Recent Updates
Recently added Catalysts

SPD602

Phase 2

Transfusional Iron Overload | Small molecule | Hematology |Takeda Pharmaceutical Company Limited|Last Updated: Jun 10, 2021

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment51

FDA Designations

No designations recorded

Clinical trial landscape

SPD602 · 1 trial · 2 indications

Phase 2 1
NCT01186419Safety and Pharmacodynamic Study of an Oral Iron Chelator Given for 6 Months to Patients With Iron OverloadTransfusional Iron Overload
COMPLETED51 Analytics
PHASE2COMPLETED
Safety and Pharmacodynamic Study of an Oral Iron Chelator Given for 6 Months to Patients With Iron Overload
Transfusional Iron OverloadUnlock trial analytics

Study Endpoints

Primary Endpoints

Change From Baseline in Liver Iron Concentration (LIC) at 96 Weeks
Baseline and 96 weeks

LIC was determined by R2 Magnetic Resonance Imaging (MRI).

Secondary Endpoints

Maximum Plasma Concentration (Cmax) of SPD602
92 weeks
Area Under The Steady-state Plasma Concentration-time Curve (AUC) of SPD602
92 weeks
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
SPD602 (16mg)EXPERIMENTAL -
SPD602 (32mg)EXPERIMENTAL -

Interventions

NameTypeDescription
SPD602 (FBS0701, SSP-004184)DRUGOral FBS0701 taken one time daily for up to 96 weeks.
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 60 Years
SexALL
Healthy VolunteersNo
Study Sites9

Inclusion Criteria: * Transfusional iron overload due to: hereditary anemias such as sickle cell disease, β-thalassemia and Diamond-Blackfan anemia; acquired anemias such as Myelodysplastic Syndrome and other forms of bone marrow failure. Patients must also be transfusion-dependent and require chro...

Countries:United StatesItalyThailandTurkey (Türkiye)United Kingdom
Unlock Eligibility Criteria

Frequently asked questions about SPD602

What is SPD602 used for?

SPD602 is an investigational small molecule being developed for the treatment of transfusional iron overload, a condition that can occur in patients who receive regular blood transfusions, such as those with beta-thalassemia. It is designed to be taken orally as an iron chelator.

What does SPD602 target?

SPD602 is an oral iron chelator. It works by binding to excess iron in the body and promoting its excretion, thereby reducing iron accumulation in patients with transfusional iron overload. This mechanism helps manage the toxic effects of iron overload.

Who makes SPD602?

SPD602 is being developed by Takeda Pharmaceutical Company Limited, a global biopharmaceutical company. Takeda's stock is listed on the New York Stock Exchange under the ticker symbol TAK.

What phase is SPD602 in?

SPD602 is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 2 clinical trial has been completed to evaluate its safety and pharmacodynamic effects in patients with iron overload.

What clinical trials is SPD602 in?

SPD602 has been studied in one completed Phase 2 clinical trial, identified as NCT01186419. This trial was a controlled, randomized study that enrolled 51 participants with transfusional iron overload or beta-thalassemia. The study was conducted in the United States, Italy, Thailand, Turkey, and the United Kingdom.

Is SPD602 the same as an oral iron chelator?

SPD602 is an oral iron chelator, a type of medication that binds to excess iron in the body to help remove it. It is being developed as a treatment for transfusional iron overload, and its mechanism of action is similar to other drugs in this class.