Drugs / Cysteamine Bitartrate
Cysteamine Bitartrate
Regulatory milestones approvals, filings & regulatory actions · 4 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Label expansions (2) | US (FDA) | PROCYSBI | — | 2015-08-14 – 2017-12-22 | fda.gov ↗ |
| Approved | EU (EMA) | Cystagon | — | 1997-06-23 | europa.eu ↗ |
| Approved | US (FDA) | CYSTAGON | — | 1994-08-15 | fda.gov ↗ |
Trials 6
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1/21 trial | ||||||
| Phase 1/2 | NCT00872729 | May → Oct 2009 | cystinosis | Amgen | Completed | No outcome recorded |
| Phase 21 trial | ||||||
| Phase 2 | NCT02473445 | May 2015 → Mar 2017 | mitochondrial disease | Amgen | Terminated | No outcome recorded Stop: Business |
| Phase 33 trials | ||||||
| Phase 3 | NCT01733316 | Jan 2013 → Feb 2015 | cystinosis | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT01744782 | Dec 2012 → Dec 2016 | cystinosis | Amgen | Completed | No outcome recorded |
| Phase 3 | NCT01000961 | Jun 2010 → Jun 2011 | cystinosis | Amgen | Completed | No outcome recorded |
| Phase 41 trial | ||||||
| Phase 4 | NCT00028262 | Feb 2001 → Nov 2013 | infantile neuronal ceroid lipofuscinosis 1 | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Completed | No outcome recorded |
| Comparator or background therapy1 trial | ||||||
| Phase 2/3 | NCT01529268 Comparator | Jun 2012 → Mar 2015 | NAFLD1 | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Completed | No outcome recorded |
Press releases naming this drug 1 release
| Date | Issuer | Release |
|---|---|---|
| 2018-04-09 | RECORDATI GROUP | RECORDATI ACQUIRES INTERNATIONAL RIGHTS TO CYSTAGON® FROM MYLAN recordati.com ↗ |
Evidence & citations 6 cited values
Every value below carries the sentence it was read from. 9 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Cysteamine Bitartrate | “Reference Product: Cystagon® (Cysteamine Bitartrate) Capsules, 150 mg/50 mg.” NCT00872729 ↗ |
| Known as | CBDR | “We performed a randomized controlled trial to determine whether 52 weeks of cysteamine bitartrate delayed release (CBDR) reduces the severity of liver disease in children with NAFLD.” PMID 27569726 ↗ Aug 2016 |
| Known as | Cystagon | “Reference Product: Cystagon® (Cysteamine Bitartrate) Capsules, 150 mg/50 mg.” NCT00872729 ↗ |
| Known as | Cysteamine Bitartrate Delayed-release Capsules | “Cysteamine Bitartrate Delayed-release Capsules (RP103) were administered twice daily, orally or via gastrostomy tube (G-tube), after a 2-hour fast.” NCT01744782 ↗ |
| Known as | RP103 | “Test Product: RP103 (Cysteamine Bitartrate) Delayed-release Capsules, 75 mg.” NCT00872729 ↗ |
| Route | Oral | “Patients received oral cysteamine bitartrate (60 mg/kg per day) and N-acetylcysteine (60 mg/kg per day)” PMID 24997880 ↗ Jul 2014 |