FERRIPROX (deferiprone)
FERRIPROX Tablets are indicated for the treatment of transfusional iron overload in adult and pediatric patients 8 years of age and older with thalassemia syndromes, sickle cell disease or other anemias. Limitation s of Use • Safety and effectiveness have not been established for the treatment of transfusional iron overload in patients with myelodysplastic syndrome or in patients with Diamond Blackfan anemia.
Development Insights
Details
- Status
- Prescription
- First Approved
- 2011-10-14
- Patent Cliff
- 2038
- Routes
- ORAL
- Dosage Forms
- TABLET, SOLUTION
FERRIPROX Approval History
What FERRIPROX Treats
6 FDA approvalsOriginally approved for its first indication in 2011 . Covers 6 distinct patient populations.
- Other (6)
FERRIPROX Boxed Warning
AGRANULOCYTOSIS AND NEUTROPENIA • FERRIPROX can cause agranulocytosis that can lead to serious infections and death. Neutropenia may precede the development of agranulocytosis. [see Warnings and Precautions ( 5.1 )] • Measure the absolute neutrophil count (ANC) before starting FERRIPROX therapy and monitor regularly while on therapy. • Interrupt FERRIPROX therapy if neutropenia develops. [see Warnings and Precautions ( 5.1 )] • Interrupt FERRIPROX if infection develops, and monitor the ANC more ...
WARNING: AGRANULOCYTOSIS AND NEUTROPENIA • FERRIPROX can cause agranulocytosis that can lead to serious infections and death. Neutropenia may precede the development of agranulocytosis. [see Warnings and Precautions ( 5.1 )] • Measure the absolute neutrophil count (ANC) before starting FERRIPROX therapy and monitor regularly while on therapy. • Interrupt FERRIPROX therapy if neutropenia develops. [see Warnings and Precautions ( 5.1 )] • Interrupt FERRIPROX if infection develops, and monitor the ANC more frequently. [see Warnings and Precautions ( 5.1 )] • Advise patients taking FERRIPROX to report immediately any symptoms indicative of infection. [see Warnings and Precautions ( 5.1 )] WARNING: AGRANULOCYTOSIS AND NEUTROPENIA See full prescribing information for complete boxed warning. • FERRIPROX can cause agranulocytosis that can lead to serious infections and death. Neutropenia may precede the development of agranulocytosis. ( 5.1 ) • Measure the absolute neutrophil count (ANC) before starting FERRIPROX and monitor regularly while on therapy. ( 5.1 ) • Interrupt FERRIPROX therapy if neutropenia develops. ( 5.1 ) • Interrupt FERRIPROX if infection develops and monitor the ANC more frequently. ( 5.1 ) • Advise patients taking FERRIPROX to report immediately any symptoms indicative of infection. ( 5.1 )
Clinical Trial Registry
15 trials| Trial | Sponsor ID | Phase | Status | Title |
|---|---|---|---|---|
| NCT02164253 SAFEFAIRALS | 2012_69 2013-001228-21 | Ph 2 | completed | Focal Accumulation of Iron in Cerebral Regions in Early ALS (Amyotrophic Lateral Sclerosis) Patients |
| NCT02655315 FAIRPARKII | 2015_22 2015-003679-31, Grant agreement No 633190 | Ph 2 | completed | Conservative Iron Chelation as a Disease-modifying Strategy in Parkinson's Disease |
| NCT03293069 FAIR-ALS II | 2016_76 2017-003763-35 | Ph 2, Ph 3 | completed | Conservative Iron Chelation as a Disease-modifying Strategy in Amyotrophic Lateral Sclerosis |
| NCT07023666 | INOVA-2023-159 | Ph 2 | recruiting | Early Screening and Treatment of Heart Complication in Sickle Cell Disease |
| NCT02728843 SKY results posted | LA48-0215 | Ph 2 | completed | Study of Parkinson's Early Stage With Deferiprone |
| NCT02443545 results posted | LA38-EXT | Ph 4 | terminated | Long-term Safety and Efficacy of Ferriprox® in Iron Overloaded Patients With Sickle Cell Disease or Other Anemias |
| NCT02041299 FIRST results posted | LA38-0411 | Ph 4 | terminated | Efficacy and Safety of Ferriprox® in Patients With Sickle Cell Disease or Other Anemias |
| NCT01825512 results posted | DEEP-2 | Ph 3 | completed | Efficacy/Safety Study of Deferiprone Compared to Deferasirox in Paediatric Patients |
| NCT01391520 | CRMD001-3001 | Ph 3 | withdrawn | Efficacy and Safety of Deferiprone in Patients With Chronic Kidney Disease Undergoing a Cardiac Catheterization and Receiving Contrast Agent |
| NCT02477631 | SHEBA-15-1908-DM-CTIL | Ph 2 | completed | Effect of Deferiprone on Oxidative-Stress and Iron-Overload in Low Risk Transfusion-Dependent MDS Patients |
| NCT01989455 results posted | LA42-0113 | Ph 1 | completed | A Blinded, Placebo-Controlled Study of the Safety and Pharmacokinetics of Single Doses of Intravenous Deferiprone in Healthy Volunteers |
| NCT01860703 results posted | LA37-1111 | Ph 4 | completed | Evaluation of Whether Deferiprone Affects QT Interval in Healthy Subjects |
| NCT01770652 results posted | LA39-0412 | Ph 4 | completed | An Open-label, Non-randomized, Parallel Group Study in Subjects With Mild, Moderate, Severe, or No Renal Impairment |
| NCT00943748 FAIR-PARK-I | 2008-006842-25 2008_19/0838, A90113-62 | Ph 2, Ph 3 | completed | Efficacy and Safety of the Iron Chelator Deferiprone in Parkinson's Disease |
| NCT00530127 | LA29-0207 | Ph 1, Ph 2 | completed | A Study Investigating the Safety and Tolerability of Deferiprone in Patients With Friedreich's Ataxia |
Active Pipeline
Ongoing clinical trials by development phase
Key Completed Trials
Completed studies with published results, ranked by significance
Trial Timeline
Full development history with FDA approval milestones
Understanding FDA Approval Types
| Count | Type | What it means |
|---|---|---|
| - | ORIG | Original approval - drug first enters market |
| - | SUPPL - Efficacy | New indication (new disease/condition approved) |
| - | SUPPL - Labeling | Label text changes (warnings, dosing updates) |
| - | SUPPL - Manufacturing | Production changes (new facility) |
| - | SUPPL - Chemistry | Formulation changes (new dosage strength) |
Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.
FERRIPROX FDA Label Details
Indications & Usage
FDA Label (PDF)FERRIPROX Tablets are indicated for the treatment of transfusional iron overload in adult and pediatric patients 8 years of age and older with thalassemia syndromes, sickle cell disease or other anemias. Limitation s of Use • Safety and effectiveness have not been established for the treatment of transfusional iron overload in patients with myelodysplastic syndrome or in patients with Diamond Blackfan anemia. FERRIPROX Tablets are an iron chelator indicated for the treatment of transfusional iron overload in adult and pediatric patients 8 years of age and older with thalassemia syndromes, sick...
WARNING: AGRANULOCYTOSIS AND NEUTROPENIA • FERRIPROX can cause agranulocytosis that can lead to serious infections and death. Neutropenia may precede the development of agranulocytosis. [see Warnings and Precautions ( 5.1 )] • Measure the absolute neutrophil count (ANC) before starting FERRIPROX the...
FERRIPROX Patents & Exclusivity
Patents (7 active)
Exclusivity
Pro Intelligence Preview
Deep insights for FERRIPROX
Revenue Insights
- • Quarterly revenue tracking
- • Historical trend analysis
Patent Timeline
- • Cliff: 2038
- • 10 active patents
Trial Analysis
- • 18 total trials
- • Stage: Declining
Competitive Landscape
- • Competitor tracking
- • Same target/indication analysis
Full approval history • All patents • Revenue trends • Competitor analysis
Data Sources
Data sourced from official FDA and NIH databases. Click links to verify on original sources.
How We Calculate These Metrics
Trial Activity Stage
Measures the current development activity pattern based on trial phases, status, and trends. Important: This measures R&D activity, not commercial lifecycle.
Trial statuses: "Active" means recruiting or ongoing. "Completed" means reached planned endpoint. "Terminated" means stopped early—often due to safety, efficacy, or business reasons.
- Growth: High proportion of early-phase trials (Phase 1/2), active development
- Expansion: Significant Phase 3 activity, approaching or pursuing approvals
- Mature: Substantial Phase 4 post-marketing studies
- Stable: Mixed phase distribution, steady development
- Declining: Low active trial ratio, reduced R&D investment