeting date: November 2026

Legend:

Completed N In progress

Not applicable N Yet to commence

Submission Details

Brand name:: SEPHIENCE®
Form and strength:: Sachet containing oral powder 250 mg

Sachet containing oral powder 1000 mg
Submission sponsor:: PTC THERAPEUTICS AUSTRALIA PTY LIMITED
Condition/indication: (therapeutic use): Hyperphenylalaninaemia (HPA) due to phenylketonuria (PKU)
Listing requested:: To request listing of sepiapterin (in combination with a low-phenylalanine diet) for the treatment of patients with HPA due to PKU. Upon initiation of treatment with sepiapterin, patients must have a baseline blood phenylalanine level above 360 micromole per L and be less than one month of age, or patients must have a baseline blood phenylalanine level above 600 micromole per L and be more than one month of age.
Funding program:: PBS General Schedule
Request authority level:: Authority Required (STREAMLINED)
PBAC Submission type:: New PBS listing (–)
Comment:: --
Other PBAC consideration:: --

Submission received for:: November 2026 PBAC meeting
2Opportunity for consumer comment:: Open 22/07/2026 and close 16/09/2026 (see PBS Website)
3PBAC meeting:: Has not yet occurred
4PBAC outcome published:: Pending PBAC outcome (see PBAC Outcomes)
5Lodgement of required documentation:
6Agreement to listing arrangements:: Has not yet commenced
7Government processes:: Has not yet commenced
8Medicine listed on the PBS:: Has not yet occurred

PBAC Recommendation:

Please see the Outcomes from the relevant meeting for more information

Case ID

a1306

Page last updated

23 July 2026

v.9.19