Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Anagrelide · 3 trials · 3 indications
A response was defined as platelet counts to \<600x10\^9/L across consecutive visits for at least 4 weeks following at least 3 months of treatment.
An active metabolite has therapeutic activity similar to the parent compound and must be considered in therapeutic pharmacokinetics.
QT interval corrected for heart rate using the subject-specific method (QTcNi) at the subject-specific time of maximum plasma concentration. The QT interval is the time it takes for the ventricles of the heart to contract and relax. Data were subtracted from the placebo value. The largest time point refers to the estimated largest mean difference between each treatment and placebo among all time points. Values for different treatments can come from different time points.
The largest time point refers to the estimated largest mean difference between each treatment and placebo among all time points. Values for different treatments can come from different time points.
QT interval corrected for heart rate using Fridericia's method (QTcF) at the subject-specific time of maximum plasma concentration. The QT interval is the time it takes for the ventricles of the heart to contract and relax. Data were subtracted from the placebo value. The largest time point refers to the estimated largest mean difference between each treatment and placebo among all time points. Values for different treatments can come from different time points.
QT interval corrected for heart rate using Bazett's method (QTcB) at the subject-specific time of maximum plasma concentration. The QT interval is the time it takes for the ventricles of the heart to contract and relax. Data were subtracted from the placebo value. The largest time point refers to the estimated largest mean difference between each treatment and placebo among all time points. Values for different treatments can come from different time points.
The QT interval is the time it takes for the ventricles of the heart to contract and relax. Data were subtracted from the placebo value. The largest time point refers to the estimated largest mean difference between each treatment and placebo among all time points. Values for different treatments can come from different time points.
| Arm | Type | Description |
|---|---|---|
| Anagrelide Hydrochloride | EXPERIMENTAL | - |
| Younger Participants (18-50 years) | EXPERIMENTAL | - |
| Elderly Participants (≥65 years) | EXPERIMENTAL | - |
| Anagrelide Therapeutic (0.5 mg) | EXPERIMENTAL | - |
| Anagrelide Supratherapeutic (2.5 mg) | EXPERIMENTAL | - |
| Moxifloxacin | ACTIVE_COMPARATOR | - |
| Placebo | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Anagrelide Hydrochloride | DRUG | Subjects will be started at 1.0 mg per day and titrated as necessary. |
| Anagrelide 0.5 mg | DRUG | 0.5mg Anagrelide single oral dose |
| Anagrelide 2.5 mg | DRUG | 2.5mg Anagrelide single oral dose |
| Moxifloxacin | DRUG | 400 mg Moxifloxacin single oral dose |
| Placebo | DRUG | Anagrelide placebo + Moxifloxacin placebo single oral dose |
Inclusion Criteria: * Subjects must have previously been treated with a cytoreductive therapy and been intolerant or refractory to that therapy. Exclusion Criteria: * Subjects should not have any other underlying conditions or medications that would confound the study analysis or interact with th...
| Company | Ticker | Trials | Lead Phase | Drugs |
|---|---|---|---|---|
| Merck & Co., Inc. | MRK | 3 | PHASE3 | Bomedemstat, Hydroxyurea |
| Incyte Corporation | INCY | 1 | PHASE1 | INCB057643, Ruxolitinib |
Anagrelide is used for essential thrombocythemia (ET), also spelled essential thrombocythaemia, a condition marked by elevated platelet counts. It has been studied in patients with this blood disorder to evaluate its platelet-lowering effects and safety.
Anagrelide is developed by Takeda Pharmaceutical Company Limited, whose stock trades under the ticker TAK. Takeda is the sponsor of clinical trials investigating anagrelide in essential thrombocythemia.
Anagrelide has completed Phase 3 clinical trials for essential thrombocythemia. It is an investigational small molecule in hematology, and its development includes completed Phase 1 and Phase 2 studies as well.
Anagrelide has been studied in completed trials including NCT00413634, a Phase 2 pharmacokinetic study in essential thrombocythaemia patients, and NCT01214915, a Phase 3 trial in Japanese adults with essential thrombocythemia. A Phase 1 trial, NCT01552928, examined heart function in healthy volunteers.
Anagrelide works by lowering platelet counts in patients with essential thrombocythemia. Its mechanism involves reducing platelet production, which helps manage the elevated platelet levels characteristic of this condition.
Anagrelide is the same as SPD422, as indicated by the Phase 3 trial NCT01214915, which studied the effect of SPD422 on platelet lowering in essential thrombocythemia. SPD422 is an alternative name for anagrelide hydrochloride.