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RAVICTI Discontinuation in CanadaCanPKU+ is working to protect treatment choice and continuity for Canadians living with Urea Cycle Disorders.
What families need to know right now:
A discontinuation of RAVICTI has been reported in Canada. This is a
planned discontinuation and does not mean that people taking RAVICTI
should change their treatment now. Continue working with your metabolic
care team regarding your individual treatment.
What is happening?CanPKU+ is aware of the planned discontinuation of RAVICTI® (glycerol phenylbutyrate) in Canada. We know that news of a treatment discontinuation can create significant concern for people who rely on that treatment and for their families. Our immediate priority is to understand what this decision means for Canadians currently using RAVICTI and to advocate for a pathway that protects continuity of care and treatment choice. What we knowRAVICTI is a prescription oral liquid containing glycerol phenylbutyrate 1.1 g/mL and is used as a nitrogen-binding agent in the chronic management of certain people living with Urea Cycle Disorders (UCDs). [1] [2]
Canadian DIN
02453304
Medicinal Ingredient
Glycerol phenylbutyrate
Canadian Status
A discontinuation has been reported through Canada's national
drug shortage and discontinuation reporting system.
Health Canada defines a drug discontinuation as a decision by a market authorization holder to permanently stop selling a drug in Canada. Manufacturers are required to report discontinuations through Canada's drug shortage reporting system so that governments, health-care providers, supply-chain partners and others can prepare for potential gaps in supply. [3] [4] Why CanPKU+ is concernedFor someone living with a rare metabolic disorder, a medication is not simply a product on a shelf. Treatment decisions may reflect years of clinical experience, previous treatment attempts, tolerability, metabolic control, daily administration requirements and individual medical needs. A replacement pathway therefore needs to consider more than whether another nitrogen-scavenging treatment exists. CanPKU+ believes Canadians currently relying on RAVICTI need a clinically appropriate, accessible and funded treatment pathway before existing Canadian access ends. What CanPKU+ is doingCanPKU+ is actively engaging on this issue. Our advocacy will focus on: Treatment continuityWorking to ensure Canadians currently receiving RAVICTI are not left without an appropriate treatment pathway. Health Canada engagementFollowing the Canadian discontinuation process and seeking clarity about measures that may prevent or mitigate a treatment-access gap. Clinical leadershipEngaging Canada's metabolic community so that decisions about alternatives and transitions are informed by clinicians experienced in Urea Cycle Disorders. Replacement optionsExploring whether glycerol phenylbutyrate or other appropriate treatment options could remain available to Canadians through another Canadian supply pathway. Access and reimbursementRecognizing that regulatory availability alone is not enough. A replacement treatment must also be practically accessible and appropriately funded. Patient experienceDocumenting what RAVICTI means to Canadians who use it, including treatment history, tolerability, administration, quality-of-life considerations and concerns about changing treatment. Accountability and timelinesMonitoring developments as the discontinuation progresses and advocating early enough that solutions can be put in place before patients are affected. We need to hear from people taking RAVICTIIf you or your child currently takes RAVICTI in Canada, we would like to hear from you. Your experience can help us advocate with evidence rather than assumptions. You may wish to tell us:
You do not need to be a CanPKU+ member to contact us about this issue. People directly affected by this discontinuation need to be part of the conversation. We want to help bring your experience and your voice to the tables where decisions are being made. Share Your Experience With CanPKU+What happens next?Health Canada notes that responding to drug shortages and discontinuations involves multiple participants, including governments, manufacturers, the drug supply chain and health-care providers. [5] Health Canada also has regulatory mechanisms that may be considered in particular shortage or discontinuation circumstances, including exceptional importation and, in certain circumstances, the Special Access Program. [5] [6] These mechanisms should not be interpreted as confirmation that a particular solution will be available for RAVICTI. CanPKU+ will continue advocating for a sustainable pathway that protects Canadians who rely on this treatment.
Please do not change your treatment based on this announcement.
If you currently take RAVICTI, continue working with your metabolic clinic regarding your individual treatment and prescriptions. CanPKU+ provides advocacy and community support. Individual medical decisions should be made with your health-care team. Stay informedCanPKU+ will continue to monitor the Canadian RAVICTI discontinuation and share meaningful updates with the UCD community as information becomes available. Canadian Sources
[1] Health Canada Drug Product Database: RAVICTI
Canadian product and regulatory information for RAVICTI, DIN 02453304. View Health Canada Drug Product Database
[2] Health Canada: Summary Basis of Decision for RAVICTI
Health Canada's regulatory decision and Canadian authorization information for RAVICTI. View Health Canada Summary Basis of Decision
[3] Drug Shortages Canada: RAVICTI Discontinuation Report
Official Canadian discontinuation report #292424. View RAVICTI Discontinuation Report
[4] Health Canada: Reporting Drug Shortages and Discontinuations
Canadian requirements and guidance concerning drug shortage and discontinuation reporting. View Health Canada Guidance
[5] Health Canada: Drug Shortages in Canada
Information about Canada's drug shortage system and the roles of governments, manufacturers, health-care providers and other partners. View Health Canada Drug Shortage Information
[6] Health Canada: Special Access Program for Drugs
Guidance describing the Special Access Program and circumstances in which requests may be considered. View Special Access Program Guidance Last updated: September 2026. This page provides general information and advocacy updates and is not medical advice. Patients and families should speak with their metabolic care team before making changes to treatment. ``` |
