Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as SSP-004184SS, SSP-004184AQ
SPD602 · 5 trials · 3 indications
LIC was determined by R2 Magnetic Resonance Imaging (MRI).
AUCinf is the area under the plasma concentration versus time curve extrapolated from time 0 to infinity, calculated using the observed value of the last non-zero concentration. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.
AUClast is the area under the concentration versus time curve from the time of dosing to the last measurable concentration. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.
Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.
AUCinf is the area under the plasma concentration versus time curve extrapolated from time 0 to infinity, calculated using the observed value of the last nonzero concentration. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.
AUClast is the area under the concentration versus time curve from the time of dosing to the last measurable concentration. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.
Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.
AUCinf is the area under the plasma concentration versus time curve from time 0 to infinity. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.
AUClast is the area under the curve from the time of dosing to the last measurable concentration. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.
Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated.
AUC 0-last is the area under the plasma concentration versus time curve from time 0 to the time of last quantifiable concentration. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body
AUCinf is the area under the curve extrapolated to infinity, calculated using the observed value of the last nonzero concentration. AUC can be used as a measure of drug exposure. It is derived from drug concentration and time so it gives a measure how much and how long a drug stays in a body.
Cmax is a term that refers to the maximum (or peak) concentration that a drug achieves in the body after the drug has been administrated
| Arm | Type | Description |
|---|---|---|
| SPD602 (16mg) | EXPERIMENTAL | - |
| SPD602 (32mg) | EXPERIMENTAL | - |
| Midazolam | ACTIVE_COMPARATOR | Administered as a single oral 6 mg dose on Day 1. |
| SSP-004184SS + Midazolam | EXPERIMENTAL | Midazolam (6 mg) + SSP-004184SS (30 mg/kg) concomitantly administered as a single oral dose on Day 1. |
| Simvastatin | ACTIVE_COMPARATOR | Administered as a single oral 20 mg dose on Day 1. |
| Simvastatin + SSP-004184SS | EXPERIMENTAL | Simvastatin (20 mg) + SSP-004184SS (30 mg/kg) administered concomitantly as a single oral dose on Day 1. |
| SSP-004184SS (fed) | EXPERIMENTAL | 21.8 mg/kg (oral capsule form) given once on Day 1 under fed conditions |
| SSP-004184SS (fasted) | EXPERIMENTAL | 21.8 mg/kg (oral capsule form) given once on Day 1 under fasted conditions |
| SSP-004184AQ (single dose) | EXPERIMENTAL | 40 mg/kg (oral capsule form) given once on Day 1 |
| SSP-004184SS (single dose) | EXPERIMENTAL | 21.8 mg/kg (oral capsule form) given once on Day 1 |
| SSP-004184AQ (2 doses) | EXPERIMENTAL | 40 mg/kg (oral capsule form) given twice (12 hours apart) on Day 1 |
| SSP-004184SS (2 doses) | EXPERIMENTAL | 21.8 mg/kg (oral capsule form) given twice (12 hours apart) on Day 1 |
| Name | Type | Description |
|---|---|---|
| SPD602 (FBS0701, SSP-004184) | DRUG | Oral FBS0701 taken one time daily for up to 96 weeks. |
| Midazolam | DRUG | - |
| SSP-004184SS | DRUG | - |
| Simvastatin | DRUG | - |
| SSP-004184AQ | DRUG | Magnesium salt |
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...
SPD602 is being developed for transfusional iron overload, a condition in which excess iron accumulates in the body from repeated blood transfusions. It is an oral small molecule iron chelator studied in adults with transfusional iron overload, including patients with beta-thalassemia.
SPD602 is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda is the sponsor of the clinical program evaluating SPD602 in hematology, specifically for transfusional iron overload.
SPD602 is in Phase 2 clinical development. It is an investigational oral iron chelator that has not been approved for commercial use, and its completed Phase 2 study evaluated safety and pharmacodynamic effects over six months of treatment.
SPD602 has been studied in the Phase 2 trial NCT01186419, titled Safety and Pharmacodynamic Study of an Oral Iron Chelator Given for 6 Months to Patients With Iron Overload. The trial enrolled 51 adults with transfusional iron overload and beta-thalassemia across the United States, Italy, Thailand, Turkey, and the United Kingdom, and it is completed.
Yes. SPD602 is also known as FBS0701 and SSP-004184. These are alternative names for the same oral iron chelator developed by Takeda for transfusional iron overload, so searches for any of these names refer to the same investigational compound.