Drugs / Cysteamine
Cysteamine
also known as
Cysteamine bitartrate · Cystagon · RP103 · b-mercaptoethylamine · Cyspera · cysteamine hydrochloride · DR-CYS · EC-cysteamine · +2 more
Regulatory milestones approvals, filings & regulatory actions · 3 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Refused (EMA) | EU (EMA) | Dropcys | — | 2016-06-24 | europa.eu ↗ |
| Approved | EU (EMA) | Procysbi | — | 2013-09-05 | europa.eu ↗ |
| Approved | US (FDA) | CYSTARAN | — | 2012-10-02 | fda.gov ↗ |
Trials 19
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 12 trials | ||||||
| Phase 1 | NCT03883984 | Jun 2019 → Feb 2021 | asthma | Children's Hospital Medical Center, Cincinnati | Completed | No outcome recorded |
| Phase 1 | NCT00001736 | May 1998 → Mar 2001 | cystinosis | National Eye Institute (NEI) | Completed | No outcome recorded |
| Phase 1/22 trials · 1 met primary | ||||||
| Phase 1/2 | NCT02212431 | Aug 2014 → Mar 2015 | cystic fibrosis | University of Aberdeen | Completed | No outcome recorded |
| Phase 1/2 | NCT00799578 | Oct 2008 → Jun 2009 | fatty liver disease | Joel Lavine | Completed | Met primary |
| Phase 24 trials | ||||||
| Phase 2 | NCT07477288 | Mar → Sep 2025 | skin atrophy | Hasanuddin University | Completed | No outcome recorded |
| Phase 2 | NCT02023866 | May 2014 → Oct 2016 | inborn mitochondrial metabolism disorder | Amgen | Completed | No outcome recorded |
| Phase 2 | NCT00001213 | Apr 1986 → Jul 2013 | cystinosis | National Eye Institute (NEI) | Completed | No outcome recorded |
| Phase 2 | NCT00002110 | — | HIV infectious disease | Mylan Laboratories | Completed | No outcome recorded |
| Phase 2/31 trial | ||||||
| Phase 2/3 | NCT02101957 | Oct 2010 → Jul 2015 | Huntington disease | University Hospital, Angers | Unknown | No outcome recorded |
| Phase 34 trials | ||||||
| Phase 3 | NCT04125927 | Sep 2020 → Dec 2022 | cystinosis | RECORDATI GROUP | Completed | No outcome recorded |
| Phase 3 | NCT05969587 | Nov 2019 → Sep 2020 | hyperpigmentation of the skin | China Medical University Hospital | Completed | No outcome recorded |
| Phase 3 | NCT02735707 | Apr 2016 → Feb 2026 overdue | pneumonia | UMC Utrecht | Recruiting | Mixed |
| Phase 3 | NCT01197378 | Aug 2010 → Jun 2017 | cystinosis | Amgen | Completed | No outcome recorded |
| Phase not applicable6 trials · 1 missed | ||||||
| — | NCT05206318 | Dec 2021 → Jun 2022 | hyperpigmentation of the skin | Chang Gung Memorial Hospital | Unknown | No outcome recorded |
| — | NCT01432561 | Sep → Dec 2011 | nephropathic cystinosis | University of California, San Diego | Completed | No outcome recorded |
| — | NCT01139125 | Sep 2009 → Jun 2012 | schizoaffective disorder, schizophrenia | Augusta University | Terminated | No outcome recorded Stop: Enrollment |
| — | NCT00715559 | Jul 2008 → May 2009 | major depressive disorder | Icahn School of Medicine at Mount Sinai | Terminated | No outcome recorded |
| — | NCT02766855 | Jan 2004 → Dec 2012 | corneal deposit, nephropathic cystinosis | The Eye Center and The Eye Foundation for Research in Ophthalmology | Completed | Missed primary |
| — | NCT00010426 | Dec 1999 → Feb 2001 | cystinosis | FDA Office of Orphan Products Development | Completed | No outcome recorded |
| Comparator or background therapy3 trials | ||||||
| Phase 1/2 | NCT05994534 Comparator | Oct 2023 → Aug 2026 overdue | cystinosis | Nacuity Pharmaceuticals, Inc. | Active not recruiting | No outcome recorded |
| Phase 2 | NCT03000348 Comparator | Dec 2016 → Apr 2018 | cystic fibrosis | NovaBiotics Ltd. | Completed | No outcome recorded |
| — | NCT06278948 Comparator | Oct 2023 → Jun 2024 | hyperpigmentation of the skin | Cosmetique Active International | Unknown | No outcome recorded |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2020-08-25 | RECORDATI GROUP | Regulatory RECORDATI: U.S. FDA APPROVES CYSTADROPS® (Cysteamine Ophthalmic Solution) 0.37%, A NEW PRACTICAL TREATMENT OPTION FOR THE OCULAR MANIFESTATIONS OF CYSTINOSIS, recordati.com ↗
Recordati today announced the U.S. Food and Drug Administration (FDA) approval of Cystadrops® (cysteamine ophthalmic solution) 0.37%. |
| 2017-01-27 | RECORDATI GROUP | Regulatory RECORDATI ANNOUNCES MARKETING APPROVAL FOR CYSTADROPS®, recordati.com ↗
Recordati announces that the European Union Commission has granted the European marketing authorization for its orphan medicinal product Cystadrops® 3.8mg/mL. |
All press releases naming this drug 3 releases
| Date | Issuer | Release |
|---|---|---|
| 2020-08-25 | RECORDATI GROUP | RECORDATI: U.S. FDA APPROVES CYSTADROPS® (Cysteamine Ophthalmic Solution) 0.37%, A NEW PRACTICAL TREATMENT OPTION FOR THE OCULAR MANIFESTATIONS OF CYSTINOSIS, recordati.com ↗ |
| 2018-04-09 | RECORDATI GROUP | RECORDATI ACQUIRES INTERNATIONAL RIGHTS TO CYSTAGON® FROM MYLAN recordati.com ↗ |
| 2017-01-27 | RECORDATI GROUP | RECORDATI ANNOUNCES MARKETING APPROVAL FOR CYSTADROPS®, recordati.com ↗ |
Evidence & citations 13 cited values
Every value below carries the sentence it was read from. 24 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | Cysteamine | “Multicentric Trial of the Treatment of Huntington's Disease by Cysteamine (RP103)” NCT02101957 ↗ |
| Known as | b-mercaptoethylamine | “Cysteamine (b-mercaptoethylamine) hydrochloride is the stable amino-thiol that acts as an antioxidant.” NCT05969587 ↗ |
| Known as | Cyspera | “5% cysteamine cream (Cyspera®) was acquired from Scientis APAC Pte. Ltd. (Singapore, Singapore).” NCT05969587 ↗ |
| Known as | Cystagon | “The current study drug, cysteamine bitartrate (Cystagon), is FDA approved for the treatment nephropathic cystinosis” NCT00715559 ↗2“The current marketed therapy is Cystagon® (cysteamine bitartrate immediate release)” NCT01197378 ↗ “(Cystagon) Cysteamine Bitartrate” NCT01139125 ↗ |
| Known as | Cysteamine bitartrate | “The current study drug, cysteamine bitartrate (Cystagon), is FDA approved for the treatment nephropathic cystinosis” NCT00715559 ↗3“To determine the long-term effects of delayed-release cysteamine bitartrate (DR-CYS) based on our previous work” PMID 24948347 ↗ Jun 2014 “Cysteamine bitartrate readily traverses cellular membranes and is a potent antioxidant.” PMID 21395631 ↗ Mar 2011 “(Cystagon) Cysteamine Bitartrate” NCT01139125 ↗ |
| Known as | cysteamine hydrochloride | ClinicalTrials.gov intervention name — accepted as the source's own label NCT00010426 ↗ |
| Known as | DR-CYS | “To determine the long-term effects of delayed-release cysteamine bitartrate (DR-CYS) based on our previous work” PMID 24948347 ↗ Jun 2014 |
| Known as | EC-cysteamine | “received twice-daily EC-cysteamine for 24 weeks.” PMID 21395631 ↗ Mar 2011 |
| Known as | Mercaptamine | ClinicalTrials.gov intervention name — accepted as the source's own label NCT04125927 ↗ |
| Known as | Mercaptoethylamine | “A Phase II/III Study of Cysteamine (Mercaptoethylamine) and Zidovudine for the Treatment of HIV Disease” NCT00002110 ↗ |
| Known as | RP103 | “Multicentric Trial of the Treatment of Huntington's Disease by Cysteamine (RP103)” NCT02101957 ↗1“cysteamine bitartrate delayed-release capsules (RP103)” NCT02023866 ↗ |
| Action | Inhibit | “Cysteamine is a thiolic compound that inhibit tyrosinase and peroxidase activity of melanocytes” NCT05969587 ↗ |
| Route | Topical | “cysteamine 0.5% topical solution” NCT00001213 ↗ |