Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Also known as SPD602
SSP-004184AQ · 2 trials · 3 indications
LIC was determined by R2 Magnetic Resonance Imaging (MRI).
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 | - |
| 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. |
| SSP-004184AQ | DRUG | Magnesium salt |
| SSP-004184SS | DRUG | Disodium 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...
SSP-004184AQ is an investigational small molecule developed by Takeda Pharmaceutical Company Limited. It is a magnesium salt formulation that has been studied in a Phase 1 relative bioavailability trial comparing it with another salt form, SSP-004184SS. The specific disease indication for SSP-004184AQ has not been publicly disclosed.
SSP-004184AQ is being developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. Takeda sponsored the Phase 1 relative bioavailability study of the compound. The program remains at an early investigational stage.
SSP-004184AQ is in Phase 1 clinical development. It is an investigational agent and has not been approved by the FDA. One Phase 1 trial has been completed, and no active trials of SSP-004184AQ are currently listed.
SSP-004184AQ was evaluated in a single Phase 1 trial, NCT01905540, titled A Relative Bioavailability Study of SSP-004184AQ (Magnesium Salt) and SSP-004184SS (Disodium Salt). The trial enrolled 28 healthy adult volunteers in the United States, used a controlled design, and has been completed.
No. SSP-004184AQ and SSP-004184SS are different salt forms of the same compound. SSP-004184AQ is the magnesium salt, while SSP-004184SS is the disodium salt. A completed Phase 1 trial directly compared the relative bioavailability of the two forms in healthy volunteers.
The Phase 1 trial NCT01905540 was a controlled, randomized relative bioavailability study of SSP-004184AQ and SSP-004184SS. It enrolled 28 healthy volunteers aged 18 years and older of all sexes in the United States. The study was not double blinded and has been completed.