CLINICAL TRIALS PROFILE FOR DEFERIPRONE

505(b)(2) Clinical Trials for Deferiprone

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Formulation	NCT02442310 ↗	Comparison of Deferiprone Delayed Release Tablets and Deferiprone Oral Solution in Healthy Volunteers	Completed	Algorithme Pharma Inc	Phase 1	2015-05-01	The purpose of this study is to look at the pharmacokinetics of a new formulation of deferiprone (deferiprone delayed release tablets) under fed and fasting conditions.
New Formulation	NCT02442310 ↗	Comparison of Deferiprone Delayed Release Tablets and Deferiprone Oral Solution in Healthy Volunteers	Completed	ApoPharma	Phase 1	2015-05-01	The purpose of this study is to look at the pharmacokinetics of a new formulation of deferiprone (deferiprone delayed release tablets) under fed and fasting conditions.
New Formulation	NCT02465489 ↗	Comparison of Deferiprone Extended Release Tablets and Ferriprox Immediate Release Tablets in Healthy Volunteers	Completed	ApoPharma	Phase 1	2015-06-01	The purpose of this study is to look at the pharmacokinetics of a new formulation of deferiprone (deferiprone extended release tablets) under fed and fasting conditions.

All Clinical Trials for Deferiprone

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00000588 ↗	Chelation Therapy of Iron Overload With Pyridoxal Isonicotinoyl Hydrazone	Completed	National Heart, Lung, and Blood Institute (NHLBI)	Phase 2	1989-06-01	To demonstrate the safety and effectiveness of orally-administered pyridoxal isonicotinoyl hydrazone (PIH) for the chronic treatment of iron overload.
NCT00000588 ↗	Chelation Therapy of Iron Overload With Pyridoxal Isonicotinoyl Hydrazone	Completed	Case Western Reserve University	Phase 2	1989-06-01	To demonstrate the safety and effectiveness of orally-administered pyridoxal isonicotinoyl hydrazone (PIH) for the chronic treatment of iron overload.
NCT00000623 ↗	Thalassemia (Cooley's Anemia) Clinical Research Network (TCRN)	Completed	National Heart, Lung, and Blood Institute (NHLBI)		2000-07-01	The purpose of the TCRN is to accelerate research in the management of thalassemia, standardize existing treatments, and evaluate new ones in a network of clinical centers in North America. The emphasis will be on clinical trials that help identify optimal therapy. Therapeutic trials may involve investigational drugs, drugs already approved but not currently used, and drugs currently used.

Clinical Trial Conditions for Deferiprone

Condition Name

Condition Name for Deferiprone
Intervention	Trials
Iron Overload	12
Beta-Thalassemia	6
Sickle Cell Disease	4

Condition MeSH

Condition MeSH for Deferiprone
Intervention	Trials
Iron Overload	20
Thalassemia	19
beta-Thalassemia	18

Clinical Trial Locations for Deferiprone

Trials by Country

Trials by Country for Deferiprone
Location	Trials
United States	39
Italy	14
Canada	12
Egypt	12
United Kingdom	9

Trials by US State

Trials by US State for Deferiprone
Location	Trials
Pennsylvania	7
California	7
Illinois	4
New York	4
Michigan	3

Clinical Trial Progress for Deferiprone

Clinical Trial Phase

Clinical Trial Phase for Deferiprone
Clinical Trial Phase	Trials
Phase 4	13
Phase 3	6
Phase 2/Phase 3	6

Clinical Trial Status

Clinical Trial Status for Deferiprone
Clinical Trial Phase	Trials
Completed	40
Unknown status	7
Recruiting	4

Clinical Trial Sponsors for Deferiprone

Sponsor Name

Sponsor Name for Deferiprone
Sponsor	Trials
ApoPharma	25
University Hospital, Lille	5
Ain Shams University	3

Sponsor Type

Sponsor Type for Deferiprone
Sponsor	Trials
Other	58
Industry	35
NIH	3