Procysbi (cysteamine bitartrate delayed-release)
An approved treatment for Cystinosis.
The same compound appears under different names depending on the context. Here is how to identify Cysteamine bitartrate delayed-release wherever you encounter it, plus the key facts at a glance.
- Generic name
- Cysteamine bitartrate delayed-release
- Brand name
- Procysbi
- Drug class
- Cystine-depleting agent
- Manufacturer
- Amgen (Horizon)
- How it's taken
- Capsules or granules every 12 hours, with juice (not grapefruit) or water.
A delayed-release form of cysteamine, taken every 12 hours, approved April 30, 2013, for nephropathic cystinosis in adults and children 1 year and older.
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Where Cysteamine bitartrate delayed-release fits
A twice-a-day alternative to immediate-release cysteamine (Cystagon), which is taken 4 times a day.
How Cysteamine bitartrate delayed-release works
Cysteamine enters the lysosome and reacts with cystine, making compounds that can leave the lysosome. That lowers the cystine that would otherwise form crystals and damage the kidneys and other organs.
Mechanism: Lowers cystine trapped inside cells' lysosomes
Side effects and safety
Warnings include Ehlers-Danlos-like skin and bone changes, severe skin rashes, stomach and bowel ulcers and bleeding, a bowel scarring condition called fibrosing colonopathy, nervous system symptoms, low white blood cell counts and raised pressure in the skull. People seriously allergic to penicillamine or cysteamine must not take it. In a trial against immediate-release cysteamine, vomiting (19% against 12%), nausea (16% against 7%) and stomach pain (14% against 0%) were most common.
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking Cysteamine bitartrate delayed-release
Capsules or granules every 12 hours, with juice (not grapefruit) or water. No food for 2 hours before or 30 minutes after a dose, and no alcohol. The dose is based on body size and adjusted to the white blood cell cystine level.
Availability and cost
Only available as the brand-name product.
Help paying for Procysbi
Pick your insurance to see which help fits. Drugmaker copay cards can't be used with Medicare, Medicaid or TRICARE; charity funds are the usual route there.
- Insurance and case manager help
A Patient Access Liaison helps with insurance and explains financial assistance options, and the program coordinates with the specialty pharmacy that dispenses Procysbi.
For: private insurance, Medicare, Medicaid, TRICARE, no insurance, underinsured · source
Good to know: The page does not publish copay amounts; ask Amgen By Your Side what you qualify for.
Access and eligibility
Approved for nephropathic cystinosis in adults and children 1 year and older.
Access program details are provided for informational purposes and may vary based on insurance coverage, geographic location, and individual circumstances. Confirm current eligibility directly with the manufacturer or your specialty pharmacy.
Development history
Approved by the FDA on April 30, 2013 as capsules, with oral granules approved on February 14, 2020. Its label lists Horizon Therapeutics, now part of Amgen.
Explore Cystinosis trials
Other Cystinosis treatments
Common questions about Cysteamine bitartrate delayed-release
▸What is Cysteamine bitartrate delayed-release (Procysbi)?
A delayed-release form of cysteamine, taken every 12 hours, approved April 30, 2013, for nephropathic cystinosis in adults and children 1 year and older.
▸How does Cysteamine bitartrate delayed-release work?
Cysteamine enters the lysosome and reacts with cystine, making compounds that can leave the lysosome. That lowers the cystine that would otherwise form crystals and damage the kidneys and other organs.
▸What are the side effects of Cysteamine bitartrate delayed-release?
Warnings include Ehlers-Danlos-like skin and bone changes, severe skin rashes, stomach and bowel ulcers and bleeding, a bowel scarring condition called fibrosing colonopathy, nervous system symptoms, low white blood cell counts and raised pressure in the skull. People seriously allergic to penicillamine or cysteamine must not take it. In a trial against immediate-release cysteamine, vomiting (19% against 12%), nausea (16% against 7%) and stomach pain (14% against 0%) were most common.
▸How is Cysteamine bitartrate delayed-release taken?
Capsules or granules every 12 hours, with juice (not grapefruit) or water. No food for 2 hours before or 30 minutes after a dose, and no alcohol. The dose is based on body size and adjusted to the white blood cell cystine level.
▸Is Cysteamine bitartrate delayed-release FDA approved?
Yes, Cysteamine bitartrate delayed-release (Procysbi) is FDA approved (2013) for the treatment of Cystinosis.
Sources and references
Every factual claim on this page is drawn from the public sources listed below. Click any reference to open the original document.
- U.S. National Library of Medicine, DailyMed · 2026-06. PROCYSBI (cysteamine bitartrate) delayed-release: prescribing information. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d3a3ec28-f746-463a-bb92-3bc8826db09e
- NCBI Bookshelf, GeneReviews · 2025-08. Cystinosis. https://www.ncbi.nlm.nih.gov/books/NBK1400/