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Neutral salts of dextroamphetamine, USP, amphetamine, USP, d-amphetamine saccharate, d, I-amphetamine aspartate · 4 trials · 1 indication
The ADHD-RS-IV consists of 18 items designed to reflect current symptomatology of ADHD. Each item is scored on a 4-point scale ranging from 0 (no symptoms) to three (severe symptoms), with the total score for the rating scale ranging from 0 to 54.
The Endpoint is the average of the values obtained at Weeks 5, 6, and 7.
| Name | Type | Description |
|---|---|---|
| Neutral salts of dextroamphetamine sulfate, USP, amphetamine sulphate, USP, d-amphetamine saccharate, d, l-amphetamine aspartate monohydrate. | DRUG | - |
| Neutral salts of dextroamphetamine sulfate, USP, amphetamine sulfate, USP, d-amphetamine saccharate, d, l-amphetamine aspartate monohydrate. | DRUG | - |
| Neutral salts of dextroamphetamine sulfate, USP, amphetamine sulfate, USP, d-amphetamine saccharate, d, l-amphetamine aspartate monohydrate | DRUG | - |
| Neutral salts of dextroamphetamine sulfate, USP, amphetamine sulfate, USP, d-amphetamine saccharate, d,I-amphetamine aspartate monohydrate | DRUG | - |
Inclusion Criteria: * Primary diagnosis of ADHD * Baseline ADHD-RS-IV score \>= 32 * Non-pregnant females of childbearing potential must comply with contraceptive restrictions. Exclusion Criteria: * Significantly underweight or morbidly obese * Comorbid psychiatric diagnosis with significant symp...
It is an investigational small molecule being studied for Attention Deficit Disorder With Hyperactivity (ADHD) in adults. The clinical program enrolled adults aged 18 years and older with ADHD, including one trial in adults with moderately symptomatic ADHD. It is being developed by Takeda Pharmaceutical Company Limited.
Its molecular target is INSR, the insulin receptor, and it acts as an agonist at that target. This target class distinguishes it from typical ADHD stimulant pharmacology, which is why the INSR agonist mechanism is a defining feature of how this asset is characterized in the pipeline.
Takeda Pharmaceutical Company Limited is the developer of this asset, trading under the ticker TAK. The company sponsored the clinical program, which includes four completed trials in adults with ADHD. The trials were conducted under the SPD465 designation, a name used in the study titles.
The asset has reached Phase 3. Three of its four trials are Phase 3 studies, and one is a Phase 2 study. All four trials are completed, with no active trials currently listed. It remains an investigational product and is not approved for marketing based on this development record.
Four completed trials make up the program: NCT00202605, a Phase 2 safety and efficacy study in 72 adults; NCT00152035, a Phase 3 safety study in 505 adults; NCT00152022, a Phase 3 efficacy and safety study in 412 adults with moderately symptomatic ADHD; and NCT00150579, a Phase 3 efficacy and safety study in 240 adults.
Yes. SPD465 is the development code used for this asset in its clinical trial titles, so searches for SPD465 refer to the same program. The full chemical name describes a mixture of neutral amphetamine salts, and the alternative naming variants, including sulfate and aspartate monohydrate forms, all refer to this same asset.