Nephropathic Cystinosis
📧 Sign up to get email alerts when something new happens for Nephropathic Cystinosis.
Sign up freeTop drugs studied for this disease
-
CLINICAL_TRIALS research · 2025-11-10Clinical Trial Update: DFT383 in Pediatric Participants With Nephropathic Cystinosis [Phase 1, Phase 2]
DFT383 is being studied in pediatric participants with nephropathic cystinosis in Phase 1/2 trials. The study is currently recruiting, spons…
-
CLINICAL_TRIALS research · 2025-03-03Clinical Trial Update: CYSTEA-BONE Clinical Study
The CYSTEA-BONE clinical study is currently recruiting participants for Nephropathic Cystinosis.
-
FDA approval · 2022-02-11FDA Approved: PROCYSBI — Supplemental Application (Horizon Therapeutics USA, Inc.)
The FDA approved a supplemental application for PROCYSBI (cysteamine bitartrate) from Horizon Therapeutics USA, Inc., resulting in a label u…
-
FDA label_change · 2022-02-11FDA Approved: PROCYSBI — Supplemental Application (Horizon Therapeutics USA, Inc.)
FDA approved a supplemental application for PROCYSBI (cysteamine bitartrate) from Horizon Therapeutics USA, Inc., leading to changes to the …
-
FDA approval · 2020-06-24FDA Approved: PROCYSBI — Supplemental Application (Horizon Therapeutics USA, Inc.)
FDA approved a supplemental application for PROCYSBI (cysteamine bitartrate) from Horizon Therapeutics USA, Inc.
- Want full summaries, importance scores, and drug timelines? Upgrade to Plus or Pro.
-
FDA approval · 2020-04-24FDA Approved: CYSTARAN — Supplemental Application (Leadiant Biosciences, Inc.)
The FDA has approved a supplemental application for CYSTARAN (cysteamine hydrochloride) from Leadiant Biosciences, Inc., indicating an appro…
-
FDA approval · 2020-02-14FDA Approved: PROCYSBI — Original Application (Horizon Therapeutics USA, Inc.)
The FDA approved Horizon Therapeutics' PROCYSBI (cysteamine bitartrate) through the original NDA 213491 for the treatment of nephropathic cy…
-
FDA approval · 2019-05-31FDA Approved: PROCYSBI — Supplemental Application (Horizon Therapeutics USA, Inc.)
The FDA approved a supplemental application for PROCYSBI (cysteamine bitartrate) from Horizon Therapeutics USA, Inc.
-
FDA label_change · 2017-12-22FDA Approved: PROCYSBI — Supplemental Application (Horizon Therapeutics USA, Inc.)
The FDA approved a supplemental application for PROCYSBI (cysteamine bitartrate) submitted by Horizon Therapeutics USA, expanding or updatin…
-
FDA approval · 2017-11-21FDA Approved: PROCYSBI — Supplemental Application (Horizon Therapeutics USA, Inc.)
The FDA approved a supplemental application for PROCYSBI (cysteamine bitartrate) from Horizon Therapeutics USA, Inc., resulting in updated l…
-
FDA approval · 2016-06-06FDA Approved: CYSTAGON — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approved a supplemental application for CYSTAGON (cysteamine bitartrate) submitted by Mylan Pharmaceuticals. The approval updates the pr…
-
FDA approval · 2016-05-13FDA Approved: PROCYSBI — Supplemental Application (Horizon Therapeutics USA, Inc.)
FDA approved a supplemental application for PROCYSBI (cysteamine bitartrate) from Horizon Therapeutics USA, Inc. The action constitutes an N…
-
CLINICAL_TRIALS trial_result · 2016-05-10Clinical Trial Update: Efficacy of Topical Cysteamine in Nephropathic Cyctinosis [NA]
A completed clinical trial evaluating the efficacy of topical cysteamine for corneal cystine crystals in nephropathic cystinosis.
-
FDA approval · 2016-03-21FDA Approved: PROCYSBI — Supplemental Application (Horizon Therapeutics USA, Inc.)
The FDA approved a supplemental application for PROCYSBI (cysteamine bitartrate) from Horizon Therapeutics USA, Inc., marking an approved mo…
-
FDA approval · 2016-03-10FDA Approved: PROCYSBI — Supplemental Application (Horizon Therapeutics USA, Inc.)
The FDA approved a supplemental application for PROCYSBI (cysteamine bitartrate) submitted by Horizon Therapeutics USA, Inc.
-
FDA approval · 2015-08-14FDA Approved: PROCYSBI — Supplemental Application (Horizon Therapeutics USA, Inc.)
FDA approves a supplemental application for PROCYSBI (cysteamine bitartrate) submitted by Horizon Therapeutics USA, Inc.
-
FDA approval · 2015-06-15FDA Approved: CYSTAGON — Supplemental Application (Mylan Pharmaceuticals Inc.)
FDA approved a supplemental application for CYSTAGON (cysteamine bitartrate) submitted by Mylan Pharmaceuticals Inc.
-
FDA approval · 2015-04-08FDA Approved: PROCYSBI — Supplemental Application (Horizon Therapeutics USA, Inc.)
The FDA approved a supplemental application for PROCYSBI (cysteamine bitartrate) from Horizon Therapeutics USA, Inc.
-
FDA approval · 2014-12-02FDA Approved: PROCYSBI — Supplemental Application (Horizon Therapeutics USA, Inc.)
The FDA approved a supplemental application for PROCYSBI (cysteamine bitartrate) filed by Horizon Therapeutics USA, Inc.
-
FDA approval · 2014-04-21FDA Approved: PROCYSBI — Supplemental Application (Horizon Therapeutics USA, Inc.)
FDA approved a Supplemental Application for PROCYSBI (cysteamine bitartrate) by Horizon Therapeutics USA, Inc.
-
CLINICAL_TRIALS research · 2014-03-12Clinical Trial Update: Cure Cystinosis International Registry
This entry provides an update on the Cure Cystinosis International Registry (NCT01327807), a patient registry focused on cystinosis and rela…
-
FDA approval · 2014-01-30FDA Approved: PROCYSBI — Supplemental Application (Horizon Therapeutics USA, Inc.)
The FDA approved a supplemental application for PROCYSBI (cysteamine bitartrate) submitted by Horizon Therapeutics USA, Inc.
-
FDA approval · 2013-10-31FDA Approved: PROCYSBI — Supplemental Application (Horizon Therapeutics USA, Inc.)
The FDA approved a supplemental application for Procysbi (cysteamine bitartrate) submitted by Horizon Therapeutics USA, Inc.
-
FDA approval · 2013-10-18FDA Approved: PROCYSBI — Supplemental Application (Horizon Therapeutics USA, Inc.)
The FDA approved a supplemental application for Procysbi (cysteamine bitartrate) from Horizon Therapeutics USA, Inc.
-
CLINICAL_TRIALS trial_result · 2013-10-09Clinical Trial Update: Study in Healthy Adults to Determine the Effect That Food Has on the Absorption and Delivery of the Drug Cystagon™ [NA]
A healthy volunteer study evaluated how food affects the absorption of Cystagon (cysteamine bitartrate); results were posted after completio…