Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
SPD422 · 2 trials · 2 indications
Baseline considered from study SPD422-308 (NCT01214915). Final assessment was defined as the last non-missing data (End of study visit in SPD422-309 \[NCT01467661\], or early termination visit either in SPD422-308 \[NCT01214915\] or SPD422-309 \[NCT01467661\], or last available study visit).
Baseline considered from study SPD422-308 (NCT01214915). Final assessment was defined as the last non-missing data (End of study visit in SPD422-309 \[NCT01467661\], or early termination visit either in SPD422-308 \[NCT01214915\] or SPD422-309 \[NCT01467661\], or last available study visit).
Baseline considered from study SPD422-308 (NCT01214915). Final assessment was defined as the last non-missing data (End of study visit in SPD422-309 \[NCT01467661\], or early termination visit either in SPD422-308 \[NCT01214915\] or SPD422-309 \[NCT01467661\], or last available study visit). Participants who achieved platelet count \<600 x 10\^9 platelets per liter at each visit were reported.
Baseline considered from study SPD422-308 (NCT01214915). Final assessment was defined as the last non-missing data (End of study visit in SPD422-309 \[NCT01467661\], or early termination visit either in SPD422-308 \[NCT01214915\] or SPD422-309 \[NCT01467661\], or last available study visit). Participants who achieved platelet count \<600 x 10\^9 platelets per liter during the post-marketing trial were reported.
Baseline considered from study SPD422-308 (NCT01214915). Final assessment (FA) was defined as the last nonmissing data (End of study visit in SPD422-309 \[NCT01467661\], or early termination visit either in SPD422-308 \[NCT01214915\] or SPD422-309 \[NCT01467661\], or last available study visit). Participants who had platelet count \<600 x 10\^9 platelet per liter and greater than equal (\>=) 600 x 10\^9 platelet per liter at the final assessment as a shift from baseline was reported. Percentage of participants with shift = number of participants with shift / Safety analysis set (53 participants) \* 100.
Baseline considered from study SPD422-308 (NCT01214915). Final assessment (FA) was defined as the last non-missing data (End of study visit in SPD422-309 \[NCT01467661\], or early termination visit either in SPD422-308 \[NCT01214915\] or SPD422-309 \[NCT01467661\], or last available study visit). Participants who had platelet count \<600 x 10\^9 platelet per liter and greater than equal (\>=) 600 x 10\^9 platelet per liter at the final assessment as a shift from baseline during the post marketing trial was reported. Percentage of participants with shift = number of participants with shift / post-marketing safety analysis set (33 participants) \* 100.
An adverse event (AE) was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse event was defined as the onset of any AE or if the severity of a pre-existing AE worsened any time on or after the date of first dose of investigational product in Study SPD422-308 (NCT01214915) and up to and including 12 days after the last dose is taken.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse event was defined as the onset of any AE or if the severity of a pre-existing AE worsened any time on or after the date of first dose of investigational product in Study SPD422-308 (NCT01214915) and up to and including 12 days after the last dose is taken.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse event was defined as the onset of any AE or if the severity of a pre-existing AE worsened any time on or after the date of first dose of investigational product in Study SPD422-308 (NCT01214915) and up to and including 12 days after the last dose is taken. Clinical Laboratory analysis included hematology, biochemistry, and urinalysis.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse event was defined as the onset of any AE or if the severity of a pre-existing AE worsened any time on or after the date of first dose of investigational product in Study SPD422-308 (NCT01214915) and up to and including 12 days after the last dose is taken. Clinical Laboratory analysis included hematology, biochemistry, and urinalysis.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse event was defined as the onset of any AE or if the severity of a pre-existing AE worsened any time on or after the date of first dose of investigational product in Study SPD422-308 (NCT01214915) and up to and including 12 days after the last dose is taken. Vital signs included pulse rate, systolic and diastolic blood pressure, and weight.
An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged in-patient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent adverse event was defined as the onset of any AE or if the severity of a pre-existing AE worsened any time on or after the date of first dose of investigational product in Study SPD422-308 (NCT01214915) and up to and including 12 days after the last dose is taken. Vital signs included pulse rate, systolic and diastolic blood pressure, and weight.
Standard 12-Lead ECG analysis was performed to identify the ECG abnormalities. Clinically significant abnormalities like QT prolongation, atrial fibrillation, were decided by the investigator during the study.
Cmax of Anagrelide (SPD422) on Day 1 and Day 8 was reported. For PK outcome measures the reporting groups were split based on administration of Anagrelide alone (Day 1) and Anagrelide in combination with Omeprazole (Day 8) to provide statistical comparison in this single arm study.
Cmax of 3-OH-Anagrelide (Active Metabolite of Anagrelide) on Day 1 and Day 8 was reported. For PK outcome measures the reporting groups were split based on administration of Anagrelide alone (Day 1) and Anagrelide in combination with Omeprazole (Day 8) to provide statistical comparison in this single arm study.
AUC(0-t) of Anagrelide (SPD422) in plasma on Day 1 and Day 8 was reported. For PK outcome measures the reporting groups were split based on administration of Anagrelide alone (Day 1) and Anagrelide in combination with Omeprazole (Day 8) to provide statistical comparison in this single arm study.
AUC(0-t) of 3-OH-Anagrelide (Active Metabolite of Anagrelide) in Plasma on Day 1 and Day 8 was reported. For PK outcome measures the reporting groups were split based on administration of Anagrelide alone (Day 1) and Anagrelide in combination with Omeprazole (Day 8) to provide statistical comparison in this single arm study.
AUC(0-infinity) of Anagrelide (SPD422) in plasma on Day 1 and Day 8 was reported. For PK outcome measures the reporting groups were split based on administration of Anagrelide alone (Day 1) and Anagrelide in combination with Omeprazole (Day 8) to provide statistical comparison in this single arm study.
AUC(0-infinity) of 3-OH-Anagrelide (Active Metabolite of Anagrelide) in Plasma on Day 1 and Day 8 was reported. For PK outcome measures the reporting groups were split based on administration of Anagrelide alone (Day 1) and Anagrelide in combination with Omeprazole (Day 8) to provide statistical comparison in this single arm study.
| Arm | Type | Description |
|---|---|---|
| SPD422 (anagrelide hydrochloride) | EXPERIMENTAL | - |
| SPD422 + Omeprazole | EXPERIMENTAL | Participants will receive 1 milligram (mg) of SPD422 (Anagrelide hydrochloride) (2\*0.5 mg) capsule orally on Day 1 in fasted state (10 hours prior to and until 4 hours following administration of anagrelide), followed by 40 mg of Omeprazole capsule orally once daily (prior to breakfast) on Days 2 to Day 7, followed by 1 mg of Anagrelide in fasted state in combination with Omeprazole 40 mg on Day 8. |
| Name | Type | Description |
|---|---|---|
| SPD422 (anagrelide hydrochloride) | DRUG | Subjects will be continued on the dose of anagrelide that controlled their platelet levels in Study 308 and titrated if necessary. |
| SPD422 | DRUG | Participants will receive 1 mg of SPD422 (2\*0.5 mg) capsule orally on Day 1 and 8 in fasted state. |
| Omeprazole | DRUG | Participants will receive 40 mg of Omeprazole orally once daily on Days 2 - 8. |
Inclusion Criteria: * Subjects must have completed Study SPD422 308
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 3 | PHASE3 | Bomedemstat, Hydroxyurea |
| Incyte Corporation | INCY | 1 | PHASE1 | INCB057643, Ruxolitinib |
SPD422 is a small molecule being developed for essential thrombocythemia (ET), a blood disorder characterized by an elevated platelet count. It has been studied in Japanese adults with ET as part of a long-term safety trial. The drug is also being investigated in healthy volunteers for pharmacokinetic purposes.
SPD422 is developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company has conducted clinical trials for the drug in Japan and the United States.
SPD422 is in Phase 3 clinical development for essential thrombocythemia. A Phase 3 trial assessing its long-term safety in Japanese adults with ET has been completed. The drug is not approved and remains investigational.
SPD422 has been studied in two completed trials. NCT01467661 was a Phase 3 study of long-term safety in Japanese adults with essential thrombocythemia, enrolling 41 participants. NCT03866434 was a Phase 1 study evaluating the effect of omeprazole on the drug's pharmacokinetics in 20 healthy adults in the United States.
SPD422 is a small molecule, but its specific molecular target has not been disclosed in the available information. The drug is being studied for its effects on platelet counts in essential thrombocythemia.